In aire interior we qualify clean rooms with OQ HVAC certification. We carry out processes to verify that there are no contaminations, optimizing preventive maintenance to improve energy performance and ensure product quality.
The OQ is the documented verification that the equipment used in the research / manufacturing process operates as designed and according to the established control variables. That is, according to the specifications required for the clean room qualification.
The HVAC validation service that we offer is aimed at those clients or sectors of action that have rooms with controlled atmosphere, laminar flows, air treatment modules, surgical areas, biosafety cabinets or gas extraction cabinets; and want to guarantee 100% in their clean room qualification.
Benefits of the cleanroom qualification
- Verify that there is no contamination.
- Optimize preventive maintenance.
- Contribute to corrective maintenance.
- Improve energy efficiency.
- Ensure product quality.
- Get the results report.
Regulations
The HVAC test service in facilities where the GMPs or “Good Manufacturing Practice” apply must be executed with a maximum annual frequency. In other sectors, the periodicity is dictated by the quality system of the organization, although we recommend that it be carried out annually for greater safety of the clean rooms and to be up to date with the updates of the clean room qualification:
- IEST-RP-CC006.3, August 2.004. National Environmental Balancing Bureau: Procedural Standard for Certified Testing Cleanrooms
- ISO 14644-1: December 2015. Cleanrooms and associated controlled environments. Classification of air cleanliness by particle concentration
- Appendix 1 GMPs, November 2008. Manufacture of sterile medicines.
- ISO 14644-3, December 2005. Clean rooms and associated controlled environments. Metrology and test methods.
- UNE-EN 12469, January 2001, performance criteria for microbiological biosafety cabinets
OQ HVAC Service Protocol
The OQ HVAC service includes in its protocol: planning, realization and preparation of the results report. The performance of the service can be:
- AS BUILT: Empty rooms with the air treatment system in operation.
- AT REST: Rooms with the air system in operation and process equipment installed (off) and without personnel.
- IN OPERATION: Air system in operation, process machines in operation and personnel at their work station.
OQ HVAC test types
Leak test
The leak test, for a clean room qualification, is used to verify the integrity of the installed filters, checking that the filtering surface does not show cracks or perimeter leaks between the sealing gasket and its fixing box. With the leak tests we guarantee the non-existence of external air entry, avoiding contamination of the controlled area.
Air flow test
The air flow test, for a clean room qualification, measures the unidirectional and non-unidirectional air flow in clean rooms. This flow test allows the safety of the air control by adjusting the clean rooms to the specifications required for the needs of the sectors of action in the services of operational qualification of air treatment systems and the OQ HVAC certification.
Pressure test
The pressure test, in an OQ HVAC validation, determines the pressure gradients in all the doors of the installation and outside, to verify that the system is capable of maintaining the pressures previously defined for the required industry. Indicators in the pressure test are determined by HVAC certified pressure gauges and gauges for use in aseptic rooms with controlled environment.
Particle test
With the particle test, the particle levels are measured “as built, at rest, or in operation” (before, after and during the process) in a clean room for their clean room qualification. Determines the cleaning classification according to international standards ISO 14644-1 and / or Good Manufacturing Practices or GMP, essential for OQ HVAC validation.
Temperature and humidity test
The HVAC certification includes the qualification clean rooms or controlled environment in relation to temperature and relative humidity (RH). With the temperature and relative humidity test, it is verified that the clean room design conditions are followed, following the reference of the UNE 100713: 2005 standard, which also determines the filtration levels and the particle filtration classes.
Recovery test
For a correct OQ HVAC certification, it is essential to measure the contamination inside your clean room. The recovery test verifies the ability of the clean room to recover its initial level to production. In this way, the environmental test of the excluded zone is determined and the return OQ HVAC test is calculated.