Biosafety Levels 3 & 4: Highest Standards in Safety and Planning
Safety Labs: Complex Requirements from Planning to Decommissioning
Laboratories of this kind are subject to specific requirements throughout their entire lifecycle – from planning and operation to decommissioning. These include structural and technical measures, organizational procedures, and tailored safety concepts, including decontamination and waste management. Regular reassessments of existing safety measures are standard practice and lead to necessary adjustments when required.
Decontamination Concept as a Prerequisite for Approval
A comprehensive and detailed decontamination concept is a central requirement for operating a BSL-3 or BSL-4 laboratory. This concept combines various methods, such as room decontamination and surface disinfection. It always includes a procedural description and verification using indicators (e.g., biological indicators, measuring devices). Depending on the application and purpose, different decontamination methods are used. The goal is to prevent the spread of pathogens, protect the environment and personnel, avoid cross-contamination, and comply with legal requirements.
In practice, physical, chemical, and biological decontamination methods are applied. Common examples include autoclaving (thermal inactivation), liquid surface disinfection, and gaseous room decontamination using formaldehyde or hydrogen peroxide. The process typically involves preparation, conditioning, and decontamination phases – always aiming for the complete inactivation or elimination of hazardous biological agents. Therefore, when using chemical methods, the effectiveness, application spectrum, compatibility, and toxicity of the agents must be carefully considered.
Such a decontamination concept defines a clear procedure to ensure laboratory safety at all times. It includes the legal framework, process flow, risk assessment, verification, and documentation. These concepts must be tailored to the specific conditions of each facility and are a fundamental requirement for obtaining operational approval from the authorities.
Legal Regulations in Germany and Austria
In Germany, the legal framework for BSL-3 and BSL-4 laboratories is defined by the Infection Protection Act (IfSG) and the Biological Agents Ordinance (BioStoffV), supplemented by technical rules (TRBA) and the Genetic Engineering Act (GenTG).
In Austria, relevant regulations include the Occupational Health and Safety Act, the Ordinance on Biological Agents, and applicable Austrian Standards (ÖNORM). These laws ensure the classification of substances into risk groups, the implementation of risk assessments, the definition of protective measures, and comprehensive documentation obligations
“Challenges arise from the specific requirements and varying conditions on-site, which necessitate customized decontamination concepts. Various methods such as surface disinfection, room decontamination, or autoclaving are used.”
In practice, risks must be assessed individually, and measures adapted accordingly – ranging from planning and technical solutions to organizational procedures.
As an experienced planning company, Lorenz Consult supports its clients in developing and implementing tailored, practical decontamination solutions – especially for laboratories with the highest safety requirements. The goal is to establish clear structures, ensure regulatory compliance, and maintain operational safety in the long term.
Photo credits:
Decontamination: © Mufid Majnun, Unsplash
Georg Dallasera: © Lorenz Consult
About Lorenz Consult
The civil engineering firm was founded in 1972 by DI Werner Lorenz. In 2000, his son DI Christian Lorenz joined the company and now leads it in the second generation. With over 60 employees, Lorenz Consult covers all planning and supervision services in the fields of healthcare facilities, cleanrooms for pharma, food, and electronics, industrial and steel construction, as well as 5D-BIM planning technology and construction digitization.
Lorenz Consult is considered a pioneer in the field of BIM. The company is headquartered in Graz, with branches in Vienna, Linz, and Villach, and a partner office in Berlin. Projects are realized worldwide, including in the USA, with a strong presence in the DACH region. In 2023, Lorenz Consult generated a turnover of €12.4 million.
www.lorenz-consult.at
