Validation for cleanrooms & operating rooms
Cleanrooms, GMP-critical areas, operating rooms,and flow benches fall under mandatory international regulations such as EU, FDA, ISO 14644 or ISO 12469, PIC/s, and GMP Annex 1. This entails an obligation for initial validation and periodic revalidation. Agidens provides advice, support and execution of validation tests.
Our Testing & Inspection Services consultants are experts in performing designated qualification tests and help verify that installations comply with international regulations. Together, we develop a protocol for the qualification of new installations (as-built) and periodic qualifications.
Types of tests
- Air volume measurements
- Differential pressure measurements
- HEPA filter integrity test with photometer or particle counter
- Air velocity and flow rate measurements
- Particle concentration measurements (dust classification)
- Recovery test or reestablishment time test
- Microbiological sampling (surface sampling and active and passive air sampling)
- Room finishing
- P&ID checks
- Airflow patterns (visualization and recording)
- Temperature and relative humidity measurements
- Light and sound measurements
Project flow
User requirements define the acceptance criteria and the measurement methods used to determine them. These qualification tests depend on the validation master plan, the applicable regulations, and the design of the cleanroom, production area, operating room, or LAF cabinet. Testing is performed according to the applicable guidelines.
Upon request, Agidens also provides advice on preparing the validation master plan or the validation protocol for the installation.
Reporting & analysis
After testing, the client receives a qualification report with conclusions, recommendations, and test data. If there is a deviation, we are happy to think along about possible solutions.
The structure of the validation report fully aligns with current guidelines. The periodic calibration documentation of our measuring equipment is also included in the validation report.
We use calibrated and validated measuring instruments to perform the tests. Based on an approved protocol, we analyze whether the systems meet the acceptance criteria.
Final conclusion & QA
After the measurement, the final report is extensively discussed, if desired in consultation with the responsible services or suppliers.
In addition to the measurement results, this report also contains recommendations to address any comments or deviations. This way, inspections and audits are guaranteed to be successful.
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