4 Ways the Pharmaceutical Factories Maintain Hygiene

Hygiene is a core aspect of industries that manufacture and handle sensitive products like drugs and medicines. The pharmaceutical industry is one such industry that constantly strives to maintain its top-tier hygiene levels to prevent contamination and ensure quality formulations. The key to the safety of both employees and end consumers lies in the hygiene and sanitation practices followed in this sector.

Pharmaceutical and biopharmaceutical companies need to comply with the changing global regulations in product process and quality, including the current Good Manufacturing Practices (cGMP) guidelines. This leads to companies looking to implement newer and more efficient changes in the hygiene and sanitation process.

When it comes to maintaining pristine hygiene levels, pharma firms focus on 4 key areas: production hygiene, personnel hygiene, plant and surface disinfection, and performance monitoring. In this article, let’s explore each of these four ways that pharmaceutical manufacturers maintain cleanliness and hygiene levels.

1. Production Hygiene

Production hygiene processes keep operations and end products safe. Pharmaceutical companies often follow comprehensive hygiene practices to maintain optimal sanitation standards in their production plants. These production hygiene measures ensure the quality of the drugs and formulations is unaffected.

Here are the key steps:

1. Designing the flow of material through plan building(s) to prevent contamination. Consider all materials, including components, drug products, drug product containers, closures, labelling, and in-process materials.

2. CIP or Clean in Place systems speed up the cleaning and sanitation process without dismantling production equipment. This system gives pharma companies a leg up against the time-consuming manual cleaning process and avoids longer downtimes.

3. Maintaining a controlled environment using cleanroom technology. This technology maintains a low level of airborne microorganisms, chemical vapours, aerosol particles, and dust.

4. Checking the premises for hard-to-clean surfaces and areas and cleaning them with disinfectants. It’s vital to ensure that disinfectants in use are lab-tested for efficacy and comply with the industry safety standards.

5. Complementing the manual disinfection process with classical, sterile or microbial-filtered disinfectants.

2. Personnel Hygiene

Despite taking stringent measures to maintain hygiene and sanitation in pharmaceutical production units, equipment, raw materials and packaging, human intervention remains the primary contaminant source. Using appropriate and clean workwear can minimise the contamination risk from human beings and raise safety standards on the production floor.

The common measures pharmaceutical units follow are:

1. Guiding workers to wear specialised hygienic garments in production facilities, storage areas, and loading and unloading units.

2. Using garments like non-shedding gowns prevents microorganisms and particles from shedding from the body and contaminating the unit.

3. Covering skin and hair with caps, protective goggles, and snoods for beards and moustaches. 

4. Sterilising the workwear before use. Sanitise gloves frequently.

5. Providing clean clothing in contamination-free bags or covers.

6. Ensuring adequate hygienic specialised garments are available at all times.

7. Instructing workers to change torn or defective gown components immediately.

8. Separating dirty and clean workwear.

9. Providing training on the importance of hygiene in the plant and the proper way to use workwear. For instance, workers must be educated to not use hygienic clothing when using toilets or smoking areas.

3. Plant and Surface Disinfection

Here are some measures to keep in mind:

1. Disinfecting the production facility and all surfaces is a measure in addition to practising production and personnel hygiene to ensure a hygienic and contaminant-free environment.

2. Ensuring floors, ceilings, and walls are washable. They need to be regularly cleaned, scrubbed, and disinfected to avoid impurities from accumulating and spreading contaminants.

3. Meeting the highest hygiene standards by implementing the use of high-performance hand disinfectants and dispensing systems. Through frequent hand hygiene, pharmaceutical personnel avert the risks of transmitting germs and impurities through their hands.

4. Using high-quality sterilisation products that have been tested for efficacy, safety, and user-friendliness.

4. Performance Monitoring

Hygiene in pharmaceutical units does not end with implementing changes. It’s equally important to monitor the effect of the measures and changes implemented, analyse the process, and continuously improve them. Performance monitoring ensures the implemented cleanliness and hygiene procedures are followed and maintained.

1. Pinpoint problem areas and take necessary actions to ease bottlenecks in the process.

2. Use digital tools to monitor progress and gain an up-to-date and comprehensive understanding of the complete storage, workwear, and cleaning process.

3. Leverage data from these tools to ensure processes run like clockwork and don’t hit any speed bumps.

4. Ensure data meets the appropriate standards and is duly reported to the relevant authorities.

5. Ensuring proper and systematic laundry processes.

In Conclusion

Pharmaceutical and biopharma manufacturing units keep hygiene at the topmost priority for preventing any risk of contamination affecting the production quality and efficacy of the drugs and formulations. They ensure top-tier hygiene by following rigorous hygiene and cleanliness processes at every step of manufacturing, from start to finish. 

From the workwear of the personnel involved in the manufacturing unit to the cleaning of the production equipment, following strict hygiene regulations and requirements ensures the safety of customers and employees at all times.