Health and Safety Guidance

Guidance on the Management

of Biological Risks

GUIDANCE/12/MBS/07 The University Policy on Biological Safety (UHSP/9/BS/05) provides the framework for managing risks from work involving biological materials. Schools and Departments are required by Policy to have local rules for the handling of biological materials, the guidance contained in this document should assist directly in the production of such notes. This guidance covers technical issues relating to laboratory work with biological materials that is not readily available elsewhere. There is a considerable body of official guidance produced and published by the Health and Safety Commission (HSC). This document is not intended to replace the official guidance but is intended to supplement it by adding practical detail where necessary. Further information and advice may be obtained from the Health and Safety Unit. January 2007 Revised June 2007 GUIDANCE/12/MBS/07

CONTENTS PAGE PART 1: INTRODUCTION AND PRINCIPLES OF PROTECTION 1

Introduction 1 Application 1 Principles of managing biological safety 1 Principles of control 2 Deciding on control measures 2 Maintaining control measures 3 Checking that standards are being maintained 3 Reviewing 4 Other key guidance 4

PART 2: SPECIFIC CONTROL MEASURES 5

A) Training and supervision 5 B) Equipment 6

Safety cabinets 6 Centrifuges 7 Ultrasonic disintergrators 7 Cryostats / microtomes 8 Waterbaths 8

C) Health surveillance and immunisation 8 Pregnant workers and breast feeding mothers 8 Immunisation 8

D) Transport of biological materials by road, rail or air 9 Classification 9 Packaging and Labelling 13

Category A 13 Category B 14 Exempt specimens 15 GMMs 16

Paperwork 17 Transport 18

Postal services 18 Importation 19

Summary of requirements 20 Indicative list of category A substances 21 References 22

E) Sterilisation and disinfection 23 Sterilisation 23

Autoclaves 25 Dry heat sterilisation 25 Ultra-violet lamps 25 Microwave ovens 26

The selection and use of disinfectants 26 Disinfectant types 26 Disinfection of people following accidents 27 Testing disinfectants 27 Formaldehyde fumigation of rooms and safety cabinets 30 Decontamination of centrifuges 31

F) Procedure for disposal of clinical waste 31 Introduction 31 What is clinical waste? 32 Disposal of clinical waste 33 Pre-treatment of waste before disposal 33 Procedures for dealing with clinical waste 33 Annex I

Clinical waste: risk summary 36 Annex II

Clinical waste: types, sources and disposal routes 37

G) Emergency arrangements 39 APPENDIX 1 Protective Equipment A1-1 APPENDIX 2 Handling human blood, blood products and other human tissues A2-1

Taking specimens of human blood Handling blood and blood products in student practicals Use of blood and blood products in research

APPENDIX 3 Animal and Plant pathogens A3-1

Animal pathogens Plant pathogens

APPENDIX 4 Filming and photography A4-1 APPENDIX 5 Who risk groups for micro-organisms A5-1 APPENDIX 6 Checklist for inspections of biological laboratories A6-1 Part 2D revised June 2007 Part 2F, minor changes August 2007 Part 2F, minor changes April 2008

Guidance on the Management of Biological Risks

PART 1 INTRODUCTION AND PRINCIPLES OF PROTECTION

Introduction The University Policy on Biological Safety (UHSP/9/BS/05) provides the framework for managing risks from work involving biological materials. The aim of the policy is to prevent, or at least to minimise risks to human health and to the environment that arise from activities involving biological materials and to set appropriate standards for control of those risks. This guidance is intended to help people in a position of responsibility for work with biological materials in Schools and Departments to identify appropriate precautions and to provide guidance on standards to be achieved in reducing the level of risk to an acceptable level. Schools and Departments are required by Policy to have local rules for the handling of biological materials, the guidance contained in this document should assist directly in the production of such notes. There is a considerable body of official guidance produced and published by the Health and Safety Commission (HSC) and referred to below under other key guidance. This document is not intended to replace the official guidance but is intended to supplement it by adding practical detail where necessary. The relevant requirements of policy are quoted at the head of each part of the guidance. Application The Biological Safety Policy applies to the handling, use, transport and storage of biological materials (including organisms that have been genetically modified*). The definition of biological materials in the Policy is as follows: Any micro-organism, cell culture, parasite, human or animal tissues (including blood, urine and other body products) or plant materials, which may cause infection, allergy, toxicity or other risks to human health or cause a risk to the environment. (* Including work to produce or construct genetically modified organisms and work with organisms already modified.) Principles of Managing Biological Safety University Policy requires that:

Appropriate measures are provided to ensure that risks arising from activities involving biological materials are eliminated or controlled

Managing biological safety involves the identification of significant risks (i.e. where there is likelihood that someone, or the environment, could be harmed if precautions are not taken) and ensuring that the appropriate precautions are put in place and maintained. These precautions are known as the control measures. These principles are encoded in the COSHH Regulations and the genetic modification regulations. Compliance with the University Policy and guidance should ensure that the requirements of these regulations are met. In the case of genetically modified organisms there are additional requirements in relation to processing assessments and notifying the Health and Safety Executive. The procedures for processing assessments are detailed in the University Policy. Assessment forms in MS Word document format are available for downloading from the World Wide Web page of the Health and Safety Unit.

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It is worth emphasising that the risks from biological materials both genetically modified organisms (GMOs) and wild-type and the means of preventing or controlling them are essentially the same. There is a concern that risks from wild-type organisms are given less priority because of the assumption that risks from GMOs will always be greater than from wild-type organisms. This is patently not the case and priorities should be based on risk assessments. Principles of Control Part of the assessment of risk includes identification of the necessary control measures. In the case of laboratory work the term Containment is used to describe those control measures. Containment however means more than the physical environment and includes procedures and practice. Two Health and Safety Commission expert committees, the Advisory Committee on Dangerous Pathogens (ACDP) and the Advisory Committee on Genetic Modification (ACGM), define hazard categories and levels of containment appropriate for those categories. The schemes for levels of hazard and containment are compatible and both have a system of categorisation into 4 levels. Containment Level 1 (CL1) is the lowest and is for agents that are unlikely to cause harm and level 4 is the highest for agents that cause severe human disease, present a risk to the community and where there is no treatment. Currently the University has no level 4 containment facilities and work with such agents is not allowed. In practice most work is usually at level 1 or 2 with a limited amount at level 3. It is good practice to select agents at the lowest hazard level possible for the work. Deciding On Control Measures The person supervising the work has the primary responsibility for making the risk assessment and identifying the control measures for work under their control. This is not done in isolation and there clearly needs to be a match between the facilities and procedures required and those available in the School or Department. There will also be common procedures and facilities that are controlled by the School or Department, which may also need assessing. Clinical waste disposal, autoclave facilities, disinfection regimes, training and transport and storage of material should be to a common standard. There is a hierarchy of control measures to be adopted when dealing with exposure to harmful agents. When deciding on the appropriate type of control measure to contain biological materials, the responsible persons doing the project assessments should work from the top of the following list and adopt the highest levels of control that is practicable in the circumstances. In most cases a combination of controls will be necessary. 1 Elimination Does the work with the hazardous biological material have to be done? Is there a non-hazardous alternative? 2 Substitution For work with pathogens, allergens, toxic or otherwise hazardous material, does it need to be a hazardous species or strain or could a less hazardous organism or material be used? For example, in undergraduate practicals there may be a non-pathogenic species or strain that could be used or it may be possible to use screened human material instead of unscreened material. 3 Physical enclosure If hazardous materials have to be used can they be physically contained to prevent exposure to the individual working with it? This will depend on the level of risk but where significant aerosols are produced microbiological safety cabinets may be needed. When material is transported outside of the laboratory it needs to be in sealed and leakproof containers. 4 Segregation The appropriate level of containment facilities (as defined by ACDP and ACGM) should mean that the more hazardous work is segregated from other work and therefore other workers and the environment

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are protected from exposure. For example work with hepatitis or HIV infected material should be performed in a segregated area away from distractions and with separate dedicated equipment. 5 Procedures Safe technique is critical when handling biological materials. Clear and safe procedures should be in place. For higher risks, Standard Operating Procedures may be appropriate. Routine disinfection and waste disposal procedures are important. 6 Information and Training Persons working with biological materials need to be trained and competent in technique and procedures. Basic lab rules such as hand washing and prohibitions on drinking and eating need to be instilled. Signs will be needed to warn people of particular hazards and identify higher risk facilities. 7 Personal Protective Equipment Where all the above cannot adequately control the risk, personal protective equipment (PPE) may also be necessary. PPE includes gloves, lab coats, goggles, visors etc. In most cases lab coats will be appropriate as a matter of good practice. Gloves and other PPE need to be carefully considered on the basis of need and the type required. Provision of PPE is the least reliable form of protection because it requires selection of the appropriate type that fits well, regular checking that they are still functioning, people remembering to use them and supervisors checking that they are in use. Immunisation is an additional precaution that is recommended and required in certain cases. It does not prevent exposure but does ameliorate the consequences of exposure. It is recommended in the case of work with unscreened human material (Hepatitis B), sewage (Hepatitis A) and work with TB or unscreened sputum. Maintaining Control Measures All equipment must be maintained in a safe condition, in particular any equipment that is designed to contain biological agents. The condition of the laboratories and other facilities should be maintained e.g. impermeable surfaces should remain intact and impermeable. There are specific requirements in COSHH to test and maintain local exhaust ventilation. In the case of work with biological agents this refers to microbiological safety cabinets, room air HEPA filters and any other extraction equipment that is used. Examination and testing needs to be carried out at least every 14 months. This guidance provides more information. Training records should be up to date and there should be arrangements for ensuring that new people are made aware of local arrangements. PPE needs to be maintained in good and effective condition. Where Respiratory Protective Equipment (RPE) or visors are provided there should be clear allocation of responsibility for their upkeep. Checking that Standards are being Maintained Once standards have been identified it is essential that checks are made to demonstrate that they continue to be maintained. Monitoring occurs at a variety of levels. The University Committees for biological safety carry out inspections from time to time on behalf of the University. There should also be local inspections co-ordinated by the BSO (Biological Safety Officer), supplemented by less formal inspections by those in a supervisory position over the work. A key measure of the effectiveness of the arrangements is whether individuals at the bench understand the risks and precautions. Paperwork and assessments need to be in place, and supervisors and the BSO should periodically check that these are up to date.

