HSE's Operational Strategy for Interventions at New Build and Major Refurbishment of High Containment Biosafety Facilities
Description: This SPC sets out HSE's operational strategy for interventions at new builds of high containment biosafety facilities (HBFs) in Great Britain. This includes major refurbishments of existing facilities which are liable to alter the biocontainment risks posed by activities at an existing HBF. It supports HSE's strategy for avoiding low frequency, high impact incidents involving biological agents.
- OG status:
- Fully open
- Author unit / section:
- HID SI4
- Target audience:
- All HID Inspectors, Band 0 to 6; Inspectors from Construction Division
This SPC sets out HSE's operational strategy for interventions at new builds of high containment biosafety facilities (HBFs) in Great Britain. This includes major refurbishments of existing facilities which are liable to alter the biocontainment risks posed by activities at an existing HBF. It supports HSE's strategy for avoiding low frequency, high impact incidents involving biological agents.
The guidance is primarily intended to apply to facilities operating at the highest level of containment, ie containment level 4 (CL4), with high-hazard pathogens. However, many of the principles also apply to containment level 3 (CL3) facilities.
HSE attaches particular importance to reducing risks as a result of appropriate consideration of health and safety in design (to ensure that risks are ALARP). During the design stage, which covers concept selection through to detailed design specification, there is a valuable opportunity for reducing risks by application of the principles of inherently safer design.
The process described in the guide is designed to ensure HSE targets its resources to the highest risks.
The guide can also be used by designers and operators of HBFs as a benchmark for demonstrating proper consideration of risks in the design management.
HBFs include a variety of laboratories and industrial premises, including specialist animal facilities. Good design is crucial as part of an overall strategy for minimising risks, preventing breaches of containment and complying with legislation. These principles apply equally to work with agents that cause human disease and those with the potential to have an adverse environmental or economic impact.
Early engagement with regulators in a design process can help to ensure that effective safety control measures are identified, considered properly and incorporated into the design at the outset. In doing so, the duty holder can resolve a variety of problems and improve the safety standards of new build projects.
The number of people (eg architects, designers and engineers) with experience of building a CL4 facility is limited. Consequently, liaison and consultation from an early stage between all parties, including regulators, is recommended for a successful build and will help to ensure that key health and safety issues are addressed before the operational stage.
Proper consideration of potential operational requirements and safety critical design features at an early stage helps avoid issues that may be costly to rectify once the facility is built. This will ensure better use of resources over the lifetime of the installation and could extend the lifetime of the facility.
In general, inspectors involved in such interventions at HBFs will be from HID SI4. Input from other specialism's in HSE may also be required at an early stage in the design intervention process, involving, for example HSE's Construction Division (regarding pre-construction information and design requirements of the Construction (Design and Management) Regulations 2007), CDM Interactions with other regulatory bodies (such as Defra, Environment Agency and Home Office) may also be necessary.
Key tasks involved in any new build project are:
- Corporate management
- Conceptual design
- Detailed design
- Project monitoring and review
Interventions will need to be targeted towards specific stages in the overall process to ensure effective and efficient use of HSE's resources. Careful planning, timely use of appropriate specialist resource and management of the duty holder's expectations are all important factors to be taken into consideration.
During the design of a new facility, HSE Inspectors do not have any specific legislative powers regarding containment standards. Nevertheless, the power provided to HSE by Section 13(1) of the Health and Safety at Work etc Act 1974, and the duty placed on it by Section 11(2) mean that HSE can advise on a range of issues where no other specific legislation applies at the time1. This includes providing advice as described within this SPC.
Approach to intervention
HSE's role in new build projects is to provide advice on the ongoing legal requirements that may come to bear once the facility is operational. This advisory role is best commenced at an early stage in the design process and may continue through to the construction and commissioning stages. HSE involvement should not be interpreted as a design approval process.
Duty holders involved in new build or refurbishment projects should consider consulting HSE early in the process although there is no statutory obligation to do so.
