Learn Cleanroom Validation
We need To tell you about cleanroom validation.
Cleanroom inspections are conducted by performing a series of tests to verify that the controlled environment is complying with applicable process requirements and regulatory guidelines, such as ISO 14644-1: 2015 or its annex. The GMP 1 with Cleanroom Standard qualification test schedule will certify the Class of your cleanroom and local air cleaning equipment and then produce a report on time within 24 hours as evidence for cleanroom test takers.
Step to Cleanroom Validation
Building your Custom Testing Schedule
Cleanroom Validation Overview
Our team will work with you to assess your needs to create a customized test schedule. In determining the best cleanliness test we will consider such factors as:
- ISO standard or GMP guideline requirements
- Validation frequency requirements, including annual and interim testing
- Your URS, risk assessment and monitoring plan
Cleanroom Validation Type
Tests will depend on whether a cleanroom procedure requires features such as:
- Installation Qualification (IQ) – meeting user and design requirements
- Operational Qualification (OQ) – operating within the defined conditions
- Performance Qualification (PQ) – producing the defined results
Summary Cleanroom Validation
Documents confirming our clean room inspections are detailed and verifiable. You will receive a report on the day of testing, followed by a full report. Reporting is in accordance with ISO standards and GMP guidelines to meet the needs of you and that of nominated regulators such as Biotech, GPO.