Qualifications

 Qualification of Clean rooms and laminar flow cabinets

• Qualification of clean rooms with environmental classification (Annex 1 GMP / ISO 14 644).
    • Qualification of infrastructure.
    • Qualification of laminar flow cabinet.

• Qualification laminar flow.

 The service is adaptable to your needs depending on the particular situation of each team and consists of:

DQ Phase

For clean rooms, we verify at design level the accomplishment of the defined requirements of the user and the compliance of the applicable regulations in each case.

IQ Phase

After implanting, we check the proper installation, status, location, instrumentation, services, documentation, etc.
• For infrastructures: panels, ceilings, floors, light fixtures and other building accessories.
• For the air conditioning system: air treatment units, filters, returns, regulation recording, instruments, recording and control system and other elements of installation.

OQ Phase

Verification of the proper operation of the facility:
• For infrastructure: working of doors, interlocking, lights, etc.
• For the acclimatisation system:
· Verification of the functionality of the control system and recording.
· Physical environmental tests: differential pressure - particles - Temperature / Humidity - Air speed - Flow - renovation per hour - Uniformity test in laminar flow.

PQ Phase

Verification of physical tests of particles contest in a ‘working’ situation.

METHODOLOGY

• Drafting of a qualification protocol, signed before starting the work • Performance of the verification described in the protocol • Analysis of the results and assessments of deviations • - Writing a qualification report.

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