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MINISTER’S FOREWORDConor Lenihan TD, Minister for Science, Technology and Innovation, on the Government’s commitment to building the infrastructure to support a healthy, vibrant industry in the life sciences sector . . . . . . . . . . . . . . . . . . 3

SECTOR OVERVIEWMatt Moran, Director of Pharmachemical Ireland, explains the reasoning behind PharmaChemical Ireland’s Innovation and Excellence Strategy, focusing on how Ireland can become a centre of manufacturing excellence and innovation . . . . . . . . . 5

BIOTECHNOLOGYMichael Gillen, Irish BioIndustry Association, explains how Ireland can be central to creating a competitive, connected and greener economy . . . 10

MEDICAL TECHNOLOGYThe massive success of Ireland’s medical technology sector has been no accident, but the result of a care-fully planned strategy, writes Sharon Higgins, Director of the Irish Medical Devices Association . . . . . . . . . . . . . 14

COVER STORYEffective outsourcing of laboratory activ-ities, such as that offered by Lancaster Laboratories, can allow biopharmaceu-tical companies to achieve improved operational performance . . . . . . . . . . 18

REGULATIONS & COMPLIANCEWesley O’Shea, Project Manager, Pilz Ireland, advises on how to choose the most effective and cost efficient route to compliance for your plant . . . . . . . . 21

CHROMATOGRAPHYWaters’ Corporation’s new ACQUITY UPLC H-Class System is designed to replace HPLC systems. . . . . . . . . . . 22

CLINICAL RESEARCHThe recently launched Clinical Research Roadmap points the way for Ireland’s development as a centre for high qual-ity, multi-centre clinical research . . 24

OUTSOURCINGOutsourcing and not just ‘out-tasking’ your maintenance and facilities services can make perfect sense for the phar-maceutical sector, writes David Lyons, Client Operations Manager, Dalkia Ireland . . . . . . . . . . . . . . . . . . . . . . . 26

PATENTSMarie Walsh, Chartered and European Patent Attorney, writes on the use of Supplementary Protection Certificates in the extension of term of protection for medicinal products in Ireland . . . . . 29

COUNTERFEIT MEDICINESThe European Federation of Pharmaceutical Industries and Associations recently unveiled a new medicine coding system to help address the growing risk of counter-feit medicines . . . . . . . . . . . . . . . . 31

SCIENCE FOUNDATION IRELANDScience Foundation Ireland is commit-ted to building a world-class research environment in Ireland . . . . . . . . . . 34

OPERATIONAL EXCELLENCEHow the industry is responding to the crises arising from the challenges thrown up by failing R&D productivity and health care cost reforms, by management consultant Jim McKiernan. . . . . . . . 36

HAZARDOUS WASTE RECYCLINGIn operation since 1994, Soltec has distinguished itself as a leader and inno-vator within the hazardous waste recy-cling industry . . . . . . . . . . . . . . . . . . 38

RECRUITMENTJoanna Houston, EMEA Operations Manager, Berkley Pharmaceutical and Life Sciences, reports on the wage stability and return to competitiveness of the pharmaceutical sector . . . . . . 40

PROCESS ANALYTICAL TECHNOLOGYNessa Moyles, PharmaChemical Ireland, explains how Process Analytical Technology is playing an increasingly important role in Ireland’s pharmaceuti-cal and chemical sectors . . . . . . . . . . . .41

PHARMA NEWSscrubEx Launches in Ireland; Proposed Pharma Centre of Excellence; Merit Medical Expands Galway Plant. . . . 42

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LISTINGSChemical Suppliers . . . . . . . .43

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MINISTER’S FOREWORD

SECURING A BRIGHTFUTURE FOR PHARMACHEM

The pharmaceutical industry is an extremely important industry and one that has enjoyed extraordinary suc-

cess in Ireland, particularly over the past two decades. As a result, I am now very pleased to say that:

pharma & biopharma investment;

pharmaceutical companies in the world and employs approximately

-rently valued at € -

exports);

that situation.-

pharmaceuticals, biopharmaceuticals and medical devices.

BUILDING A HEALTHY, VIBRANT INDUSTRY

was established to promote world-class research activ-

THE PARTNERSHIP BETWEENINDUSTRY & EDUCATION

set ourselves, a partnership approach

-

-

success.

GLOBAL COMPETITIVENESS

--

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sectors.

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FACING UP TO THE CHALLENGES

€

Conor Lenihan TD, Minister for Science, Technology and Innovation.

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MINISTER’S FOREWORD

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productivity.

--

Conor Lenihan TD, Minister for Science, Technology and Innovation.

SECTOR OVERVIEW

5

PharmaChemical Ireland published a major strat-egy document in March 2010, entitled “Innovation

and Excellence - PharmaChemical Ireland Strategic Plan”. The document, which was launched at the Drug Chemical and Allied Technologies (DCAT) meeting at the Waldorf Astoria, New York City, on March 16, outlines the industry response to the major challenges being faced by the global industry: DCAT attracts many of the key decision makers in the USA, an ideal audience for the plan.

BACKGROUND

The global pharmaceutical, biophar-maceutical and chemical industries face a challenging decade ahead. One of the major drivers of this will the patent expiry of a number of blockbuster drugs manufactured in this country. Once a blockbuster

comes off patent, revenues fall sharply - by up to 80%. Many com-mentators predict a drop in revenues of as much as €100 billion over the next five years. In the past, research pipelines provided replacement prod-ucts for these drugs: unfortunately, such pipelines are now far less pro-ductive, meaning that companies will need to pursue alternative strategies to survive. An initial response by big pharma has been to merge: the recent Pfizer-Wyeth and Merck-Schering Plough mergers are examples of this, as companies seek to enhance their product and research portfolios.

This scenario presents a set of real challenges for the industry in Ireland as it prepares to absorb the effects of the first of these major pat-ent expiries - that of Pfizer’s Lipitor -

in 2011. Exporting products valued at €47 billion in 2009, the sector is enormously important to the Irish economy: therefore, it is paramount that the industry is well prepared for these challenges.

TRANSFORMING THEPHARMACHEM SECTOR

Matt Moran, Director of PharmaChemical Ireland, explains the

reasoning behind PharmaChemical Ireland’s Innovation and

Excellence Strategy, focusing on how Ireland can become a centre of

manufacturing excellence and innovation.

20072006Year

2008 2009

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Fig. 1. Total Average Big Pharma*Revenue Decline Due to Scheduled

Patent Expires

Matt Moran, Director, PharmaChemical Ireland.

*Big Pharma average includes J&J, Novartis, Merck & Co., Abbott, Eli Lilly, Glaxo SmithKline, Pfizer, Sanofi,

Bristol Myer Squibb and Roche. Source: Moody’s FM.

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Fig. 2. Global Pharma: Sales & Sales Growth 2001-2008

Growth Linear (Growth)

Source: IMS Health Market Prognosis /(March, 2009)

SECTOR OVERVIEW

6

STRATEGY WORKING GROUP

In order to come up with a coherent and well thought-out response, PharmaChemical Ireland (PCI) established a group comprising industry heads to prepare a plan. They consulted widely among the sector here in Ireland, with other industry sectors such as med-tech and ICT, the research community and Government and its agencies. This period of consultation prompted PharmaChemical Ireland to put this group onto a standing footing and to widen its membership to include strategic partners to the industry, such as IDA Ireland, Enterprise Ireland, Science Foundation Ireland, UCC, UCD, TCD, The Department of Enterprise, Trade and Innovation, NIBRT and Forfás.

This standing committee was responsible for the final strategy, which was published earlier this year. The same committee is responsible for the execution of the strategy.

FUTURE SHAPE OF THE INDUSTRY IN IRELAND

The membership of PCI have defined what characteristics each site must possess if it is to survive in the long term - the so-called ‘factory of the future’. These are summarised below:

full implementation of the principles of lean manufac-turing and operational excellence;

principles of quality by design and process analytical technology;

fully integrated into manufacturing;

latest principles of Lean, Six Sigma, etc;

corporate structure;

where it makes economic sense to concentrate them at one location;

ongoing basis.

HOW CAN THE INDUSTRY ACHIEVE THIS?

PCI has clearly identified a range of measures that need to be taken by companies themselves if they are to become factories of the future. A number of companies are already well on the way to attaining this status and becoming stra-tegically relevant within their own corporate networks. These are summarised below:

closely monitoring and benchmarking those key indica-tors that allow them to track their own efficiency and productivity.

in on-site innovation – this should include process optimisation, product development and clinical trial manufacture, scale up and technology transfer.

or co-ordinating clinical trials out of Ireland. An indus-try taskforce comprising PharmaChemical Ireland,

community, ICRIN, IPPOSI, and IBIA, should be established to examine its feasibility.

community, industry should prepare a comprehensive marketing plan for an Irish life sciences cluster. The plan would address all components of a successful cluster, such as industry, research centres, Government agencies and all other supporting cluster components. Consideration should be given to positioning the coun-try as a bridge between the US and Asia.

operating costs across the board in order to recover relative competitiveness within their own corporate networks. All cost components, including labour, energy, cost of capital, waste treatment, local authority charges, etc, need to be controlled.

Technology Foresight Exercise recommends a rapid response regulation strategy. This strategy recognises the need for Ireland to be the most favourable global location to meet the properly stringent national and international regulatory requirements. It covers all forms of regulation, including quality, health, safety and environment. It makes reference to a number of regulatory bodies including the Irish Medicines Board (IMB), the European Medicines Agency (EMEA), the

Environmental Protection Agency (EPA).

benefit to industry of quickly meeting regulatory

SECTOR OVERVIEW

7

requirements. In the case of a medicine, this can result in significant financial savings for the company. It is essen-tial that the industry ensures that the necessary expertise is available in Ireland. Moreover, companies need to actively invest in up-to-date regulatory approaches, such as those which have been identified by the FDA in its

Process Analytical Technology, etc. It is important that companies apply these principles rigorously to achieve real efficiencies and cost savings through reduced testing and regulatory track streamlining.

WHAT CAN GOVERNMENT DO?

Given the strategic importance of the sector to the economy here - over 50% of all merchandise exports are pharma-chem related - it is vital that Government works closely with the industry to assist it in achieving its aims. PCI has set a clear set of recommendations which should be well within the capacity of Government to deliver. These are:

endorse the 12.5% rate for corporate tax. -

ing the R&D tax credit scheme. It should be a purely volume-based scheme and, in addition, companies should be permitted to write off R&D expenditure against operational costs.

-tive location for highly-skilled employees. It should consider tax breaks for overseas employees to encour-age them to locate here. They in turn will then promote Ireland as a location for future investment and attract more similarly skilled people.

-ing of physical sciences at second level. The recommen-dations of the Task Force on Physical Sciences need to be implemented in full.

integrated strategy for industry development and actively promote interaction between foreign-owned and indigenous firms.

number of measures to support business at the level of the firm. These include the establishment of a manu-facturing forum, support for productivity improvement, benchmarking and support for R&D and training. It is important that the Government implements these recommendations and ensures that the pharmachemical sector has access to them.

-mendations of the European Commission high-level group on chemicals.

Bio-processing Research and Training Centre. This is a welcome development and will provide valuable

the pharmachemical sector as a whole is to broaden its remit to embrace process development in a meaningful way, it will be necessary to expand the centre to sup-port the chemical and the specifically pharmaceutical part of the industry, commonly referred to as ‘small molecule’. It would provide expertise in such areas as organic synthesis, drug formulation, reactor design and green chemistry. The need for such a facility was identified by the Irish Council for Science Technology and Innovation and Forfás in their statement, titled ‘Embedding the PharmaChem Industry in Ireland’.

public funding for applied research and in-firm R&D should be progressively increased to match that pro-vided by the Department of Enterprise Trade and Employment for basic research. This includes support for in-firm capability, development, commercialisa-tion, and cluster-led academic research and innovation partnerships. There are some notable examples of how this approach has already paid dividends through the Science Foundation Ireland (SFI) sponsored Centres for Science, Technology and Engineering (CSETs) and the Strategic Research Cluster in crystallisation, recently established at the University of Limerick. The Government needs to ensure that this activity is prioritised and that the level of investment in applied research at least matches that in fundamental research.

-tural supports are in place, with a waste disposal infra-

SECTOR OVERVIEW

8

structure, including provision for thermal treatment of hazardous waste.

through excessive charges for its services or those delivered via local authorities, examples of which include commercial rates, development levies, waste and water charges etc.

-

the industry is subject to regulatory oversight from the US-based FDA and European EMEA. It is critical that the regulatory burden placed upon the sector in Ireland does not place the industry at a relative competitive disadvantage to its competitors for investment.

THE ROLE OF RESEARCH

Central to the PCI strategy is the growth of development activities within the sector, thereby anchoring manufac-turing along the so-called development + manufacturing (D+M) model and positioning Irish sites to be the sites of choice for new product launches, bringing them more centre stage in global supply chains. Therefore, it is vital that the industry collaborates actively with the research community in order to build this type of capability, both on

contains some recommendations for the research commu-nity, developed in consultation with them:

ensure that industry is aware of their research pro-grammes, thereby enabling collaboration at an early

and dynamic translational research programmes in place, in addition to fundamental research programmes.

to identify and exploit intellectual property (IP) as it arises. They should be open to innovative approaches to exploitation of IP, which may entail licensing to industry. They should ensure that effective IP units are in place, reflecting and promoting best practice, as outlined in the Forfás guides on IP.

be further enhanced if a six-month period of industrial

placement were integrated into courses in physical sciences and chemical engineering. This would expose graduates to the world of industry, provide them with an insight into an industrial environment and promote future collaboration.

for Research into Third Level Institutes (PRTLI), which in turn has invested in a major infrastructure programme. The Government has also committed major funding to the research base via SFI, prioritising life sciences. It is critical that this work takes account of pharmaceutical, biopharmaceutical and chemical supply sector needs, where applicable, in conjunction with SFI funding objectives. PRTLI centres should be promoted to the industry by the relevant research institutions and, where applicable, provide research support and services to the sector.

CONCLUSION

If Ireland is to sustain its leading position as a global supplier of pharmaceutical and biopharmaceutical and chemical products, the pharmaceutical, biopharmaceutical and chemical supply sectors will have to transform. This transformation will take place at company level, with the Government, its agencies and the research sector playing a key collaborative role in this process.

Manufacturing alone will not be enough to ensure the long-term presence of the industry in Ireland. Research, development and innovation will drive the transformation process forward. Many factors present hurdles, including: expiry of patents on blockbuster drugs manufactured in Ireland; a rising cost base; competition from Asia and other locations; and the further consolidation of supply-chains. These factors will erode the country’s manufacturing base unless action is taken.

Companies need to embrace the concepts of manufac-turing and supply-chain excellence, as well as those of on-site innovation, such as process and product development. Ultimately, If Irish sites achieve this goal and the country can become a global centre of excellence for development and manufacturing, they will be well positioned to par-ticipate meaningfully in discovery-related activities. Also, opportunities for indigenous companies in areas such as high-end synthesis, biotechnology, contract research, spe-cialist centres and contract manufacturing will inevitably

sustainable sector will emerge.In order to achieve these goals, it is necessary that stake-

holders are aligned in a collaborative manner. Ireland does not have the time or resources to duplicate its effort. Now is the time to be smart and agile. The existing Government support network and the local management of pharmachem-ical companies in this country are strong and integrated. It should be more than possible to build upon this strong his-tory and for this country to move on to become a centre of manufacturing excellence and innovation.

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The EU Strategy for 2020 envisages an economy based on smart, sustainable growth – a powerful, ultra-efficient

engine, driving high levels of employ-ment, productivity and social cohesion. This echoes the strategy outlined by the Irish Government in 2008. However, achieving these ambitious goals requires not just addressing today’s most pressing challenges – healthcare affordability, our ageing demographics, economic instabil-ity, climate change, energy security and the global food supply – but also build-ing a lasting framework that will allow Europe and, by extension, Ireland to prosper over the long term.

Biotechnology already plays an invaluable role in this agenda. No other industrial sector sits so comfortably at the intersection of enhancement of quality of life, knowledge, innovation, productivity and environmental protec-tion. From new drugs that can address unmet medical needs and fight epidemics and rare diseases, to industrial processes that use renewable feedstocks instead of crude oil, to drought-resistant crops that allow farmers in third world countries to feed more people under ever-harsher climatic conditions, biotechnology can and will pay eco-nomic, social and environmental dividends.

These bold technologies – and the ones still on the drawing board or in the pipeline – promise a brighter future for Ireland and the world, but they don’t simply happen by themselves. They require:

-neurial risk-taking;

-ment in research and development over short-term gain and quick consumption;

well-informed about how biotechnol-ogy is helping to create a healthier, greener, more productive, and more sustainable economy.

Indeed, a proper strategy to foster biotechnological innovation is vital to achieving Ireland’s and the EU’s economic, ecological and social goals for the coming decade. Encouraging biotech helps create economic growth, provides incentives to innovate to busi-nesses both small and large, and boosts industrial and agricultural outputs, while reducing their impact on the environment.

SMART ECONOMY

Biotechnology offers smart, efficient answers to today’s economic, social and environmental challenges. Healthcare

providers can offer personalised, innovative, safe and effective biotech diagnostic medicines and therapies that improve quality of life without overwhelming government budgets. But the benefits spread beyond healthcare to the economy as a whole.

Many biotechnology companies are SMEs, and are thus the backbone of European business and innovation. In the EU, SMEs comprise approximately 99% of all firms and employ more than 100m people. Biotech SMEs are knowledge-based enterprises that provide the high value-added jobs that will help the EU achieve its goal of becom-ing the foremost knowledge-based economy in the world.

Healthcare offers a vivid example of how setting smart policy today will pay big rewards down the road. By 2015, healthcare biotechnological knowledge is likely to be used in the development process for all new pharmaceuticals. Through smart partnerships between companies of all sizes, and also between the public and private sectors,

Michael Gillen, Director, Irish BioIndustry Association

and Senior Executive, Pharmachemical Ireland,

explains how Ireland can be central to creating a

competitive, connected and greener economy.

BIOTECH: BUILDING ABRIGHTER FUTURE

Michael Gillen, Director, Irish BioIndustry Association and Senior Executive,

Pharmachemical Ireland.

BIOTECHNOLOGY

1 1

innovation in healthcare biotech pushes the frontiers of science, increasing our understanding of the mechanisms of diseases daily and addressing unmet medical needs.

Fast Facts: Healthcare Biotechnology

By doing so, it provides patients with newer, safer, more effective and targeted therapies for a wide range of major diseases such as cancer, diabetes and stroke. New preventive tools such as predictive diagnostic tests or vac-cines can already address diseases even before they affect patients. Biotechnology will also contribute to national healthcare services by, for example, replacing hospital stays with new treatments, or by altering the type of medi-cal intervention, for instance by replacing long-term drug therapies with cures due to gene or stem cells therapies.

HIGHLY SKILLED JOBS

Healthcare biotechnology is also a source of highly skilled jobs, increasing the competitive value of the sector in Europe. Nowhere is this more pronounced that in Ireland. Approximately 50,000 people are employed, both directly and indirectly, in the life sciences sector (this includes pharmachemical, medical devices and biopharmaceutical in Ireland). Indeed over 50% of the value of exports from

Ireland originates in this sector (in excess of €44 billion in 2008).

However, while healthcare biotechnology can support governments in their efforts to enhance the sustainability of their healthcare systems, cost containment measures can also have the perverse effect of hampering innovation and access for patients by delaying or limiting entry into market of new technologies. Often short-term by nature, these measures, including stricter Health Technology Assessments (HTAs) or pricing and reimbursement proc-esses, should ensure that patients benefit in the long-term from these healthcare innovations.

THE ISSUE OF SUSTAINABILITY

Faced with global warming and limited fossil fuel resourc-es, we need to encourage the development of new biological processes and the use of agricultural waste streams and renewable raw materials derived from plants, crops and trees. Using these processes and materials to produce biobased fuel, innovative materials and chemicals, has the potential to enhance quality of life while reducing negative environmental impact and thus reducing our eco-footprint.

Making the transition from a fossil fuel to a biobased economy will reduce the dependency of future generations on fossil fuels for energy and industrial raw materials. Biobased products play a valuable role in contributing to a more sustainable society, with the potential to reduce greenhouse gas emissions, generate less waste, and use less fossil fuels and water.

Fast Facts: Industrial Biotechnology

The benefits of biotechnology are repeatedly reaffirmed by scientific studies and reports, such as the OECD’s report on the application of biotechnology to industrial sus-tainability and, most recently, by the World Wide Fund for Nature (WWF) report on the potential of industrial bio-

BIOTECHNOLOGY

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technology to cut CO2 emissions and help build a greener economy. The WWF report concludes that the full climate change mitigation potential of biotechnology processes and bio-based products ranges from between 1 billion and 2.5 billion tonnes of CO2 equivalent per year by 2030. To put this in context, this represents more than Germany’s total reported emissions in 1990.

CREATING A MORE INCLUSIVE WORLD

The EU Strategy for 2020 is about more than just boost-ing Europe’s competitiveness. It is about creating a more inclusive world and in this context, biotechnology will be a major part of the new global vision of Europe’s strategy for economic growth, sustainability and inclusion.

