Cleanroom Validation | GMP IQ OQ PQ Qualifications | HVAC Commissioning

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Cleanroom Validation | GMP IQ OQ PQ Qualifications | HVAC Commissioning

HVAC Commissioning and Qualification

HVAC Commissioning and Qualification

Lab prova | HVAC Commissioning and Qualification

A well designed Heating, Ventilation and Air-Conditioning (HVAC) system play an important role in ensuring the manufacture of quality pharmaceutical and microelectronic products and will also provide comfortable conditions for operators or any personnel that staying in (or passing through) the area supplied with air from HVAC system.
In comfort air-conditioning (such as hotels, restaurants, shopping malls, business offices etc.), HVAC system should mainly ensure pleasant environment for the people staying inside.
For the pharmaceutical production, the architectural components of the HVAC systems have an effect on performances such as room pressure differential cascades, prevention of contamination and cross-contamination control. Those performances should primarily ensure product protection, personnel protection and environmental protection.

HVAC Commissioning

Commissioning should include the setting up, balancing, adjustment and testing of the entire HVAC system, to ensure that it meets all the requirements, as specified in the User Requirement Specification (URS), and capacities as specified by the designer or developer.
The installation records of the system should provide documented evidence of all measured capacities of the system. The data should include items such as the design and measurement figures for airflows, liquid flows, system pressures…
The commissioning plan should start at the early stages of a project so that it can be integrated with system qualification procedures.

We can provide professional independent full HVAC commissioning supported with commissioning protocol and execution of all activities, including documented measurements of main HVAC system capacities, such as:

  • Air duct leakage test
  • Measurement of airflow
  • Measurement of fluid flow (liquid)

HVAC Qualification

The qualification of the HVAC system should be described in a Validation Master Plan (VMP) – mainly applicable in pharmaceutical and related industries.
It should define the nature and extent of testing and the test procedures and protocols to be followed.
Stages of the HVAC system qualification should include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Critical and non-critical parameters should be determined by means of a Risk Analysis (RA) for all HVAC installation components, subsystems and controls.

Our team of experts is specialized for performing HVAC qualification activities, including design and development of custom VALIDATION AND QUALIFICATION DOCUMENTATION and execution of all activities, together with documented measurements of critical HVAC system parameters, such as:

  • Classification of air cleanliness by particle concentration
  • Installed filter system leakage test
  • Supply airflow rate and air change rate for non-unidirectional airflow installation
  • Supply airflow velocity and uniformity of velocity for unidirectional airflow installation
  • Temperature test
  • Humidity test
  • Air pressure difference test
  • Airflow direction test and visualization
  • Recovery test

Periodic requalification of critical parameters should be done at regular intervals (e.g. annually). Requalification should also be done when any change, which could affect system performance, takes place.

Lab prova | Cleanroom Validation

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Cleanroom Validation

LAB PROVA was founded with the aim to fullfill the need of the local market for laboratory that would be able to provide professional cleanroom validation service. Specific needs of the pharmaceutical industry, through the years, naturally shaped our professional approach, dedicated to customer satisfaction.

Knowledge about applications, experience, research and development helped us to establish strong co-operation with world leading manufacturers of measuring equipment, for a wide range of industrial applications.