Engineering advances in safe laboratory design for pharmaceutical microbiology and assessment of their biohazard risk measures

• Published in: Safety science 2024-06, Vol.174, p.106458, Article 106458
• Main Authors: Kumar Teotia, Anil, Singh Chauhan, Aishwarya, Thota, Prasad, Kumari, Bhavna, kumar, Piyush, Verma, Om, Phathak, Chetananand, Kumar Pandey, Manoj, Singh Raghuvanshi, Rajeev
• Format: Article
• Language: English
• Subjects: Health and environmental risk assessment; Laboratory acquired infections; Pharmaceutical Microbiology; Regulatory and Quality Control Requirements; Safe Laboratory Design
• ISSN: 0925-7535; 1879-1042
• DOI: 10.1016/j.ssci.2024.106458

•Construct a safe laboratory design for pharmaceutical microbiology laboratory and assess biohazard risk management.•Evaluation of laboratory safety features to protect personnel, test articles and laboratory infrastructure from the potential source of cross-contamination.•The assessment of all associated risk measures according to the strict safety regulatory guidelines of international authorities.•Future use of this article by various microbial testing laboratories and industries for the construction and design of a well-equipped and biohazard-free pharmaceutical microbiology laboratory. In times of pandemic outbreak, the accidental leakage of pathogenic microorganisms from the laboratory has fatal consequences for human health and the environment. Due to extensive work on microbial cultures in microbiology laboratories, poor laboratory infrastructure and safety practices can result in the laboratory inadvertently spilling microbial contaminants inside and outside the laboratory premises leads to the laboratory acquired infections. Therefore, special attention must be paid to designing a microbiology laboratory equipped with advanced biosecurity features and supporting infrastructure for handling microbial cultures in the laboratory areas. Good laboratory design proactively supports workplace excellence through the quality of test results and compliance with biosafety and sterility procedures. Limited research articles were available online detailing the safety design features of the microbiology laboratory and its risk assessment protocols. The main objective of this article is to provide concise literature on how to design a modern pharmaceutical microbiology laboratory with all recommended safety features by various pharmaceutical regulatory guidelines. This laboratory design includes a three-zone corridor separation system, a buffer zone, a positive and negative pressure control area with ventilation units, the presence of a dynamic passage box (for material and media transfer) and a separate entrance for handling reference cultures room. This article helps develop a common understanding among pharmaceutical testing centres about the goals of designing a well-resourced and safe pharmaceutical microbiology laboratory.