Industrial biorefineries will, thanks to their optimal location, add skilled jobs in rural areas. A growing market for sustainable biotech products benefits the agricultural, rural and healthcare economies, and will create new skilled and green jobs in Europe and around the world.

Biotechnology will be an indispensable tool in the effort to feed the world’s growing demand for food, even as we endeavour to reduce the impact of agriculture on our climate. The Food and Agriculture Organisation of the United Nations (UN FAO) has estimated that we will have to produce 70% more food for an additional 2.3 bil-lion people by 2050. Green biotechnology will allow us to increase yields and help meet these market demands, while promoting sustainable agricultural practices and mitigating and adapting to the impact of climate change.

Fast Facts: Agricultural Biotechnology

CALL TO ACTION

The development of a biobased economy fits perfectly with the aims of the EU Strategy for 2020 to support innova-

tion, build a knowledge-based economy and to speed up the transition towards a low-carbon economy. It also fits in perfectly with building a smart economy in Ireland. But it will not happen unless we take action.

Creating a sustainable and competitive bio-economy requires an integrated action plan, based on a holistic approach by the European Commission and the indi-vidual Member States, including Ireland. It must also offer real partnerships between businesses – including the pharmaceutical, medical devices and diagnostic industry, civil society including patient advocacy groups, national governments, the scientific community, consumers and the agricultural and forestry sectors – within the EU as well as between the EU and less industrialised nations.

A key element of any strategy for the development of an innovative, knowledge-based, sustainable economy must

the benefit of society and the economy. To achieve this will require the various stakeholders to:

1. Concentrate funds on targeted research, training and innovation programmes.

2. Design projects with clear objectives and a compulsory transfer to end products by working with industry, academia and policymakers.

a solid reward system: i.e. via a competitive patent sys-tem and data exclusivity regimes.

4. Promote translational research projects – from bench to market – via public-private partnerships, particu-larly in the field of genomics and pharmacogenomics. Moving forward, it will be important that the private sector plays an increasingly active role in steering these partnerships towards the development of products and applications according to society’s demand.

5. Foster the development of processes for the valida-tion and approval of biomarkers to ultimately improve patient outcomes.

6. Implement the industry recommendations formulated during the revision of the Clinical Trials Directive to ensure that trials conducted in the EU remain safe, effective, competitive and adapted to emerging tech-nologies.

7. Nurture and promote coherent pro-growth and pre-development policies that do not discriminate against promising technologies.

8. Design schemes to support the funding of innovative SMEs to strengthen the climate for these groups during their capital intensive, long pathways to sustainability and towards the commercialisation of biotech products, retaining value and jobs within the EU.

GREATER INTEGRATION

In addition, the establishment of a sustainable knowledge based bioeconomy will require greater integration with a variety of initiatives to:

advantages and the existing regulatory framework.

framework adapted to the current paradigm shift in healthcare biotech – the so-called personalised medi-cine approach.

that incentivise innovation and foster future access to innovative biotech therapies and personalised medicine products and services in particular.

orphan medicinal products (OMPs) are approved to increase the successful rate of OMPs available to treat and cure rare diseases.

to establish truly patient-centred healthcare systems, placing long-term patient benefits at the heart of all industry and healthcare policies.

support, demo-projects (such as bio-refineries) and legislation that secures the market development for biobased products.

Such an integrated and fully harmonised strategy is the only way that the bio-economy can develop in a sustain-able manner and help drive the EU toward its EU 2020 economic, environmental and social goals. Ireland is well positioned to be at the centre of this innovative, knowl-edge-based and sustainable economy.

BIOTECHNOLOGY

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Michael Gillen’s article is adapted from a EuropaBio position paper, published

June 24, 2010.

14

MEDICAL TECHNOLOGY

Ireland’s medical technology sector has evolved into one of the leading clusters for medical device and diagnostic products globally, so much so that today, companies design, develop and manufacture medical

devices and technology platforms that are exported across the world. The success has been truly exceptional, so that now, the country boasts a thriving multinational and a rapidly growing indigenous sector that continues to attract investment to the point where:

during 2009 increased by over 9% over 2008 to €6.8billion.

in Ireland are exported around the world.-

capita, of medical technology personnel across increase staff numbers in the third quarter of this year and that a similar number intend retraining existing staff.

MED-TECH STANDING TALL

The massive success of Ireland’s medical technology sector has been no

accident, but the result of a carefully planned strategy, writes Sharon

Higgins, Director of the Irish Medical Devices Association (IMDA).

Pictured at the IMDA AGM in November 2009 are (l-r): Gerry McDonnell, VP Operations, Stryker

Orthopaedics; Sharon Higgins, Director, Irish Medical Devices Association, and Pat Gallagher, General Manager

of Baxter Manufacturing in Ireland.

January:

-ices to minimally invasive device companies.

Veryan closed a €

developed a coronary stent product.

Clearstream signed a contract for the distribution of its

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MEDICAL TECHNOLOGY

16

The success of the sector has not been accidental but an integral part of a 40-year strategy that successive Governments and agencies in Ireland have adopted and refined to attract internationally mobile investment and grow indigenous companies. The taxation model, skills pool, proximity to Europe, availability of high quality services, regulatory infrastructure, and operational excel-lence knowledge and R&D supports that exist enable the country to continue to compete for investment.

Nonetheless, as an export driven industry, the future success of the industry here is highly dependent on inter-national events. A general analysis of both the global and domestic economies throws up more positives than nega-tives. Forecasts for global GDP growth have been revised upwards with the IMF now expecting growth of over 4% in both 2010 and 2011.

In Ireland, data for Q1 shows that GDP grew by 2.7% relative to Q4 2009. The trading sector benefited from the international recovery and export growth in the first quarter at 6.9% was very strong. Improving international demand and the significant weakening of the euro over recent months has provided a much more positive environ-ment for Ireland’s export sector.

However, pressures on healthcare systems have resulted in a greater focus on enhanced efficacy of treat-ments and cost reduction. There is no sense of compla-cency across the sector in Ireland, where industry and Government alike are constantly looking for new ways to enhance competitiveness, develop new capabilities and ultimately generate new sustainable growth.

INFLUENCING NATIONAL POLICY

A recent report, The ‘Health LifeSciences in Ireland – an Enterprise Outlook’, published in November 2009, con-cludes that Ireland is well positioned to take advantage of global trends in the sector, including convergence products and devices, functional foods, and remote diagnostics and healthcare delivery. It goes on to say that investments made in R&D in areas directly relevant to the sector, together with our depth of capabilities in ICT and engineering, will continue to serve us well as we shift towards increasingly innovative and research intensive activities. The specific recommendations made in the report are:

of contributors for enhanced collaboration;

-ports in translational medicine;

in manufacturing and process R&D;

-structure.

As outlined above, one of the key recommendations in the report includes the establishment of an industry-led Life Sciences Alliance to drive and influence the implementation of the actions identified in the report as necessary to support the growth and evolution of the sec-tor in Ireland. The Alliance, chaired by Paul Duffy, Head of Irish Manufacturing, Pfizer, is made up of industry representatives, the enterprise development agencies, and representatives of the health sector in Ireland. The Irish Medical Devices Association has significant representation on this important national group.

The Irish Medical Devices Association (IMDA) strat-egy is built around four pillars:

Manufacturing and Operational Excellence: Consolidate the substantial manufacturing base of the medical technology industry in Ireland and grow investment in manufacturing and operations by deliv-ering higher value to investors than that available in competing locations globally.

Innovat ion, Research, Development and Commercialisation: Exploit innovation and R&D opportunities in the medical technology sector by nurturing strong inter-disciplinary and cross sectoral collaboration(s), and thereby maximise the potential for commercialisation within Ireland.

Global Business Services/ Shared Services:Increase the footprint of and value generated in medical technology companies operating in Ireland by attracting significant levels of global business/ shared services investment.

Skills and Knowledge:Continuously develop the Irish medical technology sec-tor’s greatest asset - our highly educated, talented and skilled workforce – who are key to meeting the future needs of the rapidly changing global industry as science technology and healthcare delivery systems advance.

OTHER TOPICS RELEVANT TO THE SECTORINCLUDE:

The Late Payments Directive is cur-rently being recast and is expected to come into force in early 2012 (co-decision process). The European Parliament IMCO voted on April 28, while MEPs will vote in September. IMDA has and continues to be in correspondence with MEPs Crowley and Gallagher and the Department of Enterprise Trade and Innovation on this matter. The Irish position calls for:

of this Directive;

secure on-time payment;

to include a lump sum compensation of 5% of the amount due to be paid by the creditor after the first day of late payment, which would strongly incentivise public authorities to pay in time. This proposal has not received any support at Parliament level;

Scope of the directive should not include business-to-business transactions. IMDA believes that the inclusion of such provisions by the European Parliament shifts the focus away from what the European Commission had found to be the most significant area of concern, which are - public authorities to private business late payment.

IRISH INDUSTRY DELEGATION MEET FDA

A delegation of senior regulatory affairs representatives travelled as part of an IMDA delegation to Washington

with Centre Directors from the FDA’s Centre for Devices and Radiological Health (CDRH).

Topics for discussion include: an Overview of CDRH’s structure, roles and responsibilities; the CDRH’s FY 2010 strategic priorities; the FDA’s requirements for post-approval studies; annual reports for Premarket

of CDRH’s review of the 510k process.The day before the FDA meeting, the delegation also met

AdvaMed to discuss regulatory issues of mutual concern.

IMDA MEET SFA FDA

The Irish Medical Devices Association (IMDA) met with Abdullah Abdulmohsin Al Rasheed from the Saudi Food

gave a review of recent developments at the SFDA, as well as upcoming changes to the

Saudi regulatory framework. Discussions also took place regarding advanced regulatory training and a number of options in this regard were discussed.

IRISH MEDTECH QA/RACONFERENCE

The IMDA are in the final stages of preparing for the flagship Irish

Medtech QA/RA Conference - IMDA’s biennial Global Access 2010

Conference. The event will be held on

in Limerick. The programme will feature influ-

(Director, Device Compliance, FDA), Christy Foreman (Acting Director, Device Evaluation, FDA), and Alberto Gutierrez (Director, Office of In Vitro Diagnostic Device Evaluation and Safety, FDA), Pat O’Mahony (CEO of the

OPERATIONAL EXCELLENCE TRAINING FOR INDUSTRY

The IMDA have been funded to build on the achievements of the successful outgoing Manufacturing Excellence Skillnet, and broaden the programme offering to appeal to pharmaceutical, biopharmaceuticals, chemical, food and drinks manufacturers. The successful new “Life Science Skillnet” application was submitted with the support of PharmaChemical Ireland (PCI) and Food and Drink Industry Ireland (FDII). The network will build on the core programme of Lean/Six Sigma training for manufac-turers (accredited at FETAC 5), and will develop a new NQF level 6 programme/qualification aimed at supervisors and technicians working in a manufacturing environment.

MEDICAL TECHNOLOGY

17

COVER STORY

18

Meeting the changing demands of develop-ment, commercialisation and manufacturing activities as part of a global organisation is a significant challenge and is key to

the success of Ireland’s biopharmaceutical operations. Outsourcing laboratory activities enables access to extended capabilities and capacity without commitment to additional fixed costs to manage both routine and exceptional demands on GMP operations. Progressive outsourced GMP service providers now present flexible solutions to allow access to resources both within their own GMP operations and those of the client, and are becoming an increasingly strategic component of the pharmaceutical operational modus operandi.

The biopharmaceutical industry in Ireland has changed significantly in recent times. Economic factors have acceler-ated the actions of global Pharma to rationalise its activities. Implications of patent expiration are forcing the industry to achieve more efficient development and commercial supply chain operations.

Companies no longer rely on pipelines being fed by self-discovered entities and the demands of acquired product candidates, combined with a shift towards large molecule technology, means operations need the ability to accommo-date changing requirements, while under the continual pres-sure to focus their fixed resources on high value activities. More than ever, the realisation that commitment to costs cannot be long term obligations is changing the way global biopharma views what is core and which activities can be delegated to service providers.

INCREASING FLEXIBILITY

Procurement is now a key discipline within the operations of Irish facilities. Initially tasked with reduction in cost,

their responsibilities are evolving to support technical dis-ciplines to create more flexible operations. “They need not only to avoid fixed costs and create a more demand-orien-tated variable cost base, but also to ensure that operations are not exposed to risk and that delegated or outsourced activities are optimised,” explains Mark Glass, Business Development Manager at Lancaster Laboratories. “This means more focus on how service providers are utilised, ensuring interactions are seamless and activities are planned rather than reactionary, so value for money is optimised in both the short and longer term.”

Lancaster Laboratories has been in operation, sup-porting the biopharmaceutical industry for 50 years. In 2007, it established its EU operations base in Dungarvan, County Waterford, through acquisition of Microchem Laboratories, which has been supporting the industry in Ireland for 25 years. The creation of a harmonised glo-bal service organisation enables the support of common requirements and demands of operations located in the US, Puerto Rico, Ireland and other industry regions in the UK and mainland Europe. Analytical expertise, methods and support models can be transferred between the US and EU as the demands of their customers dictate, ensuring best practice is accessed and set-up activities are not duplicated.

The pressure from the emergence of new markets and locations in Asia and Eastern Europe accentuated the need to provide flexible service models to enable facilities to meet the demands of their global organisations. GMP service providers have evolved to meet these needs. “This has led to in- and out-sourced service solutions, allowing access to technology and human resources to optimise short, medium and long-term operational needs,” notes Glass. “In many cases, adoption of continuous improve-

LANCASTER EXCELSIN OUTSOURCED SOLUTIONS

Effective outsourcing of laboratory activities, such as that

offered by Lancaster Laboratories, can allow biopharmaceutical

companies to achieve improved operational performance.

Lancaster Laboratories’ Pennsylvania facility.

Lancaster Laboratories’ EU operations base at Dungarvan, County Waterford, Ireland.

COVER STORY

19

ment frameworks, such as Lean, are on parity with client organisations. Concerns over financial security and access to capital for investment to meet client requirements no longer exist, as many are part of global diversified corpora-tions, with the ability to respond to industry needs.

“These factors are critical in allowing operating facili-ties to rely on third parties to support development, manu-facturing and supply chain activities. However, successful delivery of facility performance is dependent on the appro-priate selection of the right service provider. Investment in that relationship is critical, so that appropriate service models can be utilised, working processes optimised, and waste and cost avoided. The effective supply of therapeutic products into the global supply chain is paramount.”

Biopharma organisations must take a risk-based approach in selecting their service partners. Outsourcing is not a new concept or practice in global industry, but only in recent times has it become part of biopharma strategy. This is due to the emergence of robust and progressive outsourced service providers whose competencies enhance their clients’ operations.

In a manufacturing dominated environment, contract analytical services present a valuable tool set to enhance both the variable demands of production facilities and assurance of quality and compliance. Here are some key factors to consider when evaluating in- and out-sourced scenarios.

Service Models:Several tiers of support exist with activities undertaken either at the service provider location or within client facilities.

Fee for Service: This is the traditional, transactional outsourcing method, which is still optimal for many sporadic or short term capacity or technology needs. Client organisations request a defined test or service which is delivered and invoiced. Raw material testing is often managed under this arrange-ment because of the inconsistent stream of samples which client facilities are increasingly reluctant to support themselves, so avoiding maintenance of costly laboratory infrastructure for this ‘non-core’ testing activity.

Full Time Equivalents (FTEs): When projects are longer term and analysts can be dedi-cated to a single assignment, utilisation of FTEs can be a more cost effective way to sub-contract laboratory projects. Clear deliverables and project milestones must be defined and regular interactions between supplier and client to ensure performance metrics are delivered and the project is on track. Longer term project based work such as proc-ess development, method remediation, stability programs and cleaning validation studies often lend themselves to the FTE service model.

Professional Scientific Staffing (PSS) Models:Many pharmaceutical operations have the facilities

and systems established to support activities but have a constraint on headcount. Often, temporary contracts are deployed to fill this interim or contingent need. This approach can create challenges for the incumbent manage-ment team, supporting training and induction needs and backfilling the often higher attrition rate of temporary staff. PSS enables more effective access to trained staff with on-site management and remote oversight, ensuring that more effective training, deployment and performance management of in-sourced teams is achieved. Lancaster has deployed PSS teams into biopharmaceutical opera-tions in Ireland and the UK. This is often implemented to allow allocation of permanent staff onto high value or core activities.

PSS Teams are a proven solution to more efficient environmental monitoring operations where key process learning from the contract environment has been success-fully applied to enhance in-facility testing operations.

PSS can also be utilised to augment functional units which need to flex as business needs change. This can be achieved by the provision of a pool of trained staff that can join development or QC testing teams as required to accommodate work loads. An on-site supervisor analyst coordinates the allocation of resources to the various client functions being supported.

GLOBAL PRESENCE WITH THE ABILITY TO INVEST

It is important that service organisations have comparable financial stability and global footprint to their clients. Many pharmaceutical companies have operations in the US, Europe and increasingly in Asia. “As part of Thermo Fisher Scientific’s Biopharma Services Division, Lancaster has established operations in both the US and Europe and can invest to meet the needs of the evolving industry,” explains Mark Glass. “Large Molecule product testing, UPLC, Genotypic Microbial Identification and a global LIMs platform are examples of capability investment to meet the needs of a changing landscape. This infrastructure and capability allows Lancaster to provide parallel services to their clients’ global locations, enabling alignment of best working practices.”

This diversity of locations, service models and client base allows varied technical and ancillary career develop-ment. Contract Analytical Services combines the need for

COVER STORY

20

excellent scientific expertise with those of client services and project management, quality assurance, IT and busi-ness development. Lancaster’s employees have the oppor-tunity to combine their technical training with important client facing skills, working within their own facilities and those of their clients.

COMMUNICATION AND CONTINUAL IMPROVEMENT

How organisations work together to ensure objectives are met and processes are improved is core to successful outsourced relationships. The service providers must be experienced in managing the communication task with dedicated client services and project management functions.

The use of performance metrics to allow objective assessment of how well activities are being expected is essential to implement continual improvement initiatives and drive efficiencies throughout laboratory service operations.

QUALITY AND COMPLIANCE

Only by having an in-depth, experienced-based under-standing of GMPs in the major regulatory zones can serv-ice providers meet the expectations of global biopharma. Many of Ireland’s operations supply global markets, so a strong inspection history with the Irish Medicines Board and the Food and Drug Administration is essential.

IN CONCLUSION

Outsourcing of GMP analytical services and the access to contingent technical staff is becoming an important part of the GMP facility tool set. World class outsourced service providers have emerged to meet these needs and now form a growing part of the industry, both in Ireland and globally. To support the biopharmaceutical client base, outsourcing partners need to have the corporate stability and access to resources to ensure capital investment and staff develop-ment continue to meet the ever increasing demands of the industry. Experience with the industry regulators and a track record of continual improvement will ensure effec-tive relationships with operational and quality counterparts across client and service provider organisations.

“Whether the challenge is to manage the variable demands of globally compliant raw materials testing, drive efficiency in environmental monitoring operations or to access analytical expertise to support in process or finished product testing,” concludes Glass, “the GMP service indus-try has the capacity and capability to enable you to achieve operational success.”

For more information on outsourced solutions and Lancaster Laboratories, visit www.lancasterlabs.com or contact Mark Glass on +353 58 48300.

Safety Engineering Services

Process Safety

Project Management

IEC 61508/61511

HAZOP

LOPA

SIL

Safety System Design

System Implementation

Validation

ATEX/EPD

Machinery Safety

Project Management

Risk Assessment

Safety Concept

Safety Design

System Implementation

Validation

CE Marking

International Compliance

Plant Assessment

Safety Training

HAZOP/LOPA

SIL

ATEX

IEC 61508/61511

CE Marking

EN ISO 13849

Electrical Safety

Safety Design

Machinery Regulations

Pilz Ireland

Business & Technology Park, Model Farm Road, Cork

T (021) 4346535

F (021) 4804994

E sales@pilz.ie

W www.pilz.ie/services

Your Projects are in Safe Hands.

Process Safety, Machine Safety, EMC, ATEX and Pressure Equipment are all commonly used buz-

zwords within the Industrial Safety Community. Depending on the application, the installation and the hazards present, varying approaches and techniques have been devel-oped to cater for the identification of hazards and the reduction of risk posed by plant and equipment. Organisations now have a choice of techniques including Risk Assessment, HAZOP, SIL Determination, Basis of Safety Analysis, Electrical and Mechanical Integrity Reviews etc., along with a range of legislation; Machinery Directives new 2006-42-EC or old 98-37-EC, Process Safety EN 61508 or EN 61511, Safety Category or Safety Integrity Level.

So how does an organisation choose the most effective and cost efficient route to compliance?

THE ROAD TO TOTAL COMPLIANCE

Whether purchasing new plant or equip-ment, making modifications or upgrades, the target must be ‘Total Compliance’. In trying to achieve total compliance, the customer is faced with the unenviable task of defin-ing all legislation and standards applicable to his/her project and then determining how to coherently iden-tify and address all risks across a range of engineering and organisational disciplines. Traditionally, plant and equipment were defined as either a machine or a process and subsequently a machine risk assessment or HAZOP would follow. However, the defining line is not so clear and often hazards and compliance requirements were only partially addressed or even missed. The industry is now moving towards Total Compliance via a more holistic approach.

