The Importance of Cleanroom Validation
Cleanroom validation offers ISO compliance and peace of mind.
When a cleanroom has been built by Angstrom Technology, 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.
Why is Cleanroom Validation Important?
Cleanroom validation is crucial in various industries, particularly in pharmaceuticals, biotechnology, medical device manufacturing, and semiconductor fabrication. Its importance lies in several key areas:
Performance Validation
Cleanroom validation involves testing the performance of HVAC systems, HEPA filters, and other critical components to ensure they function correctly and maintain the required cleanroom standards.
Preventing Contamination
Validating cleanroom environments helps prevent contamination from particulates, microorganisms, and other pollutants, which is essential for industries that require high levels of purity and sterility.
Regulatory Compliance
Compliance with industry regulations and standards, such as ISO 14644, FDA (Food and Drug Administration), and GMP (Good Manufacturing Practices), is mandatory. Cleanroom validation demonstrates adherence to these strict guidelines.
Maintaining Consistency
Ensures that the cleanroom environment consistently meets required standards. This consistency is critical for the reproducibility of processes and the reliability of products.
Validation Scope
We offer customer choice to provide a balance to ISO or GMP 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 14644-3:2019
- Containment leak testing according to ISO 14644-3:2019
- Recovery rate testing according to ISO 14644-3:2019
- 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.
REQUEST A VALIDATION APPOINTMENT
Our cleanroom validation documentation is detailed and auditable. You will receive an interim report on the day of testing, followed by the full report within 10 working days. Reporting is aligned with ISO standards and GMP guidelines to meet your requirements and those of any nominated regulatory body, (e.g. the MHRA).
You can choose from one of our testing packages, or we can build a custom schedule based on your requirements.
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