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Reviewing The purpose of review is to learn from experience and improve the arrangements for preventing or reducing risk. For individual assessments a formal review should be carried out after 3 years. However a review must be carried out where the work has changed significantly. Other Key Guidance The following official guidance should be read in conjunction with this guidance. Schools should ideally have copies of relevant guidance available. The documents are revised from time to time and the Health and Safety Unit will advise Schools of revisions. Some of this guidance is freely available on the internet and the University's Health and Safety Unit website includes links (see below) to the documents. It is essential that current versions of the following guidance are available: ACDP Guidance The Approved list of Biological Agents – available via University's Health and Safety website [http://www.hsu.bham.ac.uk/othinfo.htm or http://www.hsu.bham.ac.uk/univ/factfile/bio2.htm] Biological agents: Managing the risks in laboratories and healthcare premises (ACDP 2005) - available via University's Health and Safety website [http://www.hsu.bham.ac.uk/univ/factfile/Bio5.htm] The Management, design and operation of microbiological containment laboratories (ACDP 2001) Specific ACDP Guidance Protection against Blood Borne infection in the workplace: HIV and Hepatitis (ACDP 1995) Transmissible Spongiform Encephalopathy agents: Safe Working and the Prevention of Infection (available on web only at http://www.advisorybodies.doh.gov.uk/acdp/tseguidance/) Working safely with research animals: Management of infection risks (ACDP 1997) The large scale contained use of biological agents – (ACDP 1998) Other related guidance The safe management and disposal of healthcare waste (Health Services Advisory Committee) Safe working and the prevention of infection in clinical laboratories and similar facilities (HSAC 2003) GM Guidance ACGM Compendium of Guidance - available via University's Health and Safety website [http://www.hsu.bham.ac.uk/othinfo.htm or http://www.hsu.bham.ac.uk/univ/factfile/bio3.htm] A Guide to the Genetically Modified Organisms (Contained Use) Regulations

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PART 2

Specific Control Measures A) Training and Supervision

University Policy requires that: Persons working with biological materials are competent to do so without undue risks to themselves, others or the environment; Persons who may be at risk, or have duties under this policy, are provided with information, instruction and training, where appropriate;

The amount of training required will depend on the competence of the individual. Supervisors should not assume competence until it has been demonstrated. Training within the University will take place at two levels: 1 Central The Health and Safety Unit runs courses every term on the safe handling of biological materials. All new research staff, technical staff and research students handling biological materials should attend unless they have received similar instruction elsewhere. More specialised courses may be run from time to time. 2 Within the School or department The training requirements of each individual should be assessed by their supervisor and an appropriate training programme drawn up locally. The individual should be monitored closely and expected to demonstrate the following:

• Awareness and understanding of the risk assessments, standard operating procedures and codes of practice for the work;

• Technical competence for the work. Procedures should be carried out under close supervision initially and then independently;

• Competence in use of equipment, e.g. safety cabinets, centrifuges, and its subsequent disinfection;

• Knowledge and understanding of disinfection arrangements; • Knowledge and understanding of waste disposal procedures; • Knowledge and understanding of emergency procedures; • Knowledge of the appropriate Personal Protective Equipment and its correct use. The

individual should also be aware of its limitations; • Awareness of the safety structure within the department/school, i.e. the individual should be

able to identify their Safety Officer and Biological Safety Officer and be familiar with the internal procedures for accident reporting etc.

Much of the training for work at containment level 2 can be given at the bench under supervision. Where work at a higher level is involved training must be more systematic and the individual should be expected to demonstrate full understanding of risk assessments and procedures as well as the required technical competence. It is important to keep training records for persons working at containment level 2 and above. This may take the form of a checksheet, against which trainer and trainee sign to confirm that training has been carried out, and the trainee has demonstrated competence in each assigned task. Work at containment level 3 will require rigorous training against approved Standard Operating Procedures. Again, trainer and trainee need to sign documentation to certify that training has taken place, and the individual has attained the required level of competence.

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B) Equipment University Policy requires that:

Equipment and facilities are maintained and tested, where appropriate, to ensure efficient and safe operation;

All equipment used should be assessed to establish the risks of contamination by biological hazards. It should be clearly established if there are any risks to users of equipment and local procedures must be drawn up. Decontamination of equipment must be performed before any outside contractor is allowed access to service or maintain that equipment. Some guidelines are set out below for the use of certain types of equipment in biological laboratories (this is not an exhaustive list). Other safety issues are raised when working with all electrical equipment and these must be considered when establishing local procedures. Safety Cabinets The British Standard on Performance Criteria for microbiological safety cabinets (BS EN 12469:2000) specifies requirements for safety cabinets with respect to safety and hygiene. It sets performance standards for cabinets for work with micro-organisms, and specifies test procedures for cabinets with respect to protection of the worker and the environment, product protection and cross contamination. The other standard relevant to microbiological safety cabinets is BS 5726:2005. This provides recommendations and guidance on information to be supplied by the University to safety cabinet manufacturers, vendors and installers on the siting and use of cabinets. There are three classes of safety cabinet:

Class I: An open fronted cabinet through which air is drawn to minimise aerosol escape. The hood is extracted to the outside via a High Efficiency Particulate Air Filter (HEPA). The cabinet protects the operator and not the work and is suitable for work with Hazard Group 2 and most Group 3 agents. An Operator protection test should be carried out at least once a year. The airflow of Class I cabinets should be checked with an anemometer, weekly or at least monthly dependent on frequency of use. Class II: An open fronted cabinet where the workspace is protected by a downflow of sterile air. Air is also drawn through the front providing operator protection. Therefore, the operator and work is protected. The hood is either ducted to the outside via a HEPA filter or is a recirculating hood with a double HEPA filter. This type of cabinet is mainly used for Tissue Culture, and can be used for work with Group 2 agents. The use of a Class II cabinet for work involving Group 3 agents must be justified and special “in-use” Operator protection tests must be carried out. The hood would generally be extracted to the outside in this case. Class III: This is a totally enclosed cabinet where the operator is separated from the work by gloves attached to ports. Both incoming and outgoing air is filtered via HEPA filters. The Hood is extracted to the outside. These cabinets provide high level protection for both work and operator and are used for Group 3 and 4 agents.

General Safety Points:

• Safety cabinets must be serviced at least every six months, and an operator protection test (KI discus test) must be carried out at least once a year on Class I and Class II cabinets. More frequent checks will be needed in containment level 3 facilities.

• Placement of cabinets should be discussed at an early stage with the Health and Safety Unit. The British Standard, BS 5726: 2005, provides guidance on siting.

• Whenever a cabinet is moved a KI Discus test should be carried out on the cabinet in its new location to ensure it provides adequate containment.

• Airflow of Class I cabinets should be checked regularly (weekly) with an anemometer. Readings should be taken at each of the four corners and the middle of the cabinet front opening and may be considered acceptable if in the range 0.7 - 1.0m/s.

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• It is important not to confuse laminar flow cabinets with safety cabinets as they do not provide user protection.

• Fume cupboards should not be used for any type of work involving biohazards. • The Manufacturer’s instructions for the cabinets must be followed and available to all users. • The cabinet should not be used unless the viewing screen is in place and the airflow is

satisfactory. Some cabinets take a few minutes to reach optimum airflow. • The operator should be comfortably seated and able to see clearly through the viewing

screen. • Equipment should be kept to a minimum (back of Class I and middle of Class II). • Centrifuges should not be used in cabinets. • Gas burners should be avoided. Ordinary Bunsen Burners must not be used but micro-

incinerators are permissible. Solenoid valves that only release gas while the cabinet fan is running should be fitted, but this does not eliminate the risk of explosion. Gas flames must not be left unattended. Methylated spirits burners can be used with minimal risk.

• Movement around the opening of cabinets should be kept to an absolute minimum when in use.

• Spillages should be cleaned up immediately and regular cleaning rotas should be established. The viewing screen should be secured when raised and not held up by hand. Night doors should be replaced when the cabinet is not in use.

• After use the cabinet should be left running for 10-15 minutes to allow aerosols to disperse. • The cabinet must be fumigated before repair (involving access to filters or internal cabinet

workings) if biohazards have been used in the cabinet. It should also be fumigated if a significant spillage occurs within the cabinet that can not easily be cleaned up. Fumigation of cabinets before service visits is mandatory at containment level 3.

Further information can be obtained from the British Standards:

BS EN 12469: 2000 Biotechnology – Performance criteria for microbiological safety cabinets BS 5726: 2005 Microbiological safety cabinets – Information to be supplied by the purchaser to the vendor and to the installer, and siting and use of cabinets – Recommendations and guidance

Centrifuges The Manufacturer’s guidelines should be followed at all times. Local assessments should be made on the use and maintenance of centrifuges in general. In particular the following points should be considered:

• Centrifuges should be positioned so that operators can see into the bowl. • All spillages should be cleaned up immediately. • Containers should be filled before placing in buckets. • Biohazards should be centrifuged in sealed buckets (mandatory at containment level 3). If

Ultra centrifuging sealed tube assemblies should be used. • If a centrifuge tube has broken the sealed bucket should be opened in the appropriate class

of safety cabinet, after allowing aerosols to settle. • All centrifuges must be locked when in operation and must not be able to be opened when

running. Ultrasonic Disintegrators These may produce aerosols which may be liberated into the environment, particularly if the probe type is used:

• A complete assessment needs to be performed and if necessary it must be used in an appropriate safety cabinet.

• Cleaning after use is essential.

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Cryostats / Microtomes • Care is needed when cutting infectious material. Unfixed material containing Hazard Group

3 agents should not be sectioned, unless appropriate containment is provided. • Blade Guards should be used when not cutting. • Cleaning/disinfecting procedures should be well established and a regular rota introduced.

Waterbaths

• These rapidly become contaminated with micro-organisms, including Legionella sp. • Anything put into the water bath may become contaminated. • Suitable biocide can be used, but none are perfect and consideration must also be given to

the effect on the waterbath material itself. • Regular cleaning rotas are essential.

The following equipment should also be assessed when considering biohazard contamination and regular cleaning and decontamination procedures should be locally established. The type of equipment includes:

• homogenisers • large scale culture equipment • filtration equipment • incubators • freeze dryers • refrigeration equipment • colworth stomachers • electron microscopes • shakers • pipettes etc.

C) Health Surveillance and Immunisation University Policy requires that:

Where appropriate, health surveillance is provided in agreement with the Health and Safety Unit; The need for people who may be at risk from microbiological hazards to receive health monitoring and immunisation must be considered, both by Departments and by the Advisory Group for the Control of Biological Hazards when new work is proposed. The assessment of the work will identify when this is necessary and the Health and Safety Unit should be approached for advice. The names of individuals working with Hazard Group 3, and some Hazard Group 2, organisms will be kept centrally. Pregnant Workers and Breast Feeding Mothers There is a particular duty to assess additional risks to workers and the foetus and child. In the case of biological agents there are certain organisms that may present an additional hazard. The risk assessment for the work should highlight this hazard. Women of child-bearing age working with agents that could cause infection with deleterious effects on foetal development (particularly rubella virus and human cytomegalovirus) should inform the University Occupational Health Physician (preferably through the Schools) as soon as possible if they think that they are pregnant. Immunisation Immunisation must never be regarded as the primary defence against laboratory infection but it may give valuable additional protection. Where work is undertaken with specific pathogens (or materials suspected of containing them), and immunisation could be important for the welfare of the worker and the community, the Health and Safety Unit should be consulted. Tetanus immunisation is recommended for people performing manual tasks where there is a significant risk of cuts or whose work involves animals or animal houses. Hepatitis B vaccination would be recommended for persons working with human blood or tissue. If a new worker is being engaged or an existing employee being asked to undertake work that would require immunisation, then this immunisation must be made a condition of acceptance for such work. The University Occupational Health Physician will carry out any immunisations that are required but individuals may make other arrangements if they so wish,

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provided that the Occupational Health Physician is notified so that a complete record is available centrally in the University. Heads of Budget Centre must notify the Occupational Health Physician of people requiring immunisation.

D) Transport of Biological Materials by Road, Rail or Air The following guidance has been prepared with help and information from a number of sources, in particular the following:

Dr Joanna Marshall, Biosafety Unit, University of Edinburgh Guidance on Transport of Biological Materials; International Air Transport Association, Montreal, Canada; World Health Organisation.

