Evaluating Process Hazards
Health and Safety
The client, a bioscience laboratory, was challenged with speeding up the development of a new delivery system for vaccines through testing and research utilizing a new drug substance. The client wanted an experienced health and safety consulting firm to determine potential hazards associated with the development process and new drug substance. The company needed a review of laboratory health and safety protocols, an analysis of the hazards associated with the new drug substance and a determination of appropriate control measures. The client selected ALL4’s health and safety team in 2021 to conduct the hazard assessment and review laboratory safety protocols.
ALL4’s approach was to immerse our dedicated project team into the facility’s and laboratory’s systems and procedures and work with every employee tasked with receiving, handling, or transporting the new drug substance. Each step of the process was analyzed for potential health and safety risks, from receipt of the packaged drug substance into the facility to separation and delivery of the substance into the appropriate research areas of the laboratory. Protocols and procedures were reviewed to determine if appropriate personal protective equipment and safety protocols were in place at every step of the testing, research, and manufacturing process.
ALL4 determined that additional safety controls were needed in the handling process through completion of a task-by-task hazard assessment. Because of the specific type of drug substance and associated hazards, ALL4 identified the need for development of a facility biosafety plan and recommended the appropriate levels of protection required. ALL4 worked with the client to provide a preliminary biosafety plan that met the requirements established by the Center for Disease Control and Prevention, National Institutes of Health (NIH) for laboratories obtaining Biosafety Level 2 (BSL-2) status.