A cleanroom is a specifically designed environment in order to keep some environmental parameters like temperature, humidty, differential pressure, particle concentration and airflow within certain limits. Cleanrooms have to be validated for various reasons:
- Proof that the design and construction fits its originally intended purpose
- Check if the user requirement specifications are met (URS)
- Proof that the concept and implementation meets the regulatory requirements and defined standards
As a result of the validation process the cleanroom can be assigned a specific cleanroom class according to ISO 14644-1.
The validation process usually consists of the following phases:
- Design qualification
- Installation qualification
- Operational qualification
- Performance qualification
- Control and monitoring
This steps purpose is to verify through objective evidence that the design fits its intended purpose
The user requirements specification defines certain minimum acceptance criteria which have to be compared to the functional specification – a description of the planned implementation. Ideally the intended realization fully meets the user requirements, otherwise the underlying concept may have to be adapted.
In order to uncover any potential risk that might lead to a non compliant or even temporary non compliant cleanroom a risk analysis has to be created. This is in fact a detailed check of all possible failure options and its occurence probaility. If there were any failure options found that might not be detected during operation, either an implementation change, adaption, or special instructions and operating procedures that cover these risks have to be created.
The purpose of this phase is to confirm through verification wether the equipment installed is fully compliant with user requirement specification. This is generally done by working off the IQ plan – a list of check points to be verified by manual inspection.
As a result the IQ protocol should ideally show no critical deviations, otherwise the installation has to be changed and related verifications have to be repeated.
The objective for this phase is to show through objective evidence that the cleanroom is consistently operating in compliance with the original design specifications and thus will meet the user requirements. In practice a set of tests and verifications have to be carried out according to the OQ list. Tests should also include so called worst case conditions in order to guarantee that the user requirements will still be met under heavy load conditions i.e. operating personell present or frequently entering / leaving the critical areas. The output of this phase is again a report stating that the cleanroom is guaranteed to operate within the specified limits.
The intended purpose of the Performance Qualification is to demonstrate with objective evidence that the cleanroom constantly operates in compliance with the requirements e.g. environmental parameters such as temperature, humidity, difference pressure, particle contentration always remain within the specified limits. Ideally this task can be done by means of a monitoring system which continuously captures and archives all relevant parameters as well as permanently compares each parameter against its specified limits. In case of any exeedance an alarm will be triggered and a non compliance entry will be recorded in the Alarm-Log. This ensures that any violation of the specification will be captured for further evaluation.
What we can do for you ?
If you decide to make use of a cleanroom monitoring system you will also need to take care of its initial qualification and further more ensure the continued qualified status of the system.
We provide validation and qualification services regarding our monitoring system, calibration of temperature, humidity, difference pressure and airflow sensors as well as particle size and concentration calibration. Thanks to our DDS sensor technology these tasks can be carried out with a minimum downtime of your cleanroom, thus being as cost effective as possible.