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CLEANROOMTECHNOLOGY.COM
THE INTERNATIONAL JOURNAL OF CONTAMINATION CONTROLDecember 2015
OUTSOURCING TIPS Why outsourcing validation andcalibration can pay dividends
DISINFECTION GUIDENew guidance on manual transferdisinfection
ADVANCED PACKAGING New methods of filling injectable drugswith reduced bioburden risk
001clt1215_cover.qxp_Layout 1 24/11/2015 12:31 Page 1
There are risks arising from the handling and administration of cytotoxic drugs (Antineoplastics) especially the safe transfer, manufacturing and preparation, waste handling and spill management of these drugs.
Occupational exposure to cytotoxics is a serious issue within the pharmaceutical and compounding industry and is likely to occur when control measures are inadequate.
Those most likely to be at risk include operators, pharmacists and laboratory staff. The types of activities which put them at risk are drug preparation and cleaning up residues and spills.
One of the challenges posed by cytotoxics is that despite being removed from surfaces
and equipment they can continue to pose a risk directly as waste. The right procedures and products must be implemented to ensure contamination is kept to an absolute minimum. Under COSHH1 there needs to be comprehensive assessments of the risks arising from handling cytotoxic drugs at every stage of use and disposal.
Control and monitoring of the effects of exposure has been studied in detail with a range of biological endpoints including, DNA damage, HPRT mutations and thioether excretion, among others, highlighting the seriousness of this issue.
Analytical methods are also now being employed to measure the level of environmental contamination in the workplace. Numerous studies have been published on environmental wipe sampling for these drugs as the issue becomes more widely known.
Similarly, the data collection and actions to identify and remedy exposure levels of cytotoxic drugs is defi nitely on the increase. Two key agencies responsible for conducting research and
making recommendations, the National Institute for Occupational Safety and Health (NIOSH) and the German Institution for Statutory Accident Insurance and Prevention in the Health and Welfare Services (BGW) have taken steps to raise awareness on the subject.
NIOSH have published an alert: Preventing Occupational Exposure to Antineoplastics and BGW an authoritative study in Germany: Monitoring-Effect for Wipe Sampling in Pharmacies (MEWIP). In these, cytotoxic drugs were found on 61% of all wipes used in three sampling positions within pharmaceutical cleanrooms: worktop, fl oor and fridge. Contamination levels of over 70%, 60% and 50% respectively were observed which in turn has led to the implementation of a reference value of 0.1ng/cm2 for pharmaceutical cleanrooms in Germany dealing with cytotoxic drugs.
Ecolab has developed a range of products that are scientifi cally proven to reduce the risks associated with cytotoxics. Uniquely, they both remove and denature the cytotoxic residues, when used in combination as described below, making disposal safer and ensuring contamination control right along the waste removal journey.
How a rigorous disinfection and waste management regime - coupled with products which actively destroy cytotoxics - is shown to reduce this risk
Recognising the Risk of Cytotoxic Exposure Among Operators
Advertisement
CONTAMINATION CONTROL
ECOLAB CONTAMINATION CONTROL Brunel WayBaglan Energy ParkNeath SA11 2GA UK
02920 854 390 (UK)
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C
Using disinfectants that vigorously denature and destroy the active chemicals in cytotoxics helps to ensure safe removal
Ecolab has developed a range of products that are scientifi cally proven to reduce the risks associated with cytotoxics
(1) COSHH - Health & Safety Executive. Control of substances hazardous to health regulations (2013).(2) MEWIP - Monitoring-Effect Study of Wipe Sampling in Pharmacies. Institution for Statutory Accident Insurance and Prevention in the Health and Welfare Services - BGW.
N.B. The trial was conducted using Ecolab’s Klercide and Klerwipe products, data is not transferable to similar products.
Klercide Sporicidal Active Chlorine Spray, Klerwipe polyester dry wipes, and Klerwipe 70|30 IPA wipes.
The elimination of cytotoxic drugs on surfaces, should be a major priority for the industry. One defi nite way to achieve this is through the controlled use of products manufactured in a cleanroom environment, with a proven and tested capability in the removal and destruction of cytotoxics.
The Institute of Energy and Environmental Technology (IUTA) recommends a combined procedure of spraying a Klerwipe polyester dry wipe with Klercide Sporicidal Active Chlorine
spray, then wiping the affected surface. Following a recommended contact time of 5 minutes, the surface should then be wiped with Klerwipe 70/30 IPA impregnated wipes. This combination is proven to have optimum effi cacy in the removal of cytotoxic compounds from surfaces, eliminating up to 99.9% of them.
*For further information on the test work carried out, please contact us for technical report TR1502R.
98.04†† 98.82†††
USE BIOCIDES SAFELY. ALWAYS READ THE LABEL AND
PRODUCT INFORMATION BEFORE USE.
SPRAYING ALONEWITH KLERCIDE SPORICIDAL
ACTIVE CHLORINE† Removes on average 85.43%
of a wide spectrum of cytotoxics from stainless steel surfaces
85.43†
%DISINFECT
SPRAY KLERWIPE POLYESTER DRY WIPE WITH KLERCIDE
SPORICIDAL ACTIVE CHLORINE AND WIPE THE SURFACE
†† Wiping as well as spraying improves the removal rate vs spraying only
to 98.04% on average
THE OPTIMAL APPROACH
ELIMINATEFINALLY WIPE SURFACE WITH
KLERWIPE 70|30 IPA WIPE FURTHER IMPROVING THE REMOVAL RATE, REDUCING SURFACE RESIDUES AND ENHANCING MATERIAL
COMPATIBILITY††† This results in a further improvement
to 98.82% removal on average
+12.61
%%
*
* *
A4 pages_Layout 1 25/11/2015 10:07 Page 1
Left to right, above: ChancellorGeorge Osborne shows PresidentXi Jinping round the NGI facilitypage 5; Weiler Engineering’s 640ASEP-Tech blow fill seal system isused by Catalent to reducebioburden in vial filling page 27;The International Space Station isthe focus of a new microbiomestudy page 33
contentsDecember 2015 3
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NEWSPRESIDENT XI JINPINGTOURS NGI’S CLEANROOM 5The Manchester-basedgraphene facility was showcasedto the visiting Chinese dignitary
FISHERS SELLS CLEANROOMLAUNDRY BUSINESS 6Fenland has bought thecleanroom laundry division
TROPICAL DISEASE LAB GETSAN OVERHAUL 8MAT has reconfigured andrevalidated labs at the LiverpoolSchool of Tropical Medicine
VANCOUVER SCIENTISTSLOOK TO REDUCE HAIS 10Canadian healthcare provider isfunding bioburden research
US FUNDING BOOST FORNANOTECH FACILITIES 12National Science Foundationwill provide US$81m to support16 sites
REGULARSEDITORIAL 5INDUSTRY NEWS 5EVENTS 12WEB WINDOWS 34MARKETPLACE 37
CLEANROOMTECHNOLOGY.COM
THE INTERNATIONAL JOURNAL OF CONTAMINATION CONTROLDecember 2015
OUTSOURCING TIPS Why outsourcing validation andcalibration can pay dividends
DISINFECTION GUIDENew guidance on manual transferdisinfection
ADVANCED PACKAGING New methods of filling injectable drugswith reduced bioburden risk
THIS MONTH’SCOVERContec offers one of the widestranges of cleanroom wipesand mops as well as a newlycompleted range of alcohols,disinfectants and detergents
Contec EuropeRP3707 – ZI du Prat56037 Vannes CedexFranceT +33 2 97 43 76 [email protected] www.contecinc.com
FEATURESOUTSOURCING VALIDATIONAND CALIBRATION 14Use of specialist services makesstrategic sense for pharmasector
GUIDANCE FOR MANUALTRANSFER DISINFECTION 17Karen Rossington looks atrecent NHS changes to theguidance and offers tips oncarrying out disinfection tests
PURE WATER ON TAP FORPHARMACEUTICALS 21Pure water is key to pharmaand it is easy to set up a reliablesupply with the right help
ASBESTOS – DEALING WITH AHIDDEN KILLER 25Many 1960–1970s industrialfacilities were built withasbestos. Its removal is agrowing safety concern
BETTER WAYS OF FILLINGAND PACKAGING DRUGS 27Advanced asepticmanufacturing and Blow FillSeal technology can reducebioburden when fillinginjectable drugs
ADDITIONAL PASSENGERSON NASA SPACE STATION 33Molecular analysis shows thathuman bacteria contributeconsiderably to the spacestation microbiome
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December 2015 Volume 23 Number 12
@CRTmagazine
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A4 pages_Layout 1 25/11/2015 10:29 Page 1
industry newsDecember 2015 5
President Xi Jinping of the People’s Republic ofChina toured the cleanrooms designed and built byClean Room Construction (CRC) at the NationalGraphene Institute (NGI) in Manchester on thelast day of his state visit to Britain.
He toured the 1,500m2 of cleanroom laboratoryspace, the largest academic area of its kinddedicated to graphene research, as part of a VIPvisit to the institute at The University ofManchester in October.
President Xi was accompanied by the Chancellorof the Exchequer, George Osborne, Viscount Hood,the Queen’s Lord-in-waiting, university staff andother senior government officials.
The official visit took place on the same day thatChinese electronics giant Huawei, China’s largestmobile phone manufacturer, announced apartnership with the NGI to research graphene and related 2D materials.
CRC worked with BAM Construction on thelandmark project, designing and installing thecleanroom facilities, partitioning and mechanicaland electrical services. The specification included amain cleanroom with a working level 3m belowground to minimise vibration, which wouldcompromise sensitive research activities carried outat nanoscales. www.crc-ltd.co.uk
Global cleanroomtechnology market willgrow to US$3.83bnover next five yearsThe global cleanroomtechnology market iscurrently estimated to beworth US$3bn and isexpected to grow at aCAGR of 4.98% over thenext five years reaching$3.83bn by 2020, a newreport by Research andMarkets forecasts.
The report, GlobalCleanroom TechnologyMarket – Market Trendsand Forecasts (2015–2020), finds that themarket is dominated byNorth America, followedby Europe, owing to thetechnologicaladvancements andinnovations taking placein healthcare.
But the expandinghealthcare/pharmamarket, with continuedgovernment initiativestowards safety ofproducts and increasingdemand for better qualityhealthcare products inemerging markets, willgenerate significantgrowth for cleanroomtechnology by 2020.
India and China will bethe fastest-growingcountries adoptingcleanroom technologyfor the forecast period,the report says.
Global cleanroomtechnology is segmentedbased on equipment,construction type,garments, consumables,application, end-usersand geography.www.researchandmarkets.com/research/rj76z8/global_cleanroom
AmerisourceBergen plans to purchase USdrug compounding firm PharMEDiumHealthcare Holdings from private equitycompany Clayton, Dubilier & Rice.
