OUR SERVICE

Quality Validations

In certifying the architecture and installations of Clean Rooms, Iguña performs qualification and validation services to ensure the applicable requirements of the GMP, ISO-EN 14644 and FDA standards are being met.

To obtain these results, Iguña has a specialized technical team in charge of developing a Validation Plan to define the scope and methodology to be followed. The scope can extend to Sanitary Architecture, Air-Conditioning Installations, Control, Electricity and Critical Fluids.

In the case of validating HVAC installations, we perform the following tests to be able to attribute an ISO classification to the classified areas:

The DQ qualification document determines if the design of the equipment is in accordance with legal safety rules, and if there is consistency between the user requirements in the design and the technical specifications ultimately defined.
IQ qualification document proves that the installation has been executed in accordance with the user requirements, and includes the following sections:

1. Check that the installations, systems and equipment are in accordance with the engineering drawings and specifications.
2. Characterization of surfaces, construction materials, and room finishes.
3. Calibration requirements.
4. Check of the air-conditioning units, conduits, and air supply and return elements.
5. Preparation of the final Installation Qualification report.

The OQ qualification document is done with production stopped, and includes results for:

1. Leak test in the room filtration system and air-conditioning system.
2. Flow test and hourly movement rates
3. Pressure differential test
4. Temperature test
5. Relative humidity test
6. Noise level test
7. Counting of suspended particles test

The PQ qualification document determines the environmental quality of the space, measuring the level of particles under normal operating conditions and with limited operating conditions. It includes results in maximum and minimum situations of:

1. Leak test in the room filtration system and air-conditioning system.
2. Flow test and hourly movement rates
3. Pressure differential test
4. Temperature test
5. Relative humidity test
6. Noise level test
7. Counting of suspended particles test