Quality validations

In certifying the architecture and facilities of the Clean Room, Iguña performs qualification and validation services, ensuring that the target standards of the applicable GMP, ISO-EN 14644 and FDA regulations are met.

In order to obtain results, Iguña has a specialized technical team, this will be in charge of carrying out a Validation Plan that defines the scope and methodology to be followed. The scope may be applied in Sanitary Architecture, HVAC Installations, Control, Electricity and Critical Fluids.

In the case of the validation of HVAC installations, in order to attribute an ISO classification to the classified areas, we will carry out the following tests:

Design Qualification (DQ)

The DQ qualification document will determine if the design of the equipment conforms to legal safety standards, and compliance with the concordance between user requirements around the design and the technical specifications finally defined.

Installation Qualification (IQ)

The IQ qualification document will show that the installation has been carried out in accordance with user requirements, and will present the following sections:

1. Verification that the facilities, systems and equipment are in accordance with the engineering drawings and specifications.
2. Characterization of surfaces, construction materials and finishes of the room.
3. Calibration requirements.
4. Checking the air conditioners, ducts, and air supply and return elements.
5. Preparation of the final report of the Installation Qualification

Operational Qualification (OQ)

The OQ qualification document will be made with production stopped and will present the results of:

1. Leak test in the room filtration and air conditioning system.
2. Test flow rates and hourly movement rates
3. Pressure difference test
4. Temperature test
5. Relative humidity test
6. Noise level test
7. Airborne particulate count test

Process Qualification (PQ)

The PQ qualification document will determine the environmental quality of the space, measuring the level of particles under normal operating conditions and, with limit operating conditions. Presenting the results in situations of maximum and minimum, of:

1. Leak test in the room filtration and air conditioning system.
2. Test flow rates and hourly movement rates
3. Pressure difference test
4. Temperature test
5. Relative humidity test
6. Noise level test
7. Airborne particulate count test