Global Biosafety Laboratory Consulting

Biosafety and GMP: From Design to Certification

Services and competences

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

Credentails 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

• Basler & Hofmann Ltd. (2024). BSL-3 Laboratory Maintenance With SOP Templates
  It is essential that all laboratories have a maintenance strategy or plan in place. Given the intricate nature of BSL-3 laboratories, it is imperative to dedicate particular focus to maintenance. The objective of the maintenance plan is to
  _ guarantee the safety of people and the environment at all times,
  _ prevent serious malfunctions and failures, and
  _ maintain the value of the facility in a long-term and sustainable manner. This Containment Talk article presents an example of a cutting-edge maintenance plan and SOP templates that meets the requirements of ISO 35001 "Biorisk management for laboratories and other related organisations", the WHO monograph "Laboratory design and maintenance" and other pertinent standards and guidelines.
  
  
• Basler & Hofmann Ltd. (2024). BSL-3 and BSL-4 Laboratory Fumigation Strategies
  BSL-3 and BSL-4 facilities must be designed and constructed in such a way that the containment and the contaminated parts of the ventilation system, including the exhaust HEPA-filter stations and enclosed systems (biosafety cabinets Class III, ducts, etc.) can be safely decontaminated by fumigation. In this Containment Talk article, possible fumigation strategies and methods are discussed with their advantages and disadvantages.
  
  
• Basler & Hofmann Ltd. (2024). Fire Protection and Safety in BSL-3 and BSL-4 Laboratories
  When designing BSL-3 and BSL-4 laboratories, fire detection, suppression and fighting will be part of every project. This Containment Talk article is an introduction for stakeholders and presents the basics for finding a solution that is effective, compliant with local fire codes, and affordable.
  
  
• Basler & Hofmann Ltd. (2024). BSL-4 Laboratory Layers of Protection
  In this Containment Talk article on BSL-4 laboratories, several layers of protection are discussed. Unlike Biosafety Level 2 and 3 laboratories, it is theoretically possible in BSL-4 facilities to completely isolate the hazard from laboratory personnel and the environment through structural and engineering risk controls. If a BSL-4 facility is designed, constructed, operated and maintained according to the state of the art, the human factor and errors become less dominant.
  
  
• Basler & Hofmann Ltd. (2024). Understanding ‘Airtight’ and ‘Gastight’ in Relation to the Design and Construction of BSL-3 and BSL-4 Facilities
  This Containment Talk takes you on a journey into the wilds of airtight, gastight and similar, poorly defined terms used in every BSL-3 and BSL-4 design, construction, and retrofit project. What does airtight, gastight mean for doors, wall-integrated equipment or penetrations? A simple and practical solution to this problem is presented.
  
  
• Basler & Hofmann Ltd. (2024). BSL-2 and BSL-3 Laboratory Air Exchange Rates: A Novel Proposal
  This Containment Talk introduces laboratory dilution ventilation systems and the concept of air exchange rate (ACH) in general and presents a proposal to reduce ACH in BSL-2 and BSL-3 microbiological and biomedical laboratories without compromising safety in routine and non-routine operations (spill management) by considering the filtering effect of Class IIA2 recirculating biosafety cabinets. For laboratory concept design, a ventilation design flowchart is also included.
  
  
• Basler & Hofmann Ltd. (2024). Autoclave Validation for Waste Decontamination in BSL-2, BSL-3, and BSL-4 Laboratories
  Autoclave validation in microbiological and biomedical laboratories at biosafety levels 2, 3, and 4 is a requirement-but there are no current guidelines or regulations on how to validate and monitor the steam decontamination process. The focus of this article is on the decontamination of liquid and solid biohazardous waste for safe disposal into the municipal waste stream (local regulations may apply).
  
  
• Basler & Hofmann Ltd. (2023). Biosafety Cabinets - Making the Most of It: Keeping Products Protected and Sterile
  This article explains how cross-contamination in the biosafety cabinet can occur and how it can be minimised. The information is relevant to laboratory personnel who are concerned with biosafety, protecting products from contamination, maintaining purity and sterility, or all of the above. Aseptic work conditions are required, e.g., for cell and tissue culture, sterile specimen handling in clinical laboratories and the maintenance of microbiological stock cultures.
  
  
• Basler & Hofmann Ltd. (2023). BSL-3 Laboratory Certification - An Introduction and Overview.
  BSL-3 certification or verification is an important post-construction element prior to handover to the owner and operator. It is carried out by an independent third party certifier. This article describes the purpose, procedure as well as methods and scope.
  
  
• Basler & Hofmann Ltd. (2023). The Swiss Cheese Risk Assessment Model for BSL-2 Laboratories
  This article looks at the multiple layers of protection or defence-in-depth concept to protect BSL-2 laboratory workers and the environment from biohazards.
  
  
• Basler & Hofmann Ltd. (2023). Risk Management for BSL-3 Laboratories Through Multiple Layers of Protection
  This article looks at the multiple layers of protection or defence-in-depth concept to protect BSL-3 laboratory workers and the environment from biohazards.
  
  
• Recommendation of the SECB on the maintenance of BSL-2 and BSL-3 Laboratories. This recommendation was developed by Basler & Hofmann.
  
  
• Basler & Hofmann Ltd. (2016). 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