The GB regulations (The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2007) covering the carriage of dangerous goods by road and rail are derived from European Directives (ADR (road) and RID (rail)), which in turn implement international modal agreements governing the transport of dangerous goods. The GB regulations directly reference ADR in relation to the classification, packaging and labelling of all classes of dangerous goods, including infectious substances, and are updated every two years. The requirements for air transport of dangerous goods, both within Great Britain and overseas, are contained in the International Civil Aviation Organisation (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air. They are essentially similar to those for road and rail as they mirror the same international modal agreements, but there are some minor differences. The classification scheme used in the transport regulations reflects the risks associated with micro-organisms during transport rather than being based on the hazard group classification scheme. The definitions and classifications of biological materials for transport purposes are complicated, but it is important to get the classification correct as this determines how the goods should be packaged and labelled. It is important to remember that it is not acceptable to be cautious and classify more stringently than is necessary, since it is an offence to consign dangerous goods incorrectly classified. It is the shipper’s responsibility to ensure that the item is correctly packaged, labelled and documented for transport. Training is key to this, and anyone involved in shipping infectious substances must be trained and certified competent. Classification Biological agents, or materials that contain or may contain them, are allocated to UN Division 6.2 - Infectious Substances. Division 6.2 includes biological products, cultures, genetically modified micro-organisms (GMMs) and genetically modified organisms (GMOs) and medical/clinical waste. Definitions Infectious substances Infectious substances are substances that are known or are reasonably expected to contain pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsia, parasites, fungi) and other agents such as prions which can cause disease in humans or animals. Patient specimens Patient specimens are those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention. Biological products Biological products are those products derived from living organisms which are manufactured in accordance with the requirements of appropriate national authorities (in the UK: the Department of Health and the Medicines and Healthcare Regulatory Authority), which may have special licensing requirements, and are used either prevention, treatment or diagnosis of disease in humans or animals

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or for related development, experimental or investigational purposes. They include (but are not limited to) finished or unfinished products such as vaccines. Biological products which do not fall under the previous paragraph and are known or reasonably believed to contain infectious substances and which meet the criteria for inclusion in Category A or Category B are assigned to UN 2814, UN 2900 or UN 3373, as appropriate. Cultures Cultures (laboratory stocks) are the result of processes by which pathogens are amplified or propagated in order to generate in high concentrations, thereby increasing the risk of infection should exposure occur. This definition refers to cultures prepared for the intentional generation of pathogens and does not include cultures intended for diagnostic and clinical purposes. Genetically modified micro-organisms and organisms Genetically modified micro-organisms and organisms are those micro-organisms and organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally. Medical or clinical wastes Medical or clinical wastes are wastes that are derived from medical treatment of humans or animals or biological research. Details of University procedures for clinical waste treatment and collection can be found in Section F of this guidance document. The following substances are not subject to the provisions of the regulations, unless they meet the criteria for inclusion in another class:

• Substances which do not contain infectious substances or substances which are unlikely to cause disease in humans or animals

• Substances containing micro-organisms which are non-pathogenic to humans or animals • Substances in a form that any present pathogens have been neutralised or inactivated such

that they no longer pose a risk to health • Environmental samples (including foodstuff and water samples) which are not considered to

pose a significant risk of infection • Dried blood spots, collected by applying a drop of blood onto absorbent material, or faecal

occult blood screening tests and blood and blood components collected for the purpose of transfusion or preparation of blood products and any tissues or organs for use in transplantation

• Patient (human or animal) specimens for which there is minimal likelihood that pathogens are present, providing the specimen is packed in a packaging which will prevent leakage (see below) and which is marked with the words “Exempt human specimen” or “Exempt animal specimen” as appropriate

Infectious substances are divided into the following categories: Category A: an infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life threatening or fatal disease to humans or animals. This includes all agents classified as HG4 in the Approved List of biological agents, many HG3 agents and two HG2 agents (Clostridium botulinum and poliovirus). Those that can cause disease in humans are assigned to UN 2814. Those that affect animals only are assigned to UN 2900 (additional requirements are in place for animal pathogens in the UK – see the DEFRA website for further details). The list is not exhaustive. Other infectious substances, including new or emerging pathogens, which do not appear in the table but which meet the same criteria must be assigned to Category A and if there is doubt as to whether or not a substance meets the criteria it is also to be included in Category A. Exposure occurs when an infectious substance is released outside of the protective packaging, resulting in physical contact with humans or animals. UN 2814 INFECTIOUS SUBSTANCE, AFFECTING HUMANS (Proper shipping name)

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UN 2900 INFECTIOUS SUBSTANCE, AFFECTING ANIMALS only (Proper shipping name) Category B: any infectious substance that does not meet the criteria for inclusion in Category A. These are assigned to UN 3373. UN 3373 BIOLOGICAL SUBSTANCE, CATEGORY B (Proper shipping name) Note: the requirement that all cultures be assigned to UN 2814 or UN 2900 as appropriate no longer applies, and many can now be assigned to UN 3373, unless they are contained in the Category A list. GMMs or GMOs that do not meet the definition of an infectious substance but are capable of altering animals, plants or microbiological substances in a way not normally the result of natural reproduction are assigned to Class 9 (UN 3245). Clinical or medical waste that contains Category B infectious substances (with the exception of cultures) or that only has a low probability of containing infectious substances is assigned to UN 3291. The regulations covering the transport of live animals are the responsibility of the Home Office and DEFRA. These are:

• the Animals Scientific Procedures Act 1986 • the Animal By-Products Order and • the Welfare in Animals Transport Order 1997

COSHH also applies, and a risk assessment that includes emergency procedures, e.g. dealing with the escape of an infectious animal, will be required. Cultures Cultures of micro-organisms that are infectious for humans and/or animals must be classified for transport as follows:

- Category A infectious substance if the particular micro-organism appears on the indicative list (or for new or emerging pathogens if they meet the Category A criteria) or - Category B infectious substance if the particular micro-organism does not appear on the indicative list (and does not meet the criteria for Category A).

Cultures of micro-organisms that are not infectious for humans or animals are not subject to control under the various transport regulations. However, when transported they must always be packaged in such a way that they are unlikely to leak in transit. Human and/or animal samples Up until the end of 2005, samples of materials such as blood, tissue, excreta, secreta, body parts, etc collected from humans or animals were considered as a minimum, Category B infectious substances. However, the classification of some samples has been amended to exempt certain of these from the regulations (such samples are “Exempt human” or “Exempt animal” specimens, and the exemption includes materials transported for research purposes –see earlier section). Samples from healthy individuals, where there is no reason to suspect that the person is suffering from an infectious disease, and the sample is not being tested for the presence of pathogens, would be exempt. All samples from humans or animals that are known, or likely, to contain pathogens are considered, as a minimum, category B infectious substances. These may not be transported as exempt specimens. Note: In determining whether a patient specimen has a minimal likelihood that pathogens are present, an element of professional judgement is required. That judgement should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. Examples of specimens which may be transported as a patient specimen for which there is a minimal likelihood that pathogens are present include blood or urine tests to monitor cholesterol levels, blood glucose levels, hormone levels, etc; tests required to monitor organ function for humans or animals with non-infectious disease, or therapeutic drug monitoring; tests conducted for insurance or employment purposes and intended to determine the presence of drugs or alcohol; pregnancy tests; biopsies to detect cancer; and antibody detection in humans and animals.

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Genetically modified micro-organisms (GMMs) or genetically modified organisms (GMOs) These are micro-organisms and organisms in which genetic material has been purposely altered through genetic engineering in a way which does not occur naturally. GMMs which meet the definition of infectious substances above must be assigned to either UN 2814 or UN 2900 or UN 3373 as appropriate. These would be genetically modified micro-organisms assessed as requiring containment level 2 or above (based on the risk assessment made under the GM regulations) because they are harmful, or potentially harmful, to humans and/or animals. EC Regulation requires notification of transboundary movements of Class 3 GMMs to the Biological Clearing House and European Commission (transboundary movements are those entering or leaving the EC). If your work involves Class 3 GMMs you should advise the Health and Safety Unit of any intention to transport these within or outside the UK. GMMs that do not meet the definition of an infectious substance, but are capable of altering animals, plants or microbiological substances in a way not normally the result of natural reproduction are classified in Class 9 - Miscellaneous Dangerous Goods under UN 3245 GENETICALLY MODIFIED MICRO-ORGANISMS. These would be GMMs which can be handled at containment level 1 but are vectors and can transfer genetic material to other organisms. Note this is in relation only to micro-organisms and does not cover, for example, naked nucleic acid, plasmids or liposome gene delivery systems, none of which are controlled under the transport regulations. Vectors which require containment level 2 or above for safe handling in the laboratory must be classified as infectious substances as described in the previous paragraph. GMMs which do not meet the definition of an infectious substance, and which are not vectors as described above, are not subject to the provisions of the transport regulations. These would be GMMs which can be handled at containment level 1 and present no significant risks to human or animal health and safety or the environment. GMOs that are not micro-organisms (i.e. plants or animals) and which are known or suspected to be dangerous to humans, animals or the environment must be transported in accordance with conditions specified by the competent authority, and are classified in Class 9 – Miscellaneous Dangerous Goods, under UN 3245 Genetically Modified Organisms. Further advice should be sought before any movement occurs. Some GMMs and GMOs are authorised for use in certain countries by the competent authority for that country. Where they have been so authorised, e.g. have received a consent for deliberate release into the environment, they are not subject to controls under the transport regulations providing that for any journey, authorisations apply in the country of origin, transit and destination. Refrigerated or frozen materials There is often a requirement to transport biological materials at low temperatures either on wet ice or dry ice. Dry ice is listed in the Dangerous Goods List and is classified in Class 9 - Miscellaneous Dangerous Goods under UN 1845 CARBON DIOXIDE, SOLID. For transport by road, dry ice is not subject to the provisions of the transport regulations. In contrast, when dry ice is transported by air various requirements must be met. Liquid nitrogen is subject to controls under the transport regulations and wherever possible its use should be avoided for refrigerating infectious substances during transport. Very specialised UN type-approved packing is required to transport infectious substances in liquid nitrogen. Schools should consign infectious substances in liquid nitrogen only if there is no suitable alternative means. Dry ice must only ever be placed in packaging designed to permit the release of CO2 gas, and to prevent a build up in pressure. If dry ice is used to cool materials it should be placed around the secondary packaging, and the outer packaging must permit the release of CO2 gas. Usually the dry ice is contained within a PI 904 compliant overpack. Dry ice must never be placed in either the primary or secondary receptacle as these will explode due to pressurisation.

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Packaging and Labelling Category A infectious substances Category A infectious substances (either UN 2814 or 2900) should be packed for road transport using Packaging Instruction 620 (PI620). This packaging must meet UN performance requirements as shown by design type testing. These are known as UN-type approved packaging for Class 6.2 substances and they are certified and marked accordingly. If air transport is to be used, the ICAO PI602 should be followed. The two instructions are essentially the same, but there are quantity limits imposed on material sent by air. For passenger aircraft, there is a 50 ml/50 g limit; for cargo craft, there is a 4 litre/4 kg limit, with a limit of 500 ml/500 g per primary receptacle.

Diagram courtesy of IATA, Montreal, Canada

Labelling Packages containing Category A infectious substances should be marked with:

• the proper shipping name, e.g. ‘Infectious substance, affecting humans’. (It is no longer necessary to show the technical name, i.e. the name of the micro-organism, on the package but the proper shipping name should be supplemented with the technical name in the accompanying transport documentation);

• the appropriate UN number (e.g. for ‘Infectious substances, affecting humans’ this would be UN 2814); and

• the appropriate warning label. The danger sign for infectious substances is shown in Figure 1.

