How to control and prevent contamination PART1

The presence of contaminants such as microbes, dust and particles in pharmaceutical products may not only affect its quality and safety, but also impact business credibility and sustenance. Pharmaceutical contamination, particularly in sterile products, can also cost significantly to companies due to non-compliance. Therefore, definitive contamination prevention and due diligence strategies must be in place to maintain a safe and hygienic sterile environment.

Discussed here are the key strategies to help control and prevent contamination in pharmaceutical manufacturing.

A.Identify the Source of Pharmaceutical Contamination

The primary step to controlling contamination in the pharmaceutical industry is identifying the source of contaminants. It is not enough to just maintain optimum bio-burden levels through cleaning and disinfection; identifying the occurrence of contaminants and preventing the same is also critical to control and eliminate. The potential sources of contamination are:Personnel, Manufacturing Facility, Materials , Manufacturing Process

B. Prevent Contamination through Personnel

Workers who access, supervise or control pharmaceutical manufacturing, packing and transportation are the major source of contamination. This primarily happens due to lack of training or inadequate regulatory and hygiene standards. Here’s who you can control contamination through personnel:

lAll workers who are directly associated with product manufacturing and handling must be thoroughly trained on hygiene standards

lMandatory use of Personal Protective Equipment, including hand gloves, face masks, overshoes, and hair caps inside the manufacturing unit must be standardised

lEnsure the workers maintain high levels of personal hygiene

Practice proper and regulatory-compliant workwear cleaning and disinfection measures

lAvoid direct contact between the worker’s hand and any part of the product

lRegulate access to production areas to ensure that only the right and trained personnel can enter the manufacturing unit