At what distance must a cleanroom be requalified? The answer to this central question of cleanroom compliance depends largely on the respective cleanroom class and the regulatory environment (ISO 14644 or GMP area).
The requalification intervals at a glance
In accordance with the current regulatory requirements, the following maximum time intervals apply for requalification:
Cleanroom class | Standard / Guideline | Maximum interval |
GMP Class A & B | EU-GMP Annex 1 | 6 months |
GMP Class C & D | EU-GMP Annex 1 | 12 months |
ISO classes 1 – 9 | ISO 14644-1 | 12 months |
Requalification is also mandatory whenever technical or procedural changes have been made, such as a filter change or modifications to the ventilation system.
The parameters that need to be checked during requalification depend on the standard according to which the cleanroom is qualified.
Requalification according to ISO 14644 and VDI 2083
The international standard ISO 14644 (sheets 1-3) defines the interval for the regular classification test of the particle concentration as one year.
Sheets 2 and 3 of VDI 2083 provide an important orientation for minimum requirements for testing further parameters at 12-monthly intervals:
- Particle concentration
- Temperature and humidity
- Air volume flow or air velocity
- Pressure cascades
- Leak-free filters
Additional tests (e.g. tightness of the cleanroom area, particle deposits or lighting) may be necessary depending on the room configuration.
Requalification according to GMP Annex 1
In the GMP environment, the requirements are often stricter. The test must be carried out at the latest when the maximum intervals are reached:
Cleanroom class | Maximum interval |
GMP A & B | 6 months |
GMP C & D | 12 months |
Essential tests in the GMP area:
The mandatory tests include particle concentration, temperature, humidity, air volume flow, air velocity, pressure cascades and the absence of leaks in the filters.
Strategic optimization through risk analyses
Both GMP Annex 1 and ISO 14644 allow strategic leeway. With the help of a well-founded risk analysis – as part of the Contamination Control System (CCS) – companies can individually determine which tests are carried out in which state(at rest or in operation).
By evaluating data from continuous monitoring systems, inspection processes can be designed efficiently. This makes it possible to minimize costs without compromising safety or compliance with standards.
Conclusion: Regular requalification is essential for the legally compliant operation of a cleanroom. While ISO cleanrooms and GMP C/D are inspected annually, GMP A/B zones require a semi-annual inspection. A data-based risk assessment can help to optimize the costs of requalification.
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