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Figure 1

For frozen specimens being transported in an overpack, any certificated markings must be visible through the overpack or repeated on the overpack itself. The packaging should also be marked to indicate any subsidiary hazards. Category B Biological Substances Category B substances assigned to UN 3373 should be packaged in accordance with PI650. The same PI number is used for air transport, but again there are limits on quantities that can be sent per package. Packaging for Category B infectious substances, packed using PI650, are not required to meet UN performance requirements provided they are capable of passing a 1.2 m drop test. For transport by road, there are no limits on the quantity of materials contained within either the primary receptacle(s) or the total package. This is in contrast to transport by air where, other than for body parts, organs or whole bodies, on both passenger and cargo aircraft there is a 4L/4kg limit per package, with a 1L limit per primary receptacle for liquids, whereas for solids the primary receptacle must not exceed the outer packaging mass limit of 4kg. The appropriate label for Category B substances is shown in Figure 2

Figure 2

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Diagram courtesy of IATA, Montreal, Canada

Exempt Specimens (human or animal) These must be packed in accordance with the packing requirements specified in the main text of the ADR and IATA Regulations. They should be marked with the words:

EXEMPT HUMAN SPECIMEN or EXEMPT ANIMAL SPECIMEN

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Diagram courtesy of IATA, Montreal, Canada

Genetically Modified Micro-organisms assigned to UN 3245 These are packaged in accordance with ADR PI 904 (Road) or IATA PI 913. Genetically modified micro-organisms assigned to UN 3245 must be packed according to the procedures (i.e. triple layer packaging system) for UN 2814, INFECTIOUS SUBSTANCE AFFECTING HUMANS, except that UN approved packaging need not be used. There are no limits on the quantity transported by road, but by air the following limits apply:

on both passenger or cargo aircraft, no limit per package, but the maximum quantity in the primary receptacle must not exceed 100ml or 100g.

The hazard warning label is the Class 9 Miscellaneous dangerous Goods label, shown in Figure 3:

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Figure 3 Packaging can be obtained from a number of companies (“home made” packaging must never be used):

DGP UK Group [www.dgpgroup.com]; Air-Sea containers Ltd [www.air-sea.co.uk]; Dangerous Goods International [www.dgiglobal.com].

Reference to these companies does not imply endorsement by the University. They are provided for information. Detailed guidance on the packaging requirements for PI 620 (road) / 602 (air) and PI 650 can be found in the World Health Organisation’s 2007/8 guidance on regulations for the Transport of Infectious Substances:

http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2007_2/en/index.html Paperwork Before sending any biological materials abroad, the person sending the goods (the consignor/shipper) should contact the person to whom they are being sent (the consignee) to let them know shipping details and to check that the substance may be legally imported. The person receiving the materials is generally regarded as the importer and the one responsible for obtaining, where necessary, all appropriate permits or licences. Importation of materials into the United States is particularly tightly regulated and there are restrictions even on some items that may be transported as non-dangerous goods. In contrast, very few items require any sort of import permit, licence or notification to be made when importing into the UK. Any carriage of goods subject to controls under the transport regulations must be accompanied by documentation as specified in those regulations. The information required must be clearly legible and for air transport must exactly meet the specified format. The following includes requirements for paperwork included within the package and for paperwork accompanying the package for the carrier etc. When transporting any biological materials, paperwork must be included within the package between the secondary container and the outer container (attached to the secondary), giving:

• the names and addresses of both the consignor (sender) and consignee (receiver), including emergency contact details (name and telephone number) at both ends and

• for dangerous goods, a description of the goods in the following format/order UN NUMBER and PROPER SHIPPING NAME In addition, for Category A infectious substances assigned to UN 2814 or UN 2900: • the proper shipping name must be supplemented with the technical name (the

recognised biological/scientific/technical name of the micro-organism). When the infectious substances to be transported are unknown, but suspected of meeting the criteria for inclusion in Category A and assignment to UN 2814 or UN 2900, the words

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"suspected Category A infectious substance" in parentheses should be used as the technical name.

• an itemised list of contents must be given, to include for each named item the number of tubes and their volume.

or • for exempt human or animal specimens, a simple statement saying what the materials are,

that there is minimal likelihood that pathogens are present and that they are exempted under the transport regulations. or

• for non-hazardous biological materials, a simple statement saying what the materials are, that they are non-hazardous and that they are not classified as dangerous goods under the transport regulations.

Written emergency response procedures must also be provided with any package containing biological materials classified under UN 2814, UN 2900, UN 3373 or UN 3245. The Health and Safety Unit must be informed of any intention by University personnel to transport (within the UK or abroad) Class 3 GMMs since advance notification must be made to the Health and Safety Executive. When using a courier, senders must always give a full description of the goods to the company when initially arranging the shipment, including the relevant UN number(s) and proper shipping name(s), in order the courier is fully aware they will be transporting dangerous goods and ensures the necessary paperwork is completed. For transport by road of packages containing dangerous goods other than those assigned to UN 3373 as category B infectious substances, the carrier (company transporting the goods) should request that a dangerous goods declaration form be completed. Typically the carrier will provide a copy of the form for completion. For transport by air of packages containing dangerous goods it is necessary to complete an Air Waybill and, in most cases, a Shipper's Declaration for Dangerous Goods. Transport Although the regulatory requirements only apply to transport of infectious material off site, on-site transport still needs to be carried out in a safe manner. Secondary containment (such as a carry box or high sided trolley) must always be used. Transport between one part of private premises and another part of those premises situated in the immediate vicinity of that first part, where both parts are occupied by the same person even if those parts may be separated by a road, does not fall within the scope of the regulations. You should always discuss your transport requirements with your chosen carrier, in particular, you may need to provide some of the information that will be used on the accompanying documentation. You will need to establish whether any of the intended transport will be by air, even within the UK, to ensure that the correct packaging is used and that quantity limits are not exceeded. Precise detail of the documentation that may be required is not given here. You should consult your carrier about this information, as it may vary depending on the carrier and/or the final destination. Examples of carriers include:

DHL (www.dhl.co.uk), FedEx (www.fedex.com/gb) or Dangerous Goods International (http://www.dgiglobal.com/index.asp).

Reference to these companies does not imply endorsement by the University. They are simply provided for information. Postal Services Infectious substances (including diagnostic or clinical specimens) are not permitted in international mail. However, many infectious substances can be sent via domestic mail (NOT materials containing

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category A substances), providing they are classified, packaged and labelled in accordance with the preceding guidelines. The Royal Mail should be contacted beforehand to ensure it will transport the materials. Only recognised laboratories or institutions or certain professional persons are permitted to send hazardous biological substances in the post. The maximum amount of infectious substances (including any items assigned to UN 3373, UN 3245 or Exempt human or animal specimens) that can be sent by post is 50g or 50ml per package. Dry ice is NOT permitted. The Royal Mail supplies “Safebox™”, a purpose designed packaging for sending Category B infectious substances in the postal system. It is supplied as a ready to use kit, and can be posted in a pillar box. It must NOT be used for sending Category A infectious substances. Details can be obtained from the Royal Mail website (www.royalmail.com) or via the Orderline on 0845 076 2000. Importation of biological agents There is no requirement under health and safety law to obtain a licence to import biological agents into the UK, other than the requirement under COSHH to notify the movement of HG4 agents (this would cover movement from, for example, the airport to the receiving laboratory). There is a requirement to notify first use of HG2-HG4 agents at a particular premises, but this relates to use of the agents in the laboratory, not the consignment of those agents. This only applies to human pathogens, importation of animal pathogens (some of which may be zoonotic agents) and plant material/pathogens is covered in separate legislation. You will also need to notify the Home Office in advance if the agent you are importing is covered under the Anti-terrorism, Crime and Security Act 2001. Security of Materials Both ADR and IATA require precautions to be taken to minimise the likelihood of theft/misuse of dangerous goods at points along the transport chain. It is therefore recommended that the following action is taken: All packages containing infectious materials should only be given to identified representatives of courier companies for transportation. While awaiting collection packages must be stored safely and securely. Where infectious substances are classified as Category A materials, and are assigned to UN 2814 or 2900 they are considered to be “High consequence dangerous goods”. These could potentially be used in terrorist incidents and may result in high numbers of casualties or high levels of damage. Additional security measures should therefore be put in place. Advice can be obtained from local Counter-terrorism Security Advisers, via the Health and Safety Unit.

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Summary of transport requirements

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Indicative list of infectious substances included in Category A in any form, unless otherwise indicated (taken from United Nations Model Regulations, 13th Edition:

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References and Further information World Health Organisation guidance on regulations for the Transport of Infectious Substances 2007 – 2008: http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2007_2/en/index.html International Air Transport Association: http://www.iata.org

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E) Sterilisation and Disinfection University policy requires that:

All biological materials are disposed of safely and in accordance with University procedures; It is important to distinguish between sterilisation and disinfection. Whereas sterilisation results in destruction of all forms of life, disinfection results in destruction of specific organisms. Microorganisms vary in their resistance to destruction by physical or chemical means. A disinfectant that destroys bacteria may be ineffective against viruses, fungi or prions. There are differences in susceptibility between gram-negative and gram-positive bacteria, and sometimes even between strains of the same species. Bacterial spores are more resistant than vegetative forms, and non-enveloped, non-lipid-containing viruses respond differently than do viruses which have a lipid coating. Sterilisation A variety of methods are available for the sterilisation of materials in the laboratory: these include heat, filtration and radiation. Generally, sterilisation is best achieved in the laboratory by the use of steam or dry heat. A summary of methods employing heat can be found in Table 1.

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Table 1 Sterilisation Methods Involving Heat Method Principle/

Conditions Advantages Disadvantages Uses

Dry Heat Thermal inactivation: destroys by oxidation

Non-corrosive Simple design and principle

Less effective than moist heat; requires longer times and/or higher temperatures

Materials that are damaged by, or are impenetrable to, moist heat

160-180oC for 2-4 hours

Penetrates water-insoluble materials. Less corrosive to metals and sharp instruments than steam

Slow penetration of heat. Loading and packing are critical to performance. Not suitable for reusable plastics

Anhydrous materials and powders laboratory glassware, instruments closed containers

Hot Air Oven

Red-heat Flame

Oxidation to ashes (burning)

Rapid Initial contact with flame can produce a viable aerosol. Possibility of accidental fire

Inoculating loops, needles

Incineration Oxidation to ashes (burning) 1-60 minutes: temperatures may exceed 1000oC

Reduces volume of waste by up to 95%

Improper use may lead to emission of pathogens in smoke. Requires transport of infectious waste. Excess plastic (>20%) content reduces combustibility

Decontamination of waste items prior to disposal.

Moist Heat Irreversible coagulation of (microbial) proteins

More rapid and more effective than dry heat

Pasteurisation Heating to below boiling point (generally 77oC for up to 30 minutes)

Can be used on heat sensitive liquids and medical devices

Not reliably sporicidal

Milk and dairy products and some heat-sensitive medical equipment

Heating to 80-100oC for 30 mins on successive days, with incubation periods in between

Resistant spores germinate and are killed on the second and third days

Time consuming not reliably sporicidal

Heat sensitive materials such as bacteriologic media, solutions of chemicals, biological materials

Tyndallization (Fractional Sterilisation)

Boiling 100oC 10-30 mins. Minimal equipment required

Not reliably sporicidal.