Under the deal, the company will payUS$2.6bn for the supplier of outsourcedcompounded sterile preparations (CSPs)to acute care hospitals in the US.
The transaction is expected to close by31 December.
‘The acquisition of PharMEDiumstrengthens our core business and
meaningfully expands our innovativeservice offerings for health systems,’ saidSteven Collis, AmerisourceBergenPresident and Chief Executive.
‘PharMEDium is a compelling additionto our business, which allows us toprovide differentiated offerings andfurther increases our ability to drive bothvalue and efficiency for our healthsystems customers in a way thatenhances patient safety and helpsimprove patient outcomes.’
PharMEDium delivers ‘sterile tosterile’ CSPs in a ready-to-use form withenhanced safety, labelling, sterilityassurance, and extended expirationdating. The CSPs are prepared in FDAand state board of pharmacy inspectedfacilities.
PharMEDium maintains fourcompounding facilities in Tennessee,Mississippi, Texas and New Jersey andprovides a broad range of 2,000 SKUs.www.amerisourcebergen.com
PRESIDENT XI TOURSCLEANROOMS AT NGI
The latest Vital Signs report released by the USCenters for Disease Control and Prevention (CDC),based on data from its Foodborne DiseaseOutbreak Surveillance System during 2010–2014,says that multi-state foodborne disease outbreakscause more deaths than localised events, despiteonly accounting for a fraction (3%) of all reportedoutbreaks. It also found that the leading causes ofmulti-state outbreaks were Salmonella, E. coli andListeria, which can contaminate widely distributedfoods and thus affect people in many US states.
CDC scientists found that while Salmonellaaccounted for the largest number ofhospitalisations and was the cause of the threelargest outbreaks, Listeria caused the most deaths.
In October, Food Standards Australia NewZealand (FSANZ) also published in its2014–2015 report, which covered 58 agency-co-ordinated food recalls, that Listeria was thepredominant microbial contamination pathogen.
Listeria poses a challenge for food processors,especially in ready-to-eat foods, as it likes the cold,wet environment that exists in many productionplants. It has also been noted thatListeria problems tend to occur in factories thatappear to be very clean; it is thought that stringentcleaning eliminates the micro-organisms thatwould otherwise compete with Listeria, allowingthe species to proliferate.
While many processes involve pasteurisation,many cases have arisen due to contamination postpasteurisation, before the product is packaged.Furthermore, where previously cases have arisenfrom meat and poultry products, recent testing,following the Blue Bell ice cream outbreak in Texasand Oklahoma, has revealed cases of low levels ofListeria in many dairy products.
The good news is that rapid testing methods,such as polymerase chain reaction (PCR) andimmunoassay-based techniques, are speeding upfood safety testing and enabling a quickerresponse. In addition, whole-genome sequencingis helping to trace where outbreaks originate fromand to identify gaps in our food safety systems.
SUSAN BIRKSDEPUTY EDITOR
The growing threatposed by Listeria
EDITORIAL
AMERISOURCEBERGEN TO BUY PHARMEDIUM HEALTHCARE HOLDINGS IN US$2.6BN CASH DEAL
Left to right: George Osborne, Dame Nancy Rothwell, SirAndre Geim, President Xi Jinping, President’s interpreter,and Sir Kostya Novoselov. Photo courtesy University ofManchester
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Scottish textile services company Fishers has soldits cleanroom laundry business to specialistcompany Fenland Laundries.
Fenland’s acquisition of the Livingston-basedbusiness is in line with the company’s strategy ofgrowing its cleanroom business in the UK under itsMicronclean brand.
The acquisition also supports Fishers’ strategy offocusing on its market-leading textile rental andlaundry business serving the needs of thehospitality sector in Scotland and the North ofEngland. The acquisition price is not beingdisclosed and the transaction is subject to clearanceby the Competition and Markets Authority.
All 46 jobs involved will transfer over to FenlandLaundries as part of the sale process and theLivingston facility will be retained and become thenew Scottish hub for Fenland Laundries. Theexisting joint venture agreement between FenlandLaundries and Berendsen will be dissolved.
Fishers and Fenland Laundries have both beenin the laundry business for more than 100 yearsand share many company and customer servicevalues. The acquired business is expected to thriveunder its new ownership.
‘As a cleanroom laundry specialist we are focusedon the laundry needs of the pharmaceutical,healthcare and manufacturing sectors and with theexpert team at Livingston on board, I am confidentthat we will continue to thrive,’ said Simon Fry,Chairman of Fenland Laundries.
Michael Jones, Fishers’ Managing Director, said:‘The Livingston team has been a credit to Fishersand I know they will go on to even greater successas part of Fenland Laundries, who share the samevalues as we do. Fishers is the market leadingtextile rental and commercial laundry company inScotland and the North of England and we plan toconcentrate on this as our area of expertise.’ www.fisherslaundrygroup.co.uk www.micronclean.co.uk
FISHERS SELLS CLEANROOM LAUNDRY BUSINESS TOSPECIALIST COMPANY FENLAND LAUNDRIES
Nitritex has added the BioClean-D Drop-DownGarment – a new single-use coverall – to itsportfolio, which makes aseptic donning simple.
The firm says its unique drop-down design and aremovable tab system make it the world’s firstsingle-use cleanroom garment that can be donnedwith virtually no cross contamination.
Suitable for ISO Class 4, and GMP Grade Aenvironments, the coverall is made from durablelow-linting CleanTough antistatic material and iscomfortable to wear. Its easy ‘over the head’ designallows the garment simply to use gravity to drop-down over the operator’s body. Using thestrategically placed removable tabs and uniquezipper positioning, the operator can zip the coverallup and around with one fluid movement. This canbe completed in 30 seconds, knocking 30% off thestandard coverall donning time. See a comparisonvideo at www.bioclean.com/drop-down.
The garment is available in a range of sizes fromX-Small to XXX-Large, to give a good fit for all.www.nitritex.com
This year's Cleanzone attracted around 20% morevisitors than last year, with 731 from 32 countries(2014: 604 trade visitors from 30 countries)attending the international trade fair and congressfor cleanroom technology, which had 88 exhibitorsfrom 12 countries.
‘We are more than satisfied,’ said Iris Jeglitza-Moshage, Member of the Extended Board ofManagement of Messe Frankfurt. ‘Cleanzone hasposted double-digit growth in every key category –exhibitors, visitors, exhibition space andinternational scope. As a result, Cleanzone is aforce to be reckoned with.’
Frank Duvernell, Managing Director ofReinraumAkademie (Leipzig) and partner ofCleanzone, agreed: ‘I am certain that Cleanzonewill continue to grow, because this is where theindustry comes together. The event hasdemonstrated yet again that manufacturing andproduction in cleanrooms is a subject ofinternational importance for the future, and onewhose relevance includes every industry,’ he said.
Besides Germany, the most important visitorcountries were Switzerland, Denmark, Austria, theNetherlands, Turkey, Belgium, Ireland, China andthe US. Visitors came from every industry whereproduction is carried out under cleanroomconditions, including the automotive,semiconductor, aerospace, laser, optics, surfacetechnology, food and pharmaceutical industries.
The fourth Cleanroom Award byReinraumAkademie (Leipzig), worth w3,000, went toInfraSolution for RobotScanFlex, an automatedfilter integrity test.
The next Cleanzone will take place on 8–9November 2016 in Frankfurt am Main.
Cleanzone sees a 20% increasein trade visitors
IEST offers new ISOcleanroomclassification andmonitoring standardsThe IEST has announcedthe international approvalof the new revisions tothe flagship cleanroomstandards ISO 14644.
The revised standardswere approved by amajority of the 20member nationsparticipating in theISO/TC 209 final vote.They will be availablefrom IEST followingeditorial revision andinternational translation.
The revision efforts bythe lead ISO/TC 209Working Group lastedmore 10 years, with theISO TechnicalManagement Boardproviding a secondextension of the draftingperiod.
A major focus inrevising ISO 14644-1(1999) was to develop arefined statisticalapproach regarding theselection and number ofsampling locations. Theunderlying assumption inthe 1999 version heldthat particle countsfollow a similardistribution across theroom. The new revisiondiscards the previousassumption to allowmore accurate samplingwhere particle countsmay vary in a morecomplex pattern.
Another revision inISO 14644-1 addressesthe issues surrounding≥5µm particle limits forISO Class 5 in the sterileproducts annexes of theEU, PIC/S, and WHOGMPs. An adaptation ofthe macroparticledescriptor is included inthe Standard toaccommodate theparticle size.
ISO 14644-2emphasises the need toconsider a monitoringstrategy in addition tothe execution orevaluation of theclassification provisionsof ISO 14644-1.www.iest.org
6 December 2015
industry news
NITRITEX ENTERS A NEW ERA OFASEPTIC DONNING
The BioClean-D Drop-DownGarment isquick andeasy to put on
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Medical Air Technology (MAT) has completed aproject at the Liverpool School of Tropical Medicine(LSTM) on Merseyside, UK, increasing laboratorycapacity to accommodate a new machine forcounting and profiling cells.
LSTM was founded in 1898 and is the oldestSchool in Tropical Medicine in the world; it isrecognised globally for its groundbreaking researchinto infectious, debilitating and disabling diseases.
MAT has worked on several Containment Level 3(CL3) laboratory suites across the UK and wastherefore able to guarantee both experience andspeed of delivery when approached by LSTM toreconfigure and revalidate its laboratories.Laboratories that handle human pathogens thatmay be transmitted via inhalation, which oftenhave a low infectious dose to produce effects thatcan cause serious or life-threatening disease, needCL3. This level of containment emphasisesadditional primary and secondary barriers tominimise the release of infectious organisms intothe immediate area and the environment, such asHEPA filtration of exhausted laboratory air.
The suite at the LSTM was required to house anew Fluorescence Activated Cell Sorting (FACS)
machine. MAT reconfigured and revalidated theexisting laboratory to accommodate the machine,carrying out work including new electricalinstallation, sinks and drainage, a DX coolingsystem, lab furniture and room fabricimprovement.
The FACS machine rapidly separates cells in asuspension, based upon the specific light scatteringand fluorescent characteristics of each cell. Thisallows researchers to profile a large number of cellssimply and accurately. www.medicalairtechnology.com
MEDICAL AIR TECHNOLOGY REFURBISHES CL3 LAB ATTHE LIVERPOOL SCHOOL OF TROPICAL MEDICINE
AdvantaPure’s AdvantaFlex biopharmaceuticalgrade TPE tubing (pictured above) is now availablewith pre-sealed ends. The ends are suitable forsingle-use biopharma and pharma applications suchas sampling and storage. By simply welding asealed tube to the tubing from a bag or container, asterile, closed system is maintained.
The company says various upstream anddownstream single-use process applications aresuitable for sealed tubing ends, including mediaand buffer preparation, microbial fermentation,and final formulation and filling.