This holistic approach promotes the use of a stan-dalone team with the internal competency to carry out a full Compliance Assessment of the plant/machine/equip-ment. The Compliance Assessment encompasses hazard and operability, machine safety, explosion risk, functional safety etc., carried out by a single team, through a single assessment and delivered in a single report. It is easy to imagine the savings achievable by this approach when we consider the potential for reduction in meetings, docu-mentation review cycles, action prioritisation and so on.

CASE STUDY

To demonstrate this Total Compliance approach, we will take the example of a customer in the pharmaceutical industry. During the planning stages of an upgrade project, whereby a batch manufacturing area was due to undergo a full control system retrofit, incorporating the purchasing of new auxiliary process equipment, it was decided a Total Compliance Approach was necessary in order to manage

the project from both a process safety and machinery safety aspect. The combination of Machine CE Marking, Process Control Hazards, Functional Safety Requirements and Explosion Protection was proving a significant challenge to the plant engineering and EHS departments. The challenge was how to best address all mandatory require-ments of relevant legislation in a timely and cost effective manner. The traditional approach of having several teams working on HAZOPs, Machine Risk Assessment, SIL determination and Explosion Protection would have paralysed the project, both from a cost and time perspective.

The Total Compliance Assessment team systematically reviewed the plant compliance status in a single assessment. So rather than

having a HAZOP, then a Risk Assessment, then a SIL meeting, a single combined assessment covered all areas. The Total Compliance Assessment team analysed E&I drawings, P&IDs, PFDs, Hazardous Area Classifications, machinery requirements, Safety Critcial Loops and EMC and noise implications for surrounding personnel and equipment.

Following the onsite assessment, a single report was delivered to the customer. This report provided an iden-tification of all risks, along with a single prioritised action listing. As a result of this integrated approach, the cus-tomer estimated that the duration of this project stage was reduced by approximately 40%, with a comparable saving on resource requirements.

As part of our Safety Engineering Services, Pilz offers our ‘Total Compliance Assessment’. This assessment offers our customers a one stop solution for all plant and equip-ment whether new or old. No longer does the customer need to decide between Machinery Directive or ATEX Directive, between HAZOP or Risk Assessment: our ‘Total Compliance Assessment’ covers all areas in a com-bined multidisciplinary approach; Several Areas - One Assessment: Total Compliance.

21

REGULATIONS & COMPLIANCE

A TOTAL COMPLIANCE APPROACH

Wesley O’Shea, Project Manager, Pilz Ireland,

advises on how to choose the most effective and cost efficient route to compliance for your

plant.

22

HPLC SIMPLICITY WITH UPLC PERFORMANCE

CHROMATOGRAPHY

Waters Corporation has introduced the new Waters ACQUITY UPLC H-Class System, incorporating the proven, robust and reliable performance of ACQUITY UltraPerformance LC (UPLC) with the operational familiarity of traditional high performance liquid chromatography. This combination of performance, simplicity and flexibility is designed to help more labo-ratories realise the scientific and business benefits of sub-2-μm (micron) particle column technology by making it more accessible to a broader range of industries, applications and operators.

With systems currently installed in Waters’ demon-stration laboratories world-wide, the ACQUITY UPLC H-Class is ready for customer shipping today.

“Working closely with our customers, it became obvious that the immediate next step for UPLC was to more closely link UPLC and HPLC to improve data quality, increase sample throughput, and reduce cost per analysis across a broader range of markets and entire enterprises,” said Art Caputo, President of the Waters Division. “Based on conversations with some of our key accounts, the introduction of the ACQUITY UPLC H-Class is the right system at the right time.”

SEAMLESS METHOD TRANSFER

Beyond improving chromatographic performance when running UPLC columns, as well as fully supporting HPLC columns, the ACQUITY UPLC H-Class system closely emulates HPLC workflows, making method transfer from HPLC to UPLC easier or more seamless. Furthermore,

the introduction of ACQUITY UPLC H - C l a s s a l l o w s organ isa t ions to standardise their approach to LC with a common technol-

ogy platform that makes the future transition from HPLC to UPLC-based methods straight-forward and practical - from product discovery through to product release testing.

“Having proven itself in the market under the most rigorous situations for the most demanding applications, UPLC technology has experi-enced a prolific adoption rate,” continued Caputo. “So much so, that today’s HPLC users, many of whom are currently unable to or prefer not to change their approach to LC, are looking for the benefits from UPLC technology, but on their terms.”

HIGH SEPARATIONEFFICIENCY

The answer to achieving UPLC performance and ben-efits without fundamentally modifying HPLC workflows came in the form of the

ACQUITY UPLC H-Class’ new quaternary solvent manager (QSM) and sample manager (SM-FTN), with flow-through needle design, thereby mimicking tradi-tional HPLC system workflow. The featured QSM and SM-FTN on the ACQUITY UPLC H-Class combine to enable the chromatographer to achieve high separation efficiency using sub-2-μm (micron) particle separations at high pressures. The result is seamless upgrade of chromatographic capabilities.

Backed by a range of ACQUITY UPLC columns that include three particle substrates in 11 chemistries, all of which are scaleable between HPLC and UPLC particle sizes, the ACQUITY UPLC H-Class introduction is com-plemented by new ACQUITY UPLC Method Transfer kits. These new kits contain both UPLC and HPLC col-umns, with specified chemistry, and an ACQUITY UPLC Columns Calculator, all designed to take the guess work out of method transfer. In addition, Method Development and Method Validation kits are available to ensure efficient method development and robustness.

For more information on the ACQUITY UPLC H-Class, please visit www.waters.com/hclass.

Waters’ Corporation’s new ACQUITY UPLC H-Class System is designed to replace HPLC systems

and accelerate UPLC adoption among HPLC users.

©2010 Waters Corporation. Waters, ACQUITY UPLC, and The Science of What’s Possible are trademarks of Waters Corporation.

WE HAVE ONE WORD FOR THOSE STILL USING HPLC METHODS.

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CLINICAL TRIALS

24

The launch of the Clinical Research Roadmap for Ireland has been widely welcomed as a sig-nificant step towards the further development and enhancement of Ireland’s clinical research

infrastructure and an important contribution towards the country’s economic renewal.

The Clinical Research Roadmap highlights the strate-gic and operational changes needed to improve Ireland’s capacity to undertake high quality, multi-centre clinical research. These changes are needed to develop new medi-cines, diagnostics, therapeutics and medical devices and to allow Ireland to participate in European research initiatives.

The Roadmap, developed by the Irish Clinical Research Infrastructure Network (ICRIN), looks at how we can create a coordinated, networked clinical research system in Ireland, bringing together the ideas and knowledge of the best minds in clinical research - regulators, funders, researchers, industry associations, hospitals, universities and patient organisations.

BACKGROUND

Ireland has the potential to be a leading country for quality clinical research, including clinical trials, to be a partner of choice in multi-national clinical trials and to generate innovative products to improve health and reduce disability.

The Irish Government is committed to providing the infrastructure for clinical research in Ireland, as evidenced by large-scale investment in recent years in facilities and expertise, the policy commitments in the Renewed Programme for Government, the Health Research Action Plan (HRAP) and the prioritisation of clinical research for funding in the Strategic Business Plan 2010-14 of the Health Research Board (HRB).

THE DEVELOPMENT OF ICRIN

The Irish Clinical Research Infrastructure Network (ICRIN) was created in 2006 by University College Dublin, Trinity College Dublin, University College Cork, National University of Ireland, Galway, and the Royal College of Surgeons in Ireland, and operates as a business unit of Molecular Medicine Ireland (MMI). Its prepara-tory phase is funded by the HRB and the Health Service Executive (HSE) and its goal is to promote harmonisation of training, processes and practice in all aspects of clini-cal research in Ireland in order to support academic and industry sponsors of research.

ICRIN was tasked by the HRB and the HSE to con-

vene the key players in clinical research in Ireland in a series of workshops to develop a comprehensive set of recommendations in the form of a Roadmap for the devel-opment of clinical research in Ireland, which was launched in June 2010.

Speaking at the launch of the Clinical Research Roadmap, Dr Damian O’Connell, Chair of Molecular Medicine Ireland, announced that the MMI partners would work together to increase the number of multi-centre clinical studies in Ireland and in particular, to improve the experi-ence of industry in conducting clinical trials in Ireland.

STRONG ALLIANCES BETWEEN THIRD LEVELINSTITUTIONS

The recently published Report of the Innovation Task Force endorses the need for strong alliances between third level institutions that focus on innovation. It highlights the opportunities for this country to capture innovation from convergent technologies in the pharmaceutical and biotech sectors and from our strengths in research on food and health and our expertise in medical device technologies.

The Report also stresses that “the development of a clinical trials research system is critical for the future growth and development of this sector in Ireland (both indigenous and MNCs) and to ensure that we leverage investments in research and development - translating from bench to bedside”.

FUNDING CLINICAL RESEARCH

Dr Damien O’Connell, who is also Vice President for Research and Development with Pfizer, spoke about

THE FUTURE FOR CLINICAL RESEARCHThe recently launched Clinical Research Roadmap points the

way for Ireland’s development as a centre for high quality,

multi-centre clinical research.

Pictured at the launch of the Clinical Research Roadmap are (l-r): Professor Larry Egan, Clinical Director of ICRIN; Dr

Ruth Barrington, CEO of MMI; Dr Damian O’ Connell, Chair of MMI; Mary Harney TD, Minister for Health & Children; John Mc Cormack, Chair of Medical Research Charities Group; and

Enda Connolly, CEO of Health Research Board.

the changes in the way the pharmaceuti-cal industry funds clinical research and what Ireland has to do to become a core site again for clinical trials. A combina-tion of logistical problems and financial pressures has led companies to reduce the number of countries in which they conduct clinical trials as a strategy to increase the speed of study execution and reduce costs, while maintaining quality.

“At an operational level, industry – both global and indigenous - wants a rapid assessment of the feasibility of a study, no undue delays between the decision to conduct the study and the recruitment of the first patients and the target patient population recruited within the agreed times-cale,” noted Dr O’Connell. “Industry wants predictable costs and a high level of regulatory compliance and it wants to be able to navigate the system of clinical research easily.

“As a small country, we cannot be good at every-thing, so we must prioritise and map our clinical research strengths and our health needs. Building the patient regis-tries and bio collections linked to those priorities, coupled with a much improved capacity to undertake clinical trials, will be of interest to industry and will generate more clini-cal research and more jobs in Ireland.”

ICRIN WORKING GROUP

The MMI Board has endorsed the creation of an ICRIN Working Group that, before the end of 2010, will address the issues identified as critical to building a clinical research infrastructure in Ireland. The ICRIN Working Group is chaired by Professor Larry Egan, Acting Clinical Director of the NUI Galway CRC at University College Hospital, Galway. Its members include leading clinical researchers responsible for the CRCs in place or planned in Dublin, Cork and Galway.

In launching the Roadmap, Mary Harney TD, Minister for Health and Children said that the Government is committed to building capacity for clinical research in Ireland and acknowledged the Roadmap as an important contribution in this regard.

Professor Lawrence Egan, Clinical Director of ICRIN and Interim Director of Galway Clinical Research Facility, said, “Our vision is to incorporate clinical research into the everyday care of patients”. Referring to the importance of partnership, he emphasised that, “ICRIN’s Clinical Research Roadmap represents an opportunity for funders, researchers, industry and the health service to build together an Irish clinical research system that will achieve this vision”.

The Roadmap was also welcomed by Enda Connolly, Chief Executive at the Health Research Board, who said, “The HRB is driving the growth of clinical research in Ireland. Developing a strong coherence across the Irish health and research systems is central to this. We have sup-ported ICRIN to develop this Roadmap because it will help create the vibrant, co-ordinated clinical research system we

need here. When this is in place, Ireland will be in a much better position to absorb new innovations and support high performance in our health system. This will improve people’s health, as well as attracting industry investment.”

John McCormack, Chair of the Medical Research Charities Group and CEO of the Irish Cancer Society, also welcomed the Roadmap, noting how “There are great opportunities to improve health outcomes for Irish people through clinical research. There is also great potential for patients to avail of the latest treatments for their conditions by taking part in clinical studies. If the recommendations of the Roadmap are implemented, the benefits of clinical research will be made more widely available.”

CLINICAL TRIALS

25

RECOMMENDATIONS OF THE ROADMAP

The Roadmap made a number of recommendations, which include:- An urgent priority is to reform the structure and

operation of ethical review of clinical research.- The Minister for Health and Children should

establish 6-8 national research ethics committees to provide a multi-site single opinion review for all categories of clinical research involving the recruit-ment of participants through the health service.

- The Minister for Health and Children should estab-lish a Central Office for Research Ethics Committees, with the necessary legal underpinning for the over-sight and support of ethics committees in Ireland.

- All clinical research conducted in Ireland should be carried out within appropriate governance structures and with the assurance of compliance to the highest international standards. The abil-ity to demonstrate that Irish researchers have the appropriate structures and skills in place to enable sponsorship and oversight of research activities is crucial to being able to lead on Irish research ideas that require the participation of multiple sites and multiple countries. This means we must develop more robust arrangements for research governance in our hospitals and universities and between those institutions.

- The Irish clinical research system should develop as a component of the emerging European biobanking and clinical research infrastructures, which are being developed as part of the European Research Area.

- An effective research infrastructure should be organised so that it improves all processes related to the design, approval, start-up, enrolment and completion of clinical trials and other research pro-grammes with a measurable impact on productivity and research outcomes for industry and academic driven research programmes.

Copies of the Clinical Research Roadmap may be ordered through infor@molecularmedicineireland.ie (€6 per copy, including postage) or may be down-loaded from www.molecularmedicineIreland.ie.

26

OUTSOURCING

In the pharmaceutical market of today, companies are striving to reduce costs, maximise efficiencies and at the same time, research and develop new products. The daily running of a modern pharma-

ceutical plant requires not only process knowledge and manufacturing know-how, but a team of skilled people to operate and maintain the peripheral building services and utilities required to create and sustain the manufacturing environment, as well as energy management and essential, non-manufacturing services such as cleaning, building maintenance, catering and a host of others.

Outsourcing of these peripheral, non-manufacturing services can offer savings and efficiencies to pharmaceuti-cal companies, allowing them to concentrate solely on the business of developing and manufacturing product.

However, before looking at what advantages outsourc-ing of these functions can bring, it is important to under-stand what is meant by outsourcing, and to differentiate it from ‘out-tasking’.

OUTSOURCING VS OUT-TASKING

Many client companies will use third party vendors or contractors to carry out various maintenance tasks, for example maintenance on specialist equipment such as Water-For-Injection (WFI) stills, compressors and boil-ers, and many see this as ‘outsourcing’ these maintenance functions. However, responsibility for quality and scope of work and internal documentation still remains with the client, so in essence it is the specific maintenance task that is being contracted out: in other words, these activities are being ‘out-tasked’.

But what if the maintenance and operation programme itself, to include regular preventative and predictive as well as corrective tasks and technical support, were contracted out? Now the client is moving into the outsourced model, where a whole function, rather than a specific task, is being contracted out, and it is in this scenario that savings and efficiencies can be made.

Outsourcing of utility services within the pharmaceuti-cal industry in most cases will include clean systems such as high purity water, clean steam, and clean HVAC systems, as well as typical plant services such as chilled water, plant steam, compressed air, waste systems etc. Facilities services will typically include building fabric maintenance, clean-ing, general building services administration and possibly security as well. A well defined scope and clear objectives should be agreed between client and service provider, encapsulated in a Service Level Agreement (SLA) between provider and client.

ENSURING CLIENT SATISFACTION

Using a risk-based approach, the scope and responsibil-ity of the service provider can be built up over time, thus ensuring client satisfaction and confidence, particularly around regulatory compliance. It is important, particularly in this regard, that the client doesn’t relinquish all respon-sibility, as ultimate regulatory responsibility lies with the product manufacturer. Appointing key subject matter experts (SMEs) to liaise with the service provider and designing escalation and process flows for change controls, equipment deviations and the like, will ensure adherence to quality and regulatory systems. This is the area that poses most risk to the pharmaceutical manufacturer, but with the proper approach and with good systems in place, this ceases to be an issue.

For the service provider, customer satisfaction is a primary focus and all experienced providers will recognise that adherence to quality systems in a highly regulated industry can ‘make or break’ any outsourced agreement in this sector.

KEY PERFORMANCE INDICATORS

Apart from strict regulatory concerns, there are other key areas where successful delivery of service can be judged: for example, safe systems of work, system availability, performance against schedule, to name but a few. These can be captured as Key Performance Indicators (KPIs) in

THE BENEFITS OF OUTSOURCING

Outsourcing and not just ‘out-tasking’ your maintenance and facilities services can make perfect sense for the pharmaceutical sector, writes

David Lyons, Client Operations Manager, Dalkia Ireland.

27

a performance score-card, which can then be linked financially to the service agree-ment contract.

Each line item can be linked to a performance metric, each metric can be weighted and scor-ing criteria agreed, a n d o n a p e r i -odic basis (monthly, quarterly), the met-rics are reviewed and scored.

Linking the score to contract payments (for example, with-holding an agreed percentage each quarter pending an

agreed KPI score), drives performance from the service provider point of view and if properly chosen, ensures client satisfaction. As the relationship between provider and client matures, the KPIs can be reviewed and changed as either the client-supplier relationship develops, or as

business needs change, possibly changing the scope of the original agreement – this would be particularly important in longer term agreements.

REDUCING COSTS

Outsourcing maintenance and facilities allows the client to reduce costs by reducing direct company head-count, and as the pharmaceutical company essentially becomes the customer of the service provider, it is much easier to drive change and continuous improvement within the facilities function. It also allows him to focus almost all of his resources on the core business of developing and manufacturing product, without having an internal team dedicated to the non-manufacturing activities involved in facilities engineering.

For the service provider, successful delivery of service means more business, particularly in an industry where reputation counts for so much.

For further reading, see ‘Maintenance and Facilities Outsourcing Excellence’ – An Industry Case Study – Padraig Liggan, ISPE Pharmaceutical EngineeringMagazine, July/August 2009, Vol 29, No. 4 - http://www.dalkia.ie/docs/doc148.pdf

OUTSOURCING

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St James Hospital has recently purchased two scrubEx® machines for our Theatre Department through our Linen provider, Celtic Linen. The implementation of scrubEx® machines has proved very successful in terms of traceability, and elimination of non return of scrub suits. The system is supported by technology that offers a suite of reports which ensures adequate stock coverage at all times and a track and trace functionality.Due to the success and cost savings achieved to date, St James Hospital is now implementing scrubEx® system to all Clinical Departments that require Scrub Suits. - Vincent Callan, GSS Manager, St. James’s Hospital

Celtic first investigated Scrub vending in an effort to stem the loss of scrubs from our Hospital clients, and prevent the negative and vague environment which surrounds the charging for lost scrubs. After a period of investigation the scrubEx® system proved to be by far the most user friendly and efficient machine with large capacity and real time flexibility. Celtic introduced scrubEx® into one of our major Hospital Clients who were suffering large scrub losses and user dissatisfaction. The machine reduced losses to zero after six months, and in fact we are seeing ‘lost’ scrubs coming back into the system from ‘private stocks’ as confidence increases. If the future aim is to provide a clean scrub to authorised users in the most cost effective way scrubEx® is the future. - Hugo Malone, Commercial Manager, Celtic Group

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29

PATENTS

Patent proprietors make use of various strategies to extend the term of their monopoly position for medicinal products. One of these strategies is the use of Supplementary Protection Certificates

(SPCs). The purpose of SPCs is to compensate patent pro-prietors for the time period that elapses between the filing of an application for a patent for a new medicinal product and the authorisation to place that medicinal product on the market.

PROTECTION PROVIDED BY AN SPC

A Supplementary Protection Certificate (SPC) does not prolong the term of the basic patent itself. Instead, an SPC comes into effect when the basic patent expires and pro-vides the same protection as that afforded by the patent but the SPC protection extends only to the product covered by the Marketing Authorisation.

RELEVANT REGULATIONS

Council Regulation (EEC) No. 1768/92 for Medicinal Products and Council Regulation (EC) 1610/96 for Plant Protection Products came into effect in the European Union States on January 2, 1993, and February 8, 1997, respectively. Following several amendments, Regulation No. 1768/92 was consolidated into Regulation (EC) No. 469/2009 effective from July 6, 2009.

Under the Regulations, a Supplementary Protection Certificate (SPC) for a medicinal product or a plant protec-tion product can be sought in any European Union (EU) state subject to a first authorisation to market the product having been obtained. SPCs are also available for the fol-lowing countries: Iceland, Norway and Liechtenstein.

The main provisions of the relevant Regulations relat-ing to SPCs, with particular reference to Ireland are discussed here.

PRODUCT FOR WHICH AN SPC MAY BE SOUGHT

An SPC can be applied for any medicinal product, includ-ing a pharmaceutical or veterinary product, or a plant

protection product for which an authorisation to place the product on the Irish market has been issued and in respect of which an Irish patent is in force.

