As part of the quality monitoring process for pharmaceutical products, maintaining a sterile environment is crucial. Best practices for pharmaceutical manufacturers should include the following clean air measures:
1. Control contaminants
Pharmaceutical manufacturers must establish primary engineering controls (PECs) to limit the risk of contamination within laboratories or other health care facilities, according to the American Society of Health-System Pharmacists (ASHP). PECs include high-efficiency particle air filters, which extract particles that could act as both chemical and physical contaminants.
2. Maintain clean areas
For its list of pharmaceutical manufacturers best practices, the World Health Organization (WHO) suggests that companies and labs designate clean areas where workers are able to practice sterile preparations. WHO said the these areas should have an air supply that is funneled through an air purification system that meets efficiency and performance requirements. It is also crucial that areas have set standards for cleanliness. For the entrances to clean areas, there should be airlocks for personnel and other necessary equipment and materials used for manufacturing to go through.
3. Filter air for sterilization by dry heat
For liquid materials that are nonaqueous or products made from dry-powder, WHO recommends that they are sterilized by dry heat. Air filters will ensure the air used for this process is sterile. Dry heat sterilization requires air to circulate in a chamber while implementing positive pressure to block nonsterile air from entering this space. The air is heated to kill microorganisms and decontaminate materials that could not be sterilized by conventional methods, such as through steam or chemical sterilizers.
4. Use for changing rooms
WHO said changing rooms should be flushed with air that has been purified. Similar to the procedures for designated clean areas, changing rooms should also include airlocks. In this way, workers wearing protective clothing can put on or take off their clothes in separate areas, preventing other spaces from being contaminated with microorganisms and particles like dust.
5. Protect worker health and safety
Workers in the pharmaceutical manufacturing space routinely handle potentially hazardous substances, such as nanomaterials, which could pose a risk to their health. Personnel in the pharmaceutical industry often work with nanoparticles, which are sized on a near-atomic scale to be used in the creation of new and innovative products. However, due to their tiny size, nanomaterials can also be inhaled if they are not isolated or contained, resulting in inflammation or damage to the lung cells and tissues, according to the Occupational Safety and Health Administration (OSHA).
However, to protect workers from nanoparticles and other hazardous materials and chemicals, regulatory organizations list air filters as effective engineering controls. OSHA recommends HEPA filters to remove nanoparticles, following research from the National Institute for Occupational Safety and Health (NIOSH).
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