Based on a contribution by Joe Govier, Managing Director at Connect 2 Cleanrooms

Cleanroom post monitoring is determined by statutory requirements of regulatory compliance, such as ISO 14644 Parts 1 and 2 and the EU GGMP (European Union Guide to Good Manufacturing Practice), but is also built around the needs and expectations of the cleanroom.

To comply with ISO 14644-2, particle counts need to be tested every 12 months as a minimum, with the exception of levels below class 5, which should be tested every 6 months. In addition to these, test air velocity and volume should be tested. This mandatory compliance as an ongoing process is similar to the requirements of a car needing an annual MOT (car safety test); success or failure informs you whether your car or cleanroom is working or not.

Treat your cleanroom as you would your car

Taking this analogy of the MOT, if you use your car on a daily basis and its function is critical to you getting to and from work, if you came out to it in the morning and found a flat tyre, you would repair it before going on your journey. You would not consider continuing to drive until the next MOT.

The logic above seems simple, but when it comes to monitoring the cleanroom, too much emphasis is directed to the annual check. Emphasis needs to be shared with the ongoing monitoring and there are various tools or tests that can assess if the cleanroom is fit for purpose', including:

• Filter pressure gauges testing to ensure airflow
• Room pressure gauges testing to ensure outward airflow
• Particle counting using a laser particle counter for conformity to ISO14644–1
• Air velocity using a vane anemometer to determine direction of flow and air changes

Other parameters such as temperature, humidity, noise and lighting levels can also be performed.

Overall, the post monitoring process should ensure the room is fit for the intended purpose at all times.

The annual validation process should be there to confirm that the continuous process is working and at no time should the system fail this check. If this occurs, it is too late and the consequence of this failure can have a far reaching impact on the business. PTE

To read the article in full go to www.pharmtech.com/govier