Masa care
Fastest way to succeed.

Cleanroom validation is provided by conducting a series of tests to qualify if a controlled environment is performing in accordance with process requirements and the applicable regulatory guidelines, such as ISO 14644-1:2015 Our team will work with you, assessing your needs to build a custom testing schedule. To determine the most appropriate cleanroom validation tests, we’ll consider factors such as: ISO standard or GMP guideline requirements Validation frequency requirements, including annual and interim testing Your URS, risk assessment and monitoring plan

Tests will also depend on which cleanroom lifecycle phase needs qualification, including:

• Installation Qualification (IQ) – meeting user and design requirements
• Operational Qualification (OQ) – operating within the defined conditions
• Performance Qualification (PQ) – in the operational state 

Our cleanroom validation documentation is detailed and auditable. You will receive an interim report on the day of testing, followed readily by the full report. Reporting is in line with ISO standards and GMP guidelines, to meet your requirements and those of any nominated regulatory body, like the MHRA.