The AdvantaFlex sealed tubing ends can be usedwith sterile tubing welders to aseptically terminatefluid paths and lessen the need for costly asepticdisconnectors. They help improve productionefficiencies and reduce operational costs. They alsosave time compared with sealing on site, as theyarrive sterilised and ready to use.www.advantapure.com
Mettler Toledo Thornton, a supplier of onlineanalytical instruments for monitoring purified water,has added the 7000RMS analyser to its portfolio.
The instrument offers realtime, continuousmeasurement of bioburden in the pharma industry.
On-line monitoring of conductivity and totalorganic carbon (TOC) for water used in pharmaapplications has been possible since 1996.However, determining microbial contamination hasalmost entirely relied on laboratory measurementof cultures. The time taken to grow cultures, andthe multiple testing of points-of-use, results indelays in identifying microbial excursions.
The 7000RMS provides continuous analysis ofmicrobial and inert particle contamination whereverrequired in a water system or at point-of-use. Thecompact unit not only provides realtimeassessment of water loop bioburden levels, butalso lowers labour costs through reducedsampling and testing, cuts energy use throughbetter management of sanitisation cycles, andleads to increased process understanding.
The laser-induced fluorescence (LIF) technologyemployed in the 7000RMS does not require time-consuming staining or use of reagents. Theimplementation of LIF in the analyser, inconjunction with Mie scattering detection andadvanced software algorithms, allows thesimultaneous measurement of particle numbersand determination of whether particles aremicrobes or inert material. www.mt.com/7000RMS
Realtime microbial monitoringsystem for pharma water
Puridify completesSeries A funding of £2.2mPuridify, a UK developerof bioprocessingpurification technologies,has closed a £2.2mSeries A funding round.
The funds will be usedto commercialisePuridify’s proprietarynanofibre purificationplatform, FibroSelect.
The company aims tohave GMP-compatiblepurification units readyfor wider industry useduring 2016.’
Puridify was formed in2013 as a spin-out fromUniversity CollegeLondon. Its FibroSelecttechnology wasdeveloped during acollaborative researchproject between theAdvanced Centre forBiochemical Engineering,UCL and the Science &Technology FacilitiesCouncil.
Puridify’s head officeand R&D facilities arebased at the StevenageBioscience Catalyst.www.puridify.com
Vaisala reports goodsales in the US andAsia-Pacific in Q3Finland-basedmeasurementinstrumentation andcontinuous monitoringcompany Vaisalareported a 5% increasein net sales in the thirdquarter from July toSeptember 2015, tow81.7m. The operatingresult increased by 12%to w14.1m.
The ControlledEnvironment BusinessArea saw its net salesincrease by 14% year-on-year to w23.4m. Net salesgrew in all regions eventhough the marketenvironment forindustrial measurementsolutions remainedstable. Orders receivedfor this part of Vaisala'sbusiness increased by6% as order intake grewin the Americas andAsia-Pacific.www.vaisala.com
8 December 2015
industry news
Medical Air Technology has refurbished a CL3 laboratoryfor LSTM to accommodate a new machine for counting andprofiling cells
NEW ADVANTAPURE SEALED TUBINGENDS REDUCE COSTS
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Canadian researchers aim to tackle healthcareassociated infections (HAIs) in bone marrowpatients in a US$400,000 pilot study.
There are an estimated 220,000 cases of HAIswith 8,000 deaths each year in Canada. Associatedcosts are estimated to be more than US$15m a yearfor Vancouver Coastal Health (VCH) alone.
Dr Elizabeth Bryce, Regional Medical Directorfor Infection Prevention and Control, VCH; DrRaewyn Broady, Director of the BMT programme;and Dr Linda Hoang, Medical Microbiologist at theBC Public Health Lab, part of the BC Centre forDisease Control, are leading the two-year study.
Bone marrow patients (BMT) are one of thehighest risk groups for HAIs since their immunesystems are weakened during the course of theirtreatment, and they are the focus of the study.
In this study, to reduce the bio-burden on alltouch surfaces, first of all, three patient isolationrooms will be re-engineered with self-disinfecting
surfaces containing copper-nickel and titaniumdioxide and outfitted with contact-free motionactivated devices, filtered water, and UV light inthe bathroom.
Second, surveillance for pathogens in patients,healthcare workers and rooms will be addressed bymicrobiome profiling and microbial culturing.
The researchers anticipate gaining valuableinsights into the role that the hospital environment(and healthcare staff) may have on the evolution ofa BMT patient’s microbiome during the transplantand recovery process. This in turn should provideideas into improved methods to reduce HAIs forthis group as well as informing general infectionprevention strategies. They hope to gather enoughevidence to establish a future large-scale studyacross Canada to reduce HAIs and ultimatelydecrease the morbidity and associated economicburden on healthcare spending. https://clinicaltrials.gov/ct2/show/NCT02463214
PILOT STUDY IN CANADA EXAMINES ENVIRONMENTALAND GENOMIC SOLUTION FOR HAIS
Ten years ago fire ripped through the University ofSouthampton’s Mountbatten Building, gutting theconstruction and destroying valuable equipmentand research.
A decade later and its award-winning successornow provides £120m of specialist facilities andequipment, enabling researchers to continue theirpioneering work tackling many of the keychallenges facing society today.
The new Zepler Institute cleanroom complexhouses a suite of research facilities. Home to theUK’s best set of nanoelectronics and photonicsfabrication capabilities, including the SouthamptonNanofabrication Centre, the complex is drivingforward some of the most innovative explorationsin optics and nanotechnology research.
The building contains a 600m2 electronic devicescleanroom, in addition to two 110m2 MEMScleanrooms.
Professor Nick Jennings, Head of Electronics andComputer Science, said: ‘The SouthamptonNanofabrication Centre cleanroom facility is bothgrounded in existing state-of-the-artnanofabrication technology and exploring the nextgeneration of fabrication methods, materials anddevices.www.ecs.soton.ac.uk
Biocides will be a US$11.9bn global market by2022, up from $7.99bn in 2014, according to a newreport from market researcher Radiant Insights.
The report, Biocides Market Analysis, Size,Share, Industry Report 2022, says growth in watertreatment process units, particularly in China,Japan and India, is likely to drive demand.
Water treatment dominated the applicationsegment and accounted for 23.2% of the totalrevenue in 2014. Factors such as the treatment ofscaling, microbial activity, disposal and corrosionare likely to support demand, the report says.
Increasing health concerns arising frompathogens and bacterial growth are also likely tofavour market expansion and an increase indemand for paints and coatings is also expectedowing to growing infrastructure spending. Butstringent compliance regulations from EPA andREACH regarding product composition and its usemay challenge market participants, says the report.
The North America biocides market accountedfor more than 40% of global revenue in 2014. Thepresence of water treatment plants and increasingconsumer awareness towards health is likely todrive regional demand.
The US accounted for approximately 80% ofdemand in North America in 2014. Mexico isexpected to witness the highest gains in the regionwith an estimated CAGR of 5.7% from 2015 to2022. Asia Pacific is forecast to see the highestgains, at an estimated CAGR of 6.4% from 2015 to2022.
The global biocide market share is moderatelyconsolidated with the top four companies covering58% of the demand, the report says. www.radiantinsights.com
Biocides market is expected tobe worth US$11.9bn by 2022
Fraunhofer IPMSupgrades cleanroomin E30m investmentThe Fraunhofer Institutefor PhotonicMicrosystems (IPMS) isupgrading itsmicrosystem cleanroomin a w30m investment.
The upgrade to theDresden, Germany-basedresearch institute willinvolve moving up fromthe current 150mm waferbase to a 200mmprocess line forresearch, developmentand pilot fabrication ofmicroelectromechanicalsystems (MEMS).
The funding comesfrom state and federalsources as well as fromthe European RegionalDevelopment Fund(EFRE). Followingapproval of theinvestment by SAB, theDevelopment Bank ofSaxony, the project isnow underway.http://www.ipms.fraunhofer.de
Merck Millipore addsMillipore ExpressPHF hydrophilicfilters to portfolioMerck Millipore hasintroduced MilliporeExpress PHF (processprotection, high-flux)hydrophilic filters for fastand efficient bufferfiltration.
These single layer,fast-flowing 0.2µm PESmembrane filters providesterilising-gradeperformance and aresuitable for buffers, pHadjusters and otherprocess additives.
The single-use,gamma ready filters areavailable in sizes from25mm to 76.2cmcartridges.
The filters arecompatible with a rangeof buffer chemistries,including acids andsodium hydroxide acrossthe pH range.
They can withstandmultiple steam-in-placeor autoclave sterilisationcycles.www.merckgroup.com
10 December 2015
industry news
The gleaming newMountbatten Building
at the University ofSouthampton has
been renovated aftera fire 10 years ago
MOUNTBATTEN BUILDING RISES FROMTHE ASHES AFTER FIRE 10 YEARS AGO
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EVENTS4 FEBRUARY 2016Good ManufacturingPracticeReading, UKThis interactive courseexamines why we haveGood ManufacturingPractice (GMP).www.rssl.com
22 – 24 MARCHFacilitiesManagement 2016NEC, Birmingham, UKThe event will be co-located with Maintec, TheHealth & Safety Event andwill feature the CleaningZone.www.easyfairs.com
29 – 31 MARCHCCE China CleanExpo 2016Shanghai, ChinaCCE China Clean Expo isAsia’s leading cleaningshow.www.chinacleanexpo.com
5 – 7 APRILLounges 2016Messe Stuttgart,Germany A cross-industry platformfor pure, clean, hygienic orsterile environmentconditions in theproduction, manufacture,process or othercontamination-relevantsectors.www.expo-lounges.de
21 – 23 APRILICEC CleanroomExhibitionIstanbul, Turkey Once again Istanbul hoststhis cleanroomtechnology, maintenanceand equipment exhibition.www.expocleanroom.com
2 – 5 MAYEstech 2016Glendale, Arizona, USThe Annual TechnicalMeeting of IEST providesa platform for national andinternational professionalsto share crucial strategies,research, and bestpractices for a wide rangeof contamination control,test and reliability, andnanotechnologyapplications.www.iest.org/Meetings/ESTECH
AMBR 15 BIOREACTOR ENHANCESMICROBIAL STRAIN SCREENING
Sartorius Stedim Biotech (SSB) has added theambr 15 fermentation system, an automated microbioreactor system designed to enhance microbialstrain screening, to its portfolio.
The system comprises 24 single-use stirred microbioreactors (each with 8–12mL working volume)integrated to an automated workstation. It offersparallel processing and walk-away control of 24micro bioreactors.
ambr 15 fermentation delivers high oxygentransfer rates, rapid pH and feed additions and issuitable for assessing the effects of different strainswith microbial cultures. It measures pH and DOevery 12 seconds and there are pumped liquid linesfor base and feed addition in each micro bioreactor,enabling tight pH control and a semi-continuousfeed supply.
