Mitigating Risk In Pharmaceutical Manufacturing

In the pharmaceutical industry, producing safe products is paramount. Product recalls are costly to businesses, both financially and in terms of reputation. And product contamination can have a devastating impact on consumers, leading to illness or even death. To mitigate those risks, pharmaceutical manufacturers must comply with strict regulatory compliance guidelines set by regulators such as the Food and Drug Administration, World Health Organization, and others.

Training for Effectiveness

Cleaning staff must be trained in Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) to comply with regulatory standards. One way to make this training more effective is to connect each practice to its purpose. Proper gowning procedures, for instance, prevent particulate contaminants from entering the cleanroom. When employees understand the connection between proper gowning procedures and product safety outcomes, they’re more likely to perform those procedures effectively.

Cleaning staff also need to be trained on standard operating procedures (SOPs) to ensure consistency. Without a solid understanding of SOPs, individuals may approach cleaning tasks differently. In highly sensitive pharmaceutical environments, there is no room for error. When every member of the cleaning staff follows the same processes at the same frequencies, overall operations are more effective, efficient, and compliant.

Selecting the Right Equipment

To meet guidelines for air cleanliness, cleanrooms need to be cleaned with equipment that enables cleaning staff to remove contaminants and reclaim active pharmaceutical ingredients. Portable industrial vacuums with superior filtration systems, such as high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA), remove harmful contaminants from the air and keep them contained. Wipes, mops, and towels made specifically for cleanroom environments also remove and capture contaminants effectively, instead of spreading them around.

Maintaining a state of control must be the driving force behind any cleanroom cleaning program. Every element of the program — from training to documentation must be established and followed in order to prevent product contamination.

Todd Savard is a Senior Vice President Operations at ABM Industries. Learn more about ABM’s specialized cleaning programs for pharmaceutical environments here.