Validation & Qualification
The validation or qualification process is executed in order to demonstrate that the facility, air handling components and equipment perform as specified in the project design documents. The primary objective is to verify and document that the facility, systems and equipment that have a direct impact on product quality are rigorously tested and performance is consistent within the defined parameters.
Operational Qualification
Operational Qualification (OQ) is a documented program to demonstrate that the Cleanroom, when operating within the defined parameters, can consistently perform and maintain the specified conditions.
In action, this means identifying and inspecting facility and equipment features that can impact final product quality.
The OQ should cover worst case scenarios. For example, if the cleanroom still operates correctly at the minimum and maximum temperature and humidity limits specified in the URS.
During OQ, each test must be carried out individually. For example, if the same sensor is used for temperature and humidity, our test engineers will test these functions separately.
The output of this phase of qualification is an OQ report detailing how the functional requirements of the cleanroom meet what is specified in the URS.
Performance Qualification
Performance Qualification (PQ) is usually the final step in initial qualification.
For the initial Performance Qualification our test engineers will repeat what has been done at OQ but now under load, rather than as built.
For a cleanroom particle count, this would be Operational, as opposed to At Rest. For a piece of equipment, e.g. a freezer or incubator, it would be working with its typical load, rather than being empty.
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Our cleanroom validation documentation is detailed and auditable. You will receive an interim report on the day of testing, followed by the full report within 10 working days. Reporting is aligned with ISO standards and GMP guidelines to meet your requirements and those of any nominated regulatory body, (e.g. the MHRA).
You can choose from one of our testing packages, or we can build a custom schedule based on your requirements.
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