‘Medicinal Product’ means the active ingredient or combination of active ingredients of a medicinal product, being a substance (or combination of substances) for treat-ing or preventing disease in humans or animals, including a substance (or combination of substances) administered for diagnostic purposes or for restoring, correcting or modify-ing physiological functions.

‘Plant Protection Product’ means active substances and products containing them intended to (a) protect plants or plant products against all harmful organisms; (b) influ-ence the life process of plants, other than as a nutrient; (c) preserve plant products, in so far as such substances or products are not subject to special Council or Commercial provisions on preservatives; (d) destroy undesirable plants; or (e) destroy parts of plants, check or prevent undesirable growth of plants.

An SPC may be sought for each qualifying product, provided that only one SPC is available for a given active ingredient or combination of active ingredients. If the

THE USE OF SPCS

Marie Walsh, Chartered and European Patent Attorney,

MacLachlan & Donaldson, writes on the use of Supplementary Protection

Certificates in the extension of term of protection for medicinal products

and plant protection products in Ireland.

Marie Walsh, Chartered and European Patent Attorney, MacLachlan & Donaldson.

BIOTECHNOLOGY

30

patent covers more than one authorised product, then an SPC can and should be sought for each qualifying product.

WHO MAY SEEK AN SPC

An SPC may be sought only by the proprietor of the basic patent. The basic patent is the patent which protects the product per se, a process for manufacturing the product or an application (use) of the product.

WHEN TO SEEK AN SPC

An application for an SPC must be filed within six months of the date on which the authorisation to place the product on the market in Ireland is issued, unless such authorisa-tion is given prior to granting of the basic patent, in which case the time for filing the application is six months from the date of grant of the patent. No application for an SPC may be filed if the basic patent has expired.

CALCULATING THE DURATION OF AN SPC

An SPC becomes effective on the day following the expiry of the basic patent. The maximum duration of an SPC is restricted to five years, subject to payment of annual renewal fees at the same level as the renewal fee for the 20th year of a patent. The actual duration of any SPC is the period between the date of the application for the basic patent and the date of the first EU authorisation for the product, less five years. Of course, the term is limited by the five year maximum term.

PAEDIATRIC USE EXTENSION OF TERM OF SPC

Extension of the term of an SPC for a medicinal product is available where steps are taken to determine the suitability of the product for paediatric use.

Regulation (EC) No. 1901/2006 on medicinal products for paediatric use was implemented in Ireland by way of Statutory Instrument No. 307 of 2008. Regulation (EC) No. 1901/2006 (as amended by Regulation (EC) No. 1902/2006) partially came into effect on January 26, 2007. Since January 26, 2009, this regulation is fully in effect.

Under the provisions of this Paediatric Regulation, the duration of any SPC for a medicinal product can be extended by six months on application to the Irish Patents Office, provided that certain measures have been taken relating to determining the suitability of the medicinal product for paediatric use.

To be able to obtain this extension of an SPC’s term, a Paediatric Investydion Plan (PIP) must be approved and completed, and the result applied to the marketing authorisation for the product. The outcome of the paedi-atric studies is irrelevant to the granting of an extension. The product must be authorised in all Member States of the European Union. An application for an SPC term extension may be made, together with an application for an SPC or after granting of the SPC, but not later than

two years prior to the normal expiry of the SPC. During a transitional period, which ends on January 26, 2012, an application for an SPC term extension can be filed up to six months before the normal expiry date of the SPC.

In addition to details concerning the SPC, an applica-tion for an extension of the term of an SPC must include a copy of the statement indicating compliance with an agreed completed PIP and proof of authorisation to place the product on the market in all Member States.

FURTHER INFORMATION

For specific information about applications for SPCs or SPC term extensions in Ireland or other European Union States, please contact Marie Walsh at walshm@maclachlan.ie or Dr. Yvonne McKeown at mckeowny@maclachlan.ie.

This article provides general information only and does not purport to provide legal advice. Specific advice should be sought as relates to particular circumstances.

PATENTS

31

COUNTERFE IT MEDIC INES

EFPIA (The European F e d e r a t i o n o f P h a r m a c e u t i c a l I n d u s t r i e s a n d

Associations), the voice of the research-based pharmaceutical industry in Europe, recently unveiled its pilot project to verify medicines and so help reduce the risk of counterfeit medicines being dispensed to patients.

The coding pilot project, launched in September, involves testing a pharmacy-based verifi-cation system using a small data matrix on each medicine pack dispensed. This will run for approximately four months in 25 pharmacies, and will assess more than 100,000 packs.

The project uses a two-dimensional barcode, similar to those found on airline boarding passes. This contains a unique product identifier, allowing pharmacists to verify the status of every pack in the pilot at the time of dispens-ing. Scanning the data matrix code with a simple barcode reader will also allow the pharmacists to automatically detect the product expiry date and the batch number. This will increase confidence that the product being dispensed is safe.

BACKGROUND TO THE EFPIA PILOT

The project is a response to the European Commission’s Draft Directive on counterfeiting, aimed at reducing the risks of counterfeit medicines entering the legitimate sup-ply chain. The proposals set out a legal basis for ensuring that safety features are obligatory on packs, allowing them to be authenticated and traced.

The logic of the Commission’s proposal is indisputable. Europe’s citizens need to be protected from the infiltra-tion of counterfeit medicines, for their own safety, as well as to maintain confidence in the legitimate supply chain. Improved identification of medicine packs entering the pharmacy and being dispensed to patients will make a valuable contribution to tackling this threat.

However, this cannot wholly eradicate the problem:

other measures are also required. To eliminate counterfeits and protect public health means hav-ing a comprehensive series of measures. These include harmo-nised product serialisation, the universal use of safety features and a ban on repackaging.

ENSURING PRODUCT INTEGRITY

The use of safety features on the packaging, to show the pack has not been opened or tampered

with, along with verification at the point of dispensing, will ensure pack integrity. Where existing safety features have been removed, it becomes easier for counterfeits to enter the supply chain undetected. The simplest method of avoiding this would be a ban on repackaging, as this would help guarantee that the integrity of the original packaging has been preserved throughout the entire distribution chain and the product has not been tampered with. However, to date the Commission does not wish to see such measures.

EFPIA strongly believes that, should repackaging be allowed to continue, robust inspection and audits by regu-latory authorities are required to ensure that this activity is strictly controlled and scrutinised.

AN OPTIMUM APPROACH TO PRODUCT VERIFICATION

Of the measures proposed, a product verification system at the point of dispense (i.e. pharmacy or hospital) offers good scope for improving both supply chain security and patient safety. The Commission has not set out how they envisage traceability working, but there are clear criteria required to ensure success.

Paramount is that the system is harmonised and inter-operable across Europe. If the free movement of medicines across borders is to be safe, a coordinated approach to identification and verification is essential. This needs all national coding systems to be interoperable and based on common standards, such as those defined by GS1.

This way, any pharmacist in any country can verify whether a pack with the same serial number has been

COUNTERING THE COUNTERFEITERS

The European Federation of Pharmaceutical Industries and Associations recently unveiled a new medicine coding system to help address the

growing risk of counterfeit medicines.

GS1 Ireland will provide you with a full verification report indicating the likely compliance ofyour barcode when it is printed on your consumer unit or product packaging. If necessary wewill suggest where you may need to make changes to meet GS1 and/or industryspecifications.

For more information on services offered by GS1 Ireland visit www.gs1ie.org or callMembership Services on 01-208 0660.

Scanning v’s Verification

A simple scan is no substitute for verification. Barcode scanners differ from wands to lasersto cameras, from manually operated to automatic. Lighting conditions, surface reflectance,print contrast and the scanner maintenance all vary.

Verification is a scientific measurement of each individual bar and space. Symbolplacement and contrast, data structure, check digit validation as well as the amount of lightreflected back are all precisely measured.

Verification is the “bridge between printing and scanning”.

The accurate scanning of barcodes is fundamental for effective supplychain management. Barcodes that do not scan properly result in wasted time and money for retailers and suppliers.

The GS1 Ireland Verification service checks thelikely scanning performance of your barcodes and how they conform to international (ISO) standards and the GS1 General Specifications.

Benefits of VerificationRisk of failed scans greatly reducedMore efficient supply chainFaster product to marketFaster order to cash cycleImproved customer relationshipsMore accurate orders, deliveries & Invoices

2D DATAMATRIX

VERIFICATION

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Barcode Verification

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33

dispensed before, irrespective of its country of origin. Accredited full-line wholesalers would also be able to have the option to access the database to check the status of the product at any time if in doubt, either before sending a product to the pharmacists or upon return of the product by the pharmacists.

Without standardisation and interoperability, there is a risk that the national identification and verification systems will be fragmented. This will limit verification of a product’s provenance to national product codes and create the problem of identifying counterfeit products crossing borders.

With parallel trade accounting for around 10% of all pharmaceutical sales in Europe, the ability to verify products that have moved cross-border is essential. Furthermore, the solution needs to garner the support of all stakeholders by addressing their needs effectively.

Imposing high-end or expensive solutions throughout the supply chain is likely to generate resistance. The pro-posed EFPIA solution is realistic, proportionate and cost-effective. This pilot project encompasses both wholesalers and retail pharmacies in the trial process, and will generate learnings from all actors.

A TIMELY SOLUTION

Finally, the solution needs to be timely. The Commission proposals mean that Member States will have to embrace mass serialisation, but without setting timelines or guide-lines on the appropriate technology.

This could create a situation where the numbers of

counterfeit medicines in the supply chain continues to increase, while Member States initiate potentially incom-patible solutions at different speeds, without addressing the needs for interoperability and standardisation.

The EFPIA project will provide proof of concept; a system using proven technology that can be deployed rapidly. It will also address the key requirements of interoperability and standardisation in a proportionate and affordable manner. This is a practical solution to the challenge of implementing unique pack verification that all actors can embrace.

It will not offer the total protection that a ban on repackaging would provide, but offers a practical, prag-matic and achievable approach that provides citizens with additional protection from this threat.

PRELIMINARY RESULTS

The pilot project will not be completed until the end of the year but early results have been very encouraging:

work days;

pharmacies do not have any significant issues;

packs coded;

completed in < 1.0 sec.

PharmaManufacturer tneitaPrelaselohWrelaselohW

Pharmacist/Hospital

Product Flow

Verification

UniqueSerialization

Verification

Dispensing

Data Transfer

ProductSerialization

Database

2D DataMatrix on 2o pack

COUNTERFE IT MEDIC INES

SCIENCE FOUNDATION IRELAND

34

SFI was set up 10 years ago when it became clear that Ireland needed to develop its research capacity and that Ireland needed highly skilled people

available to carry out research and to support the industries coming here for manufacturing purposes.

In recent years, Ireland, through sub-stantial Government investment, has made significant progress in building its scientific research capacity. Last December, the Irish Government reiterated this commitment, through the publication of its strategy for economic recovery, ‘Building Ireland’s Smart Economy: A Framework for Sustainable Economic Renewal’, and more recently, in the Irish Government’s Infrastructure Investment Priorities for the period 2010-2016. The plan has, at its core, a sustained commitment to innovation, to attracting world-class researchers to Ireland, and to har-nessing opportunities from diverse research areas.

UTILISING HUMAN CAPITAL

Ireland is one of the key players in the global life sciences sector. Despite the current economic climate, the sector continues to attract foreign investment by investing in research and development, and education with links to industry. The aim is to ensure that Ireland remains a key location for leading edge research and development, and the quality jobs it can deliver.

The focus is essentially about the utilisation of human capital – the knowledge, skills and creativity of people – and our ability and effectiveness in translating the outputs into valuable processes, products and services.

It is clear that successful economies of the future will be those that embrace knowledge and learn how to use it. For Ireland, this involves bringing together our best scientists, educators, engineers and entrepreneurs to work across sectors and industries.

INVESTING IN THE FUTURE

SFI is investing in high quality investigators and research teams, who are most likely to generate new knowledge, leading edge technologies and competitive enterprises in the fields of science and engineering which underpin the broad areas of:

-

The ultimate goal of the Government invest-ment through SFI is that economic benefit should, in due course, arise from the actions and projects funded.

SFI now directly supports 3,225 researchers in the higher education sector

leveraged further funding from other sources to effectively double this community to over 6,000 active researchers. Total expenditure/payments on SFI funding awards in 2009 amounted to €171m, with over 251 new awards to 19 research bodies being approved across its suite of award programmes.

Substantial benefits have already arisen from this investment:

has contributed significantly to Ireland’s on-going ascent from below EU average volumes of scientific output to

rankings in terms of scientific quality – Ireland now ranks in the top 20 nations, up from 36th in 2003.

-

-

growing Ireland’s scientific networks/international reputation. 1,967 academic-academic collaborations

with Irish partners.-

RESEARCH FOR IRELAND’S FUTUREScience Foundation Ireland (SFI) is committed to building a world-class

research environment in Ireland, investing in research teams to

generate new knowledge, leading edge technologies and competitive

enterprises in the fields of science and engineering.

SCIENCE FOUNDATION IRELAND

35

SFI researchers were outside of Ireland, spanning 56 different countries.

€159m worth of research investment from non-SFI sources such as the EU’s framework pro-gramme, Enterprise Ireland and the Wellcome Trust.

DEVELOPING LINKS WITH INDUSTRY

In order to bring about real and meaning for economic ben-efits from investment in scientific research, it is crucial for SFI and its funded researchers to develop strong links with industry. It will be key industry partners who pose the ques-tions and, through partnership with academic researchers, find the solutions to technological, environmental, medical and economical issues. It is these industry partners who, in association with SFI-funded projects, will commercialise the outputs of the research and bring about smaller incremental changes in the existing operations, thereby increasing the competitiveness of business in Ireland.

An integral part of SFI investment is to focus research in areas of strategic importance to Ireland. The SFI

-tion with industry around strategic areas of research.

-ences space, including the Solid State Pharmaceuticals

Between them, these clusters alone have over 30 industry partnerships with a diverse range of international compa-

GlaxoSmithKline.

Sciences include:

Alimentary Pharmabiotic Centre (APC) at University College Cork - www.ucc.ie/research/apc

developing new therapies for debilitating gastrointestinal

-

and positioning Ireland at the forefront of this exciting

Biomedical Diagnostics Institute (BDI), Dublin City University - www.bdi.ieBDI is carrying out cutting-edge research to develop the next generation of biomedical devices that will directly

affect the quality of people’s lives worldwide over the coming decades. The diagnostic devices and sensors will aim to detect minute concentrations of disease related molecules in biological samples like blood, saliva and

Systems Biology Ireland, University College Dublin - www.ucd.ie/sbiSystems Biology Ireland will build the foundations of the science through the development of platforms and expertise in systems biology by focusing on defined sci-entific projects. In an effort to solve critical biological and biomedical problems, SBI research projects will be driven by the need to address biological questions for tangible benefits. In order to achieve a systems level understanding, the conceptual framework to rationalise complex biologi-cal relationships will come from mathematical modelling.

-

Siemens Ireland, Ark Therapeutics and Protagen AG.

MAINTAINING MOMENTUM

momentum and to firmly establish Ireland as a centre for excellent research in leading areas of science and technol-ogy. SFI activities have become increasingly relevant to the economy and this trend will continue, in the belief that high-quality scientific research and researchers are the drivers needed to develop Ireland into a high-value, knowledge-based economy.

For more information about the research SFI supports and details of up coming calls, see www.sfi.ie.

36

OPERATIONAL EXCELLENCE

These days, the pharmaceutical industry is relentlessly pursuing a drive to reduce costs as it tries to maintain competitiveness

and, at the same time, retain its historical attractiveness to the investment commu-nity. Profitability has been significantly challenged as traditional blockbuster products lose patent protection and the industry has no like-for-like replacements.

The traditional model is under severe threat with the pressures of healthcare cost containment, the widespread adop-tion of generic products and more target-ed treatments based on genomic profiling and demands for a clearer link between cost and therapeutic benefit.

The growing cost of health care is leading insurers and governments to demand greater use of generic substitu-tion and enforced price cuts on medi-cines. For long neglected by corporate headquarters as of little consequence to the overall cost paradigm, manufac-turing and supply chains are under the microscope like never before. Historically high costs (CoGS – Cost of Goods Sold) and poor levels of efficiency were unimpor-tant in the past since margins were comfortably high.

SMART IDEAS BUT LITTLE NEW UNDER THE SUN

As a response to these cost pressure and, indeed, to try to guarantee survival of in-house manufacturing, companies are now implementing management approaches long since used in other industries such as Lean and Six Sigma. Using the umbrella term of Operational Excellence, we can also consider techniques and practices such as Continuous Improvement (Kaizen), Risk Management and Design for Manufacturing.

Whereas Six Sigma was developed fairly recently (the US electronics company, Motorola developed it as a statistically-based analysis of variation in the mid-’80s), other practices have been around for much longer. There is evidence of process flow in the way in which the Italian navy built ships in Venice in the 11th Century, while Henry Ford was well ahead of his peers in lean think-

ing over a century ago. (There was a scientific reason behind the “any colour as long as it’s black” approach – Henry Ford’s approach to customer service! In fact, black paint dries faster than any other colour, thus improving processing time on his newly introduced assembly lines, a classic lean concept.)

WHAT’S DIFFERENT THOUGH?

The differences between, say, the Total Quality and Re-Engineering move-ments of the ’80s and ’90s that make lean and six sigma more compelling are now understood. Amongst other things, Operational Excellence demands:

-standing customers as a starting point;

sponsorship and commitment;

‘coal-face’;

using the 5-step DMAIC (Define, Measure, Analyse, Improve, Control) methodology;

-nomic value to the business;

driver of improvement.

typically last no longer than four to six months, ensuring focus and quick returns. All of these factors combine to provide a winning formula for success and sustainability.

DOES IRELAND HAVE A USP?

These new approaches present both risks and opportunities for Irish sites, as global companies continue to rationalise their manufacturing networks, following patent expirations

In two cycles of benchmarking conducted by PharmaChemical Ireland over the past five years, it is clearly seen that most Irish pharma sites have embarked

THE PRESCRIPTIONS FORFUTURE SUCCESS

How the industry is responding to the crises arising from the challenges

thrown up by failing R&D productivity and health care cost reforms, by

management consultant Jim McKiernan of McKiernan Associates GmbH.

37

have been demonstrated in terms of reduced throughput times, reduced inventory levels and more productive use of expensive capital assets - all 35 sites benchmarked have such initiatives under way.

When we look at the industry, both internationally and in Ireland, three classes of site emerge in terms of maturity in the adoption of Operational Excellence:

-ment but also actively looking outside the industry for examples of best practice across other sectors such as electronics, automotive and aerospace;

sites but beginning to implement important new per-formance measures such as OEE (Overall Equipment Effectiveness) and process capability;

-

from their more advanced colleagues and avoiding mistakes made by the pioneers.

Ireland’s USP is its talent pool, combined with an active

Ireland) as well as IDA and government initiatives which seek to combine solid operational excellence with the appropriate economic, scientific and skills environment.

BREAKING OUT OF PHARMA’S CULTURAL GRAVITY

Historically, pharma manufacturers have been constrained by what we term “Cultural Gravity” (Fig 1). This is seen in the traditional response to ideas from outside - “This won’t work here; we’re a regulated industry”, “We’re not Toyota”, “We have SOPs to follow”. And yet industry leaders with insight recognise that ensuring their manufacturing sites survive and thrive in the future will demand game-changing strategies which have never been seen in the industry before.

Organisations are being turned sideways as compa-nies adopt process-oriented structures with minimised hierarchical layers. In the past, it was common to find quality departments with up to one quarter of a site’s headcount – these numbers are being drastically scaled back as quality at source becomes the norm, with much

less after the fact inspection and greater use of in-process control and right first time quality (Quality at source and Design for Manufacture). Active ingredient manufacturers are looking at innovative scientific solutions to the tradi-tional batch-driven approach, which will allow continuous processing and a much greater emphasis on flow.

LOOKING TO THE FUTURE

Nobody could have predicted the changes we have lived through in the past decade and equally, we cannot be certain of what the future holds. Nevertheless, there are encouraging signs that Ireland’s response to recent challenges are beginning to bear fruit. Recent announce-ments about manufacturing site rationalisation have not left the country unscathed but this is not surprising, given the breadth of our manufac-turing footprint.

What has been encouraging are the announcements in which Irish sites’ strategic importance has been recognised and this has been reinforced by additional investments and research collaborations. We must continue to leverage these successes and in this operational excellence will play a cen-tral role in ensuring the future competitiveness of Irish sites.

Jim McKiernan is MD of McKiernan Consultants GmbH, a professional services firm, offering manage-ment consulting to the pharmaceutical and life sciences industries and professional development training and coaching to management across all sectors. For more information, contact McKiernan Associates GmbH,

www.mckiernan.ch. Email: info@mckiernan.ch. Tel: +41 61 225 4264.

Fig 1 – Combining Strategic Relevance with Operational Excellence

OPERATIONAL EXCELLENCE

38

HAZARDOUS WASTE RECYCL ING

As leaders in hazardous waste recycling, Soltec ensure excellence in all areas of operation and their ISO 9001:2008 accreditation and EPA Licensed Facility are a credit to that fact.

Soltec take pride in the fact that their company offers a fully traceable waste collection service from point of col-lection to point of recovery or disposal. As a customer, you can be confident that any waste collected by Soltec will be treated and disposed of in accordance with all environ-mental, Health and Safety legislation, and that all relevant documentation will be available to you as proof of this for your own records and for audit purposes.