If an inspector becomes aware of a project that may fall within the scope of this SPC, they should first consult their line manager and the New Build Project Lead before further interaction with the duty holder on the subject.
Once HID SI4 becomes aware that a qualifying project is underway then the extent and nature of the resources likely to be required needs to be determined. The extent of HSE's likely involvement and any decision to proceed will lie with the New Build Project Manager and the New Build Project Lead. The level of involvement should be decided at Band 2 level, subject to resource availability and competing priorities. HID SI4 will develop an intervention plan for each project.
Input from Inspectors from other specialisms will need to be planned. In practice, this means specialist time needs to be profiled in advance to allow it to be allocated and properly resourced. During the construction phase there may also be a need to liaise with HSE's Construction Division.
A diagrammatic overview of the HSE intervention process for an HBF is provided in Figure 1. This includes the issuing of this SPC including the standard question set (Appendix 2) to the duty holder to inform their decision making and identify areas where HSE's input might be of benefit.
The question set is arranged to reflect different aspects of the design and planning process and to help determine which of the specialist resources described in Appendix 1 may be useful.
The Intervention Process
The key aspects of the process to be followed are:
- HID SI4 takes the lead within HSE relating to a qualifying new build project. The HID SI4 New Build Project Lead and Site Inspector (if appropriate) will initiate discussions with the duty holder
- The duty holder will be provided with the SPC during the design phase
- The duty holder will identify areas where specialist HSE input and advice is likely to be required during the new build process and provide HSE with a written proposal
- HID SI4 Band 2 Intervention Managers will consider the proposal and the level of input to provide (including whether or not there is a need to bid for additional HSE resource)
- The HID SI4 New Build Project Lead and Site Inspector will devise an appropriate plan to be agreed with the duty holder
- The HID SI4 New Build Project Lead and Site Inspector will co-ordinate the process and ensure that HSE resource and advice is provided in accordance with the agreed plan
This SPC should be used as a guide to assist the intervention process throughout the various stages. The aim should be to enable the duty holder to ensure that suitable management arrangements are in place at the start and throughout the life cycle of the project (including the design, construction and operation of the facility).
- It is important to make clear to the duty holder that:
- The responsibility to comply with legal requirements remains with the operator of the facility and no conclusions reached during a review or assessment of the design by HSE personnel diminishes that duty
- HSE cannot accept responsibility for any element of risk management arising from the design or build phase. The responsibility for management of risk remains with the dutyholder
- Any review or assessment of the design by HSE personnel does not preclude HSE inspectors requiring improvements where later found necessary in accordance with HSE's enforcement policy.
- They must act as a focus to receive and collate information on the project
- It is their responsibility to ensure HSE's input is appropriate and timely in accordance with the agreed plan
- They must ensure that HSE is kept informed of significant issues or developments that may affect the agreed plan
- HSE should ensure any generic design issues are captured for future analysis and that a record of interventions and any advice given is kept on COIN.
With new build projects, there should be no risks from deliberate use of biological agents until after the commissioning phase.
Formal enforcement under legislation covering activities involving biological agents is therefore unlikely to be a consideration before the commissioning stage.
When the newly built or refurbished facility has been commissioned, HSE involvement will move to standard regulatory interventions, including any necessary enforcement in accordance with the HSE Enforcement Policy Statement, EPS.
Figure 1: Template for HSE Intervention in a new build process
Appendix 1: Specialist support that may be requested
- Biological Agents
Advice on working with animal and human pathogens and genetically modified organisms to maintain containment and prevent infection in the workplace. Lead role on containment and primary contact with the duty holder, including the coordination of input from other HSE specialists
- Control and Instrumentation
Advice on the adequacy of risk control provided by safety-related systems
- FOD Construction Division
Specialists in this division could assist with construction site safety issues
- Process Safety
Advice on the suitable design of plant and equipment to prevent the unintentional releases of biological agents as well as appropriate mitigation measures and emergency procedures
- Human Factors
Advice on how the various physical, mental, social and organisational influences affect the behaviour and performance of individuals and groups so as to prevent accidents and ill-health.
