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 should be agreed by the customer and supplier and may include:
- Filter integrity testing according to ISO 14644-3:3:2019
- Airborne particle counts
- Airflow readings
- Air changes and volumes
- Smoke visualisation testing according to ISO 14644-3:3:2019
- Containment leak testing according to ISO 14644-3:3:2019
- Recovery rate testing according to ISO 14644-3:3:2019
- Air pressure differentials according to 14644-1:2015
- Comfort tests such as lux, noise levels, temperature and RH readings
- Safety cabinet testing including KI Discus testing & Fume Cabinet Testing including Carbon Breakthrough Testing to BS7989
Calibration certificates will be provided for every instrument used in your validation.
The format of the report is in line with the ISO standards or EU GMP, as required by your facility, to meet your requirements and those of any external auditors.
DQ IQ OQ PQ
Validation protocols are a method of establishing documented evidence that shows a high degree of as...Read more
Validation Frequency Requirements
To ensure that your cleanroom continues to perform efficiently and enhance your business process, it...Read more
Discover the different classes within the cleanroom ISO standards and their Federal Standard and GMP...Read more