The single-use micro bioreactor vessel containsan impeller suitable for fermentation and providesenhanced capability compared with shaking culturesystems. www.sartorius.com
JSNN RECEIVES US$1.8M FROM NATIONAL SCIENCEFOUNDATION FOR NANOTECHNOLOGY INFRASTRUCTUREThe Joint School ofNanoscience andNanoengineering(JSNN), an academiccollaboration betweentwo universities inNorth Carolina, US, isone of 16 programmesacross the US to receivefunding from theNational ScienceFoundation (NSF) todrive innovation innanoscale science,engineering and technology.
The academic institutions are the University ofNorth Carolina at Greensboro (NCG) and NorthCarolina Agricultural and Technical StateUniversity (NC A&T).
JSNN has teamed up with Georgia Tech to createthe Southeastern Nanotechnology InfrastructureCorridor (SENIC), a partnership that will receiveUS$8m over five years.
JSNN will receive $1.8m, allowing companies and
organisations to use itsfacilities, tools andresources to test anddevelop technologythrough the fabricationof nanostructures.
NSF will provide atotal of $81m in fundingto support the 16 sitesand a co-ordinatingoffice as part of a newNationalNanotechnologyCoordinated
Infrastructure (NNCI).‘Collaboration and shared infrastructure are
integral to JSNN’s operating model,’ said DrJames Ryan, founding dean of the JSNN. ‘TheNNCI will help JSNN to expand its partnershipsand leverage its state-of-the-art capabilities forresearch and economic development.’
The partnership is the first of its kind betweenJSNN and Georgia Tech. www.jsnn.ncat.uncg.edu
12 December 2015
industry news
The antimicrobial plastic market is expected to beworth US$16.17bn by 2020, growing at a CAGR of8.7% between 2015 and 2020, finds a new report.
Antimicrobial Plastic Market by Type (CommodityPlastic, Engineering Plastic, and High PerformancePlastic) by Application (Healthcare, Packaging,Consumer Goods, Automotive, Construction, andOthers) & by Region – Global Forecast to 2020, byMarketsandMarkets, defines antimicrobial plasticsas polymer materials infused with antimicrobialagents and additives such as organic-metallicbiocides and arseni-based oxybisphenox arsine(OBPA). They are mainly used to kill micro-organisms such as bacteria, algae and fungi, andinhibit their growth in the end-use products.
Growing consumer awareness of health-relatedissues, rapid urbanisation and growing populationsin the Asia-Pacific and South America regions aredriving the expansion of the market, but volatility inraw material prices and stringent regulations areholding back its growth. The manufacturing cost ofantimicrobial plastic is high, which increases theoverall cost of the existing products and affects theprofit margins of the manufacturers.
Healthcare is the key application of antimicrobialplastic, with a one-third market share, followed bypackaging and consumer goods. The Asia-Pacificregion dominates the market for healthcareapplications, followed by North America andEurope. Healthcare and packaging applications willsee the highest CAGR of 8.8%, between 2015 and2020. www.marketsandmarkets.com
Antimicrobial plastic market toreach US$16.17bn by 2020
Sartorius ambr 15 fullsystem image with
vessel in front
JSNN cleanroom (Photo: Gateway University Research Park)
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14 December 2015
OUTSOURCING
The pharmaceutical industry haschanged dramatically in the past couple ofdecades. Drug targets have become morechallenging; regulators are demandinglonger and more expensive clinical trials toprove safety; and healthcare systems andinsurance companies are actively trying todrive down cost. Add in the rise of genericmedicines – and the range of therapeuticareas now well served by these generics –and the financial pressures facing bigpharma companies become clear.
Outsourcing has become a keycomponent in pharmaceutical companies’cost-saving strategies. There is a muchgreater reliance on in-licensing of targetsand drug leads, allowing pharmaceuticalcompanies to focus more on thoseexpensive clinical trials that the biotechsand academics cannot afford to runthemselves. Production has beendramatically downsized and outsourcedtoo, with far more manufacturing nowcarried out by third parties that haveflexible capacity and capabilities.
Other, perhaps less obvious, activitieshave also been ripe for outsourcing,particularly those where an expert thirdparty’s economies of scale allow costs tobe driven down. Specialists in fields asdiverse as supplier qualification, auditing,calibration, validation and eventechnology transfer have found profitablebusiness niches that supply these services.It is often more economical and effectiveto use a reliable partner than to train andemploy in-house experts. Overheads arereduced, expertise is maintained, and
contractors automatically focus onkeeping up with those ever-changing GMPdemands of the different regulatorsaround the world. These expertoutsourcing partners are in demand fromthe contract manufacturers as well.
Validation, qualification and calibrationare not just one-off activities. They mustbe carried out on an ongoing basis if afacility’s development, operation andmaintenance are going to continue tomeet all regulatory requirements.Validation involves the collection andanalysis of data in a systematic manner
that proves that an analytical method ormanufacturing process will give consistentresults that meet all specifications whencarried out in the prescribed manner.Qualification is the analogous term forequipment and machinery. Installationqualification (IQ) is performed for newequipment, and operation qualification(OQ) and performance qualification (PQ)monitor the day-to-day running of thatequipment.
The validation of computer systems
Outsourcing validation andcalibration has become a keycomponent in pharmaceuticalcompanies’ cost-savingstrategies. Marco Benvenuti,Business Manager, SGS LifeScience Services Italy, outlineswhat to look for in anoutsourcing partner
Medifill is an Irish manufacturer of medicaldevices. The company chose SGS as anexternal consultant for assistance invalidating a TM Innova 12K filling andsealing machine during the commissioningof a new Class 100 aseptic fill facility forthe production and packaging of surgicalglues and synthetic skin adhesives.
The setup of the facility sees the fillingmachine placed downstream of a BS700machine that forms the blisters, andfollowed by a TR50 die-cutter. First, thesurgical glue is filled into the pre-mouldedunit doses in strips of five. The vials aremade from a thermoplastic polymer thathas been pre-sterilised via gammaradiation. The units are then sealed,separated, and finally blistered, with agamma-treated dispensing tip added ifnecessary.
In-spec operation of the filling machine iscritical if sterility is to be maintained. Filling,sealing and blistering operations must becarried out under a laminar airflow system toensure an aseptic environment until the finalblisterpack containing the single-unit dose
has been sealed. A risk-based approach was applied to the
validation process, which was begun beforethe development phase even started. Userrequirements were determined incollaboration between Medifill and SGS, withthe risk assessment identifying any potentialGMP hazards and risks, and the mostcritical areas of the equipment. Controls tomitigate these risks were defined; thesemight include additional checkingprocedures or extra instrumentation at thecritical points, or developing a standardoperating procedure.
The most critical areas were the fillingsection, where the correct volume must befilled each time; the unit dose weldingsection, which must seal each unit correctly;the pick-and-place system that places eachunit dose and dispensing tip, which must
Medifill chooses SGS as a consultant in validating a TM Innova 12K
IT MAKESSENSETO OUT-SOURCE
014-015clt1215 SGS H a.qxp_Layout 1 24/11/2015 14:59 Page 14
CONTACTMarco Benvenuti, Business Manager, SGS Life Science Services [email protected]/lifescience
January 2014 15STERILISATION
installing new equipment. These externalexperts are ideally placed to carry outfactory and site acceptance tests. Factoryacceptance tests incorporate aninspection, and involve both dynamic andstatic testing of systems and their majorcomponents to support the qualification ofequipment. This takes place at thesupplier’s site before it is shipped to theend-user. Site acceptance tests,meanwhile, are similar, with the majordifference being that they are carried outwhere the equipment is to be used.
Choosing the right partnerThe critical nature of validation,qualification and calibration activitiesmakes it essential that the right GMPservice provider is chosen. It is a falseeconomy to outsource such an importantprocess to a lower-cost company thatcannot meet all regulatory requirements.The risk is that those upfront savings willbe more than wiped out if they lead to aroutine regulatory inspection being failed,or worse, a major product recall.
The following list of questions providesa guide to what a pharmaceuticalcompany should be looking for in anoutsourcing partner:• Do they have a strong quality management system?• Are their technicians and engineers trained and qualified?• Do they have sufficient equipment of their own, which is maintained and checked in a way that meets GMP requirements?• Do they guarantee high-quality standards in both technical skills and documentation?• Are they highly responsive to fluctuating workloads at their customers’ operations?• Are they fully accredited for validation, qualification and calibration by a recognised authority?• Do they have expertise in IT compliance and validation that meets 21 CFR Part 11?• Do they offer a range of GMP services, allowing customers to source more than one activity from the same supplier?• Will they meet all our requirements, while at the same time containing costs?
December 2015 15OUTSOURCING
must not be forgotten. The computersystem validation (CSV) process is used toensure that all IT applications adequatelyfulfil their intended purpose. CSV is animportant element of the facility’svalidation master plan, and all thedocumentation necessary for equipmentmust also be prepared for computersystems – much of the data they handle is
relevant to a GMP process, and thus anyfailure can have a negative impact onproduct quality. The complexity of suchcomputer systems means an even more in-depth validation process is appropriate,backed up by a methodical risk analysisthat allows validation efforts to be focusedon the most critical aspects of the system.
All phases of design, development,testing and the software’s routine usemust be controlled throughout thelifecycle of a computerised system if it isto remain properly validated. This isparticularly important inbiopharmaceuticals, as GMP demandsspecific controls and procedures. CSVincludes every activity involved in theapplication of appropriate controls andprocedures throughout the softwaredevelopment lifecycle, and creating all thedocumentation required by the regulators.
Meanwhile, calibration is vital inproving and maintaining the legitimacy ofqualification and validation. It is designedto show that any instrument or devicegives results that fall within specifiedlimits, in contrast to results producedusing a traceable standard over a suitablerange of measurements. Calibration mustbe carried out using qualified instrumentsby an accredited laboratory.
Accurate calibration is essential whenbuilding a solid quality managementsystem using experts and qualifiedspecialists. Companies will frequently seekoutside support, particularly whenupgrading, refurbishing and constructingnew facilities, and when sourcing and
accurately place into every blister;production parameters such as inletpressure and welding temperature; and anymaterials that might come into contact withthe product. As a result, a leak tester, acheckweigher and a camera-based controlsystem were added to the filling line tocheck every product.
A dedicated laminar air flow system wasinstalled, with air pushed into the systemthrough HEPA filters. Filter integrity, airspeed and flow pattern testing and airparticle counting were an important part ofthe validation process. In addition, anintegrated computerised system was usedto control the machine and recordproduction data, as required to meet GMPcompliance, including meeting the demandsof FDA 21 CFR Part 11. A GAMP category 4software package commonly employed inpharmaceutical production environmentswas chosen.
