Clean Room, Cabinets & Thermal Requalifications

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.

Clean Room & Cabinets Standard Qualification Tests

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.

Pressure difference

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.

Recovery test

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

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.

Thermal Qualifications

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)

  • Leak test
  • Bowie-Dick test
  • Temperature distribution (without load)
  • Temperature penetration (with load)
  • Lethality F0 calculation
  • Biological indicators incubation

Freeze-dryers

  • Temperature distribution and shelves uniformity (without load)
  • Temperature penetration (with load)
  • Steam sterilization temperatures

Warehouse and storage areas

  • Temperature distribution without load
  • Temperature distribution without load
  • MKT (mean kinetic temperature) calculation

SIP systems

  • Temperature distribution
  • Lethality F0 calculation
  • Biological indicators incubation

Oven and sterilization tunnels

  • Temperature distribution (without load)
  • Temperature penetration (with load)
  • Lethality Fh calculation
  • Biological indicators incubation/endotoxins reduction

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)

  • Thermal mappings (with or without load)
  • MKT (mean kinetic temperature) calculation

Telstar Value Services

We work alongside our customers in close partnership, supporting them throughout the full life cycle of their plant and equipment to ensure lasting business success.

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