Occupational Safety in Biomanufacturing and Pharmaceutical Facilities

The mention of workplace safety conjures images of hard hats, steel-toe boots, and thick gloves. Add biomanufacturing and pharmaceutical facilities into the mix, and we may think of people covered from head-to-toe in hazmat suits. In reality, occupational safety for these industries falls between those two extremes.

The COVID-19 pandemic introduced new health considerations. At its onset, laboratory workers were exposed to an unstudied virus that brought with it an unknown hazard level. As knowledge advanced and scientists developed vaccines, new workplace safety concerns arose. The mRNA-vaccine technology developed by companies including Pfizer and Moderna depended on nonstandard transport conditions that required extremely low temperatures, introducing an industry-specific hazard for occupational safety.

In addition to the safety concerns inherent to laboratory work, biopharmaceutical companies face many of the same safety considerations that other workplaces must manage. Repetitive-strain injuries, workplace illnesses, and a tendency of many employees to come into work sick, also known as presenteeism, are three such examples.

Key Hazards and Risks
The US Bureau of Labor Statistics (BLS) registered 1.6 nonfatal workplace-related injuries per 100 full-time workers in 2020. According to the US Occupational Safety and Health Administration (OSHA), the causes behind those accidents can be divided broadly into four groups.

Chemical hazards include carcinogens, irritants, and corrosive substances. Formaldehyde is one of the most common chemical hazards found in life-science laboratories.

Biological hazards in such environments can stem from blood and other bodily fluids, culture specimens, and animal subjects. Some substances are highly contagious and lack effective treatments. The US Centers for Disease Control and Prevention (CDC) distinguish four levels of biosafety with ascending levels of risk for workers.

Physical hazards include radiation, noise, and most prominently, repetitive-motion problems that can cause ergonomic injuries. Pfizer, the largest pharmaceutical company in the United States, lists such injuries as the leading type occurring in both manufacturing and research and development (R&D) (1).

Safety hazards include general risks from using laboratory equipment and components, such as sterilizers, centrifuges, compressed gases, cryogenic freezers, and dry ice. With such causes broadly identified, OSHA leaves it to manufacturers to create safe working environments for their teams.

Best Practices and Compliance
Adhering to best practices for occupational safety begins with thorough risk assessments to identify the most pressing hazards. Health and safety teams might need to address a wide variety of potential hazards that require different approaches. For example, employees who work with potentially harmful or toxic substances should receive specialist training and have access to a high level of medical care both on site and externally. Workplaces should keep first-aid kits on hand to provide immediate medical assistance in the event of an accident. Other best practices include understanding biosafety levels in different areas of a facility and limiting access to those areas accordingly. Biomanufacturers can enhance the scope of their training to enable more employees to act in cases of injury or illness.

Organizations such as OSHA provide detailed safety guidelines for the biomanufacturing and pharmaceutical industries. Industry-leading companies regularly exceed OSHA demands, which helps to ensure that their policies meet their organizations’ individual needs. Nevertheless, company executives can instill a “culture of health” that rewards safety-conscious behaviors. Companies also can provide state-of-the-art personal protection equipment (PPE) that exceeds minimum standards. Stocking first-aid supplies for specific hazards is another efficient and cost-effective way to mitigate damages from accidents and injuries.

Preparing for New Threats
The COVID-19 pandemic showed that some of the biggest hazards in biomanufacturing and pharmaceutical facilities could arise from unanticipated threats. When the novel coronavirus first began to spread, neither OSHA nor the CDC’s scientists were sure about how to protect workers and researchers. Interim guidelines, such as those published by the CDC, were critical for early risk mitigation, as were efforts to update and adapt them to keep workers safe.

Manufacturers can prepare for new threats by reviewing existing guidelines regularly to ensure that employees are as safe as possible at work. A certain level of risk remains in laboratory and manufacturing environments, but training workers to the highest level will mitigate safety concerns.

Reference
1 Prioritizing Health & Safety. Pfizer: New York, NY, 2023; https://www.pfizer.com/about/responsibility/health-safety.

Steven Cumper is founder and director of Medshop Australia, 2/52 Fox Drive, Dandenong South VIC, 3175, Australia; https://www.medshop.com.au.