SGS managed the selection andcommissioning process on behalf ofMedifill. Integrating the commissioningand validation saved both time andmoney because of the sharedverification plan, and the resultinghomogeneous documentation format.
Whether a company is setting up anew plant, transferring technology toanother facility or an outsourcingpartner, or simply concerned aboutmeeting specifications and regulatoryrequirements on an ongoing basis,working with an expert partner is oftenthe most effective way of ensuring allruns smoothly and as it should. Yes, thecompany itself is ultimately responsiblefor maintaining GMP standards for itsproducts and production, but expertpartners should be able to assist instreamlining the processes, whilesimultaneously containing costs.
Innova Filling Machine, model 12K, produced byTM srl, Italy
014-015clt1215 SGS H a.qxp_Layout 1 24/11/2015 14:59 Page 15
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It has always been acknowledgedthat one of the greatest sources ofcontamination in an aseptic preparationarea is the transfer of materials into andout of the cleanroom or Grade A productcontact area. EU GMP Annexe 11 requiresthat all components, containers andequipment required where aseptic worktakes place should be sterilised throughdouble-ended sterilisers sealed into thewall or by a procedure which achieves thesame objective. This could be by means ofUV sanitisation, application of vaporisedH2O2 or in-situ sterilisation. However, formany smaller compounding facilities thisis not an option and, driven by the needfor small batches and fast turnaroundtimes, the main method of transferdisinfection is still a highly manualprocess with liquid sanitisers.
Manual transfer disinfection:Historically, 70% alcohol solutions, eitherdenatured ethanol (IMS) or isopropanol(IPA), have been used for the spraying ofcomponents prior to pass through intoaseptic preparation areas, due to their fastcontact time and lack of residue. They arealso able to be terminally sterilised andare relatively inexpensive. Denaturedethanol solution has a higher workexposure limit than IPA and tends to bethe preferred solution of choice, especiallyin the UK. Items would simply be sprayedor dunked in denatured ethanol beforebeing passed into the transfer hatch.
Work carried out in 2001 by Cockcroft etal2 highlighted how ineffective thisprocess could be, especially on spores asneither alcohol solution is sporicidal, andthey recommended that the process beimproved by the introduction of a wipingphase. Work was carried out comparingthe effectiveness of spraying/wiping/spraying and wiping with 70% alcoholsolution on pre-contaminated items. Thereport concluded that a combined processof wipe then spray, or spray then wipe wasmost effective. This work was added intothe guidance of the NHS QC Committee:The Quality Assurance of AsepticPreparation Services 4th Edition3, whichrecommends at least two decontaminationstages for transfer disinfection, one ofwhich must include wiping.
Recent regulatory changes: Thisspray and wipe approach with 70% alcoholsolution has formed the basis of manualtransfer disinfection for the past 15 years.In January 2015, the UK Medicines andHealthcare products Regulatory Agency.(MHRA) through the Questions andAnswers for Special Manufacturers4,revised its guidance on transferdisinfection. Their previous
recommendation was for a minimum oftwo discrete decontamination steps, sprayand wipe in the first stage followed by awiping phase. Best practice wasconsidered to be spray and wipe at bothstages. This has been revised in thecurrent edition to specify that the sprayand wipe phase carried out before transferto the manufacturing room, shouldinclude the use of a sporicide. Beforetransfer to the working zone, a secondsanitisation step should be carried outagain using a spray and wipe technique.‘The minimum expectation is therefore twodiscrete decontamination steps, with aspray and wipe performed at both stepsand the first decontamination steps mustuse a sporicidal agent’.
The NHS Pharmaceutical MicroProtocols Group, a sub-committee of theNHS Pharmaceutical Quality AssuranceCommittee, has concluded that it isnecessary for all NHS aseptic units to alsoheed the warnings and apply the MHRAGuidance, to improve technique andincorporate additional measures toenhance the sterility assurance of asepticpreparation. In a document provided forNHS facilities, Guidance for AsepticTransfer Processes in the NHS5 it
suggests the first consideration should beto look at double- or triple-wrapped sterilecomponents as a way to reduce reliance onthe operator during transfer disinfection.
Where this is not practical then itfurther refined the MHRA guidanceregarding the two-stage disinfectionprocess to specify that the sporicideshould be applied in the form of apresaturated wipe. ‘Although spraying isthe most effective method of application,evaluation of best practice recommendsthat the sporicidal agent is applied as animpregnated wipe in order to limit healthand safety and corrosion effects.’
This is a significant change to the waymanual transfer disinfection has beencarried out and it needs carefulconsideration as to how it can beimplemented, to a great extent due to thevery differing nature of a sporicidaldisinfectant versus 70% alcohol solutions.As with any change, this should beimplemented via a robust change controlsystem and an assessment of all relevantfactors impacting the transfer disinfectionprocess. Some considerations relevant tosporicide choice are discussed below.
Choosing an appropriate sporicidefor transfer disinfection: The NHS
December 2015 17DISINFECTION
�
Recent revisions to guidance have led to changes in the methods oftransfer disinfection. Karen Rossington looks at the changes andconsiderations when carrying out the necessary disinfectant tests
IMPROVING MANUALTRANSFERDISINFECTIONIN ASEPTICPREPARATION AREAS
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18 December 2015
DISINFECTION
Micro Protocols group after carefulconsideration has created a guide to whatthe ideal disinfectant for aseptic transferdisinfection should look like. Obviously, akey factor is the level of sporicidal efficacyrequired. There are no specific EUstandards for a sporicide especially fortransfer disinfection. According to EN137046 — a suspension test for sporicidaleffectiveness — a log 3 reduction in sporesin 60 minutes is the pass criterion forestablishing a product as a sporicide. Inuse, the product will neither be insuspension nor have such a long contacttime, so the NHS Micro Protocols grouphas specified the minimum sporicidalefficacy to be a minimum of a log 2reduction within 2min or ideally a greaterthan log 3 reduction in 2min.
However, it has not stipulated whichtest method should be used to verify thisefficacy. When comparing manufacturers’literature for the efficacy of a particulardisinfectant, a number of test methods arenormally cited. It is important to have abasic understanding of these disinfectanttests to ensure that users are notcomparing apples with bananas, as thedata presented can be confusing.
Disinfectant testingFor life science facilities in Europe thevalidation of disinfectant effectiveness isusually carried out to the standard testsunder the control of CEN TechnicalCommittee 216, Quantitative tests forchemical disinfectants and antisepticsused in food, industrial, domestic andinstitutional areas. Table 1 shows thedifferent tests available.
A manufacturer will use a mix of thesetests to show the effectiveness of adisinfectant. The basic suspension testsare usually used at an R&D stage to checkbasic efficacy while establishing shelf life
or concentration. As can be seen fromTable 1, it is harder to kill organisms onthe surface, as the pass criterion is one logreduction lower than the suspension test.As the disinfectants in the cleanroom areto be used on hard surfaces then this testis a good starting point to demonstratesporicidal efficacy. It is sometimes mootedthat there is no surface test for spores,however there is no reason why EN13697cannot be used with spore formingorganisms. The method of creating thespore suspension can be taken fromEN13704 but any deviations from thestandard need to be declared, whether it ischoice of organisms, contact time orsurface material used.
So when looking to validate adisinfectant with at least a log 2 sporicidalefficacy for cleanroom use, a good startingpoint would be to see how it performed inthe lab against EN13697 at the 2mincontact time required. A disinfectant withonly a log 2 reduction against asuspension test is unlikely to achieve thesame log reduction on a surface.
Disinfectant wipe testing: If apresaturated wipe is to be used anypotential incompatibilities between thedisinfectant and the wipe need to bevalidated. This was discussed in moredetail in Cleanroom Technology, December2014 pp.29–31. One simple way to do thisis to make sure the EN 13697 test iscarried out on fluid removed from thewipe and is not just the result from testscarried out on the fluid in a bottle.
This testing is still not representative ofthe product in use, which will involvemechanical action during wiping. Untilrecently there was no EN standard forassessing disinfectant wipe efficacy butEN166157 was recently launched as acarrier test for establishing whether awipe has a bactericidal or yeasticidal
effect. It is designed for presaturatedwipes but the wipe could be saturatedwith the chemical at point of use. Thereare options to include an interferingsubstance to replicate clean and dirtyconditions. The contact time can also bevaried from 1–60min. Wiping is carriedout with the wipe wrapped around agranite block weighing 2.3–2.5kg tostandardise the wiping procedure and tosimulate average pressure when wiping.
The block is wiped over four fieldsmarked on a PVC sheet. The organismunder test is dried onto Field 1. Thegranite block is then passed over all thefields. In test Field 1; a log 5 reductionneeds to be achieved against bacteria or alog 4 reduction against yeasts. In Fields2–4 there needs to be a carry-over of lessthan 50cfu for each organism.
The test is very new and not many UKlabs have validated this method yet forefficacy testing. To date there is very littledata available. The laboratory whichpioneered this test method in Germanyidentifies some key factors which affectwipe efficacy including wipe material,wipe quality, impregnation volume,application pressure and applicationtechnique. It claims the method is suitableto differentiate between wipes. While thetest is being validated somemanufacturers have generated their ownlab tests to mimic the wiping ofcomponents used in asepticmanufacturing. Contec has used amodified EN13697 surface test to validateits disinfectants for transfer disinfection;by drying bacillus spores onto coupons ofsyringe packaging materials but applyingthe disinfectant by wiping. Results werecompared with a coated stainless steelcoupon which was untreated.
In use testing: Once standard labtesting results and ‘practice mimicking’
lab results havebeen taken intoconsideration, inuse tests can becarried out withthe disinfectant ofchoice or a shortlist of disinfectants.Two commonlyused methods ofanalysing thetransferdisinfection processinclude contactplating and a totalimmersionbioburdenevaluation method.Work by S.J. Hiom8
�
TABLE 1: STANDARD EN DISINFECTANT TESTS Test Type of test Organisms Pass criteria Interfering substance Contact time
EN1040:2005 Basic Suspension (Phase 1) Bacteria Log 5 Not added Not specified
EN1275:2005 Basic Suspension (Phase 1) Fungi/Yeasts Log 4 Not added Not specified
EN14347:2005 Basic Suspension (Phase 1) Spores Log 3 Not added Not specified
EN1276:2009 Suspension (Phase 2 Step 1) Bacteria Log 5 Yes 5 min
EN1650:2008 Suspension (Phase 2 Step 1) Fungi/Yeasts Log 4 Yes 15 min
EN14476:2013 Suspension (Phase 2 Step 1) Viruses Log 4 Yes 60 min
EN13704:2002 Suspension (Phase 2 Step 1) Spores Log 3 Yes 60 min
EN13697:2015 Surface (Phase 2 Step 2) Bacteria Log 4 Yes 5 min
Fungi Log 3 Yes 15 min
EN16615:2015 Surface with mechanical Bacteria Log 5 Yes 1 min to
action (Phase 2 step 2) Fungi Log 4 60 min
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December 2015 19DISINFECTION
in 2000 showed the total immersionmethod to be more sensitive.
