Maintaining Hygiene in the Pharmaceutical Industry: A Glimpse of Effective Practices to Implement

Proper hygiene is essential in the pharmaceutical industry to prevent any kind of contamination that can affect the quality of medicinal products. When it comes to delivering highest quality standards of pharmaceutical products, key hygiene factors need to be upheld. High levels of cleanliness and sanitation must be practiced through all stages of manufacturing through a comprehensive screening – from the personnel working in manufacturing plant to the production process.

Every pharmaceutical company should adhere to strict hygiene laws to ensure high-quality drugs are manufactured and packaged in a contamination-free environment. Discussed here are the important hygiene practices that a company should implement.

Production Hygiene

For your GMP-compliant production unit, it is crucial to follow tailored hygiene strategies to ensure safe implementation and use of products in life science, biotechnology, cosmetic and medical applications.

  • To prevent contamination and maintain highest standards of sanitation, pharmaceutical manufacturing companies must implement use of classical, sterile or microbial filtered disinfectants in addition to manual disinfection process.
  • Innovative hydrogen peroxide vapour generators are streamlining the process of maintaining hygiene in production facilities. These powerful machineries facilitate fast and effective decontamination of the manufacturing unit and equipment.
  • The concept of clean room is also gaining remarkable popularity in the pharmaceutical industry. A controlled environment is designed for specialised pharmaceutical manufacturing that maintains a low level of airborne microbes, dust, chemical vapours and aerosol particles.
  • Significant product contamination may also occur at the time of loading or unloading the medicinal products. Therefore, it is essential to check the premises carefully to identify dirty spots or breeding zones, and clean the areas with disinfectants that are lab-tested and compliant with industry safety standards.
  • Ensure all cleaning equipment meet key requirements of optimal ergonomics, sterilisation and clean room requirements
  • The storage areas and walkways should be cemented to minimise the risk of spreading impurities

Following these basic hygiene practices will help maintain optimal sanitation standards in pharmaceutical production plants and ensure the drug quality remains unaffected.

Personnel Hygiene

Despite effective measures taken to maintain hygiene for production facilities, equipment, raw materials and product packaging, one of the primary sources of contamination are human beings. Having state-of-the-art manufacturing unit or stringent Quality Control measures is not enough to ensure superior hygiene in the pharmaceutical industry unless there are trained personnel to take the responsibility for ensuring high standards of sanitation and product quality.

  • Educate and train all personnel working in the pharmaceutical sector regarding the importance of hygiene
  • Implement use of hygienic workwear in specified work areas such as production facility, storage areas, loading & unloading unit, etc. Proper training should also given regarding not using the hygiene clothing when away from the manufacturing environment or using the canteen, smoking area and toilets
  • Such hygienic workwear should be available in sufficient numbers and must have a suitable design to prevent product contamination. It should also include caps for scalp hair and snoods for moustaches and beards
  • Laundering of workwear should be implemented only by an approved contractor or in-house facility conforming to industry-defined criteria that validates the entire process. The following measures must be undertaken to ensure highest standards of hygiene in workwear laundering:
    • Appropriate segregation of dirty and cleaned clothing
    • Effective cleaning of workwear following industry standards
    • Cleaned clothing must be supplied in contamination-free bags or covers
  • Proper verification and validation of the laundry process should be in place and practiced thoroughly
  • Implement use of high-performance hand disinfectants and dispensing systems to meet the highest standards of hand hygiene – one of the most critical preventive measures to avert the risk of germ & impurity transmission by the hands of the personnel.

The use of proper and hygienic workwear is crucial to maintain high standards of pharmaceutical safety and ensure wellbeing of the end consumers. At the same time, effective measures must be taken to facilitate high quality cleaning, sterilisation and delivery of workwear to uphold hygiene at the workplace. Proper training should also go to every employee regarding maintaining efficient personnel hygiene.

Plant and Surface Disinfection

In addition to practicing effective production hygiene, proper measures should also be taken to disinfect the plant and surface.

  • Use high-quality, industry-approved sterilisation products that are tested for efficacy,
    user friendliness and occupational safety
  • Ensure the plant walls, ceilings and floors are washable; regular cleaning and scrubbing
    is important to avoid impurity accumulation and spreading contaminants

Ensuring Pharmaceutical Hygiene through Performance Monitoring

When it comes to complying with the hygiene standards suitable for the pharmaceutical industry, effective monitoring holds immense significance. Merely implementing hygiene strategies is not enough; it is crucial to monitor performance of the measures taken in a simple and efficient manner. Consider using cutting-edge tools and products that aid in comprehensive and precise hygiene monitoring of the entire manufacturing, storage and cleaning process.

Such tools are efficient in identifying the limitations in hygiene, enabling pharmaceutical companies to take necessary measures to eliminate the bottlenecks and practice high levels of sanitation. There is no need to conduct complex laboratory tests or submit samples. The tools are easy to use and do not require any preparation time. Monitoring hygiene performance becomes fast and convenient with such effective products.

Conclusion

Hygiene in the pharmaceutical industry holds utmost importance to ensure safety of both end consumers and staff. A hygienic manufacturing environment, especially in disinfected production processes, is an effective measure to ensure high quality of the medical products. The government has implemented mandatory regulations to achieve a defined hygiene standard and conform to the industry practices.

In addition to upholding high-performance sanitation strategies, it is important to monitor hygienic conditions for the production facility, the people working in such units and product manufacturing or handling. Additionally, the reporting data must meet BRC Global Standards. Proper training of all personnel is also imperative to help maintain high levels of personnel hygiene.

Practicing key hygiene measures can help avert contamination in advance and uphold a clean and germ-free environment.