Operational Qualification "OQ"

The purpose of the operational qualification is to test the "empty" performance of equipment or installations.

The containment is complete, walls, ceilings, doors, joints are completed.

Air facilities serving the ZAC are operational.

The installations have been "rinsed" (Getting started with the ventilation before mounting the final filters)

The flow rates and gradients of the air overpressures are adjusted and "balanced" (Balancing flows and overpressures performed according to the specifications).
It is time to check whether the specifications defined at the outset (QC DESIGN QUALIFICATION) are in agreement with the measurements made.
It will then be possible to use the EQUIPMENT / INSTRUMENTS bearing calibration certificates to carry out the following checks:

- Filter integrity control (EMERY test)
- Speeds and airflow
- Control of airflow direction
- Visualization of the direction of the air flows
- Measurement of differential pressures (Control of overpressure gradients)
- Control of climatic conditions
- Lighting level control
- Control of the noise level

Controls will be performed according to pre-established protocols and compliance criteria that should be pre-approved by the client.
In the reports of qualifications should at least figured:
- The customer name
- The name and address of the qualification provider
- The qualified object
- The type of qualification performed
- The date or dates of the checks and the report
- The qualification method used (protocol)
- The type of equipment used with the serial number and calibration certificate
- The reference standards used
- The conformity criterion (s)
- Test results with (conspicuous)

This step completed, we will be able to consider using the equipment / installation for the actual conditions of use, in the presence of the product and staff who will have previously been informed
Caution: This operational qualification stage will have to be regularly redone to take into account the risks of loss of performance of the installations / equipment over time.



Prestations