The current and proposed transferdisinfection process can also be validatedusing finger dabs of the operators. If a twophase transfer disinfection process,spraying and wiping with alcohol in bothphases, is also compared, this will clearlyshow what subsequent reduction inbioburden has been achieved by the use ofthe sporicide. A comparison of thepercentage of spore-forming organismsfound to non-spore forming organisms willshow any deficiencies in technique if a highproportion of non-spore forming organismsare present. Environmental monitoringresults should also show a reduction inthe number of spore-forming organismsfound. The Guidance for AsepticProcessing states that the acceptancecriteria should be defined before theevaluation process is started and could be,for example, the absence of any organismson any item post wiping.
There are many other factors toconsider before introducing a sporicideinto the transfer disinfection process. The
main difference between the majority ofsporicides and alcohol is that they areaqueous based and will not dry as quicklyso consideration needs to be given todrying times and components not endingup too wet. Compatibility withcomponents used, health and safetyprecautions, in-use shelf life, effect onresource and budget also need to beconsidered.
References1. EudraLex. Rules Governing MedicinalProducts in the European Union Vol. 4 EUGuidelines to Good ManufacturingPractices for Medicinal Products forHuman and Veterinary Use. Annexe 12. MG Cockcroft, D Hepworth, J C Rhodeset al, Hospital Pharmacist September 2001.3. The Quality Assurance of AsepticPreparation Services 4th Edition Oct 2005Edited A M Beaney4. www.mhra.gov.uk5. Guidance for Aseptic TransferProcesses in the NHS: Addressingsporicidal issues July 2015 Edn. 1 NHSPharma. Quality Assurance Committee by
CONTACTKaren Rossington is a marketingconsultant for Contec Inc [email protected]
the NHS Pharma. Micro Protocols Group.Lead authors Mark Oldcorne, Tim Sizer6. BS EN 13704:2002 Chemicaldisinfectants and antiseptics –Quantitative suspension test for theevaluation of sporicidal activity ofchemical disinfectants and antisepticsused in food, industrial, domestic andinstitutional areas – Test method andrequirements (phase 2, step 1)7. BS EN 16615:2015 Chemicaldisinfectants and antiseptics. —Quantitative test method for theevaluation of bactericidal and yeasticidalactivity on non-porous surfaces withmechanical action employing wipes in themedical area (4-field test). Test methodand requirements (phase 2, step 2)8. Sarah Joanna Hiom, 2000. ThePharmaceutical Journal, Vol 265 pp.277-278
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Purified water is critical to thepharmaceutical industry, in operationsranging from formulating drugs to rinsingglassware. The bigger the operation, themore purified water will be needed.Considering just a few applications withinpharmaceutical development – cellculture, media preparation, DNAsequencing and genome research –illustrates the crucial need for purifiedwater of the highest quality.
So that these and other processes can becarried out safely and effectively – and befully validated – water has to be purifiedto approved standards. Pharmaceuticalcompanies are experts in their fields, so itmakes sense to outsource the critical jobof water management to an equivalentexpert.
In the pharma sector, water quality isregulated by national and internationalbodies, specifying three commonly usedgrades of water: United StatesPharmacopoeia (USP) specifies two grades– purified water (PW) and water forinjection (WFI); while EuropeanPharmacopoeia (EP) specifies a furthergrade – highly purified water (HPW).
These rules outline specific parametersand measuring criteria for the water usedin certain applications, but do nottypically detail the system designconsiderations or maintenance regimesneeded to achieve these quality levels.Instead, this falls within the remit ofvalidating bodies, such as the US Foodand Drug Administration (FDA), whichaim to ensure compliance with standardsby checking that system design,installation, monitoring and maintenanceprocedures are in place to facilitateconsistent, traceable performance to therelevant standards.
In addition to these organisations,documents such as the current GoodManufacturing Practice (cGMP) and theISPE Water and Steam Guide can helporganisations with purified waterrequirements.
Water auditWhen developing a water purificationsystem from scratch or scaling up fromlow volume laboratory trials to batch orfull production, it helps to have a clearunderstanding of the critical phasesinvolved. The key consideration is that thefinal product remains unchanged, and thesame applies to the quality of purifiedwater required to produce it and theverification procedures used to ensurecompliance.
The first step involves drafting the UserRequirements Specification (URS), which
defines and specifies the requirements ofthe water purification system. It shouldprovide enough detail and information fora prospective system provider or advisorto suggest a solution that will providepurified water that reaches the quality,quantity and consistency needed.
This initial audit involves sendingsamples of the existing feedwater supplyfor detailed mineral and microbiologicalanalysis. While the local authority orwater supplier should supply relevantinformation, it is nonetheless prudent tohave this confirmed by an independentspecialist. If a surface water or boreholesource is being used, a detailed evaluationof water characteristics is critical. Thepre-treatment system can therefore beappraised and a specification drawn up. Ifwater conditions are changeable, then thedesign of raw water treatment systemsand the provision of pre-treatment willneed to take account of this.
Calculating the size of the waterpurification system is the next step.Working out peak demand whileestablishing the volume required on aregular basis ensures that any immediateand future needs can be met whileavoiding subsequent costs that may beincurred by changing the design – whichwould mean revalidating the system.
The quantity and pattern of water useare important considerations whendesigning the system. Technicians oftenlook at total consumption over a daily,weekly or monthly period, but should alsoanalyse the pattern of daily use andconsider peaks and troughs in waterrequirements.
A system must be sized correctly: largeenough to cope with demand, but nolarger than necessary. An oversizedsystem takes up precious space, and canalso affect performance; for example,Reverse Osmosis (RO) is potentially lessefficient if the plant is operational only forrelatively short periods. For this reason,designers should accurately estimate thenumber of points that will be in use at
any one time. If it is assumed that allpoints will be in use at once – drawingmaximum flow – this can lead to anoversized system.
Once purified, the water must beaccessible to lab or production staff –through self-contained, individual unitsthroughout the lab, a ring-maindistribution system or in-line processunits. Space is a precious commodity inlabs, so options need to be as unobtrusiveas possible. If supplies are required atdifferent manufacturing locations, acentralised system that feeds a ring-mainmay be the better option, offering acompact solution that can deliver highvolumes at verified quality. Providing theright capacity can also mean that storagehas to be part of the solution.
Higher volume production typically uses
December 2015 21WATER PURIFICATION
�
Pure water is a key factor in the production of pharmaceuticals –and an audit of operations can help identify the best way to set upa water purification system, says Mark Bosley, SUEZ WaterPurification Systems UK
KEYREQUIREMENTSFOR SETTING UPPURE WATER ON TAP
Pure water is required for all aspects of drugproduction and quality testing
021-022clt1215 Suezpurite H.qxp_Layout 1 23/11/2015 15:45 Page 21
CONTACTMark Bosley, Business SupportDivisional Manager, SUEZ WaterPurification Systems UK (formerlyPurite Ltd), Thame, Oxon, UKT +44 1844 217141www.purite.com
22 December 2015
WATER PURIFICATION
scaled-up versions of the smaller waterpurification systems supplemented bysystems such as: sand and multi-mediafilters to eliminate particulates; activatedcarbon adsorption systems, which removeorganic contaminants and chlorinecompounds that can affect colour, tasteand odour; cartridge filtration for pre-treatment; and reverse osmosis, whichremoves ionic contaminants. All of thesemust be fully validated to the appropriatestandards.
Filtering techniquesWater goes through a series of operationsto make it acceptable for production. Thefirst stage, pre-treatment, removesparticulate and organic matter using avariety of techniques, such as sand ormultimedia filtration, or finer cartridge-type filters. Filters are commonly used inseries, with each filtration stage takingout smaller particles than the previousone. If raw water quality is particularlypoor and has a high fouling potential,ultrafiltration using membranetechnologies can be more cost effective.
Pre-treatment also eliminatescontaminants that might interfere withRO, in which pressurised feed water ispassed through specialised semi-permeable membranes to removeinorganic ions and dissolved organiccontaminants.
The feed water for an RO system istypically softened to prevent build-up ofcalcium deposits on the membranes. Thisis normally achieved using softeningresins that remove hardness byexchanging calcium ions – the maincontributor to hardness – with sodiumions. The process is reversible, allowingthe softener to be automaticallyregenerated.
Another process used in pre-treatmentis carbon filtration, which removes freechlorine – used as a disinfectant indrinking water – and reduces the level ofdissolved organics.
RO removes around 98% of mineralsand salts from a water sample. Themembranes can operate at an efficiencyup to 75%, depending on feed waterquality. As well as demineralising water,the membrane also removes micro-organisms.
Next, the remaining ions need to beremoved by way of deionisation.Conventionally, this was achieved usingcation or anion specific ion exchangeresins. These were later regenerated usingacid or caustic soda. But a more efficientprocess called electro-deionisation (EDI),which uses no hazardous chemicals, is
now preferred. It uses ion exchange resinssandwiched between charged membranes.Under a voltage, the ions are attracted outof the water and towards the relevantelectrode. Hydrogen and hydroxyl ions,generated in situ, make the process self-regenerating.
Defining the systemOnce the water side of the audit isconcluded, it is important to considerwhat the equipment will be used for.Within the URS document, a sectionrelating to ‘System Definition’ mayinclude, for example, details as to thepreferred functionality and operatingschedule. Once all of this has been takeninto account, the owner or operator willbe in a good position to create a scaled-down model, which will represent theresulting larger system.
To make the transition to highervolume products, manufacturers shouldfind a water purification provider with asolid track record of developing, installingand supporting high quality technologythat is validated specifically for this sector.A correctly chosen partner can then guidecustomers towards a system that canhandle both current and future needs.
An effective water purification systemmust maintain water quality as well asproduce it in sufficient volume to meetdemand. Purified water storage anddistribution systems must be hygienicallydesigned. It is important to minimise thelength of pipework between the source ofpurified water generation and the pointsof use, and avoid dead-legs or static water.Once the purified water is generated,
consideration must be given to thematerial of all wetted parts, ascontaminants can leach out of manymetals and plastics.
Typically, sanitary welded 316Lstainless steel piping with equivalentgrade pumps, heat exchangers andcomponents are used to store anddistribute purified water. Stainless steel isrelatively inert, can be installed toeliminate potential traps for bacteria, andcan be thermally disinfected at very hightemperatures.
To ensure that a system maintains itsquality, in terms of bacterial counts, it isessential that system and distributionpipework can be easily and completelysanitised. For the distribution loop,sanitisation is commonly in the form ofheat, using either hot water (>80°C) orpressurised steam – both of which areroutinely available in mostpharmaceutical environments. Ozone ishighly effective and also widely used inthis regard, but its hazardous naturedictates that safety systems andmonitoring be put in place.