Small instruments and equipment

Autoclaving Steam under pressure 121oC/15 psi for 15-90 mins (gravity displacement autoclave) 132oC/27 psi for 4-20 minutes (pre-vacuum autoclave)

Minimal time required. Most dependable sterilant for lab use

Loading and packing critical to performance. Maintenance and quality control essential. May damage heat-sensitive items.

Sterilisation of glassware, media and instruments. Decontamination of reusable supplies and equipment. Decontamination of infectious waste

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Autoclaves Although many microorganisms are killed by comparatively low temperatures, others (e.g. bacterial spores) are much more resistant. Steam sterilisation is normally the most efficient and convenient method for equipment, media and contaminated materials. A holding time and temperature policy such as 15 mins at 121oC (1.1kg cm-2 or 15psi) should be chosen. To calculate the length of the cycle the time taken for the load to reach the required temperature must be added to the above holding time. These times should be determined using thermocouples placed in the coolest (normally 2/3 way down) of typical and 'worst case' loads. The temperature indicated by the autoclave thermometer (normally the drain temperature) might be very different to the load temperature.

• Autoclaves must be properly maintained and pressure vessels inspected annually by the insurance assessor.

• Autoclaves should be operated by trained individuals. • Clear operating instructions should be displayed beside each autoclave. • Visors and heat resistant gloves must be worn as appropriate. • Separate autoclaves should be used for sterilisation (media, glassware etc.) and for

decontamination where possible. • Efficient steam penetration is essential and failure to displace air will lower the temperature

reached for a given pressure. Lids must be removed or slackened and plastic bags undone. Autoclaves must not be overloaded. Porous load autoclaves (which remove air by creation of a vacuum) should be used for coats, dressings, etc.

• Autoclave indicator tape should be applied to distinguish processed and unprocessed items. A colour change is not a guarantee of sterility.

• Portable autoclaves must have suitable gas or electric heaters. Adequate water must be added and the steam allowed to purge the vessel of air before the exhaust is closed. Portable autoclaves should not be left unattended or cooled under a tap if they contain bottled fluids and should be emptied of water after use to prevent corrosion.

• Autoclaves must not be opened unless the pressure gauge indicates atmospheric pressure and the exhaust valve has been opened.

• Autoclaves containing screw capped bottles or other sealed or partially sealed containers must have warning notices and must not be opened until the load has cooled below 80oC.

• Materials likely to explode (e.g. nitrocellulose, highly flammable liquids and oxidising agents) or produce toxic or corrosive fumes (e.g. volatile solvents, some disinfectants) must not be autoclaved.

The performance of all autoclaves should be checked every 6-12 months using thermocouples placed in the load. Spore strips containing heat resistant spores of Bacillus stearothermophilus or chemical or physical indicators such as Brown’s tubes should be used to test autoclaves at more frequent intervals, but do not replace the use of thermocouples. Unusual loads or Group 3 hazards should be monitored on a load-by-load basis. Autoclaves handling Group 2 hazards should be monitored at a maximum of 3-6 month intervals. All records of performance testing should be kept. Dry heat sterilisation Heat resistant gloves must be worn when filling or emptying hot ovens. Ultra-violet lamps The light (approximately 260 nm wavelength) emitted by UV lamps is germicidal, and can be used to reduce the number of microorganisms on exposed surfaces and in air. However, UV light has poor penetrating power; accumulations of dust, dirt, grease or clumps of microorganisms may shield microorganisms from the direct exposure required for destruction. UV light presents skin and eye burn hazard, and factors such as lamp age and poor maintenance can reduce performance. The radiation produced by UV lamps should be checked regularly since the presence of blue light is not an indication of effectiveness. Exposure of the skin and eyes to UV light must be avoided and warning signs must be displayed.

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Microwave Ovens Domestic microwave ovens do not provide a method of effectively disinfecting or sterilising materials. They may be useful in warming solutions and bringing agar into solution. However, due to the nature of their operation they may generate a significant hazard in use. Vessels placed inside must not be sealed because of the explosion risk, loose non metallic caps or fresh dry cotton wool plugs (moist or used cotton wool may ignite) must be used. When melting solidified agar there is a risk of explosion due to superheating of the centre of the media and they should not be used for this purpose. The interior of microwave ovens must be kept clean as dried organic matter may ignite. When purchasing new microwave ovens stainless steel or enamel linings should be chosen to limit the spread of any fire starting in the chamber. The Selection and Use of Disinfectants There is no 'universal disinfectant' and chemical disinfection is a less reliable method of decontamination than steam sterilisation. Schools and Departments should have policies or procedures stating which disinfectants can be used for what purpose, the in-use concentration, the minimum exposure time (overnight if practicable) and the frequency of changing. The choice of disinfectants depends on several factors including the:

• nature of the micro-organism(s) • nature of the material being disinfected • circumstances of disinfection • hazards presented by the disinfectant.

Disinfectants have variable activity against different types of organism. They can be inactivated by organic material or other chemicals and need to be used at the correct dilution. Table 3 summarises the factors that need to be considered when selecting a disinfectant. Disinfectants should be used at concentrations appropriate for the work taking into account the manufacturers' recommendations. Caution is needed when mixing disinfectants with each other (or with detergents) as some mixtures are incompatible (e.g. mixtures of formalin and hypochlorite may produce the carcinogen bis chloromethyl ether). Disinfectants should be diluted with care and not by guesswork. The effective life of diluted disinfectants varies but it is normally good practice to renew solutions regularly, often daily, and to mark and date containers. Objects usually placed in disinfectants must be completely immersed. Used disinfectants can normally be poured carefully down a sink or sluice but any solid material must be sieved out and incinerated or autoclaved and the container cleaned thoroughly before re-use. When handling hazardous disinfectants the appropriate precautions indicated in the COSHH assessment should be used. Disinfectant Types Hypochlorite solutions containing 1,000 ppm available chlorine (e.g. 1% Chloros) are suitable for routine disinfection of bench tops and other surfaces. 2.5% Chloros or equivalent is suitable for pipette jars and spillages of normal blood etc. 10% Chloros or equivalent should be used for blood and other materials with a high organic content if the presence of infectious agents is suspected. Granules containing chlorine releasing compounds such as sodium dichloroisocyanurate are useful for dealing with spillages. Clear soluble phenolics have a wide range of activity and are suitable for tuberculosis material but not bacterial spores and non-lipid containing viruses.

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Alcohols (e.g. 70% ethanol, 60% propanol v/v in water) are flammable but are useful for decontamination of clean surfaces and electrical equipment. Formalin has a wide range of antimicrobial activity but it is too irritant for routine use as a disinfectant. It is useful as a fumigant. Other disinfectants Quaternary ammonium compounds, Chlorohexidine, Cetrimide, hexachlorophane, chloroxylenols etc are too limited in their range of action to be of general use in the laboratory but may be satisfactory for general hygiene and cleansing of surfaces. Disinfection of People Following Accidents Iodine and iodophores Tincture of iodine (1% iodine in alcohol) is an effective skin disinfectant, but is irritant and may cause tissue damage, delayed wound healing or skin sensitisation. It should only be used under medical supervision. Iodophor containing surgical scrubs have a wide range of activity, are stable, have detergent properties and are non-toxic at in-use concentrations. The skin should be washed thoroughly afterwards to prevent staining. Hypochlorite solutions are irritant and must not be used for personal decontamination unless under medical supervision. Alcohols are non-irritant and may be used as skin disinfectants : a small quantity of 70% v.v. ethanol or 60-70% isopropanol should be rubbed into the skin and allowed to dry. Chlorhexidine may be added to a concentration of 0.5% w.v. Alcohols are flammable and must be stored and used with appropriate precautions. They should not be used for disinfecting large areas nor in safety cabinets. Antiseptics (Cetavalon, Hibitane, Savlon etc.) have a limited range of activity (mainly against Gram +ve bacteria) and are inactivated by organic matter. 0.5% Chlorohexidine is useful (in alcoholic solution) as a skin disinfectant or (in aqueous solution) as a mouthwash. 2.5% Savlon is useful for wound cleaning. Testing Disinfectants Starch iodide papers are useful for testing hypochlorite solutions. They are turned deep blue by an available chlorine concentration of 200 ppm but are bleached by strong hypochlorite solutions. Disinfectants in use may be tested by diluting them 1:10 in diluent (quarter strength Ringers solution for phenolic disinfectants and nutrient broth containing 0.5% w.v. sodium thiosulphate for hypochlorites) and pipetting 10 drops (10-20μl) onto each of 2 nutrient agar plates which are incubated for 72h at 37°C and room temperature respectively. Growth on either plate indicates a failure of disinfection. More elaborate tests can be devised to meet individual requirements.

TABLE 2 Factors to consider when selecting a disinfectant Disinfectant Active against Not recommended

for Inactivation by organic matter

Incompatible detergents

Other comments

HYPOCHLORITES Vegetative bacteria, spores(esp. at pH7.6), fungi, viruses

Mycobacteria Moderate to severe

Cationic Bleaches fabrics, corrodes many metals, irritant. Environmental disinfectants

Vegetative bacteria (incl. mycobacteria), fungi

Spores, some viruses Low Cationic Irritant, absorbed by rubber& plastic. Environmental disinfectants

CLEAR PHENOLICS

Vegetative bacteria, fungi, viruses

Spores (long exposure required)

Low Anionic (iodophores)

May corrode metals. Iodine is irritant, iodophores much less so and useful skin disinfectants

IODINE AND IODOPHORES

GLUTARALDEHYDE Bacteria (incl. mycobacteria), fungi, viruses

Grossly contaminated surfaces, slow action on spores

Low but penetrates slowly

RESPIRATORY SENSITISER SHOULD NOT BE USED UNLESS NO ALTERNATIVE AVAILABLE and then with strict control. Expensive. May be useful for disinfecting instruments

ALCOHOL Bacteria, fungi, many viruses, protozoa, parasites

Grossly contaminated surfaces, spores

Low but penetrates slowly

Flammable. Useful skin disinfectant, must be diluted

Gram+ve bacteria, fungi Some spores, gram-ve & myco-bacteria, viruses

Severe Anionic, soap Useful skin disinfectant CHLORHEXIDINE

Gram+ve bacteria, fungi, some viruses

Spores, Gram-ve & myco bacteria

Severe Anionic, soap Dilute solutions may become contaminated. Useful cleansing agent

QUATERNARY AMMONIUM AND AMPHOLITIC COMPOUNDS PEROXYGEN (Virkon)

Bacteria, spores, fungi,viruses and mycobacteria

Low Can be corrosive

HEXACHLOROPHANE Gram+ve bacteria Other microorganisms Severe Anionic, soap Dilute solutions may become contaminated. Some residual activity.

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Formaldehyde Fumigation of Rooms and Safety Cabinets In certain circumstances it is necessary to fumigate microbiological safety cabinets and occasionally rooms for decontamination purposes. Formaldehyde is often used as the fumigant. It has a Workplace Exposure Limit (MEL) of 2ppm (or 2.5mg.m-3), which means that exposure levels must be kept below this limit. • Containment level 3 labs may be fumigated by vapourising 100ml formalin (40%

formaldehyde solution) and 900 ml of water for every 28.3 cubic metres. Methods involving permanganate should be avoided as potentially explosive mixtures can be made. Heating units or commercially available formaldehyde generating kits may be purchased for the purpose. Fumigation should take place if there is a significant spillage or aerosol release outside a safety cabinet. Subject to local risk assessment it may also be required before routine maintenance, or at the end of work programmes to prevent cross contamination. Fumigations must only be carried out by nominated persons, trained in the procedure. The following should be observed: • Hydrochloric acid and chlorinated disinfectants should be removed from the room before any

routine fumigation. This is to prevent the possibility of forming bis (chloromethyl) ether, which may be carcinogenic. In the event of a spillage of infectious material the laboratory should be vacated immediately, however.