- Risk Assessment
Advice on hazard/risk and consequences of major accident scenarios at major hazard sites (eg HAZOP, LOPA, SWIFT)
- Engineering eg Mechanical/Electrical)
Advice on mechanical containment integrity, general engineering plant and equipment in relation to major accident hazards.
Appendix 2: Standard Question Set
1. Are Health and Safety objectives clearly stated?
2. Will relevant guidance including HSE/ACDP guidance be used?
3. Have suitable arrangements for selecting competent designers and constructors been made?
4. Has a User Requirement Specification (URS) or equivalent been generated which covers all key design requirements eg lobbies and pressure cascades?
5. Has a clear risk target been established and are the consequences of a release considered?
6. Have the requirements for verification at subsequent stages been considered (this may extend to a Validation Master Plan or equivalent)?
7. Is there an effective change control procedure in place with adequate provision for repeating any safety assessment eg via risk assessment, HAZOP, HACCP, FMEA, FMECA?
8. Does the design take account of additional requirements for any animal experimentation?
9. For animal facilities, has the proximity of an animal housing area, necropsy room, carcass disposal area, contaminated corridor etc been considered?
10. Have wider exposure risks and containment needs eg animal allergens, radioactive materials and toxic chemicals been considered?
11. Has security of the building been considered eg bioterrorism legislation, public disorder aspects and animal activists?
12. Has flexibility to meet changing needs been planned?
13. Is the procurement process for key building materials and future raw materials sufficiently robust?
14. Are the locations of audible/visual outputs eg alarms appropriate?
15.Will the principles and recommendations in the EEMUA 191 guide (or an equivalent) be applied to alarm system design and management?
16. Have emergency procedures been effectively considered eg fire, flood, ill health, exposure and spillage and has access for emergency services, service response times been considered?
17. Will the designer and/or CDM coordinator maintain a design risk register to monitor identified issues?
18. Has sufficient space been allowed for ductwork?
This is particularly important if the laboratory is a conversion or renovation of an existing room where the location of ductwork will be influenced by existing building structures.
19. Does the design facilitate adequate maintenance arrangements eg access to ductwork, filters and pipe work etc with minimal access to the containment area?
20. What arrangements are there for staff to change into work clothes?
21. Does the design facilitate emergency procedures whilst maintaining full containment (where possible)?
22. If necessary, how will separation of laboratory/animal facility clothing from outside clothing be achieved?
23. Will size/capacity be appropriate including laboratory space, storage space, write-up areas and offices?
24. Have fluctuations of pressure caused by air disturbances been considered?
25. Are airlocks included and if so how are doors interlocked to prevent simultaneous opening?
26. How will penetrations into high hazard areas eg for entry of service lines be sealed?
27. What communication equipment will be provided eg telephones/CCTV to ensure additional security outside of normal operations and allow staff to report issues?
28. Will there be a means of viewing/monitoring work activities to allow staff outside of a room to see actions inside and provide assistance if necessary and is this likely to be effective?
29. Are the specifications of fixtures and fittings including flooring, windows, coving at floor/wall interfaces, ceilings, doors, locks, showers appropriate?
30. Will the facility be able to retain the largest possible spillage via bunds or other secondary containment?
31. What class of HEPA filters are included in the design eg H14 as defined in BSEN1822.
32. If necessary, how will the ductwork be disinfected and how will this be validated?
33. Is double HEPA filtration of exhaust air allowed for?
34. What assurance that the emergency power supply cannot be diverted from critical circuits (eg air handling systems, MSC's) by demand from non-critical equipment?
35. Have safety critical components been identified, detailing what their specification should be and what arrangements will be implemented to make sure they are adequately monitored and maintained?
36. Have all containment measures required by the legislation and guidance eg The Principles, Design and Operation of Containment Level 4 facilities been considered?
