Clean Room and HVAC/AHU Validation/Qualification

We provide and extensive range of services pertaining to clean room validation by our panel of expert professionals/Executors available with us.

Creative Consultancy perform HVAC validation as per ISO 14644, EU cGMP, USFDA ,Schedule M (National Regulatory Body), WHO Geneva, TGA (Australia), and MHRA (European Countries) guidelines for all Clean room classifications.

Following test to be done in Clean Room and HVAC Validation

a. Air Velocity Test And Calculation of ACPH. :

Air velocity test is important to conduct periodic monitoring of filter attributes such as uniformity of velocity across the filter (and relative to adjacent filters). Variations in velocity can cause turbulence that increases the possibility of contamination. Velocities of unidirectional air should be measured 6 inches from the filter face and at a defined distance proximal to the work surface for HEPA filters in the critical area. Velocity monitoring at suitable intervals can provide useful data on the critical area in which aseptic processing is performed. HEPA filters should be replaced when non uniformity of air velocity across an area of the filter is detected or airflow patterns may be adversely affected.

b. Installed HEPA Filter Leakage (Integrity) Testing – DOP/PAO Test :

HEPA filters are an essential component in any Clean Room design. In fact, their use is dictated by GMP regulations. In a properly designed HVAC system for a Pharmaceutical facility, HEPA filters are essential for maintaining the cleanliness (classification) of an area. Therefore, International standard “ISO 14644” guidelines dictate that HEPA filters shall be periodically tested to verify their integrity. HEPA filters will lose their efficiency over time due to clogging, they may be ineffective due to improper installation or they could be damaged (holes, rips) during installation or plant maintenance activities. To verify the Leakage (integrity) testing of HEPA/ULPA filters and to stay in conformance with various standards and/or governing agency requirements, filters should be tested and evaluated at potentiality annually. Proper documentation and certification also helps predict potential performance issues and increases filter life. This test is previously Known as DOP test also.

This test is performed to confirm that the filter system is installed and that leaks have not developed during use. The test verifies the absences of leakage, relevant to the cleanness performance of the installation. The test is performed by introducing an aerosol challenge upstream of the filter and scanning immediately downstream of the filter and support frame or by a downstream duct. The test is a leak test of the complete filter installation comprising the filter media, frame, gasket and grid system. The installed filter system leak test should not be confused with the efficiency test of individual filter at the place of manufacture. The test will be applied to clean rooms “as-built” or in “ at rest” occupational states, and be undertaken when commissioning new clean rooms, or when exiting installation require retesting, or after the HEPA filter have been replaced.

c. Airborne particle measurement (Non Viable Particle Count) Test :

Non Viable Particle Counters are used to determine the air quality by counting and sizing the number of particles in the air. This information is useful in determining the amount of particles inside an Classified Area or in the ambient air. It is also useful in understanding the cleanliness level in a controlled environment. Clean rooms are used extensively in Pharmaceutical Industry, Pathology Laboratories & Vaccine centers, Engineering sector, Medical Devices sector, Hospital, Food & Beverages industry, Dairy industry, Geo Sciences and Electronics plants and other fields that are very sensitive to environmental contamination. Inter National Standards & regulatory have defined particle count limits. Non Viable particle counters are used to test and classify a clean room to ensure its performance is up to a specific clean room classification standard. We provides complete airborne particle count cleanliness classification test is performed to determine the actual particle count level within the facility at the time of the test (As-Built, At-Rest, or Operational).

d. Recovery test

This test is performed to determine the ability of the HVAC System to eliminate airborne particles from classified clean rooms. Cleanliness recovery performance after a particle generation is one of the most important abilities of the HVAC System. This test is only important and recommended for non unidirectional airflow system because the recovery performance is a function of air circulation ratio, inlet outlet airflow geometry, thermal condition and the air distribution characteristics within the controlled zone, where as in unidirectional airflow system, the contamination is displaced controlled airflow and the recovery time is a function of locality and distance. This test should be carried out upon an installation in the as-built or at-rest state.

e. Air Flow Direction/Pattern test (Smoke Study) :

The purpose of airflow direction test and visualization is to confirm that the airflow direction and its uniformity confirm to the design and performance specification and, if required, spatial and temporal characteristics of airflow in the installation. The purpose of the airflow parallelism test is to show the actual airflow pattern throughout the unidirectional clean room. It can also be used to demonstrate the effects on airflow caused by equipment. This test should be performed after all airflow velocity and uniformity tests and room pressurization tests have been performed.

STANDARD AND REGULATION

The preparation of the Documents and the Execution of the OQ/PQ testing are in accordance with the following guidelines, as a minimum:

All testing and measurements are accomplished by the use of special NABL Certified calibrated Instrument.