Biosafety and GMP: From Design to Certification


Biosafety in BSL-3Ag Laboratory

Full protection suit in ABSL-3 &slash; BSL-3Ag Laboratory

[Deutsch]

Felix Gmünder and the Basler & Hofmann Switzerland team suppport you as global biosafety consultants.

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

Felix Gmünder's experience and track record include:

  • 20+ years experience in biosafety and laboratory safety 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

Videos


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