37. Will windows be able to withstand operating pressures?
38. How will access be restricted and managed?
39. Have NaCTSO Security /Biosecurity requirements for compliance with the Anti-terrorism, Crime and Security Act, ATCSA, 2001 for been met?
40. Have people with experience/expertise in operating the proposed final process been involved at the design stage to ensure that operational considerations are addressed?
41. Have up-front risk assessments been compiled by the duty holder and have key control measures been selected?
42. Will staff (or contractors) with experience in front end definition of projects be involved?
43. Have detailed risk assessments been generated and will residual risks be addressed appropriately?
44. Have failure modes been identified using a recognised process such as FMEA, FMECA, HACCP and HAZOP (Appendix 3) and if so have the appropriate people from all relevant disciplines participated in the assessment process?
45. Have planned-preventative maintenance (PPM) requirements and issues relating to the projected lifetime of the facility been considered?
46. Will modifications/changes to the initial design be effectively controlled ie effective change control process?
47. Has key equipment that must be on a back-up generator/uninterrupted power supply been considered?
48. Will equipment be compatible with process materials including those used for cleaning and fumigation?
49. Have the class(es) and types of MSC been planned eg Class I, II or III, by-pass exhaust, bespoke etc been appropriately considered?
50. Have appropriate arrangements for safe venting of fumigant from MSCs been considered (especially if recirculating models are proposed)?
51. If an air-fed suited system is to be used, has design/specification and validation of the system been considered?
52. Has the final process scale been defined and is this liable to change in the future (ie lab scale, pilot plant or large scale)?
53. Has the need for lone working in the new facility been assessed?
54. Has storage capacity for biological agents been considered along with back-up facilities and alarm systems (including low oxygen warnings where appropriate)?
Issues associated with commissioning
55. Is an effective commissioning plan is in place that will provide assurance that the HBF will meet the regulatory requirements and provides the required degree of personal and environmental protection?
56. What plans for witnessing, testing and independent verification form part of the commissioning process?
57. How will confirmation be achieved that the rooms will be able to withstand the loading characteristics imposed by negative air pressure when in operation?
Issues associated with disinfection and decontamination
58. What routine disinfection arrangements are required eg fumigation and how will they be validated?23
59. How will sealability be demonstrated on an ongoing basis after commissioning?10
60. Have neighbouring pressure cascades and impact on sealability been considered?
Issues associated with waste
61. Has the designer considered waste and effluent treatment?
62. Is the method of inactivation/disposal appropriate?
63. Will autoclave capacity match the anticipated volumes of waste that will be generated and is there a contingency plan to allow for planned or unplanned autoclave downtime?
64. Has the appropriate autoclave(s) been selected?
65. For double-ended autoclaves, will autoclave doors to be interlocked so that the outer door can only be opened after the completion of the sterilising cycle and will the simultaneous opening of both doors be prevented?
66. Will sufficient steam capacity/quality be available?
67. Do wash waters need to be collected and treated?
68. Has the decontamination of materials and equipment that are steam or heat sensitive been considered eg has a fumigation chamber or chemical dunk tank been included?
Issues associated with pipework and drains
69. Has the necessary drainage infrastructure been considered?
70. Will drains and pipes need to be contained and, if so, which ones eg from hand basins, showers etc?
71. How will blockages and leaks in pipes, valves etc containing live material be identified?
Note: for a gravity system, the size and fall combination is critical to ensure adequate velocity of product for self-cleaning of pipe.
72. How will initial integrity be demonstrated (eg drop testing)?
73. Has the requirement for ongoing testing for leakage been considered (eg pressure testing)?
74. Is there an effective design, including routing, sizing, material and construction quality?
75. Is there a requirement for a completely welded system to reduce leak risk or is mechanical jointing acceptable for risk level?