HAZBIN

As innovators, Soltec are always looking for new cost-friendly solutions to their customers’ ever-changing needs. These solutions need to be effective, easy to implement but more importantly, remain in line with the company’s quality ethos.

An example of such innovation is evident in their HazBin, a new addition to their range of Haz products. The HazBin is a Certified Fire Retardant Bin (Cert No SII210/2) which is suitable for wipes, oily rags, air filters and contaminated Personal Protective Equipment and can hold up to 90 Litres.

Used predominantly to collect hazardous waste from production lines or labs, the HazBin performs an integral role in the collection process and can help reduce costs when used in conjunction with the HazBag or HazBox.

Waste is collected by the opera-tor in the red polypropylene lined HazBin. This process ensures that only hazardous waste is placed in the easily identifiable colour coded bags, thus eliminating the possibility of general waste been sent along with the hazardous waste, a situation which would increase disposal costs unnecessar-ily. Full bags of waste are then removed from the bin, tied and transferred to either the bulk HazBox or HazBag.

REDUCING COSTS

The HazBag and HazBox are FIBC containers pioneered by Soltec for the disposal of solid hazardous waste. The unique feature of these two products is that they can hold up to five times the amount of an ordinary 200-litre open top barrel, resulting in a reduced need for repeat purchase for barrels and thus, reduced costs.

As leaders and innovators within the hazardous waste recycling industry, it is easy to see why major pharma-ceutical manufacturers trust Soltec with their hazardous waste disposal and are keen to implement the cost-saving measures, outlined above, into their current waste manage-ment plan.

Interested in reducing your hazardous waste disposal costs? Soltec are always happy to share their expertise for those seeking assistance with any waste management queries.

SOLTEC:MAKING WASTE WORK

In operation since 1994, Soltec has distinguished itself as a leader and

innovator within the hazardous waste recycling industry. As innovators,

Soltec are always looking for new cost-friendly solutions to their

customers’ ever-changing needs.

CONTACT DETAILS:For more information, or to find out how Soltec can help reduce your hazardous waste disposal costs, visit www.soltec.ie. Tel: 044 93 35133. Email: info@soltec.ie.

Tel: +44 (0) 116 288 1588Fax: +44 (0) 116 281 3000

Email: sales@measomfreer.co.uk

Web: www.measomfreer.co.uk

Measom Freer (Sales) Ltd.

37-41 Chartwell Drive, Wigston, Leicestershire LE18 2FL England.

f r o m c a p s t ob o t t l e s . . . Whether it needs dispensing, dropping or plugging, Measom Freer has an

extensive stock range of plastic dropper caps, nozzles, spouts and plugs

to complement our bottle and packaging ranges. You could find that we

have the perfect solution for dispensing your solution right here, ready

for dispensing. Whatever you need, we’ve been providing a personal

service with great attention to detail for 70 years – so you can rely on

Measom Freer to provide the ideal plastic packaging solution.

For an illustrated catalogue, or to request samples, contact our

sales department.

70Pack

aging Quality

Pack aging Q ualit yYears

Caps & Plugs

Dropper Caps & Dispensers

Nozzles, Spouts & Plugs

Bottles, Jars & Boxes

Measures & Spatulas

Scoops & Spoons

Tubes & Fasteners

Stock Products

Bespoke Packaging

Screen Printing

www.measomfreer.co.uk

CB

1

40

POSITIVE OUTLOOK FORPHARMACHEM SECTOR

RECRUITMENT

The last year has seen a remarkable change in the pharmaceutical recruit-ment landscape and most

importantly, we are seeing positivity returning to it, particularly over the last six months.

Organisat ions took a lean approach to the way they recruited by utilising more combined recruit-ment models at favourable rates and engaging niche service providers, who could deliver accurate candidates in a streamlined manner. Berkley found that it was important to be able to offer clients flexibility that allowed them to ramp up and down as required to suit the business needs.

With niche skills being in demand and organisations concentrating on talent management on a global basis, we have seen the value in providing an international service that allows unique skills to brought into Ireland where needed, as well as providing a consistent recruitment service across global teams.

It is increasingly becoming the case that all service providers in engineering and resourcing have to be regional and global. With all the consolidation within the industry, increasingly companies want univer-sal suppliers, local input and decision powers are being centralised.

In 2010 to date, Berkley has seen additional requests from European and Asian colleagues to present short-lists for key management roles internationally, while in a local context, we have found a lift in the number of organisa-tion considering operations here, with an increase in the requests for due diligence information for new builds or expansion programmes.

STABILISING LABOUR SUPPLY

The labour supply has stabilised, with a lot of restructur-ing at the low level and middle management functions. Organisations were faced with triple and quadruple applications for certain skill sets, however, the need for direct headhunting increase for critical roles and proactive searches are still required to extract specialist skills. Our

recent survey has also revealed that 52% of people are still open to moving roles, while 46% are happy to retain their current salary rates. Salary infla-tion is not as common when moving to a new role or seeking an internal promotion, so wage costs are increas-ingly stable as a result.

In analysing the Irish market in global terms, Berkley compared the current rates and cost factors that their clients are working with. Over the past 12 months, the competitive-ness and normalisation of the Irish market has been dramatic. While the economic factors at a corporate level are always attractive, the wage infla-tion and expectations of the work-force were becoming un-sustainable. When the weakness of the US dollar was also taking hold, projects and costs were soaring. The US dollar has now retreated almost 15-18%, the project costs are more competi-tive, while added to this, salaries have adjusted 10-15%.

REALISM IN THE MARKET

When you add the third component of wage increase expectation, Ireland is the lowest in the global league of expectation, i.e. we expect lowest per-

centage of increases, if any. In fact, 65% of Irish candidates are more flexible on salary, a genuine show of realism in the market.

Take all of this into account, we are now once again, dollar for euro, more cost effective. While a lot of resources have taken up roles internationally in the contract engi-neering sector, most are awaiting the opportunity to return for new projects in Ireland.

Joanna Houston, EMEA Operations Manager,

Berkley Pharmaceutical and Life Sciences, reports on the wage stability and return to competitiveness

of the pharmaceutical sector.

ABOUT BERKLEY

Berkley Group have been providing resourcing and engineering solutions in the Irish, European and Asian markets for over 15 years. For more information, contact Joanna Houston, EMEA Operations Manager, Berkley Pharmaceutical and Life Sciences. See www.berkley.ie or call +353 (0)1 8724666 / +353 (0)21 4289600.

41

PAT: MEASURING ITS IMPACT

PROCESS ANALYT ICAL TECHNOLOGY

Pr o c e s s A n a l y t i c a l Technology (PAT) is a term used to describe the application of a variety of

different analytical methodologies in-line, on-line or at-line to allow timely measurement of product attributes during manufacturing and the use of this data to increase the level of proc-ess understanding and control.

PAT is a set of tools which can be applied to achieve a goal, not a goal in its own right. The goal is to reduce variation in a process and achieve RFT (Right First Time) manufactur-ing. It provides a window to enhance process understanding and is applied based on comprehensive process risk assess-ments. It can be used to enhance process safety and enable a more cost effective manufactur-ing operation. PAT facilitates the develop-ment of knowledge during development and maintenance of control during manufacturing.

PAT: THE BENEFITS & CHALLENGES

As with most things in life, there are both benefits and challenges when it comes to PAT. Benefits include:

-standing

-tion

attributes that impact on product quality

-ency of product, data generation for CAPAs

innovation

Challenges to PAT are:

application to manufacturing

oversight

to senior management - can be difficult to show positive payback

filing, developing high level skills

creating methods

already begun or is in the process of imple-menting PAT. PAT technology in use on Irish sites includes:

SHARING INFORMATION

While there is much shared content on the subject, the majority of information is not at

limits the ability of Irish entities to leverage the combined

needs and interaction with regulatory authorities. In order to address this deficit, Irish pharma sites have come together in 2010 and formed a PAT group, the aim of which is to facilitate candid sharing between PAT practitioners of both successes and failures. The group will focus on the follow-ing objectives:

PAT is playing an increasingly important role in qual-ity systems and has an invaluable role to play in process

PAT will be an integral part of how sites evaluate and establish product quality.

Nessa Moyles, Senior Executive,

PharmaChemical Ireland, explains how Process

Analytical Technology is playing an increasingly

important role in Ireland’s pharmaceutical and

chemical sectors.

Nessa Moyles, Senior Executive, PharmaChemical

Ireland.

42

PHARMA NEWS

Recently launched into the Irish phar-maceutical market by O’Flynn Medical, scrubEX is an easy to operate gown manage-ment system which

can be customised to suit individual plant requirements. Employees simply swipe their security badge/ID and the relevant protective clothing is dispensed/returned.

scrubEx encourages cGMP and lowers operating costs. It is set-ting the benchmark standards in gowning by using modern technol-ogy in an innovative and traceable approach to the prevention of instances of contamination through the misuse of protective clothing; working in conjunction with an easy-to-use management computer and software system, which allows for multi site usage.

The system has already proved popular in the Irish healthcare market, with Limerick Regional Hospital describing scrubEX as “probably the most effective piece of equipment that I purchased in the past few years...it has made life so much better!! I would recom-mend it to everyone.”

IRELAND could soon have a global pharmaceutical centre of excellence in Tralee if a group, headed by Cork-based Pharmadel, have their way. The proposed centre of excellence would offer “the largest single employment placements on the island of Ireland”, with 4,800 jobs, and would become one of the largest research and development centres in the world.

The group behind the proposal are in constant con-tact with the Department of Enterprise and if given the green light, the new centre could be open by September 2012, employing 116 leading academic professionals, 321 corporate management executives and more than 4,300 graduates.

Merit Medical is to invest €6.7m in an expansion of its plant in Galway, which will allow for the creation of 100 new jobs. The firm is to enter the surgical pre-pack busi-ness in Europe and establish Galway as its European cen-tre. Merit Medical Ireland Limited (MMIL) established in Galway in 1994, manufacturing guidewires and inflation devices used in hospitals worldwide. The chairman and chief executive of Merit Medical, Fred P. Lampropoulos, said: “Merit employs 250 people in Galway and when it was decided to venture into the surgical pre-pack market in Europe, a number of location options were considered. The success of Merit’s established operation in Ireland and the skills set of the existing Irish management team made Ireland Merit’s location of choice.”

Quitmann O’Neill Packaging Ltd is one of the leading suppliers of specialist packaging products and services to the phar-maceutical, chemical, hazardous waste and food industries.

Quitmann O’Neill Packaging is based in the midlands with easy access to all major routes. They operate a modern trans-port fleet that meets the latest European pollution standards.

Quitmann O’Neill Packaging provides tailored services to customers’ pack-aging requirements. Their range includes steel, plastic and fibre drums, IBCs, FIBCs, tin plate containers, buckets, bottles, pots and UN corrugated boxes.

The company recently launched their plastic bucket and small pot range. For further details, please contact Shane McEnroy at 085 8022626 or smcenroy@quitmannoneill.com.

SCRUBEX LAUNCHES IN IRELAND

PROPOSED PHARMACEUTICAL

CENTRE OF EXCELLENCE

MERIT MEDICAL EXPANDS

GALWAY PLANT

QUITMANN O’NEILL HAVE PACKAGING COVERED

Tadhg O’Flynn, MD of O’Flynn Medical, pictured with the new scrubEx gown management system.

IRISH PHARMACHEM 2010

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ACIDS & ALKALIS

ABB LtdAssociated Chemicals LtdBrenntag IrelandCamida LtdCarbon GroupChemco Ireland LtdCorcoran Chemicals LtdEnva Ireland LtdFisher ScientificGoulding Chemicals LtdNational Chemical Co. LtdP.K. Chemicals LtdSciChem - CorkSciChem - DublinSigma-Aldrich Ireland LtdUnivar Ltd

BIOCHEMICALS

Associated Chemicals LtdCamida LtdCarbon GroupCorcoran Chemicals LtdFisher ScientificNational Chemical Co. LtdSigma-Aldrich Ireland Ltd

BIOCIDES

ABB LtdBrenntag IrelandCamida LtdFisher ScientificUnivar Ltd

CATALYSTS

Associated Chemicals LtdBrenntag IrelandCamida LtdCarbon GroupCorcoran Chemicals LtdP.K. Chemicals Ltd

CHIRAL COMPOUNDS

Brenntag IrelandCamida Ltd

National Chemical Co. LtdSigma-Aldrich Ireland Ltd

EXCIPIENTS

ABB LtdAssociated Chemicals LtdBetco Marketing LtdBrenntag IrelandCamida LtdCarbon GroupChemco Ireland LtdCorcoran Chemicals LtdNational Chemical Co. LtdP.K. Chemicals LtdUnivar Ltd

FINE CHEMICALS

Associated Chemicals LtdBetco Marketing LtdBrenntag IrelandCamida LtdCarbon GroupChemco Ireland LtdFisher ScientificNational Chemical Co. LtdP.K. Chemicals LtdSigma-Aldrich Ireland LtdUnivar Ltd

GASES

Corcoran Chemicals LtdNational Chemical Co. Ltd

HETEROCYCLICS

Brenntag IrelandCamida LtdNational Chemical Co. Ltd

INORGANIC CHEMICALS

ABB LtdAssociated Chemicals LtdBrenntag IrelandCamida LtdCarbon Group

Chemco Ireland LtdCorcoran Chemicals LtdEnva Ireland LtdFisher ScientificGoulding Chemicals LtdNational Chemical Co. LtdP.K. Chemicals LtdSciChem - CorkSciChem - DublinSigma-Aldrich Ireland LtdUnivar Ltd

LABORATORY REAGEANTS

Brenntag IrelandCarbon GroupFisher ScientificNational Chemical Co. LtdOcon Chemicals LtdSciChem - CorkSciChem - DublinSigma-Aldrich Ireland Ltd

MISC. CHEMICALS

ABB LtdAssociated Chemicals LtdBrenntag IrelandCamida LtdCarbon GroupChemco Ireland LtdCorcoran Chemicals LtdEnva Ireland LtdFisher ScientificP.K. Chemicals LtdSciChem - CorkSciChem - DublinSigma-Aldrich Ireland LtdUnivar Ltd

OILS, FATS AND WAXES

Associated Chemicals LtdBrenntag IrelandCarbon GroupCorcoran Chemicals LtdP.K. Chemicals LtdUnivar Ltd

CHEMICAL SUPPLIERS

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ORGANIC INTERMEDIATES

ABB LtdAssociated Chemicals LtdBetco Marketing LtdBrenntag IrelandCamida LtdCarbon GroupChemco Ireland LtdCorcoran Chemicals LtdFisher ScientificNational Chemical Co. LtdUnivar Ltd

ORGANOMETALLICS

Associated Chemicals LtdBrenntag IrelandCamida LtdNational Chemical Co. LtdSigma-Aldrich Ireland Ltd

REAGENTS

Brenntag Ireland

Camida LtdCarbon GroupChemco Ireland LtdCorcoran Chemicals LtdFisher ScientificNational Chemical Co. LtdOcon Chemicals LtdSciChem - CorkSciChem - DublinSigma-Aldrich Ireland LtdUnivar Ltd

SILANES

ABB LtdCamida LtdNational Chemical Co. LtdCarbon GroupChemco Ireland LtdNational Chemical Co. LtdSciChem - CorkSciChem - DublinSigma-Aldrich Ireland LtdSoltec (Ireland) LtdUnivar Ltd

SOLVENTS

Brenntag IrelandCamida LtdCarbn Group Chemco Ireland LtdCorcoran Chemicals LtdFisher ScientificNational Chemical Co. LtdSciChem - CorkSciChem - DublinSigma-Aldrich Ireland LtdUnivar Ltd

SURFACTANTS

ABB LtdAssociated Chemicals LtdBrenntag IrelandCamida LtdCarbon GroupCorcoran Chemicals Ltd National Chemical Co. LtdUnivar Ltd

Sustainable and Cost-effective Waste ManagementIndaver’s trademark is delivering fast, effi cient and

cost effective services in the specialist hazardous

and non-hazardous waste market.

Hazardous Waste Management

Total On Site Waste Management

Solvent Recovery

Disposal of Laboratory Chemicals

info@indaver.ie Tel. +353 1 280 4534

www.indaver.ie

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ACTUATORS

Festo LtdFlexachem Manufacturing LtdNorgren Ireland LtdPetrochem Pipeline Supply LtdTyco Valves & Controls Ireland Ltd

AERATORS

Flexachem Manufacturing LtdManotherm LtdWrenTech Ltd

AGITATORS

Fisher ScientificFlexachem Manufacturing LtdQuitmann O’Neill Packaging LtdWrenTech Ltd

AIR FILTRATION/MONITORING

/ POLLUTION CONTROL

Norgren Ireland LtdSciChem - CorkSciChem - Dublin

ALARMS

P.J. Boner & Co. Ltd

ALUMINIUM PRODUCTS

Topchem Laboratories Ltd

ANALYSIS SERVICES

AnectoCatalent Pharma SolutionsLancaster Laboratories

ANALYTICAL EQUIPMENT

P.J. Boner & Co. LtdCalibration Technology Carbon GoupFisher ScientificPetrochem Pipeline Supply LtdPPD Inc.Sartorius Mechatronics Ltd

SciChem - CorkSciChem - DublinSigma-Aldrich Ireland LtdWaters Chromatography IrelandWeber Labelling & Coding

ASSOCIATIONS

Irish Exporters Assoc.-Life Sciences Irl.

AUTOCLAVES

Fisher ScientificGoliath Packaging Systems LtdSciChem - CorkSciChem - DublinWrenTech Ltd

AUTOMATION

P.J. Boner & Co. LtdBosch Rexroth LtdFesto LtdFlexachem Manufacturing LtdGoliath Packaging Systems LtdNorgren Ireland LtdPilz IrelandWeber Labelling & Coding

BALANCES

P.J. Boner & Co. LtdCalibration TechnologyFisher ScientificIrish National Accreditation BoardOcon Chemicals LtdSartorius Mechatronics LtdSciChem - CorkSciChem - DublinWrenTech Ltd

BARCODING/LABELLING/TRACEABILITY

P.J. Boner & Co. LtdFlexachem Manufacturing LtdGoliath Packaging Systems LtdGS1 IrelandWeber Labelling & CodingZetes

BARRIERS SAFETY

WrenTech Ltd

BIOTECHNOLOGY

Catalent Pharma SolutionsFlexachem Manufacturing LtdIdex Pump Technologies (Ireland) LtdPM GroupSciChem - CorkSciChem - DublinSigma-Aldrich Ireland Ltd

BLENDERS

Fisher ScientificFlexachem Manufacturing LtdOcon Chemicals LtdSciChem - CorkSciChem - Dublin WrenTech Ltd

BLISTERING / DE-BLISTERING

Catalent Pharma SolutionsSepha Ltd

BLOWERS

Flexachem Manufacturing LtdLianco

BPRV

BS&B Safety Systems Ltd

BURSTING / RUPTURE DISCS

BS&B Safety Systems LtdFlexachem Manufacturing Ltd

CABINETS

Festo LtdFisher ScientificProSys Containment and Sampling TechnologySartorius Mechatronics LtdWrenTech Ltd

GENERAL SUPPLIERS

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CALIBRATION

P.J. Boner & Co. LtdCalibration TechnologyDalkiaFlexachem Manufacturing LtdIrish National Accreditation BoardOcon Chemicals LtdSartorius Mechatronics LtdWaters Chromatography Ireland

CENTRIFUGES

Fisher ScientificGEA Process Technologies LtdSartorius Mechatronics LtdSciChem - CorkSciChem - DublinSigma-Aldrich Ireland Ltd

CHEMICAL CONSULTANTS

Enva Ireland LtdHazchem Training LtdJohnston Logistics LtdPilz IrelandTopchem Laboratories Ltd

CHROMOTOGRAPHY

Fisher ScientificIdex Pump Technologies (Ireland) LtdOcon Chemicals LtdSciChem - CorkSciChem - DublinSigma-Aldrich Ireland LtdWaters Chromatography Ireland

CLEANROOMS

Pilz IrelandPM GroupWrenTech Ltd

CLINICAL REASEARCH

ORGANISATION

Java Clinical Research Ltd

CLEANING SERVICES /EQUIPMENT

Goliath Packaging Systems LtdWrenTech Ltd

COLD CHAIN PACKAGING

Catalent Pharma SolutionsCross Technical SolutionsCRS Mobile Cold Storage

COMPRESSED AIR/COMPRESSORS

Festo LtdFlexachem Manufacturing LtdIdex Pump Technologies (Ireland) LtdNorgren Ireland Ltd

COMPUTER SYSTEMS

O’Flynn Medical Ltd

CONDENSORS

Cross Technical SolutionsFlexachem Manufacturing Ltd

CONDITION MONITORING

P.J. Boner & Co. LtdFlexachem Manufacturing LtdDalkia

CONSTRUCTION MANAGEMENT

PM Group

CONVEYORS

Bosch Rexroth LtdFlexachem Manufacturing LtdGoliath Packaging Systems LtdWeber Labelling & CodingWrenTech Ltd

