Biosafety Laboratories and High-Level Isolation Units

For the commissioning of containment laboratories (BSL 3, BSL 4), biosafety laboratories with heightened requirements (BSL 2+) and high-level isolation units, it is particularly important to define all biosafety requirements for the technical implementation – and to monitor their concretization and implementation in the further course of the project. During the last few years it became an industry standard to apply the method of facility qualification, which originally stems from the GMP industry, to the field of laboratory biosafety (biosafety qualification). There is a need for coordination with other requirement areas, in particular: fire protection requirements, requirements for the handling of hazardous substances, and last but not least the user's requirements for the usability and functioning of the laboratory.  (In the case of high-level isolation units, the health and wellbeing of the patient is an additional requirement that needs coordination with biosafety.)

We support you - in any project phase

We support you in defining and reviewing biosafety requirements and developing interfaces to other areas of requirement. If you are already advanced with your project, we will help you to solve problems and independently verify the implementation of biosafety requirements. In general, the course of the project profits greatly from defining the validation and commissioning concept in due time.

Please contact us for a project-specific solution.

• Biosafety consulting
• URS (user requirements specification): we support you in determining and specifying your requirements for technical systems. The foundation is, in particular, the intended use, technical requirements (e.g., existing construction) as well as the regulatory basis (e.g., BioStoffV, GenTSV, TRBA 100, WHO, Canadian Standard ...).
• Risk assessment (e.g., in accordance with WHO LBM4)
• Traceability matrix
• Process planning and process description
• Creation of layouts and pressure cascade planning
• Preparation of a biosafety manual for technical biosafety measurements: we summarize all biosafety measurements and their technical implementation in a biosafety manual. The manual facilitates the training of the user and the start of operations.
• Operating and incident matrix: we create an operation and incident matrix and handle the necessary communication with the individual suppliers (in particular, ventilation system and monitoring system) and other project participants, especially those for fire protection. The operating and incident matrix allows a largely automatic control of plant components and – depending on the situation – puts the system into the safest possible state. Here, e.g., gas-tight flaps are controlled and alarms are triggered if serious incidents occur during operation.

• Design review
• Biosafety qualification
• Cycle development for the fumigation of rooms and air locks with H₂O₂
• Validation for fumigation with H₂O₂ (chemical and biological indicators)
• Measurement of air exchange rates (ACH)
• Measurement of differential pressures between rooms (pressure levels)
• Measurement of particle count and recovery time (acc. to ISO 14644-3)
• Testing of air flow direction, visualization of air flow (acc.to ISO 14644-3)
• Temperature testing
• Humidity testing
• Document reviews
• Verification of the implementation of the operation and incident matrix
• Incident simulation
• Training of technicians and users in biosafety-relevant technical functions of the facility