This article presents considerations for preventing hazards associated with dust in pharmaceutical production, particularly as relates to the United Kingdom's Control of Substances Hazardous to Health (COSHH) Regulations.
The manufacturing of products including vitamins, drugs, minerals, or herbs involves a broad range of processes that hold the potential to create harmful dust. Due to the potential effects on workers, pharmaceutical dust can present unique challenges and threats if left uncontrolled. This article outlines what pharmaceutical dust is and how to control the associated risks.
Pharmaceutical dust is generated during the production and packaging processes in pharmaceutical manufacturing plants. This hazardous dust can occur when grinding, drying, mixing, pressing, and coating in the production of a pill as well as during the cleaning of the equipment.
Some substances, such as steroids, hormones, or narcotics, may pose a risk if they escape into the atmosphere. If the operator is exposed by breathing or touching them, it may cause side effects such as respiratory illness, skin reactions, and other physiological effects.
Many substances, including cellulose, corn-starch, dextrin, lactose, and other organic ingredients, have the potential to explode. In addition, cross-contamination of dust with other materials can impact on product quality and safety.
In the United Kingdom, under the Control of Substances Hazardous to Health (COSHH) Regulations (1), employers need to either prevent or reduce their workers' exposure to substances that are hazardous to their health, including all processes that emit dust. The COSHH Regulations require employers to assess the risk to their employees and to prevent or adequately control those risks.
Source capture. Begin by capturing and controlling the contaminant at the source. Look at where the equipment is positioned and ensure there are no leakage points around handling systems that produce dust. Source capture is the most effective means of capture and requires the least amount of energy and initial investment to accomplish. Utilize fume extraction arms or local fixed hoods incorporated as part of the machine (e.g., conveyor or mixer).
Filtration and extraction. Installation of an industrial filtration system will ensure that compliance with regulatory standards of both related hazards and cross-contamination issues. Filtration solutions for pharmaceutical processes may also require special options or accessories to improve the safety and reliability of the system. Bag-in/bag-out filter and collection drum options can be used to eliminate exposure and cross-contamination when performing filter and dust-removal maintenance.
Protection and monitoring. Ensure that the workforce has the correct equipment to protect them from exposure routes identified by the workplace exposure limits (WELs), which include breathing in dust. (2) To identify whether exposures are below the WEL, monitoring is key; a consultant who can perform air sampling can help ensure that a pharmaceutical workforce is safe.
Achieving full regulatory compliance is a mixture of equipment and ways of working to reduce exposure. No measures, however practical, can work unless they are used properly. Failing to comply with regulatory standards increases the risk of fatal explosions, which can seriously injure the workforce and severely decrease productivity and profitability of a company.
1. Health and Safety Executive, “Control of Substances Hazardous to Health Regulations 2002,” www.hse.gov.uk/coshh/index.htm, accessed 5 March 2018.
2. Health and Safety Executive, “Workplace Exposure Limits 2005,” www.hse.gov.uk/pubns/books/eh40.htm, accessed 6 March 2018.
Pete Dawson is director of Sales at Dustcheck, peted@dustcheck.com.