ENVIRONMENTAL

CONSULTING

PM Group

COOLING SYSTEMS

Cross Technical SolutionsGraham Hart (Process Technology) LtdWaters Chromatography Ireland

DATA ACQUISITION

P.J. Boner & Co. LtdManotherm LtdWaters Chromatography IrelandWeber Labelling & CodingZenith Technologies

DEHUMIDIFIERS

Cross Technical Solutions

DESIGN

Pilz IrelandPM Group

DISPERSERS

Ocon Chemicals LtdWrenTech Ltd

DISTILLATION

Soltec (Ireland) LtdWrenTech Ltd

DRIERS

Complas Packaging LtdFlexachem Manufacturing LtdGEA Process Technologies LtdWrenTech Ltd

DRUMS/CONTAINERS

Carbon GoupComplas Packaging LtdFlexachem Manufacturing LtdIndaver IrelandIndustrial Packaging LtdInterpacQuitmann O’Neill Packaging LtdSoltec (Ireland) LtdWrenTech Ltd

DRY ICE

Carbon Goup

ECONOMIC DEVELOPMENT

AGENCY

Invest Northern Ireland

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EDUCATION & TRAINING

Ann McGeeCalibration TechnologyFesto LtdHazchem Training LtdHenley Forklift Group LtdIrish Exporters Assoc.-Life Sciences Irl.Pilz IrelandPM GroupWaters Chromatography Ireland

EFFLUENT MONITORING/TREATMENT

Axium ProcessP.J. Boner & Co. LtdCarbon GoupEnva Ireland LtdFlexachem Manufacturing LtdLancaster LaboratoriesNorgren Ireland Ltd

ELECTRICAL

Cross Technical Solutions

ELECTRONIC COMPONENTS

Cross Technical SolutionsPilz Ireland

ENERGY EFFICIENCY /MANAGEMENT

Cross Technical SolutionsESB Independent EnergyFlexachem Manufacturing LtdIrish National Accreditation BoardPM GroupSustainable Energy Authority of Ireland

ENGINEERING SERVICES

Berkley GroupP.J. Boner & Co. LtdCroom Precision MedicalCross Technical SolutionsFlexachem Manufacturing LtdGEA Process Technologies LtdHenley Forklift Group LtdPilz IrelandFesto LtdNederman LtdPM Group

ENVIRONMENTAL CONSULTING

Ocon Chemicals LtdPilz Ireland

ENVIRONMENTAL SERVICES/EQUIPMENT

P.J. Boner & Co. LtdCross Technical SolutionsEnva Ireland LtdIdex Pump Technologies (Ireland) LtdOcon Chemicals LtdPilz IrelandPM GroupQuitmann O’Neill Packaging LtdSoltec (Ireland) Ltd

EVAPORATORS

Cross Technical SolutionsFisher ScientificFlexachem Manufacturing LtdGEA Process Technologies Ltd

EXPLOSION PROOFING

BS&B Safety Systems LtdFlexachem Manufacturing LtdGunnebo Ireland LtdHenley Forklift Group LtdNorgren Ireland LtdPilz IrelandSartorius Mechatronics Ltd

EXPLOSION PROTECTION /PANELS

BS&B Safety Systems LtdHenley Forklift Group LtdPilz Ireland

EXTRUDERS

WrenTech Ltd

FACILITY DESIGN

PM Group

FACILITIES MANAGEMENT

Goliath Packaging Systems LtdHochtief Facility Management

FILLING EQUIPMENT

Flexachem Manufacturing LtdIdex Pump Technologies (Ireland) LtdQuitmann O’Neill Packaging LtdWeber Labelling & CodingWrenTech Ltd

FILTERS

Axium ProcessCarbon GoupFisher ScientificFlexachem Manufacturing LtdIdex Pump Technologies (Ireland) LtdNederman LtdNorgren Ireland Ltd

FILTRATION

Axium ProcessEnva Ireland LtdFlexachem Manufacturing LtdGEA Process Technologies LtdIdex Pump Technologies (Ireland) LtdNederman LtdNorgren Ireland LtdOcon Chemicals LtdSciChem - CorkSciChem - Dublin

FLOW CONTROL

P.J. Boner & Co. LtdFisher ScientificFlexachem Manufacturing LtdGEA Process Technologies LtdIdex Pump Technologies (Ireland) LtdManotherm LtdNorgren Ireland LtdPetrochem Pipeline Supply LtdTyco Valves & Controls Ireland Ltd

FLUID HANDLING

Fisher ScientificFlexachem Manufacturing LtdGEA Process Technologies LtdIdex PumpTechnologies (Ireland)Norgren Ireland LtdPetrochem Pipeline Supply LtdSciChem - CorkSciChem - DublinTyco Valves & Controls Ireland LtdWrenTech Ltd

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FUME CUPBOARDS

Fisher ScientificNederman LtdSciChem - CorkSciChem - DublinWrenTech Ltd

FURNACES

Fisher ScientificSciChem - CorkSciChem - Dublin

GAS DETECTION

Fisher ScientificSciChem - CorkSciChem - Dublin

GAUGES

P.J. Boner & Co. LtdFisher ScientificFlexachem Manufacturing LtdGEA Process Technologies LtdManotherm LtdNorgren Ireland LtdPetrochem Pipeline Supply Ltd

GLASSWARE

Fisher ScientificFlexachem Manufacturing LtdOcon Chemicals LtdSciChem - CorkSciChem - DublinSigma-Aldrich Ireland Ltd

HAZARDOUS WASTE

DISPOSAL/TREATMENT

Enva Ireland LtdHazchem Training LtdIndaver IrelandIdex Pump Technologies (Ireland) LtdInterpacQuitmann O’Neill Packaging LtdSoltec (Ireland) Ltd

HEALTH & SAFETY/FIRST AID

Fisher ScientificHazchem Training LtdPilz Ireland

HEAT EXCHANGERS

Axium ProcessCross Technical SolutionsFlexachem Manufacturing LtdGEA Process Technologies LtdGraham Hart (Process Technology) LtdPetrochem Pipeline Supply LtdProSys Containment and Sampling TechnologyTyco Valves & Controls Ireland LtdWrenTech Ltd

HOMOGENISERS

Fisher ScientificFlexachem Manufacturing LtdGEA Process Technologies LtdSciChem - CorkSciChem - DublinWrenTech Ltd

HOSES

Flexachem Manufacturing LtdHenley Forklift Group LtdMicro Hydraulics Ltd/Micro Industries LtdNederman LtdNorgren Ireland Ltd

HUMIDITY/HUMIDIFIERS

P.J. Boner & Co. LtdCross Technical SolutionsFisher ScientificInterpacManotherm Ltd

HYDRAULICS

Bosch Rexroth LtdHenley Forklift Group LtdMicro Hydraulics Ltd/Micro Industries Ltd

INCINERATION

Indaver IrelandOcon Chemicals Ltd

INCUBATORS

Fisher ScientificSciChem - CorkSciChem - Dublin

INSPECTION EQUIPMENT

P.J. Boner & Co. LtdFlexachem Manufacturing LtdSartorius Mechatronics LtdWeber Labelling & Coding

INSTRUMENTATION

P.J. Boner & Co. LtdCarbon GoupCross Technical SolutionsFisher ScientificFlexachem Manufacturing LtdManotherm LtdPetrochem Pipeline Supply LtdSciChem - CorkSciChem - DublinTyco Valves & Controls Ireland LtdWaters Chromatography IrelandWeber Labelling & CodingZenith Technologies

IT

BrightwaterWeber Labelling & Coding

INVESTMENT

Glanbia EstatesScience Foundation Ireland (SFI)

INVESTMENT

PROMOTION AGENCY

IDA Ireland

LAB EQUIPMENT/SUPPLIES

P.J. Boner & Co. LtdCalibration TechnologyCarbon GoupFisher ScientificOcon Chemicals LtdProSys Containment and Sampling TechnologyQuitmann O’Neill Packaging LtdSartorius Mechatronics LtdSciChem - CorkSciChem - DublinSepha LtdSigma-Aldrich Ireland LtdWaters Chromatography IrelandWeber Labelling & CodingWrenTech Ltd

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LEGAL/FINANCIAL/INSURANCE

MacLachlan & DonaldsonMatheson Ormsby Prentice

LOGISTICS

C+G Logistics GroupCeltic Forwarding LtdJohnston Logistics LtdKWE (Ireland) LtdOne Stop HandlingWeber Labelling & Coding

LIFTS & HOISTS

Goliath Packaging Systems LtdGunnebo Ireland LtdHenley Forklift Group LtdNorman Lauder LtdWrenTech Ltd

MACHINE TOOLS

Idex Pump Technologies (Ireland) LtdLister Machine Tools LtdSoltec (Ireland) Ltd

MAINTENANCE

Cross Technical SolutionsFesto LtdFlexachem Manufacturing LtdGEA Process Technologies LtdGoliath Packaging Systems LtdGunnebo Ireland LtdLister Machine Tools LtdSartorius Mechatronics Ltd

MATERIALS HANDLING/FORKLIFTS/PALLET TRUCKS

Goliath Packaging Systems LtdHenley Forklift Group LtdInterpacJohnston Logistics LtdOne Stop HandlingWaters Chromatography IrelandWrenTech LtdToyota Material Handling Ireland Ltd

MECHANICAL ENGINEERING

SERVICES

Axium ProcessCroom Precision MedicalCross Technical SolutionsFlexachem Manufacturing LtdGEA Process Technologies LtdHenley Forklift Group LtdGoliath Packaging Systems LtdPilz Ireland

MECHANICAL & PROCESS

ENGINEERING

Axium ProcessFlexachem Manufacturing LtdGEA Process Technologies LtdNorgren Ireland LtdPilz IrelandWrenTech Ltd

MEDICAL DEVICE

MANUFACTURE

B.Braun MedicalCroom Precision Medical

MEMBRANE

FILTRATION SYSTEMS

MICROFILTRATIONAxium ProcessFisher ScientificGEA Process Technologies Ltd

NANOFILTRATIONAxium ProcessFisher ScientificGEA Process Technologies Ltd

ULTRAFILTRATIONAxium ProcessFisher ScientificGEA Process Technologies Ltd

METERS

P.J. Boner & Co. LtdFisher ScientificFlexachem Manufacturing LtdGEA Process Technologies LtdManotherm LtdPetrochem Pipeline Supply

MICROSCOPES

Fisher ScientificOcon Chemicals LtdSciChem - CorkSciChem - Dublin

MILLING

Flexachem Manufacturing LtdSciChem - CorkSciChem - DublinWrenTech Ltd

MIXERS

Fisher ScientificFlexachem Manufacturing LtdSciChem - CorkSciChem - DublinWrenTech Ltd

NOISE/ODOUR CONTROL

Flexachem Manufacturing Ltd

OEM MANUFACTURING

Flexachem Manufacturing LtdIdex Pump Technologies (Ireland) LtdGEA Process Technologies LtdSigma-Aldrich Ireland Ltd

PACKAGING/DESIGN

AnectoCatalent Pharma SolutionsCharpak MedicalChesapeakeComplas Packaging LtdIndustrial Packaging LtdInterpacMeasom FreerNPP Group LtdPrimePac LtdQuitmann O’Neill Packaging LtdSmurfit Kappa IrelandWeber Labelling & Coding

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PACKAGING/MACHINERY

ChesapeakeGoliath Packaging Systems LtdInterpacNPP Group LtdQuitmann O’Neill Packaging LtdSepha LtdWeber Labelling & CodingWrenTech Ltd

PALLETS

Complas Packaging LtdGoliath Packaging Systems LtdHenley Forklift Group LtdInterpacJohnston Logistics LtdQuitmann O’Neill Packaging LtdSmurfit Kappa IrelandWrenTech Ltd

PHARMACEUTICAL FABRICATION

Axium ProcessCatalent Pharma Solutions

PIPES/CORES

Flexachem Manufacturing LtdIndustrial Packaging LtdPetrochem Pipeline Supply LtdSmurfit Kappa Ireland

PLASTIC CONTAINERS

ChesapeakeFisher ScientificFlexachem Manufacturing LtdIndustrial Packaging LtdMeasom FreerOcon Chemicals LtdPrimePac LtdSciChem - CorkSciChem - DublinSoltec (Ireland) LtdWrenTech Ltd

PLASTIC CORES / TUBES

Fisher ScientificFlexachem Manufacturing LtdMeasom FreerSigma-Aldrich Ireland LtdSmurfit Kappa Ireland

PNEUMATICS

Bosch Rexroth LtdP.J. Boner & Co. LtdFesto LtdFisher ScientificFlexachem Manufacturing LtdIdex Pump Technologies (Ireland) LtdNorgren Ireland Ltd

POLLUTION CONTROL

Nederman LtdO’Flynn Medical Ltd

POWDER HANDLING

Carbon GoupFlexachem Manufacturing LtdGEA Process Technologies LtdGoliath Packaging Systems LtdIdex Pump Technologies (Ireland) LtdProSys Containment and Sampling TechnologyQuitmann O’Neill Packaging LtdWrenTech Ltd

POWER SUPPLY

ESB Independent Energy

PRESSURE MEASUREMENTS/SWITCHES/VESSELS

Axium ProcessP.J. Boner & Co. LtdBS&B Safety Systems LtdCross Technical SolutionsFlexachem Manufacturing LtdGraham Hart (Process Technology) LtdManotherm LtdNorgren Ireland LtdPetrochem Pipeline Supply Ltd

PRESSURE VESSELS

Flexachem Manufacturing LtdPetrochem Pipeline Supply Ltd

PRESSURE RELIEF

BS&B Safety Systems LtdFlexachem Manufacturing LtdGEA Process Technologies LtdManotherm LtdNorgren Ireland LtdPetrochem Pipeline Supply LtdPilz IrelandTyco Valves & Controls Ireland Ltd

PROCESS CONTROL

Axium ProcessP.J. Boner & Co. LtdFlexachem Manufacturing LtdGEA Process Technologies LtdManotherm LtdNorgren Ireland LtdO’Flynn Medical LtdPetrochem Pipeline Supply LtdPilz IrelandSartorius Mechatronics LtdWeber Labelling & CodingZenith Technologies

PROCESS DESIGN

GEA Process Technologies LtdPilz IrelandPM GroupWeber Labelling & Coding

PROCESS & MECHANICAL

ENGINEERING CONTRACTORS

Axium Process Pilz IrelandGEA Process Technologies Ltd

PROJECT MANAGEMENT

Axium ProcessCross Technical SolutionsGEA Process Technologies LtdGlanbia EstatesGoliath Packaging Systems LtdJohnston Logistics LtdPilz IrelandPM GroupZenith Technologies

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PROTECTIVE CLOTHING/APPARATUS

Fisher ScientificO’Flynn Medical Ltd

PUMPS

Fisher ScientificFlexachem Manufacturing LtdGEA Process Technologies LtdIdex Pump Technologies (Ireland) LtdProSys Containment and Sampling Technology

QUALITY & COMPLIANCE

Ann McGee Consulting Ltd

REACTORS

Flexachem Manufacturing LtdGraham Hart (Process Technology) Ltd

RECRUITMENT

Berkley GroupBrightwaterICDS Recruitment ConsultantsLancaster RecruitmentMatrix RecruitmentO’Loughlin PartnershipScience Recruitment IrelandZenith Technologies

R & D

Axium ProcessLancaster LaboratoriesPPD Inc.SciChem - CorkSciChem - DublinTopchem Laboratories LtdWrenTech Ltd

REFRIGERATION/FREEZING

Cross Technical SolutionsCRS Mobile Cold StorageDalkiaFisher ScientificGEA Process Technologies LtdSciChem - CorkSciChem - Dublin

RENEWABLE ENERGY

ESB Independent EnergySustainable Energy Authority of Ireland

SANITARY TUBING

Flexachem Manufacturing LtdMicro Hydraulics Ltd/Micro Industries LtdPetrochem Pipeline Supply Ltd

SCADA/DCS/MIS

P.J. Boner & Co. LtdCross Technical SolutionsZenith Technologies

SCRUBBERS

Flexachem Manufacturing LtdGraham Hart (Process Technology) Ltd

SEALS & GASKETS

Flexachem Manufacturing LtdGEA Process Technologies LtdMicro Hydraulics Ltd/Micro Industries LtdQuitmann O’Neill Packaging Ltd

SIEVING

Fisher ScientificWrenTech Ltd

SOFTWARE

O’Flynn Medical LtdSartorius Mechatronics LtdWaters Chromatography IrelandWeber Labelling & CodingZenith Technologies

SOLVENT RECOVERY/SERVICES

Associated Chemicals LtdIndaver IrelandSoltec (Ireland) Ltd

STAINLESS STEEL/FITTINGS/PRODUCTS

Festo Ltd Fisher ScientificFlexachem Manufacturing LtdGEA Process Technologies LtdIdex Pump Technologies (Ireland) LtdInterpacMicro Hydraulics Ltd/Micro Industries LtdPetrochem Pipeline Supply LtdQuitmann O’Neill Packaging Ltd

STEAM EQUIPMENT

Flexachem Manufacturing LtdManotherm LtdPetrochem Pipeline Supply Ltd

STORAGE/BUNDING

C+G Logistics GroupCRS Mobile Cold StorageInterpacJohnston Logistics LtdSciChem - CorkSciChem - Dublin

SUPPLY CHAIN MANAGEMENT

Catalent Pharma SolutionsCarbon GoupC+G Logistics GroupChesapeakeJohnston Logistics LtdKWE (Ireland) Ltd

SUSTAINABILITY

PM Group

TABLETING EQUIPMENT

Flexachem Manufacturing LtdGEA Process Technologies LtdGoliath Packaging Systems LtdSepha LtdWrenTech Ltd

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TANKS

Axium ProcessCeltic Forwarding LtdComplas Packaging LtdEnva Ireland LtdFlexachem Manufacturing LtdGEA Process Technologies LtdMicro Hydraulics Ltd/Micro Industries LtdQuitmann O’Neill Packaging LtdWrenTech Ltd

TEMPERATURE CONTROL

P.J. Boner & Co. LtdCross Technical SolutionsFlexachem Manufacturing LtdJohnston Logistics LtdManotherm LtdPetrochem Pipeline Supply Ltd

TESTING SERVICES

AnectoP.J. Boner & Co. LtdFlexachem Manufacturing LtdGEA Process Technologies LtdIrish National Accreditation BoardLancaster LaboratoriesPPD Inc.

THERMAL IMAGING/THERMOGRAPHY

Manotherm Ltd

TRANSPORT & LOGISTICS

C+G Logistics GroupCeltic Forwarding LtdHazchem Training LtdIrish Exporters Assoc.-Life Sciences Irl.Johnston Logistics LtdKWE (Ireland) LtdQuitmann O’Neill Packaging Ltd

TUBE SETS/DISPOSABLES

Fisher ScientificMicro Hydraulics Ltd/Micro Industries Ltd

VACUUM SYSTEMS

Fisher ScientificFlexachem Manufacturing LtdNederman LtdNorgren Ireland LtdWrenTech Ltd

VALVES

Axium ProcessP.J. Boner & Co. LtdBS&B Safety Systems LtdFlexachem Manufacturing LtdGEA Process Technologies LtdManotherm LtdMicro Hydraulics Ltd/Micro Industries LtdNorgren Ireland LtdPetrochem Pipeline Supply LtdProSys Containment and Sampling TechnologyTyco Valves & Controls Ireland Ltd

VALIDATION

Ann McGee Consulting LtdCarbon GoupCross Technical SolutionsGEA Process Technologies LtdPilz IrelandPM GroupPPD Inc.Waters Chromatography IrelandZenith Technologies

VENTILATION

Cross Technical SolutionsNederman Ltd

VISION SYSTEMS

Lister Machine Tools LtdWeber Labelling & Coding

WAREHOUSE MANAGEMENT

Celtic Forwarding LtdComplas Packaging LtdGoliath Packaging Systems LtdJohnston Logistics LtdZenith Technologies

WASHING EQUIPMENT

GEA Process Technologies LtdGoliath Packaging Systems LtdSciChem - CorkSciChem - DublinWrenTech Ltd

WASTE MANAGEMENT/BALERS/RECYCLING

Axium ProcessGoliath Packaging Systems LtdIndaver IrelandIdex Pump Technologies (Ireland) LtdInterpacOcon Chemicals LtdQuitmann O’Neill Packaging LtdSoltec (Ireland) Ltd

REVERSE OSMOSISAxium Process

WATER TREATMENT

ABB LtdAssociated Chemicals LtdAxium ProcessCarbon GoupFlexachem Manufacturing LtdNorgren Ireland LtdPM Group

WEIGHING

P.J. Boner & Co. LtdCalibration TechnologyFisher ScientificGoliath Packaging Systems LtdSartorius Mechatronics LtdSciChem - CorkSciChem - DublinWeber Labelling & CodingWrenTech Ltd

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COMPANY LISTINGS

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ABB LTDAddress: Belgard Road,

Tallaght, Dublin 24.Tel: (01) 405 7300Fax: (01) 405 7327Email: marketing@ie.abb.comWeb: www.abb.comType of Business: Lifescience

solutions.

ANECTOAddress: Mervue Business

Park, Co. Galway.Tel: (091) 757 404Fax: (091) 757 387Email: sales@anecto.comWeb: www.anecto.comType of Business: Dangerous goods

packaging testing laboratory.