• The fumigated area must be effectively sealed and room ventilation and safety cabinets must be switched off.

• People in adjoining areas, cleaning and security staff, etc. must be warned as appropriate and warning notices displayed prominently.

• Exposure should be for at least 12 hours and preferably overnight. • The room ventilation system and safety cabinets should be remotely activated the next day.

Discharged vapours must not come in contact with people or be drawn into ventilation systems.

• The area must be thoroughly ventilated after fumigation. Formaldehyde levels should be checked before anyone re-enters the laboratory. This can be achieved by sampling through a purpose made port in the door. The room may not be re-occupied if the level in any part exceeds the Workplace exposure limit.

Safety Cabinets should be fumigated before any maintenance work involving access to internal parts of the cabinet, such as filters or fan motor, or after any major spillage which results in contamination of inaccessible surfaces. Safety cabinets in CL3 facilities must always be fumigated before servicing. Cabinets may be fumigated by vaporising 60ml of formalin and 60ml of water per cubic metre. Using this formula the following quantities of formalin are recommended: Class I 20ml (plus equal volume of water) Class II (900mm) 20ml (plus equal volume of water) Class II (1200mm) 25ml (plus equal volume of water) Class II (1800mm) 30ml (plus equal volume of water) The cabinet must be sealed and after 15 minutes the fan should be switched on for 20 – 30 seconds to allow penetration of the vapour into the filters and ductwork. The cabinet must be adequately labelled during fumigation, which should last at least 5 hours and preferably overnight. Warning signs should also be displayed on the laboratory door to indicate that fumigation is in progress. The cabinet must be thoroughly purged with air after fumigation, the airflow should be checked and surfaces washed down to remove deposited paraformaldehyde. For recirculating Class II cabinets, flexible “elephant’s trunking” should be attached to the cabinet exhaust to allow discharge of formaldehyde vapour through a ducted cabinet, fume cupboard or adjacent window. If the latter is used it is important to ensure that formaldehyde vapour will be dissipated harmlessly and not taken back into the building through windows, air inlets etc thereby exposing other people to the vapour. Appropriate protective clothing must be worn when cleaning and fumigating.

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Further information on the fumigation of microbiological safety cabinets can be found in the ACDP guidance document, “The management, design and operation of microbiological containment laboratories”.

* It should be noted that the use of Vaporised Hydrogen Peroxide as a fumigant is increasing within Universities in the UK. At present this is not used widely within this University, but may become more popular over time. It is important to ensure that the efficacy of VHP is proven under the conditions of use. Further guidance will be made available on this in due course.

Decontamination of Centrifuges Sealed buckets should be used wherever possible, and are mandatory for work at containment level 3. Routine disinfection of clean surfaces

• Swab with a suitable non-corrosive disinfectant • Rinse with water, dry.

Tube breakage in unsealed bucket or rotor

• If possible, leave the centrifuge closed for at least 30 minutes. • Place all broken tubes, caps, trunnions and the rotor in a suitable disinfectant for at least 1

hour (preferably overnight) or autoclave them. Broken glass must be picked up with forceps or swabs held in forceps.

• Unbroken, capped tubes may be swabbed with disinfectant and the contents recovered. • Swab the bowl thoroughly with disinfectant, leave overnight, then swab again, rinse with

water and allow to dry. Tube breakage in sealed buckets or rotors

• Take the bucket/rotor to a safety cabinet and open. • Decontaminate as above.

Rotor Failure This may lead to extensive contamination of the centrifuge. The Health and Safety Unit must be informed before repairs are attempted. General

• Gloves must be worn during decontamination procedures and a visor and plastic apron if there is a risk of splashing.

• All swabs and debris must be rendered safe before disposal, preferably by autoclaving and/or incineration

F) Procedure for Disposal of Clinical Waste

University Policy requires that: All biological materials are disposed of safely and in accordance with University procedures;

Introduction This protocol is intended to ensure compliance with environmental and health and safety legislation, to satisfy the needs of the contractor and act as a minimum standard for application across the University. Schools and departments are free to use more stringent controls if they so wish. Because it is a University-wide procedure it may need to be adapted to local circumstances to take into account specific types of waste or existing practices. It is not intended to be rigid and proscriptive. If in doubt please contact the Health and Safety Unit.

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What is Clinical Waste? The management of hazardous waste in the UK has changed to incorporate the requirements of the European Hazardous Waste Directive 91/689/EC. There are now two sets of regulations covering the management of hazardous waste: The Hazardous Waste Regulations • Define hazardous waste in England and Wales • Require producers or consignors of hazardous waste to register their premises • Restrict mixing and require separation of hazardous waste where appropriate • Make sure that companies document the movement of hazardous waste • Require consignees receiving hazardous waste to keep thorough records The List of Wastes Regulations • Introduce the “List of Wastes”, known as the European Waste catalogue, which categorises

wastes based on a combination of what they are and the process or activity that produced them • Explain the list, giving guidance on selecting a correct six digit code for the waste • Show how waste is classified as either hazardous or non-hazardous • Show limits for certain hazardous properties 'Hazardous Waste' is waste that is listed in the List of Waste regulations because it displays one or more properties that are hazardous to health, safety or the environment. Clinical wastes, from laboratories and healthcare premises, may be hazardous if they are infectious. Further guidance on this may be found in The safe management and disposal of healthcare waste. The Environment Agency's technical guidance document WM2, Interpretation of the definition and classification of hazardous waste, also provides information on waste classification. This can be found on the Environment Agency website. “Clinical” waste produced by the University will fall into the H9 "infectious" hazard property: substances containing viable micro-organisms, or their toxins, which are known or reliably believed to cause disease in man or other living organisms. In practice very little of the University’s waste is infectious as pre-treatment is required before disposal. However, the University adopts a “belt and braces” approach and currently sends all its clinical waste for incineration, for reasons outlined below. Other items for disposal as clinical waste Whilst the prime concern is for agents that are infectious, there may be other agents (e.g. plant and animal pathogens requiring a DEFRA licence) that present an environmental risk and where clinical waste is the most appropriate route for disposal. Equally sharp items that may not be contaminated still present a significant risk of physical injury to those handling waste. In many cases it will be sensible to dispose of them safely by placing them in "Sharps boxes". Clinical waste will include limbs, organs and recognisable human tissue, animal carcasses, microbiological, tissue culture and GM waste (these should be treated, preferably by autoclaving, before disposal) and "sharps" (which include contaminated* broken glass and any other contaminated* disposable sharp instrument or item, including contaminated plastic pipette tips).

* In the context of this procedure "contaminated" means contaminated with potentially infectious agents

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Note: Most Prescription-Only Medicines (POMs) will not be classified as hazardous waste, but they will be if they are Cytotoxic or Cytostatic. Cytotoxic or Cytostatic medicines are defined as any medicinal product which has one or more of the following hazardous properties: toxic, carcinogenic, mutagenic and toxic for reproduction. Examples from human healthcare include antineoplastic agents, many hormonal drugs, some antivirals, immunosuppressants, and others. Further advice may be obtained from the Health and Safety Unit. Disposal of Clinical Waste Waste taken away by the University’s clinical waste disposal contractor may ultimately be treated and disposed of in one of two ways:

1 By incineration 2 By treatment at an “Alternative Technology” plant. This involves shredding the waste and

then subjecting it to dry heat, steam or chemical treatment, followed by landfill. Given the nature of waste produced by the University, and the difficulty in ensuring correct segregation of this waste, it has been decided that ALL clinical waste will be incinerated. All yellow bags and sharps boxes should be placed in yellow 770 litre bins. When full and ready for collection bins should be labelled with the yellow, pre-printed, indestructible labels supplied by the University clinical waste manager in Hospitality and Accommodation Services (HAS). This will ensure they are taken away and ultimately disposed of by incineration. Pre-Treatment of Waste Before Disposal Most types of clinical waste need pre-treatment before final disposal. This applies particularly to microbiological cultures, tissue culture, GM waste, any material known to be infectious and waste associated with infected animals, in which cases the waste should be autoclaved before it is incinerated. Small items of contaminated broken glass may be placed in sharps containers. Glass that cannot easily be placed into a sharps box should be treated to make it safe, ideally by autoclaving, before disposal down the usual broken glass route. SEE TABLE at Annex II for types of waste, sources and appropriate disposal routes. Procedures for Dealing with Clinical Waste Schools and Departments must identify areas producing clinical waste and provide clearly identified containers (sharps boxes, disposafe jars, yellow sacks or autoclave bags). Waste should be labelled with the department name, and where appropriate, a lab number. A local decision must be made whether to designate rooms or laboratories as clinical waste areas so that all waste goes in the clinical waste stream (mandatory for Category 3 containment facilities, for example) or whether to segregate between non-harmful (black bag waste) and clinical. Where segregation is allowed particular attention must be given to ensuring that no clinical waste is placed in the wrong bag, e.g. by separation, notices and training and information. Offensive clinical waste, such as Carcasses and recognisable human tissue, should be placed in a solid container before putting into yellow waste sacks, e.g. carcasses could be placed in the original disposable transport box. Double bagging is recommended. Carcasses and human tissue should be kept appropriately e.g. frozen, chilled or fixed until taken to the clinical waste bin. Producers should delay putting containers containing this waste into the waste bins until as close as practical to the collection time to avoid decomposition etc. Clinical waste must be placed in appropriate containers at the point of production. Laboratories and other facilities should have Sharps containers so that contaminated sharps can be placed in containers immediately after use. Sharps containers should be of yellow plastic and comply with BS 7320:1990.

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Each room producing clinical waste should have a bin or bag holder provided, with a yellow clinical waste sack or autoclave bag. Bags should be to the current standard. On no account must clinical waste be put into any container other than a sharps box, disposafe jar yellow sack or autoclave bag.

NOTE: pressurised containers such as aerosol canisters should not be placed in clinical waste containers as they present a risk at the incinerator.

Yellow clinical waste sacks, autoclave bags, disposafe jars and sharps boxes should never be overfilled and must be sealed and labelled before removal. Clinical waste sacks should be sealed either daily or when three-quarters full. Overfilling of the sack may make it difficult to seal and carry. Sacks should be sealed with the ties provided and the name of the department or School written on the tab, or on a label, then affixed to the waste container. Sharps boxes should be sealed, using the lid provided before it becomes unsafe to put more sharps in. Staff should be instructed not to press down sharps in the container to make more room and on no account to attempt to remove sharps from the box. Sharps boxes should not be placed in yellow sacks and should have the name of the University and School/Department marked on them. Where waste is to be autoclaved the usual procedures should be followed and the autoclaved waste that is destined for incineration (e.g. disposable culture dishes) placed in yellow sacks as above. Sealed and Labelled containers should be taken to the collection bins by nominated staff. Who takes the containers will depend on local circumstances. In most cases it will be laboratory staff, but in some circumstances this duty may fall to porters/cleaners. Whoever carries the waste must be aware of the special concerns relating to the waste, the procedures for noting the amount of containers and for dealing with a spillage. Staff carrying waste containers should wear overalls or laboratory coats and gloves. They should:

• Check that the containers are effectively sealed and are labelled with lab number and department

• Carefully check the weight of each container before lifting to avoid injury and not attempt to carry large numbers of bags at once.

