Heating, ventilation and air-conditioning (HVAC) play an important role in ensuring the manufacture of quality pharmaceutical products. The good manufacturing practice (GMP) requirements for the prevention of contamination and cross-contamination are an essential design consideration for a HVAC system. A well designed HVAC system also provides environmental protection, operator protection as well as comfortable working conditions for operators.
Airborne particle count
A particle counter is used to conduct the test. An airborne particle count is taken before the operation as well as during the working condition. The particle count should be within the range as per the standards of Annex I GMP Grade A, B, C, and D or ISO 14644-1 Class 5, 6, 7 and 8 areas.
Filter integrity test (DOP/PAO test)
This test is performed to confirm that the system filter is properly installed and that leaks have not developed during use. The HEPA filter integrity is tested by generating a PAO aerosol by an aerosol generator, allowing the upward flow of the aerosol. The 100% upward flow of the aerosol is ensured and then the receptor probe of the HEPA is monitored to measure the amount of the aerosol reversed. It should not exceed the higher limit of the HEPA filter.
To verify the capability of the complete installation to maintain the specified pressure difference between the installation and its surroundings, including between separate spaces within the installation.
Air flow velocity and changes per hour
For this test, the area of HEPA filters is divided into hypothetical grids and the air velocity is measured at each grid and then the average air velocity is calculated. The volume of the room is calculated and the air changes per hour are obtained by dividing the total air change by the volume of the room.
This test is performed to confirm that the area to be tested recovers to the correct air classification within the specified time. Usually this is used during the opening of the Isolator chamber doors/area doors etc.
Air flow visualization test or smoke pattern
This test is performed to confirm that the airflow direction and its uniformity conform to the design and performance specifications and, if required, spatial and temporal characteristics of airflow in the installation.
Viable monitoring is performed by employing an air monitoring system and media plates using nutrient agar medium for the incubation of microorganisms.
Temperature and humidity uniformity test
The purpose of this test is to demonstrate the capability of the installation’s HVAC system to maintain the temperature and relative humidity levels within the control limits.
Light and noise level test
The uniformity of light and noise are measured by using calibrated equipment. The two parameters are monitored to ensure that the environmental conditions are to the required levels set out by the customer.
Containment leak test
This test is performed to determine if there is an infiltration of contaminated air into the clean zones from surrounding non-controlled areas, and to check pressurized ceiling systems for leaks. If a cleanroom is pressurized correctly air will flow out to areas of lower pressure and contamination will not enter the cleanroom.
Alarms and safety test
To check the alarms and safety system installed in the laminar flow works correctly.
Qualification of thermal equipment is one of the most important activities to ensure that the product and facility areas comply with normative and standard regulations.
Telstar Q&V department has extensive experience in thermal equipment qualification with an expert staff of engineers and technicians. The department has access to the latest technology test equipment to perform all required qualification tests.
Autoclaves (steam sterilizers)
Warehouse and storage areas
Oven and sterilization tunnels
Stability chambers, hot-rooms, incubators, stability baths, fridges (2 to 8 ºC), freezers (-10 to -30 ºC) ultralow freezers (-40 to -80 ºC) and cryogenic freezers (-100 to -196 ºC)
Telstar Value Services
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