Cleanroom Performance Qualification

As specified earlier, the purpose of Performance Qualification (PQ) of the cleanroom is to demonstrate with objective evidence that the cleanroom consistently operates within defined parameters to produce the defined, desired environmental outcome.

Cleanroom performance qualification involves testing and monitoring of the following:

Plan development in Abiolabs’ own qualification format, adapted individually to customer requirements

Annual re-qualification of all cleanrooms in compliance with ISO 14644-1

Determination of the particulate purity class

Filter leak test

Flow visualisation

Determination of the room air change

Recovery time measurement

Determining volume flow

Differential pressure measurement

Temperature and humidity measurement

Performance of the cleanroom re-qualification in the course of extension of production facilities and conversions

Qualification of laminar flows (FFUs)

The output of the Performance Qualification (PQ) phase is a PQ report that analyses the performance of the cleanroom using specified equipment parameters. PQ is a pre-requisite for certification.

Abiolabs uses traceable and calibrated equipment

Applied standard:

ISO 14644-1/2/3

Test details:

HEPA filter integrity test:

Confirm that the HEPA filter, or its frame, is not damaged or improperly placed during installation. A properly applied HEPA filter produces a fairly uniform discharge of air velocity and direction.

Air flow velocity profile and air exchange rate:

Air flow velocity outing HEPA filters is obtained using a calibrated anemometer. Calculation of the air exchange rate with air velocity results.


Recovery test:

non-viable particles (DEHS) are introduced into the cleanroom and the recovery time is obtained by measuring the time for the airborne particle concentration to decay by a factor of 100.


Air flow visualization:

Airflow visualization studies are used to observe airflow patterns, which can directly affect the sterility of a product. These studies provide visual evidence of air flow direction


Temperature control test:

Measurement of temperature using a calibrated thermometer to verify compliance with required specifications.


Humidity control test: 

Measurement of humidity using a calibrated hygrometer to verify compliance with required specifications.


Pressure control test:

The purpose of this test is to confirm the capability of the air system to control pressure levels within pre-established specifications. The pressure is monitored using a calibrated pressure gauge.


Over-pressure control test:

Control the over-pressure between connecting rooms (SAS and clean room). Verify that the over-pressure comply with required specifications.


Air particle count:

Controlling particulate matter are extremely important for product quality control. A particle counter is used to filter and count non-viable particle populations having size ranging from 0.3 to 0.5µm. The number of sampling points is set as per ISO 14644-1


Aerobiocontamination:

Active air sampling using an air sampler. Filtration and count of viable microorganisms (total bacterial flora and yeast and molds) per volume of air.


Surface contamination:

Sampling of surface (table, floor, walls…) using non selective culture media. Count of viable microorganisms (total bacterial flora and yeast and mould) per surface unit.

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