Rooms

Qualification of Rooms

In the pharmaceutical and medical industries, rooms are used, among other things, for manufacturing processes, laboratory tests and storage of raw materials and finished products.

During the design process of new facilities and the modernization of the existing buildings, beginning from the conceptual phase one has to take into account the requirements related to the obligation to meet good manufacturing practices.

To ensure safety of the products, before the rooms are commissioned, a proof of the fulfilment of the relevant GMP requirements must be obtained.

Room qualification is most often conducted together with HVAC qualification. Environment testing (temperature, humidity, particulate measure, air flow, etc.) is done as HVAC testing. The individual installations on the premises are qualified in the form of installation-specific qualification, for example compressed air, purified water, nitrogen, steam, etc.

We perform room qualification with regard to:

Manufacturing and laboratory cleanrooms in A, B, C and D zones based on ISO14644-1

Special facilities
(stability rooms, high dust content rooms)

Airlocks for people and goods,

Warehouses

Sample Project

Subject

The qualification of manufacturing rooms

The qualification of
storage rooms

The qualification of laboratory rooms

The qualification of
airlocks in clean zones

Scope

In connection with the building of a new plant, all the rooms identified during risk assessment as critical were subject to full qualification. The cleanrooms were divided into organizational divisions and a separate qualification was performed for each such division.

All in all, 5 separate processes were conducted. Each time a Qualification Plan and relevant reports were produced. The DQ was conducted with the architect whereas the IQ and the OQ with the general contractor.

The scope of testing excluded environment checks and the tests of individual installations as those were qualified as separate processes.

Results of implementation

At the Room OQ stage only the operation of access control systems and cross-locks in the airlocks were verified.

The final room qualification report contained references to all the related qualifications of the individual installations. The closing of the room qualification report required that the reports of the related qualifications were successfully closed.

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