The control and prevention of contamination is integral in the pharmaceutical industry to ensure safety and quality of products  

  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:

 

  • All workers who are directly associated with product manufacturing and handling must be thoroughly trained on hygiene standards
  • Mandatory use of Personal Protective Equipment, including hand gloves, face masks, overshoes, and hair caps inside the manufacturing unit must be standardised
  • Ensure the workers maintain high levels of personal hygiene
  • Practice proper and regulatory-compliant workwear cleaning and disinfection measures
  • Avoid direct contact between the worker’s hand and any part of the product
  • Regulate access to production areas to ensure that only the right and trained personnel can enter the manufacturing unit

 

C. Building Requirements for De-contamination

         

The design and quality of the building can also be a potential source of pharmaceutical contamination. Here’s how you can maintain building hygiene:

  • Make sure the interior surfaces like ceilings, walls and floors are free from cracks and smooth; it should facilitate effective cleaning
  • Viewing panels and windows must be sealed and non-opening to prevent collection of microbes, dust and particles
  • Install stainless steel sinks inside the manufacturing unit
  • Light points, ventilation and pipe work must be designed so as to facilitate efficient cleaning

         

D. Manufacturing Facility Design

High standards of hygiene, regulatory compliances and optimal design must be implemented to prevent contamination inside the manufacturing facility. Here are some key steps to control facility contamination:

 

  • Maintain aseptic process rooms at a high differential air pressure
  • Do not set ambient humidity or temperature at an uncomfortable levels
  • Based on product risk assessment / facility, use Restricted Access Barrier System, Isolators Systems, Ventilated Cabinets, etc. to help contain microorganisms
  • Maintain a laminar flow of air with optimal velocity over critical areas
  • Use ultraviolet door barriers and air locks to separate areas
  • Implement impermeable barriers such as vacuum or pumped transfer of materials, closed systems, etc. to prevent cross-contamination
  • Adequately set air change and air filtration rate to maintain statutory clean room standards
  • All surfaces and rooms must be thoroughly maintained and monitored to identify viable and non-viable particles; get the facility recertified on half-yearly basis
  • Ensure the HVAC system is designed and located to prevent contaminants from being spread inside the room

E. Hygiene and Disinfection

         Proper cleaning, hygiene and sanitisation measures should be practiced throughout the building, manufacturing facility and storage units:

  • All areas must be thoroughly cleaned and disinfected on a regular basis
  • Make sure you use only fully trained personnel to use cleaning agents and minimise health risks
  • The application, contact time, chemistry, mechanical action, and temperature of the cleaning agent must be considered while designing the cleaning process
  • Make sure the cleaning materials do not come in direct contact with the pharmaceutical products
  • Regulate cleaning practices throughout the building and manufacturing unit for effective control and elimination of microbial contamination

       

F. Prevent Contamination through Utilities

Water is one of the biggest sources of bacteria, viruses and other contaminants that can significantly affect the pharmaceutical product quality and compromise with patients’ safety. Here’s how you can control water-borne contamination:

  • Water used in the manufacturing process must be microbiologically controlled, pharmaceutical-grade and ideal for intended use
  • Steam, humidification and supply for autoclaves must be free of additives and clean

Conclusion

         Failure to maintain optimal pharmaceutical contamination control measures can have detrimental repercussions on the quality and safety of the products. Lindstrom supports pharmaceutical companies by providing professional and reliable workwear rental services in India. We maintain highest standards of hygiene and comply with regulatory standards to design, maintain, transport and replace workwear. Our cleanroom services are designed to provide clean and fully disinfected uniform, helping control contamination through personnel.