ANN MCGEE CONSULTING LTDAddress: Unit 63, Grange

Close, Baldoyle Industrial Estate, Baldoyle, Dublin 13.

Tel: (01) 832 5948Fax: (01) 832 5949Email: info@annmcgee.comWeb: www.annmcgee.comType of Business: Pharmaceutical

Quality, Compliance and Training Specialists.

Contact: Office Manager:Jane Lyons

ASSOCIATED CHEMICALS LTDAddress: 16D Euro Business

Park, Little Island, Co. Cork

Tel: (021) 435 1014Fax: (021) 435 1015Email: info@acl.ieType of Business: Chemical SuppliesContact: Managing Director:

Sylvester Cotter

ATC AUTOMATION LTDAddress: Unit B7, Centre Point

Business Park, Oak Road, Dublin 12.

Tel: (01) 460 7070Fax: (01) 461 0771Email: automationsales@atc.ieWeb: www.atc.ie

AXIUM PROCESSAddress: Hendy Industrial

Estate, Hendy, Swansea,SA4 0XP.

Tel: (0044) 1792 883882Fax: (0044) 1792 886049Email: info@axiumprocess.comWeb: www.axiumprocess.com

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BASF IRELAND LTDAddress: Bracetown Business

Park,Clonee,Co. Meath.

Tel: (01) 825 5701Fax: (01) 825 2038Email: yvonne.mullins@basf.comWeb: www.basf.comType of Distributor ofBusiness: chemicals.

B. BRAUN MEDICALAddress: 3 Naas Road

Industrial Park, Dublin 12.

Tel: (01) 709 1801Fax: (01) 709 1889Email: bill.proctor@bbraun.comWeb: www.bbraun.comType of Business: OEM

manufacturing.Contact: Business Unit

Manager: Bill Proctor

BERKLEY GROUPAddress: Dublin:

509 The Capel Building,Mary’s Abbey,Dublin 7.Cork:Mill House,Carrigrohane,Co. Cork.

Tel: (01) 872 4666(021) 428 9600

Email: pharma@berkley.ieWeb: www.berkley.ieContact: Joanna Houston

BETCO MARKETING LTDAddress: Exham House,

The Fingerpost,Douglas, Co. Cork.

Tel: (021) 436 4999Fax: (021) 436 5739Email: dhalpin@betco.ieWeb: www.betco.ieContact: Managing Director:

Diarmuid Halpin

P.J. BONER & CO. LTDINSTRUMENT & WEIGHINGSPECIALISTSAddress: 35 Western Parkway

Business Centre, Ballymount Drive, Ballymount, Dublin 12.

Tel: (01) 450 5050Fax: (01) 450 5183Email: info@pjboner.comWeb: www.pjboner.comType of Instrument &Business: weighing specialists.Contact: Managing Director:

Patrick M. BonerSales Executive:Rory Keane

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BOSCH REXROTH LTDAddress: Unit 6, Lismard

Business Park, Timahoe Road, Portlaoise,Co Laois.

Tel: (057) 867 8200Fax: (057) 867 8201Email: info@boschrexroth.ieWeb: www.boschrexroth.ieType of Business: EngineeringContact: Regional Sales

Manager:John Doran

BRENNTAG IRELANDAddress: Unit 405, Greenogue Business Park, Rathcoole, Dublin 24.Tel: (01) 401 3500Fax: (01) 405 3501Email: bill.maher@brenntag.ieWeb: www.brenntag.ieContact: General Manager:

Bill Maher

BRIGHTWATERAddress: 36 Merrion Square,

Dublin 2.Tel: (01) 662 1000Fax: (01) 662 3900Email: e.moloney@brightwater.ieWeb: www.brightwater.ieContact: Eileen Moloney

BS&B SAFETY SYSTEMS LTDAddress: Raheen Business

Park, Raheen, Co. Limerick.

Tel: (061) 484 700Emergency Delivery:086 241 0615Direct Line: 086 838 5556

Fax: (061) 352 240Email: sales@bsb.ieWeb: www.bsb.ieType of Business: Pressure relief

devices.Contact: Sales Manager:

Patrick Murphy

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CALIBRATION TECHNOLOGYAddress: Innovation Works,

National Technology Park,Co. Limerick.

Tel: (061) 503 132Fax: (061) 338 065Email: service@calibrationtech.ieWeb: www.calibrationtech.ieType of Business: Accredited

calibration of all makes of laboratory equipment.

CAMIDA LTDAddress: Tower House,

New Quay, Clonmel,Co. Tipperary.

Tel: (052) 612 5455Fax: (052) 612 5466Email: info@camida.comWeb: www.camida.comContact: Company Secretary:

Deirdre McGrath

CARBON GROUPAddress: Factory Cross,

Ringaskiddy,Co. Cork.

Tel: (021) 437 8988UK Local Lo-Call:(0044) 8708 504 831

Fax: (021) 437 8950Email: cdeegan@indigo.ie sales@carbon.ieWeb: www.carbon.ieType of Business: Pharmachemicals.Contact: Area Sales Manager:

Carol Deegan

CATALENT PHARMA SOLUTIONS

Address: Unit 26, Cherry Orchard Industrial Estate,Dublin 10.

Tel: (01) 620 0600Fax: (01) 626 2815Email: diarmuid.wilson@catalent.comWeb: www.catalent.comType of Contract manufacturing Business: capabilities as well as

packaging and printedcomponents to the pharmaceuticalindustry.

Contact: Director of Business Development:Diarmuid Wilson

CELTIC FORWARDING LTDAddress: Dublin:

Celtic House,30 Marlborough Street,Dublin 1.Waterford:Belview Port,Slieverue,Co. Waterford.Limerick:2 Church Street,John’s Square,Co. Limerick.

Tel: (01) 865 6000(051) 851 821(061) 467 969

Fax: (01) 874 6745(051) 851 823(061) 467 972

Email: info@celticfwd.ieWeb: www.celticfwd.ieType of Business: Shipping.

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Contact: Director:Finbarr ClearySales Manager:Gerald Kiernan

DGSA Tank Division Manager: Patty deCourcey

C + G LOGISTICS GROUPAddress: Westpoint Business

Park, Navan Road,Mulhuddart, Dublin 15.

Tel: (01) 820 8455Fax: (01) 820 8457Email: info@cglogistics.ieWeb: www.cglogistics.ieContact: General Manager/

Director :Patrick Wogan

CHARPAK MEDICALAddress: 30 St. Peters Road,

Huntingdon,Cambs. UK.

Tel: 0044 1480 434434 Fax: 0044 1480 434545Email: sales@charpak.co.ukWeb: www.charpakmedical.com

CHEMCO IRELAND LTD.Address: Unit 2,

Stadium Business Park, Ballycoolin Road, Cappagh,Dublin 11

Tel: (01) 829 3600Fax: (01) 885 5029 Email: sales@chemco.ieWeb: www.chemco.ieType of Business: Chemical

Distribution.Contact: Sales Director:

Peter Fitzgerald

CHEMTEK SALES LTDAddress: Estuary House,

New Street, Malahide, Co. Dublin.

Tel: (01) 845 3766/63Fax: (01) 845 3172Email: sales@chemtek.ieWeb: www.chemtek.ie

CHESAPEAKEAddress: Enterprise Way,

Hightown Industrial Estate, Newtownabbey,Belfast, BT36 4EW.

Tel: (0044) 2890 804 000Fax: (0044) 2890 804 301Email: sales.pharma@chesapeakecorp.comWeb: www.chesapeake.com/pharmaType of Business: Pharmaceutical and

healthcare packaging (cartons, labels, leaflets and more).

COMPLAS PACKAGING LTDAddress: Naas Industrial

Estate, Dublin Road, Naas, Co. Kildare.

Tel: (045) 874 088/9Fax: (045) 874 090Email: sales@complas.ieWeb: www.complas.ie

CORCORAN CHEMICALS LTDAddress: Kingsbridge House,

17-22 Parkgate Street, Dublin 8.

Tel: (01) 633 0400Fax: (01) 679 3521Email: info@corcoranchemicals.comWeb: www.corcoranchemicals.comType of Business: Distribution.Contact: Sales Department

CROOM PRECISION MEDICALAddress: Enterprise Centre,

Croom,Co. Limerick.

Tel: (061) 397 744Fax: (061) 397 639Email: info@croomprecision.ieWeb: www.croomprecision.comType of Business:Medical device

manufacture.Contact: Managing Director:

Patrick Byrnes

CROSS TECHNICAL SOLUTIONSAddress: Unit 24,

Cookstown Industrial Estate, Cookstown, Tallaght, Dublin 24

Tel: (01) 405 6777Fax: (01) 413 6932Email: jmcgrath@cross

technicalsolutions.ieWeb: www.crosstechnical

solutions.ieType of Business: Refrigeration.Contact: Technical Director:

Jonathan McGrathGeneral Manager:Jason Keating

CRS MOBILE COLD STORAGEAddress: Arctic House,

Carnisle,Kildalkey,Co. Meath

Tel: (046) 943 5000Fax: (046) 943 5068Email: enquiry@crs.ieWeb: www.crs.ieType of Business: Cold storage,

pharmaceuticalstorage, bespoke refigeration

Contact: John Tyrell

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DALKIAAddress: 145 Lakeview Drive,

Airside Business Park,Swords,Co. Dublin

Tel: (01) 870 1200Fax: (01) 870 1201Email: info@dalkia.ieWeb: www.dalkia.ieContact: Managing Director:

Pat GilroyIndustrial DirectorPharmaceutical &Health:Fergus Elebert

DIONEX IRELAND LTDAddress: Unit 9A, Suite 3C,

Plato Business Park, Damastown,Dublin 15.

Tel: (01) 644 0064Fax: (01) 885 1673Email: ireland.info@dionex.comWeb: www.dionex.comType of Business: Scientific analytical

equipment.

E

ENVA IRELAND LTDAddress: Raffeen

Industrial Estate, Ringaskiddy, Co. Cork.

Tel: (021) 438 7200Fax: (021) 438 7299Email: cork@enva.ieWeb: www.enva.ie

ENVIRONMENTALPROTECTION AGENCYAddress: PO Box 3000, Johnstown Castle

Estate,Co. Wexford.

Tel: (053) 916 0600Fax: (053) 916 0699Email: info@epa.ieWeb: www.epa.ie

ESB INDEPENDENT ENERGYAddress: Dublin:

Woodford Business Park, Santry, Dublin 17.Belfast:Forsyth House, Cromac Square, Belfast, BT1 8LA

Tel: (01) 862 8300 (048) 9051 1246

Fax: (01) 862 8350(048) 9027 8400

Email: info@esbie.ieWeb: www.esbie.ieContact: Marketing Manager:

John ConlonCustomer Operations Manager:Susan KinaneCommerical Manager:Derek Russell

EUROLECINSTRUMENTATION LTDAddress: Technology House,

Cluan Enda, Dundalk,Co. Louth.

Tel: (042) 933 3423 Fax: (042) 933 1758 Email: eurolec@esatclear.ieWeb: www.eurolec-instruments.comType of Business: Electronic

instrumentation.Contact: Sales/Marketing

Executive: Chris Mears

F

FESTO LTDAddress: Unit 5,

Sandyford Park, Sandyford Industrial Estate,Dublin 18.

Tel: (01) 295 4955Fax: (01) 295 5680Email: sales_ie@festo.comWeb: www.festo.com/ieType of Business: Automation

company specialising in factory and process automation.

Contact: Sales Manager:Diarmaid Cowhie

FISHER SCIENTIFICAddress: Suite 4, Plaza 212,

Blanchardstown Corporate Park 2, Ballycoolin,Dublin 15.

Tel: (01) 885 5854Fax: (01) 899 1855Email: fsie.sales@thermofisher.comWeb: www.ie.fishersci.comType of Business: Laboratory

supplies.Contact: Marketing

Manager:Gerry Fitzmaurice

FLEXACHEMMANUFACTURING LTDAddress: Donnybrook

Commercial Centre,Douglas, Co. Cork.

Tel: (021) 461 7200 Fax: (021) 489 1297Email: sales@flexachem.comWeb: www.flexachem.comType of Business: Manufacturer/

Distributor.Contact: Commercial Director:

Agnes Mullins

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GEA PROCESS TECHNOLOGIESIRELAND LTDAddress: Ash House,

Lime Tree Avenue,Millennium Park,Naas,Co. Kildare.

Tel: (045) 981 200Fax: (045) 981 232Email: postbox@geapt.ieWeb: www.geapt.ieContact: Business

Development Manager:Adrian Field

GLANBIA ESTATESAddress: Glanbia House,

Ring Road, Co. Kilkenny.

Tel: (056) 777 2288Email: gmullally@glanbia.comWeb: www.kilmeadenfields.comType of Business: Property Business

Unit of Glanbia PLC.Contact: CEO: Ger Mullally

GOLIATH PACKAGINGSYSTEMS LTDAddress: Beechwood, Nenagh,

Co. Tipperary.Tel: (067) 37893Fax: (067) 34794Email: info@goliath.ieWeb: www.goliath.ieType of Business: Supply &

installation of packaging equipment and materials handling systems.

Contact: Director:George O’Leary

GOULDING CHEMICALS LTDAddress: Centre Park Road,

Marina, Co. Cork.Tel: (021) 491 1611Fax: (021) 491 1660Email: pollockm@gouldings.ieWeb: www.gouldings.ieType of Business: Chemical

distributor.

GRAHAM HART(PROCESS TECHNOLOGY) LTDAddress: Friars Ind. Estate,

Bradford Road, Idle, Bradford, BD10 8SW, UK.

Tel: (0044) 1274 617021Fax: (0044) 1274 618614Email: sales@graham-hart.comWeb: www.graham-hart.comContact: Sales Director:

Stephen Hart

GS1 IRELANDAddress: The Nutley Building

Merrion Road, Dublin 4.

Tel: (01) 208 0660Fax: (01) 208 0670Email: info@gs1ie.orgWeb: www.gs1ie.orgContact: Member Support Services: Karen Murphy

GUNNEBO IRELAND LTDAddress: Dublin:

601 Western Industrial Estate, Dublin 12.Cork:Unit 4, Hillview Campus,Euro Business Park,Little Island, Co. Cork.

Tel: (01) 458 4836(021) 452 4940

Fax: (01) 458 4835(021) 452 4409

Email: noel@gunnebolifting.com bryan@gunnebolifting.comWeb: www.gunnebolifting.com

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HAZCHEM TRAINING LTDAddress: G10, Maynooth

Business Campus,Maynooth, Co. Kildare.

Tel: (01) 629 1800Fax: (01) 629 1822Email: info@hazchem.ieWeb: www.hazchem.ieContact: Director:

Michelle Cleere

HENLEY FORKLIFTGROUP LTDAddress: Henley Industrial

Park, Killeen Road, Dublin 10.

Tel: (01) 620 9200Fax: (01) 626 5406Email: fwilson@henley.ie

phammett@henley.ieWeb: www.henley.ieType of Business: Forklifts &

Warehousing Equipment. Specialists in flameproof forklifttrucks.

Contact: Director:Mark KennyDirector:Brian O’Connell

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HOCHTIEF FACILITYMANAGEMENTAddress: Ireland:

HOCHTIEF Facility ManagementIreland Ltd.,Landscape House,Landscape Road,Churchtown,Dublin 14. UK:HOCHTIEF Facility Management UK Ltd,HOCHTIEF House,2 Ibis Court, Centre Park, WarringtonWA1 1RL

Tel: (01) 215 7000+44 1925 404 500

Fax: (01) 215 7070+44 1925 404 598

Email: contactus@hochtief-fm.comWeb: www.hochtief-fm.ie www.hochtief-facilitymanagement.co.ukType of Business: Facilities

Management.Contact: Region Operations

Manager:Ray Casey

H.R. HOLFELD(HYDRAULICS) LTDAddress: 2-4 Merville Road,

Stillorgan,Co. Dublin.

Tel: (01) 288 7361Fax: (01) 288 7380Email: pumps@holfeld.ieWeb: www.holfeld.ieType of Process Pump Business: Supplier.Contact: Business

Development & Key Accounts:Emmet Connelly

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ICDS RECRUITMENTCONSULTANTSAddress: 24 Upper Fitzwilliam

Street, Dublin 2.Tel: (01) 632 1200Fax: (01) 676 2079

Email: info@icds.ieWeb: www.icds.ieType of Business: Recruitment

consultants.Contact: Recruitment

Director:Anthony McLoughlin

IDA IRELANDAddress: Wilton Park House,

Wilton Place,Dublin 2.

Tel: (01) 603 4000Email: idaireland@ida.ieWeb: www.idaireland.comType of Business: Investment

promotion agency.Contact: Global Head of Life

Sciences:David Shanahan

IDEX PUMP TECHNOLOGIES(IRELAND) LTDAddress: R79, Shannon

Industrial Estate, Shannon, Co. Clare.

Tel: (061) 471 933Fax: (061) 475 046Email: chennessy@idexcorp.comWeb: www.blagdonpump.com

www.vikingpump.comContact: Customer Service

Administrator:Carmel Hennessy

INDAVER IRELANDAddress: 4 Haddington Terrace,

Dun Laoghaire,Co. Dublin.

Tel: (01) 280 4534Fax: (01) 280 7865Email: info@indaver.ieWeb: www.indaver.ieType of Business: Hazardous & non-

hazardous waste disposal and recovery ensuring full compliance.

INDUSTRIAL PACKAGING LTDAddress: Killarney Road,

Bray, Co. Wicklow.Tel: (01) 286 4010Email: mail@industrialpackaging.ieWeb: www.industrialpackaging.ieType of Business: Manufacturer of

fibre drums.Contact: Managing Director:

Norman Lee

INTERPACAddress: 67E Heather Road,

Sandyford Industrial Estate, Dublin 18.

Tel: (01) 294 0600Email: ian@interpac.ieWeb: www.interpac.ieType of Business: Packaging.Contact: Managing Director:

Ian Sutton

INVEST NORTHERN IRELANDAddress: Bedford Square,

Bedford Street, Belfast, BT2 7ES.

Tel: (048) 9069 8601Fax: (048) 9043 6536Email: patricia.oneill@investni.comWeb: www.investni.comType of Business: Economic

development agency.Contact: Patricia O’Neill

IRISH EXPORTERS ASSOCIATION - LIFE SCIENCES IRELANDAddress: 28 Merrion Square,

Dublin 2.Tel: (01) 661 2182Fax: (01) 661 2315Email: raulmolina@ irishexporters.orgWeb: www.irishexporters.orgType of Business: Life Sciences

Ireland is Industry Grouping within the Irish Exporters Association.

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IRISH NATIONALACCREDITATION BOARD, THEAddress: Wilton Park House,

Wilton Place, Dublin 2.

Tel: (01) 607 3003Fax: (01) 607 3109Email: inab@inab.ieWeb: www.inab.ieType of Business: Provides

accreditationof laboratories, certification & inspection bodies.

Contact: Information Officer:Orla Doyle

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JAVA CLINICAL RESEARCH LTDAddress: Fitzwilliam Buiness

Centre, 26 Upper Pembroke St,Dublin 2.

Tel: 01 637 3903 Fax: 01 637 3907 Email: info@javacr.comWeb: www.javacr.comType of Business: Clinical ResearchContact: Managing Director:

Ruth Nallen

JOHNSTON LOGISTICS LTDAddress: Blackchurch Business

Park, Rathcoole,Co. Dublin.

Tel: + 353 1 401 3333Fax: + 353 1 458 8015Email: info@jol.ie

chrisf@jol.ieWeb: www.johnstonlogistics.ieType of Business: Logistics & distribution

(Complete SupplyChain Management).

Contact: Sales Executive:Chris Fogarty

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KWE (IRELAND) LTDAddress: Dublin: Unit 4

Horizon Logistics Park, New Naul Rd, Harristown, Swords, Co. Dublin.Cork: Unit 4&5, South RingWest Business Pk,Tramore Road,Co. Cork.

Tel: (01) 823 9600(021) 497 5722

Fax: (01) 836 1111(021) 497 5727

Email: kwedub@ea.kwe.com kweork@ea.kwe.comWeb: www.kwe.comContact: Sales Manager:

Karl O’Reilly

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LANCASTER LABORATORIESAddress: IDA Business Park,

Clogherane, Dungarvan,Co. Waterford

Tel: (058) 48 300Fax: (058) 42 855Email: info@lancasterlabs.comWeb: www.lancasterlabs.comType of Business: Contract Analytical

ServicesContact: Business Development

Director:Mark Glass

LENNOX LABORATORYSUPPLIES LTDAddress: John F. Kennedy

Drive, Naas Road, Dublin 12.

Tel: (01) 455 2201Fax: (01) 450 7906Email: sales@lennox.ie

greg@lennox.ieWeb: www.lennox.ieType of Business: Laboratory suppliers.

LIANCOAddress: Rathclaren,

Kilbrittain, Co. Cork.Tel: (023) 49681

087 260 5447Fax: (023) 49677Email: lianco@iol.ieWeb: www.lianco.netType of Powder drying, Business: processing,

conveying,and containment.

LISTER MACHINE TOOLS LTDAddress: PO Box 838,

Bluebell Industrial Estate,Dublin 12.