• Handle the bags by the neck only and avoid throwing or dropping them where possible. If a trolley or cart is needed to move large numbers of bags this should ideally be dedicated to use for clinical waste and be made of material that can readily be disinfected in the event of a spillage. Types of clinical waste loaded into the collection bins must be recorded on the University’s Clinical Waste Disposal form when the bins are ready for collection. It is essential that copies of the completed forms are kept by the department. For each clinical waste collection point the nominated “keyholder” should possess a book of forms obtainable from the Clinical Waste Manager within Hospitality and Accommodation Services (HAS). One form should be completed for every collection. The department should keep one copy of the completed form and the remaining copy/copies should be placed in a protective plastic sleeve and securely attached with cable ties or string to one of the yellow-label tagged wheelie bins. The driver will remove these and take them to the Clinical Waste Manager who will then fill out the statutory Consignment Note on behalf of the University. The waste will be given the appropriate six digit code from the European Waste Catalogue, in the case of all clinical waste from the University, this is 18 01 03 – wastes whose collection and disposal is subject to special requirements in order to prevent infection. Accident, Incident and spillage procedures should be developed by the School or Department and made known to all persons handling and transporting clinical waste. Any accident, untoward incident or spillage must be reported to the Clinical Waste

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Manager as soon as possible. In the event of an injury from a sharp the Occupational Health staff in the Health and Safety Unit should be contacted as soon as possible. Spillages should be contained, liquids absorbed and the waste repackaged. Particular caution is needed in this procedure, particularly with wet waste or sharps spillage. In the first instance the area should be cleared. Further precautions will be necessary, e.g. the provision of gloves and eye protection. If possible the producers should be contacted and asked to assist. Disinfection of contaminated areas should be carried out using appropriate disinfectants. Once the incident has been dealt with a report of the incident and the actions taken should be sent to the Health and Safety Unit in the usual way and copied to the Clinical Waste Manager. The local “keyholder” must ensure that bins are locked at all times. Broken bins/locks should be reported immediately to the Clinical Waste Manager. All staff and, where relevant, students, visitors or others working in areas where clinical waste is produced should be trained and informed of the risks and procedures to be followed. The level of training and information will vary according to the involvement of individuals. For example producers of waste will need to be informed of the risks to themselves and others, the procedures for segregation and the filling of containers. Summary of Clinical Waste Procedure All clinical waste is to be sent for incineration

Waste should be pre-treated as outlined in Annex II of this procedure

Bags and sharps boxes should be labelled with lab number and department name and placed in yellow clinical waste wheelie bins. Bins should be kept locked. Each collection point should have a nominated “keyholder”

When full, all bins for disposal must carry pre-printed yellow infectious waste labels (available from clinical waste manager)

The keyholder for each waste collection point must fill in a clinical waste disposal form for each collection. The keyholder must keep a copy of the form and leave the remaining copy in a protective sleeve attached to a yellow label tagged wheelie bin

The contractor’s driver will collect these and leave them with the University’s clinical waste manager who will use them to fill out a consignment note for the University

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Clinical Waste - ANNEX I Risk Summary Risks from producing and handling clinical waste can be divided into risks from exposure to harmful agents, physical risks from handling the waste and risks to the environment. Risks are to those generating the waste in the laboratory, those packaging and transporting the waste to the collection bins, employees of the contractors involved in disposal away from the University, and members of the public. ALL are owed a duty of care to protect them from potential infection or injury. Biological risks The primary concern with clinical waste is that of exposure to infectious agents. With clinical specimens the greatest risk comes from blood-borne viruses (HIV, Hepatitis B, C, D, etc). The most significant risk by far is from inoculation or sharps injury. Used hypodermic needles may also be the target of drug users and particular care must be taken to ensure secure storage. Tissue may contain other pathogens e.g. lung tissue may contain Mycobacterium tuberculosis (TB causing organism) and neural tissue may carry agents for transmissible spongiform encephalopathies, which may not be inactivated by normal fixing in formaldehyde. Routes of infection include inoculation injury, aerosol inhalation and ingestion. Spillage of a bag’s contents could lead to exposure by contact, aerosols or sharps injuries. Physical risks Bags of clinical waste can be heavy and awkward to carry. The bags have to be manually handled into large bins and there is a risk of physical injury if not appropriately handled or if bags are carelessly filled. Sharps sticking through bags have caused problems to those carrying them in the past both as an infection risk and risk of cuts. Environmental risks Environmental risks in the case of clinical waste are similar to health and safety risks in causing harm to persons but also include causing offence to persons. Risks can arise from spillage from inadequate or overfilled packaging, careless handling or inadequate segregation allowing clinical waste to get into the wrong waste disposal stream. The incineration process itself generates pollutants to the atmosphere and as toxic ash residues. These risks are beyond the scope of this document and are primarily the responsibility of the disposer. The University as a producer has a duty of care to ensure that the disposal contractor is properly authorised and licensed to dispose of the waste and has the necessary facilities or access to them.

Clinical Waste: ANNEX II Types, Sources and Disposal Routes

TYPE SOURCE OF WASTE TREATMENT/CONTAINER OTHER INFORMATION Contaminated* Sharps Hypodermics, scalpel blades, pipette tips

All Sharps box. If sharps are contaminated with GMMs the box should be autoclaved. Disposafe jars can be used for pipette tips but NOT for sharps.

Contaminated* broken glass Small items Large items

Sharps box (and then as above) Treatment to render safe (ideally autoclave)

Broken glass waste

Carcasses All Solid container in double yellow bag and keep chilled or frozen until near to collection or maceration (as available)

Animal Bedding

Known infectious All other

Autoclave first then yellow bag Yellow bag

Animal Carcasses infected with GMMs

All Autoclave, container, then double yellow bag

Cultures of micro-organisms, cell-culture And items contaminated with same; Genetically modified Micro-organisms / Material contaminated with GMMs

All Autoclave first then yellow bag if solid or sluice if liquid

Limbs and organs - Includes recognisable portions of organs, limbs or tissue

All

Fix unfixed items then double yellow bag and/or outer container chilled or frozen until near to collection

Tissues e.g. unrecognisable or macerated tissue

All Fix or autoclave human tissue or high risk tissue from other species then yellow bag

Blood and body fluids e.g. csf, aspirates etc.

All Treat to render safe (autoclave etc.) then yellow bag

Containers for unfixed tissue any laboratory Autoclave and Yellow bag

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Clinical Waste: ANNEX II (cont.) TYPE SOURCE OF WASTE TREATMENT/CONTAINER OTHER INFORMATION Faeces and Urine Known highly infectious risk

No known highly infectious risk

Autoclave or fix then to sewer via sluice To sewer via sluice

Normal waste

General laboratory waste (Includes gloves, paper towels etc.)

Microbiology or tissue culture laboratories, GM laboratories working areas Paper from non-work areas (e.g. writing area)

From category 3 labs, all GM labs or high risk specimen handling areas - to be autoclaved then yellow bag Otherwise yellow bag Black bag (except category 3 laboratories)

General laboratory waste (including gloves etc.)

From laboratories not handling biological agents or GMMs

Black bag

Radioactive Clinical Waste Any source Medibins and special arrangements CONTACT the Health and Safety Unit

NOTE: If the waste contains other hazardous materials, e.g. radioactive or chemical, further action may need to be taken

Infective or genetically modified plant material (environmental risk)

Laboratories and glasshouses Autoclave then Yellow bag Clinical waste

G) Emergency Arrangements Arrangements will need to be put in place to deal with emergencies, such as a spillage or other accidental exposure to a biological agent. These will need to include:

• The foreseeable types of incidents, accidents or emergencies that might occur; • The role and responsibilities of individuals during an emergency; • Clear procedures for individuals to follow, these should include regular “dry” or training runs

to test the effectiveness of these procedures; • Safety equipment and personal protective equipment to be used; • Arrangements for liaison with the Health and Safety Unit, and the emergency services; • First aid facilities; • Procedures for clean up/decontamination and disposal of waste.

(Guidance on fumigation of safety cabinets and CL3 laboratories is given in this guidance document.) Procedures for dealing with accidental releases should be displayed locally. A number of factors need to be considered when drawing up local spillage arrangements:

• Type of agent involved and its hazard group, route of transmission, infectious dose, stability in the environment;

• Type of accident, e.g. dropped flask; • Amount and concentration of material released; • Location of accident, e.g. within open lab space, in safety cabinet; • Who is likely to be exposed.

In addition to the need for emergency arrangements, there are specific requirements for dealing with incidents involving the release of a Hazard Group 3 biological agent, or Class 3 Genetically Modified Micro-organism. Details of the emergency arrangements will, in these cases, be sent to the Health and Safety Executive in advance. Individuals should report incidents to their supervisor, health and safety co-ordinator or Biological Safety Officer immediately. The Health and Safety Unit should also be informed. Following any exposure to a biological agent medical advice should be sought from the University’s Occupational Health Service. If the incident occurs out of hours medical advice should be obtained from the A&E Department at Selly Oak Hospital. Any emergency plan should include details of any appropriate post-exposure prophylaxis (PEP), and how it will be accessed. This should be discussed in advance with the University’s Occupational Health Service.

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APPENDIX 1

Protective Equipment See also Policy on Personal Protective Equipment, UHSP/19/PPE/03. Appropriate protective equipment should be worn. It should conform to the appropriate British Standard and should be clean, complete, in good condition and worn correctly. It should be removed, decontaminated, cleaned and repaired as necessary. General Trousers and shoes give better protection than thin tights and sandals. High heeled shoes or loose sandals may lead to trips and falls. Long hair must be tied back or worn under a cap. Sharp instruments must not be kept in pockets. Laboratory Coats/Gowns must be worn, adequately fastened, at all times in areas where microbiological hazards are handled (including people not involved in the work). Ordinary laboratory coats are adequate for containment levels 1, but high necked, side or back fastening gowns with elastic cuffs (or equivalent) give better protection and must be worn in containment Level 2 and 3 areas. Containment level 3 gowns must not be worn elsewhere. The wearing of laboratory coats/gowns is prohibited in rest rooms, canteens, libraries, lavatories, hospital wards and offices (other than those accessible from laboratories) and should be kept to a minimum in corridors and areas to which there is general access. Coats/gowns must be changed regularly (e.g. daily at Level 3 and weekly at Level 2) and those worn in Level 2 areas should be autoclaved before laundering (obligatory in Level 3 and 4 areas). Some materials containing man-made fibres may melt and cause serious skin burns if ignited. They are not suitable for work close to a naked flame. Gloves of adequate resistance and durability must be worn for messy operations, post mortems, decontaminating equipment, cleaning up spillages, handling Group 3 hazards (including blood suspected of containing Hepatitis B virus and human immunodeficiency virus), handling concentrated disinfectants or when the hands are cut or abraded. When wearing gloves care must be taken not to transfer contamination inadvertently. Gloves used to remove hot objects from autoclaves must be heat resistant and insulated gloves used for low temperature work (e.g. operating liquid nitrogen banks) must be of an appropriate type. Where gloves are used for biological laboratory work, low allergen, powder free latex gloves should be used if latex is deemed necessary for the task, otherwise nitrile gloves should be used to avoid the possibility of latex allergy. If exposure to any glove material produces a skin rash, or respiratory discomfort you should cease using the those gloves and seek medical attention straight away. Plastic aprons and/or boots must be worn for messy operations where there is a risk of splashing. A visor must be worn where there is a significant risk to face or eyes and it is not practicable to use a safety cabinet (e.g. when removing vials from liquid nitrogen banks, using freeze dryers, pouring materials down sinks or sluices, removing bottled fluids from autoclaves, inoculating animals and replenishing acid or alkali reservoirs used for pH control of fermentation and when handling concentrated solutions of disinfectants). Respiratory protection. Those working in a laboratory setting are unlikely to need Respiratory Protective Equipment (RPE) to control exposure to biological agents during routine work as all laboratory operations generating significant aerosols should be performed in a safety cabinet. However, there may be circumstances when its use is required. E.g. Respirators should be worn when hosing down water tanks and other installations which may harbour Legionella spp. To be effective Respiratory Protective Equipment (RPE) must be properly fitted and used correctly. The Control of Substances Hazardous to Health Regulations require fit testing of facepieces (full mask, half mask or filtering facepieces (disposable masks)) to be carried out to ensure the selected facepiece is of the right size and fitted correctly. The protection given by respirators depends on the quality of the fit (e.g. beards may allow passage of unfiltered air). Ordinary surgeons’ masks give negligible protection against infection. If there is a significant risk that room air has become contaminated by agents in Hazard Groups 3 that are infectious by the airborne route, suitable positive

