Cleanroom 7 or 8 - Drug Manufacturers are looking for quality assurance

Clean Room Classification for Biopharma

The common requirement for cleanroom classification in the manufacturing of biopharmaceutical drugs is usually set at ISO Class 7 or 8. While there are cases where ISO Class 5 or better is necessary, many manufacturers prefer to use isolators or laminar flow hoods.

If drug manufacturers are requiring their suppliers to implement cleaner processes to reduce particulates in products obtained from single-use components suppliers or assembly providers, why do some suppliers still operate under ISO Class 8 cleanroom conditions?

The primary reasons for this are cost and product validation. Suppliers with experience in medical devices and multi-use manufacturing often already have cleanrooms in place before transitioning to single-use products or biomanufacturing. Some have only worked in laboratory settings and are now looking to expand to larger-scale production. However, I believe that this leniency towards cleanliness will be short-lived, as scrutiny on particulates is likely to increase, and cleanliness standards will heavily rely on the supplier.
What does it cost to convert an ISO Class 8 cleanroom to ISO Class 7, and what is the difference between the two?

The key differences lie in the number of 0.5 µm particulates per square foot
and the number of microbiologically active air particles (measured in cfu/m)

To convert from an ISO Class 8 environment to an ISO Class 7 environment, it is essential to implement procedures that minimize the generation of particulates and microorganisms in the air. This may involve increasing the frequency of air exchanges, enhancing the gowning process, and ensuring proper separation between the gowning room and the cleanroom.

Additionally, this conversion might require rearranging the room layout and upgrading equipment. In some cases, installing a new HVAC system may be necessary.
When building a new cleanroom or discussing cleanroom installation with facility management, it is essential to consider the future needs of the business.