While great attention is focused on thetreatment of incoming water, whichensures final product quality, it isimportant not to forget the treatment ofwastewater. The effluent frompharmaceutical manufacture may not lookdirty, but potentially it contains moreharmful substances than wastewater frommany other industries.
Some of the techniques used in waterpurification can also be put to use ineffluent treatment. Reverse osmosis, forexample, removes the majority of mineralsfrom effluent to allow safe discharge intowater courses. Alternatively, concentratedeffluent evaporation drives off all thewater, so there is no need for a liquiddischarge, with systems such as Evalix,from SUEZ Water Purification SystemsUK, using plant-generated biogas toevaporate the water. Cleaning-in-place(CIP) water can also be treated, usingphysico-chemical treatment.
All these measures help to ensure thatthe water that leaves the plant is at leastas clean as the water that comes in.
�
Select Fusion provides small volumes of ultrapurewater to 18.2MΩ.cm from a mains supply
021-022clt1215 Suezpurite H.qxp_Layout 1 23/11/2015 15:45 Page 22
A4 half pages.qxp_Layout 1 25/11/2015 11:09 Page 1
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A4 pages_Layout 1 29/09/2015 16:40 Page 1
CONTACTChalcroft LtdT+44 1553 [email protected] www.chalcroft.co.uk
of correct respiratory protectionequipment (RPE).
Following the initial securing of thearea, it is vital to undertake sampling andsurveys to monitor both the health ofindividuals who may have been exposedand the air in the surroundingenvironment. The disposal process mustbe very carefully managed, from thecomplete removal of the materials to thetransportation to a licensed facility fordestruction – as well as the replacement ofthe asbestos with a safe alternative.
To complete the process, documentationand consignment notes must be provided,but for conscientious constructioncontractors, the work doesn’t stop there –on any refurbishment project they mustconstantly assess structures for thepresence of asbestos as part of a robustand ongoing identification process.
While this proposal is in its infancy, theimpact of removing asbestos can besevere, especially for open-planpharmaceutical manufacturing facilitieswhere isolation of a small area may provevery difficult and bring production to acomplete halt. Ultimately, proactivity inthe removal of asbestos rather thanwaiting for rules to be imposed will be ofgreat benefit to business landlords –allowing the safe removal of this highlydangerous substance to fit aroundproduction schedules or planneddowntime, and minimising the effect onregular operations.
The European Parliament has proposed the removal of asbestosfrom all European public buildings by 2028. Todd Hallam,Chalcroft’s QEHS Director, looks at how the pharma industrycan safely implement an asbestos management plan
An estimated 2,000 deaths from lungcancer are attributed to asbestos exposureeach year, and while these figures areslowly decreasing, another illnessassociated with asbestos is sadly on therise. Mesothelioma, a more specific form ofcancer that often originates in the lunglining, can be caused by a much lowerexposure to asbestos and is the cause of anincreasing number of deaths. TheEuropean Parliament is thereforeconsidering introducing a completeremoval of asbestos particles in public andcommercial buildings to prevent illnessand fatalities – policies which are alreadyin place in Australia and Poland.
After centuries of use, the asbestosindustry was established in 1858 whencompanies began mining the materialspecifically for industrial insulation.Indeed, the substance is still mined todayin countries such as Russia, Brazil, Chinaand Kazakhstan.
In the UK, asbestos was usedextensively in construction in the 1950sand 1960s; it is actually a group of sixsubstances with the most popularly-usedtypes being chrysotile, amosite (alsoknown as brown asbestos) and crocidolite(blue asbestos). The most common, usedin roofing, ceilings, walls and floors of alltypes of buildings, was chrysotile. Amositeconsists of needle-like fibres and waspredominantly used in insulating boards,ceiling tiles and pipe insulation.Crocidolite, while it provides the highestheat resistance of all types of asbestos, isalso the most dangerous and was mainlyused in cement products, insulatingcoatings and pipework.
The import and use of blue and brownasbestos was banned in 1985, with acomplete ban imposed in 1999. However,while its use was prohibited within newbuildings, the removal of old asbestos wasnever legislated for unless disturbed bypost-ban construction work – meaningthat any building older than 30 years,including cleanrooms and pharmafacilities, may contain asbestos.
Asbestos fibres can lie dormant in thelungs for 15–50 years following initialexposure, explaining why deaths are onthe rise. Some 80% of people diagnosedwith mesothelioma are men, whichreflects the demographic of theconstruction industry throughout the lastgeneration, and in 2012 a total of 2,535deaths were attributed to this specific typeof lung cancer. During 2013, 2,145 newcases of mesothelioma were assessed forIndustrial Injuries Disablement Benefit.Overall, the HSE predicts that by 2050, astaggering 91,000 asbestos-related deaths
will have occurred in the UK and,according to the British Lung Foundation,exposure to this substance claims a lifeevery five hours.
The case for the full removal of asbestosboards, fibres and coatings is compelling,even though the proposed deadline forremoval seems a long way off. Forbusiness landlords planning to refurbishor extend their premises, however, thedeadline may come around a lot sooner asbuilding work typically uncovers ordisturbs asbestos in buildings more than30 years old.
With experience in refurbishingproperties as diverse as foodmanufacturing facilities, cleanrooms,temperature-controlled warehouses andcommercial premises, it is a situation thatChalcroft encounters frequently.
Whether there are a small number ofasbestos-based panels or fabrics or anentire roof, an asbestos management plandeveloped in line with Health & SafetyExecutive (HSE) regulations and guidanceshould be instantly deployed. Highlytrained site managers and supervisors,working with licensed contractors whererequired, will be responsible for handlingthe isolation of the area and the provision
MANAGINGASBESTOSERADICATION
December 2015 25LEGISLATION
The disposal process for asbestos must be verycarefully managed
000 clt 1215 Chalcroft H.qxp_Layout 1 23/11/2015 15:45 Page 25
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December 2015 27PACKAGING
For pharmaceutical manufacturers,quality of product is the most importantfactor. The challenges of manufacturingsterile injectable products, which aretraditionally filled into glass vials orampoules, under aseptic conditions are farmore stringent than traditional oral tabletoperations. Because of the route ofadministration, there is a far greater riskto the patient from contamination duringmanufacturing, either from glass orforeign particulates, or microbial ingress.The consequences of these out-of-specification products reaching the patientare extremely serious and product recallsresult in disruption to supply chains andcan compromise patients’ therapeuticregimes.
Traditional aseptic filling of glass vialsis a highly complex operation, whichinvolves multiple human interactionswithin the process. The humanintervention introduces numerousvariables, all of which increase the risk ofproduct contamination. Often, the asepticfilling is undertaken within large ‘GradeA’ suites and involves multiple operationsto prepare the container components tofeed the filling lines. These containers andcomponents are exposed to theenvironment on the filling line for a longduration, increasing the risk ofcontamination, even after sterilisation.
Advanced aseptic manufacturingwith blow fill seal (BFS): To overcomethe challenges that traditional glass vialaseptic filling presents, one option is toreplace the traditional glass vial fillingwith the advanced aseptic manufacturingprocess of BFS. This technology has beenwidely used and accepted for decades inthe sterile manufacturing of respiratoryand ophthalmic products. Based on anautomated aseptic filling technique, BFSis fundamentally rooted in the principlesof Quality by Design and has beendesignated as an advanced aseptic processby the industry.1 This designation is basedon its equipment design, automation, andoperational controls, as well as the resultsof numerous microbial challenge testsproving its ongoing aseptic nature duringprocessing.
As the name suggests, Blow Fill Sealtechnology creates, fills and seals theprimary sterile container in one process.The process takes seconds and iscontained within ISO 5 aseptic conditionsconfined within the machine. The processbegins with raw virgin plastic pellets,which are fed through a hot melt extruder.High pressures and temperatures melt thepellets to form molten tubes, calledparisons that are then enclosed within a
mould. The key strength of BFS lies in thetwo-stage mould concept, where the bodyof the container is cooled in the bottompart of the mould while the top remainsmolten. After the container body is formednozzles then fill the open container. Atthis point, a sterilised stopper can beautomatically inserted into the containerusing vacuum tubes.
The final step is to close the secondstage of the mould and seal the contentsinto a fully integral container. Theproduct then leaves the machine throughconveyors and is ready for secondarypackaging.
The advantages over a traditional fillingline are numerous. The primary containerclosure simply does not exist before it isformed – so individual components do notneed to be handled, washed or sterilised,
Injectable drugs require careful biocontamination control duringfilling into vials or ampoules. Here Catalent looks at howadvanced aseptic manufacturing using blow fill seal technologyreduces the risk of contamination during filling and can alsoprovide greater freedom in container design
PROVIDING A SAFE ANDRELIABLE SUPPLY OFINJECTABLE DRUGS
and the temperature and pressure atwhich it is formed act as another lever formicrobial control. This process drasticallyreduces the requirements and variablesassociated with handling components. Italso allows for a compact footprint; theGrade A filling conditions are maintainedwithin the footprint of the machine,reducing the need for large, complexsterile suites.
Reduced foreign particulates As the automated nature of BFS virtuallyeliminates human intervention in thecritical fill application, and because thecontainer is created at virtually the sametime as filling, the potential for �
Above: Model 640 ASEP-Tech blow fill sealSystem. Picture courtesy of Weiler Engineering
027-029clt 1215 CatalentJHa.qxp_Layout 1 23/11/2015 15:47 Page 27
28 December 2015
PACKAGING
contamination is drastically reduced. Forinstance, when measuring foreignparticulates, manufacturing undertakenusing BFS technology can provide adrastic reduction in particulates comparedwith both the industry standards,measured by USP <788>,2 and theindustry average of injectable products.3
USP <788> states that there should beno more than 6,000 particles larger than10µm, and no more than 600 larger than25µm.
In 2004, a study was conducted on 406drug lots, across 295 Abbreviated NewDrug Applications (ANDAs), which foundthe average numbers across these lotswere 219 particles greater than 10µm, and15 greater than 25µm. However, whencomparing Catalent’s patent pending BFSfilling technology, the particulates arereduced to a fraction of the industryaverage. A design of experiment wasconducted to review the specificprocessing conditions within the BFSprocess to produce an Advasept*10mLvial. This study reviewed 32 differentconditions within the process and yieldedan average of 5.0 particles greater than10µm, and just 0.9 greater than 25µm onaverage. This represented a reduction ofmore than 95% in foreign particulatescompared with the industry average.
