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:
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.
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