A well-functioning HVAC system or conditioning system is fundamental when providing the necessary level of hygiene to everything that surrounds your product. The HVAC system should be adopted in order to give the hygiene level that your process requires, whether it be manufacturing, packaging or development.
The HVAC system qualification of our clean rooms is the answer to the question we ask ourselves about whether our HVAC system is capable or not of giving and maintaining key parameters on hygiene such as temperature, relative humidity and differential pressure, among others, to ensure the correct operation and efficiency of the cleanroom.
With the aim of giving credibility and sustainability to the design and functioning of your HVAC system, Qualipharma developed a certification system, includes the following stages:
Qualification Plan: To define the qualification global scope. In this phase, the frame work is determined, including the aspects to be taken into account such as qualification scope, recommended strategy, process methodology, responsibility, application policies and more.
Design Qualification (DQ): Includes the documented check of planning documents and technical speciﬁcations for conformity of the design with the process, manufacturing, GMP and regulatory requirements.
Installation Qualification (IQ): It is the documented veriﬁcation that the premises, HVAC system, supporting utilities and equipment have been built and installed in compliance with their approved design speciﬁcation.
Operation Qualification (OQ): It is the documentary evidence to verify that the equipment operates in accordance with its design speciﬁcations in its normal operating range and performs as intended throughout all anticipated operating ranges. Key parameters are strictly measured.
Performance Qualification (PQ): It is a documented program to demonstrate that the Cleanroom, when operating within the defined parameters, can consistently perform and maintain the Cleanroom conditions.
- Complete support including the OQ and PQ tests execution
- Comprehensive project management
- Direct contact with your suppliers to improve documentation
- On-site or external implementation