Proof of aseptic processing andcritical control parameters: Key to thedesignation of BFS as an advanced aseptic
process was through a microbial challengeof the system. This was undertaken by theconstruction of a self-contained area, androom with separate air handling andenvironmental monitoring systems thathoused a commercial BFS machine. Thefacility then executed a series of tests andexperiments to challenge the parametersof the system and resulting impact of thefinished container with respect to itssterility. Over the course of the studies,the three critical areas were determined:the room, the fill zone and the resin.
To challenge the room, it wascontinuously filled with a 106 aerosolisedBacillus subtilis suspension throughoutthe media fill processing.4 A number offills and processing conditions werecarried out. The experiments provided theknowledge of the critical controlparameters needed to provide 10-6
reduction of microbial contamination. To challenge the fill zone, the surfaces
of the BFS machine were loaded with 106
B. subtilis spore suspension.5 Again aseries of tests was conducted to explorethe critical parameters and it was revealedthat with proper air flow around thenozzles, the process yielded zerocontaminated media samples.
Finally, to challenge the polymer resinused to make the containers, it too wasloaded with a 106 spore suspension of B.subtilis.6 After this was used in a standardBFS media fill run, the temperature and
pressure revealed a 10-3 bioburdenreduction.
This series of tests identified a numberof critical control parameters within theprocess. These include, but are not limitedto, the sterilisation of components in situ;the need for proper air flow in the nozzleshroud area; that the HEPA filtered areain the parison areas (shown in Figure 1) isrunning; and fill shroud doors remainedclosed. As an additional precaution, theair around the fill zone is continuouslymonitored for both viable and non-viableparticulates throughout the run tomonitor the in-process conditions andestablish incoming resin material specs.
Risk reduction through automationBFS equipment, and the procedures thatare associated with it, provide significantadvantages for providing a high level ofsterility assurance. Decades of studyingthe process means that the critical controlparameters have been defined. Akers andAgallaco – leading aseptic manufacturingindustry experts – consider that advancedaseptic filling via BFS reduces the risk ofcontamination 100 fold compared withtraditional glass vial filling.7
The technology drives to eliminate theroot cause of the contamination issues �
�
Figure 1: Schematic of the blow fill seal process
Advanced Aseptic Manufacturing with Blow FillSeal technology has advantages, e.g. reducedhandling and sterilisation of components,reduced bioburden and a small footprint
027-029clt 1215 CatalentJHa.qxp_Layout 1 23/11/2015 15:47 Page 28
December 2015 29PACKAGING
that are being seen in the injectablesmarket today. The reduction of variables,automation of the process and eliminationof human intervention, drives at a morerobust supply of products into theindustry based on the reduction of risk inthe manufacturing process.
Beyond manufacturing – safety indelivery: Few manufacturers considerthe implications once the product has leftthe facility, but Catalent has looked toevolve its Advasept* platform to ensuresafety for the patient through to theadministration of the drug containedwithin the container.
A major advantage with BFS technologyis that it offers the freedom to provideunique container designs and the abilityto tailor vials to the needs of the product.Advasept containers can be made to avariety of sizes and shapes, withnumerous opportunities to allow forenhanced safety features, and branddistinction within the marketplace.Additionally the technology hasadvantages in its ability to reduce theheadspace within vials, which can beminimised to reduce the potential of
agitation effects of products duringtransport and handling; also shapes ofvials can be altered to reduce packingsizes, and ultimately shipping cost.
One such evolution is Advasept Lock,which combines the glass free plasticdesign with an easy twist off stopperlesscontainer to allow for dispensing via asyringe through a luer lock connection.For a practitioner, this eliminates both theuse of needles and the need to open glassampoules, and the risk of associatedsharps injuries and loss of product duringhandling. This provides just one exampleof how the primary container can addvalue to the supply chain.
References1. US Pharmacopeial Convention. (2014).General Chapter <1116>, MicrobiologicalControl and Monitoring of AsepticProcessing Environments. In USP 37, pp.931–9422. US Pharmacopeial Convention. (2014).General Chapter <788>, ParticulateMatter in Injections. In USP 37, pp.398–401.3. Presenter Shabushnig, John.
(November, 2010). Regulatory andCompendial Considerations for Particlesin Parenteral Products. Presented atAAPS, New Orleans, LA. 4. Bradley, A., Probert, S.P., Sinclair, C.S.,& Tallentire, A. (1990). PDA Journal ofParenteral Science and Technology,July/August 19905. Catalent Internal Report – MCF-022 –Air Dispersions, LTD C. Sinclair, 11/20026. Leo, F., Poisson, P., Sinclair, C.S.,Tallentire, A. (2004). PDA Journal ofPharmaceutical Science and Technology,Vol. 58 (3), May–June 20047. Akers, J., & Agalloco, J. (2006).Pharmaceutical Technology, July 2006.
*Advasept is a registered trademark ofCatalent
CONTACTCatalent Pharma Solutions EU/ROW T 800 8855 6178 US +1 877 587 [email protected]@catalent.com
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available as a wipe system for saturationat point of use, Contec’s SATWipes havebeen specifically designed for transferdisinfection.
VALIDATIONContec has conducted transferdisinfection studies using ProChlor toprovide guidance to operators using theproduct for transfer disinfection. Thestudies were conducted by anindependent laboratory. B. subtilis sporeswere applied to the paper and plasticsides of syringe packaging and air-dried.
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SPORICIDAL WIPES FORTRANSFER DISINFECTIONResponding to the need for a sporicidalwipe for aseptic transfer disinfection,Contec, a leading manufacturer ofcontamination control products forcritical cleaning and disinfection in lifescience manufacturing environmentsworldwide, has added Contec SATWipeswith ProChlor to its range.
With more than 25 years of experiencewe understand the unique cleaningrequirements of this specialist marketand are uniquely placed to helpcustomers find or create a Contecproduct that best meets their needs.Contec’s extensive existing product rangefor life science and electroniccleanrooms, includes sterile and non-sterile, knitted and non-woven dry wipes.Presaturated wipes are available in avariety of formats, substrates and sizessuitable for every size and cleanliness ofcleanroom.
CONTEC PROCHLORContec ProChlor is one of the fast acting,sporicidal disinfectants available for lifescience cleanroom use. Manufactured ina Grade B cleanroom and filtered to0.2µm Contec ProChlor is especiallysuitable where a fast acting and effectivesporicide is needed. With a contact timeof only 1 min and low residue, ContecProChloris is validated to meet theMHRA’s new requirement of a sporicidalphase during transfer disinfection.
Contec ProChlor has a validated, 100%reduction in spores (EN13697) in under 1minute. Remarkably, for this level ofefficacy, Contec ProChlor carries noassociated hazard, as it is neither anirritant or corrosive substance. Now
The surfaces were then either wiped orsprayed with Contec ProChlor and left fora contact time of 2 mins before wipingwith 70% alcohol. A log 6 reduction inspores was achieved on the plastic sidefor both options. On the paper side, alog 4 reduction was achieved by wipingand a log 5.75 reduction by spraying.
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CONTEC PROCHLORSporicidal disinfectant solutionSuitable for sporicidal transfer disinfection due to its short contact time and low residue, Contec ProChlor is a new, innovative, sporicidal biocide validated for use in hospital pharmacies. Available fi ltered and sterile, Contec ProChlor is one of the fastest acting, cleanroom sporicides available.
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December 2015 33
MICROBIAL CONTAMINATION
The International Space Station photographedfrom the space shuttle AtlantisPhoto courtesy of NASA
The results of a recent NASA study, obtained using newmolecular analysis methods, provide strong evidence that specifichuman skin-associated bacteria make a substantial contributionto the space station microbiome
NASA STUDIES THE MAKE UP OF THE SPACESTATION’S MICROBIOME
State-of-the-art molecular analysis ofdust samples from the International SpaceStation (ISS) has been employed to revealnew information about some of thepotential bacterial agents present in theastronauts’ space environment. Theresearch, published in the open accessjournal Microbiome1, reported presence ofthe opportunistic bacterial pathogens thatare mostly innocuous on Earth but canlead to infections that result ininflammations or skin irritations.
The findings of this study help NASAestablish a baseline for monitoring thecleanliness of the ISS, which will in turnhelp manage astronaut health in thefuture. However, since the study is basedon genetic analysis, it could not concludewhether these bacteria are harmful toastronaut health.
The ISS is a unique built environment,experiencing microgravity, space radiationand elevated carbon dioxide, and constantpresence of humans. Understanding thenature of the communities of microbes –the microbiome – in the ISS is key tomanaging astronaut health andmaintenance of ISS equipment.
Traditional microbiology techniques,which culture bacteria and fungi in thelab, have previously been used to assessthe composition of this community. Nowscientists from NASA’s Jet PropulsionLaboratory have used the latest DNAsequencing technologies to identify themicro-organisms present on the ISS,filling in the gaps left by traditionalmethods, and highlighting pathogens thatmay pose a threat to astronauts.
The team collected air filter samplesand vacuum bag dust from the ISS. Theythen compared these samples with dustfrom NASA ‘cleanrooms’, environmentallycontrolled and closed built spaces onEarth. Key differences between thecleanrooms and the ISS are that thecleanrooms circulate fresh air while theISS filters and recirculates air, and theISS is inhabited continuously with onlysix people while 50 people may be in acleanroom in a day but not inhabit itcontinuously. While these Earthcleanrooms are not air-tight, they haveseveral layers of rooms that would preventfree exchange of air particulates.
The researchers analysed the samplesfor micro-organisms, and then stainedtheir cells with a dye to determinewhether they were living or dead. Thisenabled them to measure the size anddiversity of viable bacterial and fungalpopulations, and determine how closelythe conditions in the Earth cleanroomscompare to the ISS environment.
Their results show that Actinobacteria,a type of bacteria associated with humanskin, made up a larger proportion of themicrobial community in the ISS than inthe cleanrooms, which the authorsconclude could be due to the morestringent cleaning regimes possible onEarth.
Two groups of opportunistic pathogensthat can lead to infections were also foundin the ISS dust samples, but the researchdid not address the virulence of thesepathogens in closed environments or therisk of infection to astronauts.
Lead author of the study, KasthuriVenkateswaran, said: ‘By using bothtraditional and state-of-the-art molecularanalysis techniques we can build a clearerpicture of the International SpaceStation’s microbial community, helping tospot bacterial agents that may damageequipment or threaten astronaut health,and identify areas in need of more
stringent cleaning.’ The authors alsohighlight how these newer DNAsequencing technologies can be used tostudy the impact of microgravity on thestability of the ISS’s microbial community,which will be important for long-durationmissions, such as NASA’s journey toMars.
References1. A. Checinska, A.J. Probst, P.Vaishampayan, et al, Microbiomes of thedust particles collected from theInternational Space Station andSpacecraft Assembly Facilities,2015 Microbiome 3: 50.http://dx.doi.org/10.1186/s40168-015-0116-3www.jpl.nasa.gov
033clt1215Nasa v2JH.qxp_Layout 1 23/11/2015 15:48 Page 33
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