Biological Hazard Management

World Health Organization updates #laboratory #biosecurity #guidance WHO recently issued updated guidance for national #authorities and #biomedical #laboratories to manage #biological #risks. Laboratories are essential components of #health #systems, critical for patient #diagnosis and rapid #clinical #care, #disease #surveillance, #pathogen characterization, and #research and #development for #treatments and #vaccines. Appropriately designed and equipped facilities, trained #staff, evidence-based risk mitigating measures, transparent reporting and layered oversight mechanisms will safeguard the #workforce and the community from pathogenic #microorganisms and #toxins. New updates in the guidance include the strengthening of #cybersecurity measures and handling of confidential information such as patient records; reducing risks from new #technologies, including those related to #genetic modification and #manipulation of pathogens, and #artificial #intelligence (AI); and advice on keeping laboratories #safe and #secure during #emergencies like #wars, civil unrest, and #disasters from natural #hazards. WHO’s updated laboratory biosecurity guidance helps all countries, especially those lacking #regulations, establish or strengthen frameworks for handling high-consequence pathogens. It highlights the importance of strong institutional governance through an Institutional Biosafety Committee with national oversight. The updated guidance provides best #practices and #recommendations, while encouraging Member States to adopt a risk-based approach, stipulated in the resolution on ‘Strengthening laboratory biological risk management’ adopted at the World Health Assembly this year. The guidance was developed in consultation with wide range of stakeholders including WHO collaborating centres and technical advisory groups, in particular, the WHO Technical Advisory Group on Biosafety (TAG-B).    By promoting engagement and #commitment from institutions and national authorities, the guidance mitigates risks associated with high-consequence pathogens and research work. These measures aim to safeguard communities from misuse and release of biological materials, be it intentional or inadvertent, all while allowing legitimate biomedical research to continue. https://lnkd.in/enwAEeFb

New USP Chapter <1110>: Microbial Contamination Control Strategy Considerations The United States Pharmacopeia (USP) has introduced a new general chapter <1110> titled "Microbial Contamination Control Strategy Considerations." This chapter provides a comprehensive framework for developing and implementing an effective contamination control strategy (CCS) throughout the entire product lifecycle, applicable to both sterile and nonsterile products. This initiative aligns with international regulatory expectations and emphasizes the integration of Quality Risk Management (QRM) principles. It encourages manufacturers to proactively identify, evaluate, and control microbiological risks by establishing a documented and science-based CCS. Key elements of Chapter <1110> include: Facility Design and Cleanroom Classification: The chapter highlights the importance of cleanroom design in accordance with ISO 14644-1 standards. ISO Class 5 conditions are required for aseptic processing areas to ensure minimal contamination. Environmental Monitoring (EM): A robust EM program should monitor both viable (microbiological) and nonviable particles. Data should be reviewed regularly (e.g., quarterly) to identify trends and adjust alert and action limits accordingly. Risk Assessment Methodologies: Tools such as Hazard Analysis and Critical Control Points (HACCP) and Failure Modes and Effects Analysis (FMEA) are recommended to identify critical control points. Risk mitigation strategies must be justified and documented. Ongoing Verification: The CCS should be reviewed periodically, incorporating existing site-specific and global microbial risk assessments to ensure continuous improvement and compliance. Why is Chapter <1110> Important? Chapter <1110> marks a significant step toward unifying standards for microbial contamination control. It promotes a proactive, lifecycle-based approach that enhances product quality and patient safety. The new guidance is also closely aligned with current global regulations, including the EU GMP Annex 1 revisions. The draft chapter was published in Pharmacopeial Forum 51(2) in March 2025, and stakeholders are invited to provide feedback during the public comment period before it is finalized.

"Plume”—a mix of visible splashes and invisible aerosolized particles. The Contamination Source Hospital sink drains and plumbing often harbor biofilms laden with opportunistic pathogens, including: Pseudomonas aeruginosa Legionella pneumophila Klebsiella pneumoniae Carbapenem-resistant Enterobacterales (CRE) Non-tuberculous mycobacteria (NTM) These organisms thrive in the moist, nutrient-rich environment of sink drains and can be released into the air and onto nearby surfaces when disturbed by running water. The Hazard Pathway Biofilm disturbance – Water flow dislodges bacteria and other microbes from the drain. Aerosolization – Droplets containing microorganisms become airborne. Dispersion – These droplets and aerosols can settle on hands, instruments, supplies, or surfaces. Transmission – If contaminated droplets land on sterile instruments, open wounds, or are inhaled, they can cause healthcare-associated infections (HAIs). Documented Risks Risk increases in scrub sinks if high water pressure creates forceful splashing, potentially contaminating surgical attire and sterile equipment before surgery. Procedural Controls: Avoid placing sterile supplies or equipment within the splash zone. Use proper handwashing technique, keeping hands below the faucet outlet. Flush sinks routinely with disinfectants if recommended by facilities. Environmental Monitoring: Include sinks and drains in environmental cultures during outbreak investigations. Implement routine drain biofilm management in high-risk areas. Prevention Strategies Engineering Controls: Design sinks with deeper basins and offset drains. Reduce water pressure to minimize splash. Use splash guards or physical barriers. Install faucet aerators only if they are routinely cleaned and disinfected. References: 1. Kotay, S., Chai, W., Guilford, W., Barry, K., & Mathers, A. J. (2017). Spread from sink drains to patients in a surgical intensive care unit—A recurrent outbreak of Pseudomonas aeruginosa. Clinical Infectious Diseases, 64(4), 404–410. https://lnkd.in/eMcgDQUH 2. Centers for Disease Control and Prevention. (2023). Facility water system management. U.S. Department of Health & Human Services. https://lnkd.in/emUARif5 3. Breathnach, A. S., Cubbon, M. D., Karunaharan, R. N., Pope, C. F., & Planche, T. D. (2012). Multidrug-resistant Pseudomonas aeruginosa outbreaks associated with contaminated hospital waste-water systems: Identification of risk areas and recommendations for improved infection control. Journal of Hospital Infection, 80(4), 312–318. https://lnkd.in/ePARYGWE