Pharmaceutical Clean Room Classification

Pharmaceutical Manufacturing Relies on Cleanrooms

Cleanrooms are very important in pharmaceutical manufacturing. They provide a controlled area with specific levels of air particles and contaminants that don’t interfere with product safety. Pharmaceutical products are very sensitive and airborne particles can easily contaminate them. The chemicals used can also be too hazardous for production to be done in an open environment.

Setting up a cleanroom for pharmaceutical operations requires a facility to adhere to the International Organization for Standardization (ISO) standards and guidelines. (see more on ISO Cleanroom Classifications) Facilities need to ensure that all their needs are addressed during the design phase for a cleanroom. Some of the things to consider when setting up a cleanroom for pharmaceutical operations include:
​

• HEPA filters that are able to filter particles that are as small as 0.3 microns. This ensures that the employees working in the cleanroom have a constant supply of fresh air.
• Proper ventilation for maintaining air quality and replacing process exhausts. As it’s energy-intensive, you’ll need extra space for cooling units, noise suppressors, larger air passageways, large intake and exhaust stacks, and a backup generator.
• Static air pressure that’s higher than the atmospheric pressure to prevent infiltration by wind. Airlocks are used to prevent pressure fluctuations.
• Stable temperature and humidity for comfort and to prevent corrosion of surfaces.
• Unrestricted airflow to prevent turbulences which can result in the movement of particles and contamination.
• Measuring equipment to help in maintaining cleanliness, temperature, humidity, airflow, and particle count at the appropriate levels.
• Electrostatic discharge to prevent potential damage caused by an electrical charge from movements.
• Good lighting for efficient operations.
• Future-proofing for possible expansions or process change.
• Use materials that don’t shed, break, or crack easily and can also be easily cleaned.
• Showers and laundry facilities to be used for decontamination. You might also want to consider hazardous waste treatment.
• Personal protective gear and separate entrances and exits to avoid contamination by hazardous materials. Consider special treatment of waste air and using negative air pressure systems too.

There are many elements you’ll have to take into consideration when designing a cleanroom for pharmaceutical operations. You will also have to consider the amount of space you have and how many pieces of equipment you’ll need for your operations. Ensure that you discuss all these with your cleanroom contractor.

Certifying Your Cleanroom

After setting up your cleanroom, it will need to be validated and certified for use in pharmaceutical manufacturing. This means that a number of tests will be undertaken and regular monitoring and revalidation also done to ensure the standards are up to date.
​
While certifications will depend on your geographic location, the International Standards Organization (ISO) standards are generally accepted and widely used at the moment.

Operating a Cleanroom

​Once the cleanroom has been validated and certified fit for operations, you will need to maintain it with the utmost care to preserve its integrity. Some of the ways of doing this include minimizing the risk of contamination, limiting access to only trained and authorized personnel, regularly cleaning and undertaking maintenance activities, and periodically updating it to the latest industry standards.