The Importance of Cleanroom Validation
Cleanroom validation offers ISO compliance and peace of mind.
When a cleanroom has been built by Connect 2 Cleanrooms, a CTCB-I qualified engineer completes a validation to International Standard ISO 14644-1:2015. Ongoing validations are not only a requirement of this standard, they also give peace of mind that your investment remains protected and continues to add value to your company and critical processes. Read more about your validation frequency requirements.
We offer customer choice to provide a balance to ISO standards and own risk assessment and monitoring plan. Tests to consider include:
- Filter integrity testing according to ISO 14644-3:2005
- Airborne particle counts
- Airflow readings
- Air changes and volumes
- Smoke visualisation testing according to ISO 14644-3:2005
- Containment leak testing according to ISO 14644-3:2005
- Recovery rate testing according to ISO 14644-3:2005
- Air pressure differentials according to 14644-1:2015
- Comfort tests such as lux, noise levels, temperature and RH readings
- Particle Counter Calibration certificates to prove instrumentation complies to ISO 21501-4:2007
- Safety cabinet testing including KI Discuss testing & Fume Cabinet Testing including Carbon Breakthrough Testing to BS7989
The format of the report is in line with the ISO standards, so should meet your requirements and those of any nominated regulatory body.
Discover the different classes within the cleanroom ISO standards and their Federal Standard and GMP...Read more
Validation Frequency Requirements
To ensure that your cleanroom continues to perform efficiently and enhance your business process, it...Read more
DQ IQ OQ PQ
Validation protocols are a method of establishing documented evidence that shows a high degree of as...Read more