Tel: (01) 450 8866Fax: (01) 450 9836Email: sales@listermachinetools.comWeb: www.listermachinetools.comType of Sale of machine Business: tools & associated

equipment.

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MACLACHLAN & DONALDSONAddress: 47 Merrion Square,

Dublin 2.Tel: (01) 676 3465Fax: (01) 661 2083 Email: mail@maclachlan.ieWeb: www.maclachlan.ieType of Business: Intellectual Property AttorneysContact: Dr. YvonneMcKeown

MANOTHERM LTDAddress: 4 Walkinstown Road,

Dublin 12.Tel: (01) 452 2355Fax: (01) 451 6919Email: info@manotherm.ieWeb: www.manotherm.ieType of Business: Distributors of controls and instrumentation.Contact: Managing Director:

R.C. Gilbert

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MATHESON ORMSBY PRENTICEAddress: 70 Sir John

Rogerson’s Quay,Dublin 2.

Tel: (01) 232 2000Fax: (01) 232 3333Email: helen.middleton@mop.ieWeb: www.mop.ieType of Business: Law firm

MATRIX RECRUITMENTAddress: Dolphin House,

George’s Street,Waterford

Tel: (051) 850 206Fax: (051) 850 530Email:waterford@matrixrecruitment.ieWeb: www.matrixrecruitment.ieType of Business: RecruitmentAgencyContact: Managing Director:

Kierán McKeown

MEASOM FREERAddress: 37-41 Chartwell

Drive, Wigston, Leicester, LE18 2FL, UK.

Tel: (0044) 1162 881588Fax: (0044) 1162 813000Email: sales@measomfreer.co.ukWeb: www.measomfreer.co.ukType of Business: Manufacturer.Contact: Sales Director:

Mark Freer

MICRO HYDRAULICS LTD/MICRO INDUSTRIES IRELANDAddress: Dublin:

2003 Orchard Avenue, CitywestBusiness Campus,Dublin 24.Cork:Unit 6/7 Cherrywood Business Park,Little Island, Co. Cork.

Tel: (01) 463 9000Fax: (01) 410 5609Email: info@microhydraulics.ieWeb: www.microhydraulics.ieType of Business: Sanitary hose, tube & accessories.

Contact: Sales Representative:Ralph FitzsimonsSales Representative:Dave O’Donavan

N

NATIONAL CHEMICAL CO. LTDAddress: NCC House,

42 Lower Leeson St.,Dublin 2.

Tel: (01) 613 1400Fax: (01) 634 0132Email: info@ncc.ieWeb: www.ncc.ieType of Business: Distributor.Contact: Sales Director:

Christy Smith

NEDERMAN LTD

Address: Premier Business Centre,3013 Lake Drive, Citywest Business Campus,Dublin 24.

Tel: (01) 469 3729Fax: (01) 469 3321Email: ciaran.wilkinson@

nederman.ieWeb: www.nederman.ieType of Business: Fume, Dust &

Materials Handling.

NORGREN IRELAND LTDAddress: 137 Slaney Close,

Dublin Industrial Estate, Glasnevin, Dublin 11.

Tel: (01) 830 0288Fax: (01) 830 0082Email: dublin@norgren.comWeb: www.norgren.comType of Business: Fluid and motion

control. ‘Pneumatics’automationcomponents.

NPP GROUP LTDAddress: Unit 509,

Mitchelstown Road,Northwest Business Park, Ballycoolin,Blanchardstown,Dublin 15.

Tel: (01) 880 9299Email: sales@npp.ie

bmcmahon@npp.ieWeb: www.npp.ieType of Business: Flexible packaging

suppliers & distributors.

Contact: Commercial Director:Ken Martin

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OCON CHEMICALS LTDAddress: Unit 5, South Cork

Industrial Estate, Vicars Road,Pouladuff, Co. Cork.

Tel: (021) 431 8555Fax: (021) 431 8560Email: info@oconchemicals.comWeb: www.oconchemicals.comContact: Managing Director:

Frank Mulcahy

O’FLYNN MEDICAL LTDAddress: Westend, Millstreet,

Co. Cork.Tel: (029) 21 799Fax: (029) 70 191Email: info@oflynnmedical.comWeb: www.oflynnmedical.comType of Business: Distributor of

Scrubex “Automated Protective Clothing Distributor”

Contact: Managing Director:Tadhg O’Flynn

O’LOUGHLIN PARTNERSHIPAddress: 1 Rowan Park Ave,

Blackrock, Co. Dublin.Tel: (01) 280 0430Fax: (01) 696 1029Email: info@olpartners.comWeb: www.olpartners.ie

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Type of Business: Executive search,selection & interim management.

ONE STOP HANDLING IRELAND LTDAddress: 113 Millennium Trade

Park, BallycoolinDublin 15

Tel: 00353 1 864 9008Fax: 00353 1 864 9028Email: info@onestophandling.ieWeb: www.onestophandling.ieType of Business: OSHI supply

Materials Handling Solutions & Lifting Equipment to indus-tries as wide rang-ing and diverse as Electronic, Computer, Packaging and Woodworking, Metal, Food, Drinks, Pharmaceutical: lit-erally all industries. We can also modify and manufacture non standard equipment for special applications.

Contact: Paul Parkes

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PEGLER & LOUDEN IRELANDA DIVISION OF BSS (IRELAND) LTD

Address: Dublin:301 South CircularRoad, White HeatherIndustrial Estate,Dublin 8.

Tel: (01) 416 5170Fax: (01) 416 5175Email: jmelinn@pli.ie

jgeraghty@pli.ieWeb: www.fcx-pli.com

Cork: South Link Park,Ballycurreen RoadGrange, Co. Cork.

Tel: (021) 497 7128Fax: (021) 491 5213Email: Cork:

p.obrien@pli.iep.cronin@pli.ie

Web: www.fcx-pli.com

PETROCHEM PIPELINESUPPLY LTDAddress: Unit 14, Euro

Business Park, Little Island, Co Cork.

Tel: (021) 435 1300Fax: (021) 435 1166Email: sales@petrochem.ieWeb: www.petrochem.ieType of Business: Supplier of

stainless pipes, fittings,flanges, fastners, valves, instrumentation and controls to the Irish Pharmaceutical and biotech markets.

Contact: Sales Manager:Dave Ahern

PILZ IRELANDAddress: Cork Business &

Technology Park, Model Farm Road, Co Cork.

Tel: (021) 434 6535Fax: (021) 480 4994Email: sales@pilz.ieWeb: www.pilz.ieType of Business: Process and

machinery saftey engineering services and training.

Contact: Sales Manager:Andrew DonnellyMD: John McAuliffe

PM GROUPAddress: Cork: Loughmahon

Technology Park,Blackrock, Co. Cork.Dublin: KillakeeHouse, Belgard Square,Tallaght, Dublin 24.

Tel: (021) 435 8922(01) 404 0700

Email: info@pmg.ieWeb: www.pmg.ieContact: Billy O’Neill

Paul HallamBusiness DevelopmentMarketing Executive:Vicki Shanahan

PPD, INC.Address: Building C, Athlone Business & Technology Park, Garrycastle, Athlone, Co. WestmeathTel: (0906) 460 300Fax: (0906) 460 301Email: susan.neenan@ppdi.comWeb: www.ppdi.comType of Business: Contract Research

Organisation Contact: Director, GMP Labs,

Europe:Susan Neenan

PRIMEPAC LTDAddress: Unit 2,

Caulside Drive, Newpark IndustrialEstate,Antrim,BT41 2DU.

Tel: (0044) 2894 428 188Fax: (0044) 2894 428 177Email: sales@primepacltd.comWeb: www.primepacltd.comType of Business: Manufacturer &

supplier of plastic containers.

Contact: Director:John McGahon

PROSYS CONTAINMENT ANDSAMPLING TECHNOLOGYAddress: Rosehill Business

Centre, Ballinacurra,Midleton,Co. Cork.

Tel: (021) 461 3890Fax: (021) 461 3891Email: mmcl@prosys.ieWeb: www.prosys.ieType of Business: Design and

maunfacture of sampling and isolators for the pharmaceutical and chemical industries.

Contact: Managing Director:Michael McLoughlin

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QUITMANN O’NEILL PACKAGINGLTDAddress: St. Brendan’s Road,

Portumna,Co. Galway.

Tel: (090) 974 1148/9Fax: (090) 974 1459Email: sales@quitmannoneill.comWeb: www.qonpack.comType of Business: Packaging stockist

& distributors.Contact: General Manager:

David O’Neill

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SARTORIUS MECHATRONICSUK LTDAddress: Unit 41, The Business

Centre, Stadium Business Park, Ballycoolin Road, Dublin 11.

Tel: (01) 808 9050Fax: (01) 808 9388Email: info.ireland@

sartorius.comWeb: www.sartorius.ieType of Business: Laboratory &

process technology provider. Sales & service of laboratory & process weighing equipment.

Contact: Nick Parsons

SCICHEM - CORKAddress: Unit 14,

Barryscourt Business Park, Carrigtwohill, Co. Cork.

Tel: (021) 488 2388Fax: (021) 488 2389Email: cork@scichem.comWeb: www.scichem.comType of Business: Laboratory

Suppliers.Contact: Branch Manager:

John Molloy

SCICHEM - DUBLINAddress: Greenhills Industrial

Estate, Walkinstown,Dublin 12.

Tel: (01) 450 4077Fax: (01) 450 4328Email: dublin@scichem.comWeb: www.scichem.comType of Business: Laboratory

Suppliers.Contact: Branch Manager:

Seamus Amond

SCIENCE FOUNDATIONIRELAND (SFI)Address: Wilton Park House,

Wilton Place, Dublin 2.Tel: (01) 607 3200Fax: (01) 607 3201Email: info@sfi.ieWeb: www.sfi.ieType of Business: Government

funding agency for research.

Contact: Head of Industry - Research Development:Dr. Paul Dodd

SCIENCE RECRUITMENT IRELANDAddress: 40 Grand Canal

Street Upper, Dublin 4.Tel: (01) 667 5008Fax: (01) 667 6714Email: info@sri.ieWeb: www.sri.ieType of Business: Specialist science

recruitment agency.Contact: Managing Director:

Helen McGardle

SEPHA LTDAddress: Unit 25,

Carrowreagh Business Park, Carrowreagh Road, Dundonald,Northern Ireland, BT16 1QQ.

Tel: (048) 9048 48 48+44 (0) 2890 48 48 48

Fax: (048) 9048 08 90+44 (0) 2890 48 08 90

Email: info@sepha.comWeb: www.sepha.comType of Business: Manufacturer of

laboratory scale blister packers, non-destructive leak

testers & deblistering machines for the pharmaceuticalindustry.

Contact: Account Manager UK & Ireland:Tanya Kilfeather

SIGMA-ALDRICH IRELAND LTDAddress: Vale Road,

Arklow, Co. Wicklow.Tel: (0402) 203 70Fax: (0402) 203 75Email: eircustsupport@sial.comWeb: www.sigma-aldrich.comContact: Business Unit Manager:

Nicola McCarthyType of Business: Chemical /

Pharmaceutical

SMURFIT KAPPA IRELANDAddress: Ballymount Road,

Walkinstown,Dublin 12.

Tel: (01) 409 0000Fax: (01) 456 4506Email: info@smurfitkappa.ieWeb: www.smurfitkappa.ie

www.skpackaging.ieType of Business: Packaging.Contact: Marketing Manager: Mark Munnelly

SOLTEC (IRELAND) LTDAddress: Zone A, Mullingar

Business Park, Mullingar,Co. Westmeath.

Tel: (044) 933 5133Email: info@soltec.ieWeb: www.soltec.ieType of Business: Soltec is Ireland’s

only commercially operated solvent recycling plant. Solid hazardous waste collections also provided.

Contact: Business Development Manager:Michael Corcoran

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SUSTAINABLE ENERGYAUTHORITY OF IRELANDAddress: Glasnevin,

Dublin 9.Tel: (01) 836 9080Fax: (01) 837 2848Email: info@sei.ieWeb: www.sei.ieType of Business: Energy advice &

information.

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TOPCHEM LABORATORIES LTDAddress: 70 Western Parkway

Business Park,Ballymount Drive,Dublin 12.

Tel: (01) 460 8818Email: sales@topchemlabs.com

dwalsh@topchem.ieWeb: www.topchem.ieType of Business: Chemical synthesis.Contact: Managing Director:

Dr. Donal Coveney

TOYOTA MATERIAL HANDLINGIRELAND LTDAddress: Killeen Road,

Dublin 12. Tel: (01) 419 0321Fax: (01) 419 0325 Type of Business: Forklift and

Warehouse Supplies.Contact: Sales Manager:

Robert O’ Reilly

TYCO VALVES & CONTROLS IRELAND LIMITEDAddress: Victoria House,

Beaumont Avenue, Churchtown, Dublin 14.

Tel: (01) 295 1101Email: tkilbane@tyco-valves.comWeb: www.tycoflowcontrol-eu.comType of Business: Industrial valves &

controls.Contact: General Manager:

Tony Kilbane

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UNIVAR LTDAddress: 536 Grants Crescent,

Greenogue Business Park, Rathcoole, Co. Dublin.

Tel: (01) 401 9800Fax: (01) 401 9142Email: pharma.sales@

univareurope.comWeb: www.univareurope.comType of Business: Ingredients -

pharma industry including API’s, excipients, process chems, solvents & intermediates.

Contact: Account Manager:John McCluskey

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WATERS CHROMATOGRAPHYIRELANDAddress: Unit 3.1 Woodford

Business Park, Santry,Dublin 9.

Tel: (01) 448 1500Fax: (01) 448 1510Email: ireland@waters.comWeb: www.waters.comType of Business: The company

designs, manufactures, sells and services HPLC, UPLC, mass spectrometry instrument systemsand support products, including chemistry consumables and post-warrantyservice plans.

Contact: National Sales Manager:Joe Kildunne

WEBER LABELLING & CODINGAddress: Kilcannon Ind. Est.,

Old Dublin Road, Enniscorthy, Co. Wexford.

Tel: (053) 923 3778Fax: (053) 923 3284Email: sales@weberireland.comWeb: www.weberireland.comContact: Operations Manager:

Patrick Hughes

WRENTECH LTDAddress: Wrentech House,

Crosshaven Hill,Crosshaven, Co. Cork.

Tel: (021) 483 2644Fax: (021) 483 1363Email: smurray@wrentech.ieWeb: www.wrentech.ieContact: Sales Administrator:

Siobhan Murray

ZZenith TechnologiesAddress: Portgate Business

Park, Ringaskiddy,Co. Cork

Tel: (021) 437 0200Email: peter.sheehan@ zenithtechnologies.comWeb: www.zenithtechnologies.comContact: Sales & Marketing

Manager:Peter Sheehan

ZETESAddress: National

Technology Park,Plassey,Co. Limerick.

Tel: (061) 333 1881890 252 869 Lo-call

Email info@ie.zetes.comWeb: www.zetes.ieType of Business: Zetes provides

innovative solutions, improving efficiency, productivity and tracebility through the supply chain.

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ACADEMY OF MEDICAL LABORATORY SCIENCE Tel: (01) 677 5602 E-mail: mail@amls.ie Web: www.amls.ie

ADVISORY COUNCIL FORSCIENCE, TECHNOLOGY& INNOVATIONTel: (01) 607 3162E-mail:firstname.surname@forfas.ieWeb: www.sciencecouncil.ie

AN BORD PLEANALATel: (01) 858 8100LoCall: 1890 275 175E-mail: bord@pleanala.ieWeb: www.pleanala.ie

CHAMBERS IRELANDTel: (01) 661 2888E-mail: info@chambers.ieWeb: www.chambers.ie

COMPANIESREGISTRATION OFFICETel: (01) 804 5200LoCall: 1890 220 226E-mail: info@cro.ieWeb: www.cro.ie

DEPT. OF CHEMICAL ENGINEERS, UCDTel: (01) 716 1825E-mail: chemical.eng@ucd.ieWeb: www.ucd.ie/chembioeng

DEPT. OF ENTERPRISE, TRADE & EMPLOYMENTTel: (01) 631 2121LoCall: 1890 220 222E-mail: info@entemp.ieWeb: www.entemp.ie

DEPT. OF THEENVIRONMENT, HERITAGE& LOCAL GOVERNMENTTel: (01) 888 2000LoCall: 1890 20 20 21E-mail: press-office@environ.ieWeb: www.environ.ie

ELECTRICITYSUPPLY BOARDTel: 1850 372 372E-mail: esbnetworks@esb.ieWeb: www.esb.ie

ENTERPRISE IRELANDTel: (01) 727 2000E-mail: client.service@enterprise-ireland.comWeb: www.enterprise-ireland.com

ENVIRONMENTAL HEALTHOFFICERS’ ASSOCIATIONTel: (01) 276 1211E-mail: amanda@ehoa.ieWeb: www.ehoa.ie

ENVIRONMENTALPROTECTION AGENCYTel: (053) 916 0600LoCall: 1890 335 599E-mail: info@epa.ieWeb: www.epa.ie

BIOTECHNOLOGYIRELANDTel: (01) 727 2692E-mail:editor@biotechnologyireland.comwww.biotechnologyireland.com

FAS - TRAINING & EMPLOYMENT AGENCYTel: (01) 607 0500E-mail: info@fas.ieWeb: www.fas.ie

FORFASTel: (01) 607 3000E-mail:firstname.surname@forfas.ieWeb: www.forfas.ie

HEALTH AND SAFETY AUTHORITYTel: 1890 289 389E-mail: wcu@hsa.ieWeb: www.hsa.ie

HEALTH RESEARCHBOARDTel: (01) 234 5000E-mail: hrb@hrb.ieWeb: www.hrb.ie

HIGHER EDUCATIONAUTHORITYTel: (01) 231 7100E-mail: info@hea.ieWeb: www.hea.ie

IDA - INDUSTRIAL DEVELOPMENT AGENCYTel: (01) 603 4000E-mail: idaireland@ida.ieWeb: www.idaireland.com

INSTITUTE OF CHEMISTRY OF IRELANDE-mail:info@instituteofchemistry.orgwww.instituteofchemistry.org

INTERNATIONAL SOCIETY FOR PHARMACEUTICALENGINERING (ISPE)Tel: +32 2 743 4422E-mail: ispe@associationhq.orgWeb: www. ispe.org

IRISH BIOINDUSTRYASSOCIATIONTel: (01) 605 1584E-mail: firstname.surname@ibec.ieWeb: www.ibec.ie/ibia

IRISH BUSINESS & EMPLOYERSCONFEDERATION (IBEC)Tel: (01) 605 1500 E-mail: info@ibec.ie Web: www.ibec.ie

IRISH CLEANROOM SOCIETYTel: 087 285 9679E-mail: info@cleanrooms-ireland.ieWeb: www.cleanrooms-ireland.ie

IRISH COSMETICS, DETERGENT & ALLIED PRODUCTS ASSOCIATIONTel: (01) 605 1584E-mail: siobhan.murphy@ibec.ieWeb: www.icda.ie

IRISH EXPORTERSASSOCIATIONTel: (01) 661 2182E-mail: iea@irishexporters.ie Web: www.irishexporters.ie

IRISH MEDICAL DEVICES ASSOCIATIONTel: (01) 605 1529E-mail: firstname.surname@ibec.ieWeb: www.ibec.ie/imda

IRISH MEDICINES BOARDTel: (01) 676 4971E-mail: imb@imb.ieWeb: www.imb.ie

IRISH NATIONAL ACCREDITATION BOARDTel: (01) 607 3003E-mail: info@inab.ieWeb: www.inab.ie

IRISH PATENTS OFFICE Tel: (056) 772 0111E-mail: patlib@patentsoffice.ie Web: www.patentsoffice.ie

IRISH PHARMACY UNIONTel: (01) 4936401E-mail: firstname.surname@ipu.ie Web: www.ipu.ie

IRISH VENTURE CAPITAL ASSOCIATIONTel: (01) 276 4647E-mail: secretary@ivca.ie Web: www.ivca.ie

INVESTNORTHERN IRELANDTel: (048) 9023 9060E-mail: eo@investni.com Web: www.investni.com

MANDATE TRADE UNIONTel: (01) 874 6321E-mail: mandate@mandate.ie Web: www.mandate.ie

NATIONAL INSTITUTEFOR TRANSPORT & LOGISTICS (NITL)Tel: (01) 402 3000E-mail: nitl@dit.ieWeb: www.nitl.ie

PARENTERAL DRUGASSOCIATION (PDA)Tel: +1 (301) 656 5900E-mail: info@pda.orgWeb: www.pda.org

PHARMACHEMICALIRELANDTel: (01) 605 1584E-mail: pharmachemicalireland@ibec.ieWeb: www. pharmachemicalire-land.com

PHARMACEUTICALSOCIETY OF IRELANDTel: (01) 218 4000E-mail:info@pharmaceuticalsociety.ieWeb:www.pharmaceuticalsociety.ie

REPAKTel: (01) 467 0190E-mail: info@repak.ie Web: www.repak.ie

SCIENCEFOUNDATION IRELANDTel: (01) 607 3200E-mail: info@sfi..ie Web: www.sfi.ie

IR ISH PHARMACHEM 2010

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