Biosafety and GMP Laboratory: From Design to Certification

BSL-3 baulich-technische Sicherheitsmassnahmen

Recommendation of the SECB on structural-technical safety measures in BSL-3 laboratories

Architectural block diagram: laboratory space programming

V-Diagram: laboratory design and quality control

Certification of inward airflow (BSL3 lab)

Certification of inward airflow (pressure cascade, BSL3 lab)

Differential pressure trending (BSL3 lab)

Full protection suit in a BSL-3Ag lab

BSL2 and BSL3 hands-on training

Ferret-Isolator (BSL3+)

[Deutsch]

Basler & Hofmann Switzerland team suppports you as global biosafety consultants.

For any enquiries you may have, please reach out to Felix Gmünder at:

Services and competences

We find and/or develop solutions for your biosafety laboratory (BSL-2) and high containment laboratory project (BSL-3, BSL-4). We specialise in combined GMP / BSL-2 or BSL-3 facilities, in particular polio vaccine production facilities conforming to WHO GAP IV.

Our services include but are not limited to:

Conceptual design and planning
Risk assessments e.g., according to WHO 2020
Selection of primary containment equipment and laboratory outfitting
Review and assistance of schematic design
Technical due diligence, gap analysis, renovation, retrofitting
Support maintenance incusive maintenance concepts
Review of tenders, support construction supervision
Support testing & commissioning, handover
Certification and validation
Biosafety training and hands-on training in the laboratory
Development and setting up and implemenation biorisk managment systems and programs, e.g., WHO 2020 and ISO 35001
SOP and work instruction development
Comprehenisve laboratory safety (including OHS, ergonomics)
Safety audits

Credentials and experience of our lead consultant Felix Gmünder include:

20+ years experience in BSL-3 and BSL-4 laboratory design and consulting
Member of the Swiss Expert Committee for Biosafety
Singapore Ministry of Health Approved BSL-3 Certifier
Ph.D., M.Sc. Swiss Federal Institute of Technology (Microbiology)
Registered Biosafety Professional (RBP, ABSA)
Certified Safety Engineer (OHS)

Reference projects

Upon request.

Reading materials & recommendations

In English, en français, in Italiano: Recommendation on Structural and Technical Safety Measures in BSL-3 Laboratories. This recommendation was prepared by Basler & Hofmann.
Recommendation of the SECB on the Maintenance of BSL-2 and BSL-3 Laboratories.This recommendation was developed by Basler & Hofmann.
BIBO HEPA-Filters in BSL-3 Labs: Yes or No?
State-of-the-art safety engineering for BSL-3 labs (pptx, presented to the 3rd International Conference on Biosafety and Laboratory)
Think outside the biosafety box (pptx, requirements for BSL2 facilities from the safety and biosafety perspectives; presented to the Swiss Biosafety Network (SBNet) annual conference)
Design a Functional Laboratory
BSL-3 Laboratory Engineering Consulting: Good Practice BSL-3 Engineering Design
Certification Standards: BSL-2 and BSL-3 Laboratories
BSL-3 Certification Requirements: Basler & Hofmann Inspection Scope

Videos

Basler & Hofmann Singapore Youtube Biosafety Video Channel

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