76. Will the pipework be exposed or the route marked to minimise the risk of damage?
77. Will appropriate and effective arrangements for monitoring and identification of blockages be implemented?
78. How will third party activities close to any drains be controlled?
79. What maintenance will be required (including cleaning requirements)?
80. Have emergency procedures eg for blockages, leakage, damage and pipeline failure been considered?
81. Will the drainage system be pressurised?
82. Will proposed drain/pipe material be compatible with cleaning/decontaminating chemicals?
83. Will the drain diameter/sizing be appropriate to minimise the opportunity for blockages?
84. Will arrangements be in place to prevent inappropriate solids from entering drains?
85. How will drains be isolated during fumigation?
Issues associated with human factors
86. Have the safety critical tasks been identified by a suitable hazard analysis technique, including those relating to the maintenance, inspection and testing of safety critical equipment?
87. For tasks identified within hazard analyses; has a structured task analysis and human error analysis been used to identify where the design of the human interface needs to take account of potential failures that may lead to an incident?
88. Has a hierarchical approach to the control of human failure been taken?
Examples include designing out the need for human intervention, optimising the ergonomics of the human interface, taking account of any performance influencing factors (such as the need for restrictive PPE) and ensuring the system provides sufficient clear information for the person to be aware of the status of the process at all times.
89. Has a structured, systematic approach for assuring the competence of persons that will be engaged in safety critical tasks (including training) been taken?
90. How will the effectiveness of the process be monitored once it is commissioned?
91. Have the principles described in HSG48, 'Reducing Error and Influencing Behaviour', been considered?
Issues associated with electrical safety
92. Will electrical systems be installed to the current standard of The IET Wiring Regulations eg BS 7671:2008+A1:2011, 17th Edition?
93. Will an appropriate level of risk control for all safety-related electrical and electronic systems be achieved?
Note: This can be demonstrated by the application of good practice guidelines or a suitable standard such as BS EN 61508-1:2010, Functional Safety of Electrical/Electronic/ Programmable Electronic Safety-Related Systems
94. Has assurance been made that enough socket-outlets have been provided to avoid overloading?
95. Have the requirements of the Electricity at Work Regulations 1989 been considered?
96. Are arrangements in place to ensure that electrical equipment will be selected that is suitable for its anticipated working environment?
97. Will electrical installations be maintained in a safe condition?
Issues associated with control and instrumentation
99. Has key safety equipment been manufactured with a defined Safety Integrity Level (SIL rating)19
100. Will planned systems ensure that contained/negative pressure areas cannot become positively pressurised?
101. Has an effective back up power supply been provided?
102. Will the commercial power supplier guarantee a supply from an alternative source within appropriate time frame of a mains power failure?
103. In the event of power failure, will the facility be equipped with an emergency generator that starts with an appropriate time delay?
104. Is the basis of operation of any safety related electrical and electronic system, including alarms adequately understood?
105. Have appropriate Life Cycle Standards been met?
Appendix 3: Glossary/Definitions
Advisory Committee on Dangerous Pathogens
Corporate Operational Information System
Failure Mode and Effects Analysis: A procedure used for analysis of potential failure modes within a system ie any errors or defects in a process, design, or item, especially those that affect the customer, and can be potential or actual. Effects analysis refers to studying the consequences of those failures.
Failure Mode, Effects, and Criticality Analysis: An extension of FMEA which includes a criticality analysis, which is used to chart the probability of failure modes against the severity of their consequences.
- Functional Safety
The part of the overall safety arrangements that depends on a system or equipment operating correctly in response to its inputs.
Hazard Analysis Critical Control Point (analysis): HACCP is a systematic preventive approach to food safety and pharmaceutical safety that addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection. HACCP is used in the food industry to identify potential food safety hazards, so that key actions, known as Critical Control Points can be taken to reduce or eliminate the risk of the hazards being realised.
- High-Hazard pathogen
ACDP guidance3 'defines' high-hazard pathogens as including those biological agents categorised by:
- EC Directive 2000/54/EC – the Community classification of biological agents, implemented in the UK by means of an Approved List and known widely as ACDP Hazard Group 4 (HG4) agents.