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pressure respirators should be worn by trained people to deal with the situation. Appropriate chemical respirators should be available when areas are fumigated with formaldehyde. RPE should be kept in efficient working order and good repair. Regular examination and, where appropriate, testing of the RPE should be carried out and records kept. Other protective equipment (safety helmets, safety footwear, ear defenders, etc.) should be worn as appropriate. Removal of Protective Clothing

• Protective clothing should be removed, if possible, without potentially contaminated areas coming in contact with uncontaminated skin or clothing.

• Gloves intended for re-use should be rinsed in disinfectant before removal. • Contaminated items must be disinfected, autoclaved or incinerated. • Uncontaminated items should be hung on pegs or stored in racks, lockers or other

containers provided for the purpose. • In Containment Level 3 laboratories, there should be a detailed protocol for the removal of

protective clothing. • Hands must be washed with soap (or antiseptic detergent) and running water after removal

of protective clothing.

APPENDIX 2

Handling Human Blood, Blood Products and Other Human Tissues All human material should be treated as potentially infectious and be handled at Containment Level 2 unless a higher degree of containment is indicated. The main concern is the possible presence of blood borne pathogens, notably human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV). Where it is known or strongly suspected that Hazard Group 3 pathogens are present the samples must then be handled at the appropriate containment level. The commonest route of blood borne infection in the laboratory is by contact and care must be taken to avoid contamination of the skin and eyes and accidents with scalpels, needles and other sharps. Although airborne infection is unlikely, it should not be assumed that it cannot occur and aerosol production must be minimised. Handling Blood and Blood Products in Student Practicals Blood and blood products for use in practical classes should be obtained from the safest source that is reasonably practicable. Animal blood should be used in preference to human blood, and blood that has been screened for evidence of HBV and HIV should be used in preference to unscreened blood. Blood products should be treated, where reasonably practicable, in ways known to inactivate HIV. Use of Blood and Blood Products in Research • All blood and blood products must be handled safely under appropriate containment conditions.

Specimens with a high risk of containing HIV or HBV must be handled appropriately. • For work with potentially infected samples the use of sharps should be avoided unless there is no

alternative. If they are used they should be placed directly in a sharps container for disposal. Needles should never be resheathed.

• Use appropriate personal protective equipment when handling human blood or tissue. Goggles and an apron may be needed if there is a risk of splashing.

• In the event of a needlestick injury the wound should be encouraged to bleed and the area washed with soap and water. If skin, conjunctivae or mucous membranes are contaminated, these areas should also be washed. All accidents should be reported to the Occupational Health Department in the Health and Safety Unit immediately. See Schedule 2 of the University Biological Safety policy on dealing with Puncture Wounds and Splash Incidents.

• Persons working with human blood or tissues should be immunised against hepatitis B in advance of the work starting. Immunisation can be arranged through the Occupational Health department in the Health and Safety Unit.

Further information and guidance on work with human blood and tissue can be found in the publication, Protection against blood borne infections in the workplace: HIV and hepatitis ACDP 1995.

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APPENDIX 3

Animal and Plant Pathogens There is legislation on holding and importing animal and plant pathogens which is the responsibility of the Department for the Environment, Food and Rural Affairs (DEFRA – http://www.defra.gov.uk). Persons working with these pathogens should make themselves familiar with the requirements. Animal Pathogens These pathogens are controlled by the Specified Animal Pathogens Order 1998, as amended in 2005. Importation Within the European Community (EC) no licence is required but the Divisional Veterinary officer (contactable via DEFRA) must be given 24 hours notice. A licence is required from DEFRA for importation from countries, other than EC countries, under the Importation of Animal Pathogens Order 1980. Handling Handling, transport, storage or possession of the specified pathogens requires a licence from DEFRA. The licence should be applied for in advance (at least 6 weeks) and the laboratory may be inspected before a licence is issued. Plant Pathogens These pathogens are controlled by the Plant Health (England) Order 2005, which prevents the introduction and spread of harmful plant pests and diseases. It imposes restrictions on the import of plants and plant produce and products into England in order to safeguard plant health. Further information can be found on the DEFRA website – http://www.defra.gov.uk.

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APPENDIX 4

Filming and Photography Film crews and photographers may not be aware of the risks of handling microbiological hazards and must be given adequate safety instruction.

1. Filming and photography in studios Dummy material should be used where possible but should be handled in front of the cameras as carefully as if it were the real thing. If necessary, Hazard group 2 materials may, with the consent of the studio staff, be used provided that appropriate safety measures are observed, materials are removed safely when filming has finished and the studio is decontaminated if necessary.

2. Filming on location. Handling of hazardous material may be filmed or photographed provided that proper safety precautions are observed and there are no legal or other constraints. Film crews etc. must be given protective clothing, immunisation etc. as appropriate and equipment decontaminated if necessary.

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APPENDIX 5

WHO Risk Groups for Micro-Organisms Risk group 4 (high individual risk, high community risk) Pathogens that usually cause severe human or animal disease, and that can be readily transmitted from one individual to another, directly or indirectly and for which effective treatment and preventative measures are not usually available; Risk group 3 (high individual risk, low community risk) Pathogens that usually cause severe human or animal disease, but do not ordinarily spread from one infected individual to another, and for which effective treatment and preventative measures are available; Risk group 2 (moderate individual risk, low community risk) Pathogens that can cause human or animal disease, but are unlikely to be a serious hazard, and, while capable of causing serious infection on exposure, for which there are effective treatment and preventative measures available and the risk of spread of infection is limited; Risk group 1 (low individual and community risk) Micro-organisms that are unlikely to cause human or animal disease.

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APPENDIX 6

Checklist for inspections of biological laboratories Regular audits/inspections of biological facilities are recommended to ensure that standards are being maintained, and the fabric of the laboratory is not deteriorating. The checklist is meant to aid this process by highlighting the main areas considered on an inspection:

• Access and signage; • Environment and Housekeeping; • Hygiene and Personal Protective Equipment; • Equipment/Apparatus; • Laboratory procedures; • Laboratory documentation; • Working arrangements.

The primary aim of this list is to ensure compliance with the requirements of the Control of Substances Hazardous to Health Regulations and The Genetically Modified Organisms (Contained Use) Regulations, and also demonstrate good practice. Work within the University is predominantly carried out in containment level 1 and 2 laboratories. There is some work at CL3, but these are specialist facilities and are dealt with separately. Guidance Notes Work with wild type biological agents and human/animal/plant material is covered by the Control of Substances Hazardous to Health Regulations CL1 is generally the standard for most undergraduate teaching work, although demonstration may involve the handling of Hazard Group 2 agents by trained personnel. HG1 agents are by definition unlikely to cause disease in healthy humans. CL2 is the most commonly used containment level and covers a wide range of clinical and research work. HG2 agents are capable of causing disease, but are unlikely to spread further to the community and, in any case, effective treatment is available. Genetically modified micro-organisms are subject to legislation of their own (The Genetically Modified Organisms (Contained Use) Regulations), although the controls for ACDP levels 1 and 2 and ACGM levels 1 and 2 are broadly equivalent. The table of control measures used to determine the Class of GMM is contained within the assessment proforma (available on the HSU website, ref: BS9gmpf) Most facilities (aside from some teaching laboratories) are designed to CL2 standard and may house a mix of work at both CL1 and CL2. In such cases it is good practice to ensure that everyone is aware of the work being undertaken in the multi-user facility, and that the higher CL2 standard is applied throughout the laboratory to avoid lapses in control standards. There may be some central facilities, such as autoclaves and wash up areas. During inspections it is advised that the distance from laboratory to autoclave is considered, as well as the route. For example, does waste have to be transported through public areas when moved from lab to autoclave? If so, can this be avoided?

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Checklist for ACDP/ACGM level 2 facilities Laboratory: Department: Research Group: Area of research: REQUIREMENT YES/NO COMMENTS Access/signage Containment level displayed Biohazard sign

Lab locked when not in use Door closed if room under negative pressure

Authorised persons only

Responsible person for lab

Contact details

Environment and Housekeeping

Lighting adequate

Comfortable temperature

Lab under negative pressure. If so, tested

Ventilation adequate, not interfering with safety cabinet

Aisles uncluttered

Floor clean and in good condition

Benches clean, in good condition and uncluttered

Lab sink clean

Disinfection regime in place Disinfectant available and made up fresh

A6-2

REQUIREMENT YES/NO COMMENTS Hygiene and PPE Wash basin near exit with elbow taps

Soap available

Paper towels available in dispenser

Waste bin for non-hazardous waste

Lab coats worn and stored correctly

Outdoor clothing stored elsewhere

Gloves available – material used

Other PPE

Equipment Electrical items tested

Absence of overloaded sockets

Centrifuges serviced and maintained

Autoclave in vicinity

Autoclave serviced and maintained

Autoclave log kept

Autoclave operators trained Safety Cabinets tested and serviced

Safety Cabinet test records kept

Other equipment maintained and serviced

Lab Procedures Waste disposal procedures in place

Fridge/Freezer inventories in place

Labelling of fridge/freezer contents

Labelling of incubator contents

Safe storage of biological agents

Labelling of biological agents Secure storage of Schedule 5 substances

Safe and proper chemical storage

Chemicals labelled and segregated correctly

A6-3

A6-4

REQUIREMENT YES/NO COMMENTS Lab documentation Biological COSHH/GM assessments readily available

Biological COSHH/GM assessments relevant and recently reviewed

All workers trained

Training record kept

Untrained staff/visitors always supervised

Local policies and procedures

Out of hours working

Lone working arrangements Working arrangements No. of people in facility at any one time

Adequate space and facilities If more than one research group, is work compatible

Interviews with Lab users – comments (satisfactory demonstration of awareness of hazards, risks, controls needed etc)

HSU\Library\Documents\Health and Safety Guidance\12mbs.doc 7.4.08