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Biotech Cleanroom Design and Build

  • 2022-09-07
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Biotechnology based remedies are rapidly coming to market to address a vast number of rare diseases and common ailments. Biotech innovations have dramatically increased the number of BSL Biosafety Level cleanrooms or BSL zones within larger cleanroom operations. BSL Protocols are put into place to manage risks related to containment, infection, transmissibility, with the Level depending on the nature of the work conducted, origin of the microbe, agent in question, route of exposure.

Biosafety Level 1(BSL-1)

Basic level of protection, appropriate for agents that are not known to cause disease in normal, healthy humans.

Biosafety Level 2(BSL-2)

Level of protection appropriate for handling moderate-risk agents that cause human disease of varying severity by ingestion or through percutaneous or mucous membrane exposure.

Biosafety Level 3(BSL-3)

Level of protection appropriate for agents of indigenous of exotic origin with a known potential for aerosol transmission that may cause serious and potentially lethal infections after inhalation.

Biosafety Level 4(BSL-4)

Highest level of protection, appropriate for exotic agents that pose a high individual risk of life-threatening disease by infectious aerosols and for which no treatment is available.

BSL-1 Biotech Cleanroom Design Requirements

Biotech cleanroom engineering and construction standards to achieve the required ISO Classification for the application, coupled with BSL-1 requirements standard engineering controls for BSL-1 laboratories and cleanrooms include the requirements outlined below.  

Biosafety Level 1:  Overview

Biosafety Level 1 is suitable for work involving well-characterized agents not known to consistently cause disease in immunocompetent adult’s humans and present minimal potential hazard to laboratory personnel and the environment.

BSL 1 laboratories are not necessarily separated from the general traffic patterns in the building.

Work is typically conducted on open bench tops using standard microbiological practices.

Special containment equipment or facility design is not required, but may be used as determined by appropriate risk assessment.

Personnel must have specific training in the procedures conducted in the laboratory.

Common BSL-1 Considerations for Architectural Finishes

Materials of construction and finishes: non-porous, smooth, cleanable, withstand cleaning / sanitization agents, not supporting microbial growth

Walls: modular construction optional

Ceilings: suspended lay-in style acoustical tile

Doors: single & double leaf rapid roll-up seamless door frame

Floors: troweled self-leveling epoxy flooring

Exterior glazing: optional but not preferred

Interior glazing: single or double glaze impact resistant and sealed

Air Changes Per Hour (ACPH):  15 minimum

BSL-2 Biotech Cleanroom Design Requirements

Biotech cleanroom engineering and construction standards to achieve the required ISO Classification for the application, coupled with BSL-2 requirements standard engineering controls for BSL-2 laboratories and cleanrooms include the requirements outlined below.  

Biosafety Level 2:  Overview

Biosafety Level 2 standards, protocols, and engineering, design, and construction techniques build upon BSL-1.

BSL-2 cleanrooms and laboratories commonly handle applications such as equine encephalitis viruses and HIV, as well as Staphylococcus aureus (staph infections).

BSL-2 cleanrooms and laboratories are separated from the general traffic patterns in the building.

Special containment equipment or facility design is required

Personnel must have specific training in the procedures conducted in the BSL-2 cleanroom or laboratory.  Personnel are trained to handle pathogenic agents and are supervised by those with advanced training.undefined

Biosafety cabinets or other physical containment for all procedures that can generate infectious aerosols or splashes.

Autoclave or other method of decontamination for proper disposal of materials or sterilization for re-use.  

Eyewash station or eyewash safety shower

Interlocking doors, and commonly with badge-controlled facility access

Extra care is taken to control routes of exposure, including advanced techniques for handling contaminated sharps

Immunizations are provided to lab personnel when appropriate

Additional PPE, such as face shields may be necessary

A lab-specific biosafety manual that outlines the necessary controls and practices for the work performed in that lab is established and well known by the trained team working in the area.

Common BSL-2 Considerations for Architectural Finishes

Materials of construction and finishes: non-porous, smooth, cleanable, withstand cleaning / sanitization agents, not supporting microbial growth

Walls: modular construction

Ceilings: modular panel system

Doors: single & double leaf sliding seamless door frame

Floors: troweled self-leveling epoxy flooring

Exterior glazing: not recommended, corridor separating exterior from BSL spaces preferred

Interior glazing: single or double glaze impact resistant and sealed

Air Changes Per Hour (ACPH): 15 minimum

BSL-3 Biotech Cleanroom Design Requirements

Biotech cleanroom engineering and construction standards to achieve the required ISO Classification for the application, coupled with BSL-3 requirements standard engineering controls for BSL-3 laboratories and cleanrooms include the requirements outlined below.  

Biosafety Level 3:  Overview

Biosafety Level 3 is applicable to clinical, diagnostic, teaching, research or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure

Personnel have specific training in handling pathogenic agents and are supervised by scientists competent in handling infectious agents and associated procedures

All procedures involving the manipulation of infectious materials must be conducted within BSCs or other physical containment devices

These labs must use controlled or directional air flow to ensure additional safety measures

Other safety features include two self-closing or interlocked doors and sealed windows: ceilings, floors, wall surfaces, and filtered ventilation systems

Common BSL-3 Considerations for Architectural Finishes

Materials of construction and finishes: non-porous, smooth, cleanable, withstand cleaning / sanitization agents, not supporting microbial growth

Walls: seamless hard wallboard

Ceilings: seamless hard ceiling

Doors: single & double leaf bubble tight sliding with inflatable seals seamless door frame

Floors: troweled self-leveling epoxy flooring

Exterior glazing: not allowed due to hazard

Interior glazing: single glaze impact resistant and sealed

Air Changes Per Hour (ACPH): 15 minimum

BSL-4 Biotech Cleanroom Design Requirements

Biotech cleanroom engineering and construction standards to achieve the required ISO Classification for the application, coupled with BSL-4 requirements standard engineering controls for BSL-4 laboratories and cleanrooms include the requirements outlined below.  

Biosafety Level 4:  Overview

Biosafety Level 4 is required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease that is frequently fatal, for which there are no vaccines or treatments, or a related agent with unknown risk of transmission.

These labs incorporate all BSL 3 features and occupy safe, isolated zones within a larger building or may be housed in a separate, dedication building.

Agents with a close or identical antigenic relationship to agents requiring BSL-4 containment must be handled at this level until sufficient data are obtained either to confirm continued work at this level or re-designate the level.

Staff must have specific and thorough training in handling extremely hazardous infectious agents.

Two types of BSL-4 Labs:

1.  A Cabinet Laboratory-Manipulation of agents must be performed in a Class III BSC

2. A Suit Laboratory-Personnel must wear a positive pressure supplied air protective suit

BSL-4 cabinet and suit laboratories have a special engineering and design features to prevent microorganisms from being disseminated into the environment.

Common BSL-4 Considerations for Architectural Finishes

Materials of construction & finishes: non-porous, smooth, cleanable, withstand cleaning/sanitization agents, not supporting microbial growth

Walls: seamless hard wallboard

Ceilings: seamless hard ceiling

Doors: single leaf bubble tight seamless door frame

Floors: troweled self-leveling epoxy flooring

Exterior glazing: not allowed due to security, hazard and terrorist threat

Interior glazing: single glaze impact resistant and sealed, only to monitor staff and operations

Air Changes Per Hour (ACPH): 15 minimum


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