- The Department for Environment, Food and Rural Affairs (DEFRA), for administering licensing under the Specified Animal Pathogens Order 1998, SAPO, for the purpose of protecting animal health from escape of organisms from laboratories.
- The Genetically Modified Organisms (Contained Use) Regulations 2000 (as amended).15
- HID SI4
HSE's Biological Agents Unit, BAU (part of HSE's Hazardous Installations Directorate)
Layers Of Protection (analysis): A semi quantitative risk assessment method used to determine and hence demonstrate the ability of existing and proposed safeguards to protect against identified hazard scenarios and to meet predetermined risk based criteria.
Microbiological Safety Cabinet
National Counter Terrorism Security Office
- New build
New build and/or major refurbishment
Planned Preventative Maintenance
Safety Integrity Level: one of four levels, each corresponding to a range of target likelihood of failures of a safety function. It is a property of a safety function rather than of a system or any part of a system.10, 11
Structured What-If Technique
User Requirement Specification
A documented procedure for obtaining, recording and interpreting the data required to show that a process/equipment/activity will consistently comply with predetermined specifications. Requirements maybe included within a Validation Master Plan.
- Design Management, SPC 179. Internal Guidance Document OSD 5.3, version 1
- Biological agents: The principles, design and operation of Containment Level 4 facilities
- Safe working and the prevention of infection in Clinical Laboratories and Similar Facilities, HSE Books 2003 ISBN 0 7176 2513 3
- Workplace (Health, Safety and Welfare) Regulations 1992 Approved Code of Practice and Guidance: L24
- Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets, 3rd Edition
- Minimum Standards For Laboratories Working With FMDV In Vitro/In Vivo
- Sealability of Microbiological Containment Level 3 and 4 Facilities
- Pressure Equipment (Safety) Regulations 2016
- Functional Safety and IEC 61508, International Electrotechnical Commission website
- British Standard BS EN 61508-1:2010, Functional Safety of Electrical/Electronic/ Programmable Electronic Safety-Related Systems, ISBN: 978 0 580 56233 4
- The Control of Substances Hazardous to Health Regulations 2002 (as amended)
- A Guide to the Genetically Modified Organisms (Contained Use) Regulations 2000
- British Standard BS EN 12128:1998Biotechnology. Laboratories for Research, Development and Analysis. Containment Levels of Microbiology Laboratories, Areas of Risk, Localities and Physical Safety Requirements, ISBN: 0 580 30066 8
- British Standard BS EN 12469:2000. Biotechnology - Performance Criteria For Microbiological Safety Cabinets, ISBN: 0 580 34869 5
- British Standard BS EN 1822-4:2009: High efficiency air filters (EPA, HEPA and ULPA). Determining leakage of filter elements (scan method),ISBN:978 0 580 61793 5
- British Standard BS EN 61511-3:2004, Functional Safety. Safety Instrumented Systems for the Process. Guidance For The Determination Of The Required Safety Integrity Levels, ISBN: 0 580 41752 2
- British Standard BS EN 62061:2005, Safety of Machinery. Functional Safety of Safety-Related Electrical, Electronic and Programmable Electronic Control Systems, ISBN: 978 0 580 70978 4
- British Standard BS EN ISO 13849-2:2008, Safety of Machinery. Safety-Related Parts of Control Systems. Validation, ISBN: 978 0 580 61835 2
- British Standard BS EN 61131-2:2007, Programmable Controllers. Equipment Requirements and Tests, ISBN: 978 0 580 55236 6
- Fumigation: Health And Safety Guidance For Employers And Technicians Carrying Out Fumigation Operations, HSG251, ISBN 978 0 7176 2999 2
- SPC/Enforcement/179, Design Management
1. In the case of animal pathogens (not zoonotic), this general HSWA power will not apply to biocontainment advice. Back