BRIEF DESCRIPTION OF HVAC (HEATING, VENTILATION AND AIR CONDITIONING SYSTEMS)

BRIEF DESCRIPTION OF HVAC (HEATING, VENTILATION, AND AIR CONDITIONING SYSTEMS)

To avoid cross-contamination and to maintain relative humidity, temperature, and Pressure Difference in the manufacturing areas with Air handling Units Provided in the manufacturing, warehouse, quality control, and microbiology section. Temperature and humidity are controlled and maintained within the limits as per the requirement of the product.

The pre-filters are cleaned as per the frequency described in the SOP for cleaning the filters.

In case of pressure differential failure, all the production activities are stopped and the filters are replaced with cleaned filters.

Validation of the air handling unit is done through the studies of parameters like-

  • Air velocity
  • Air change per hour,
  • Temperature,
  • Relative humidity,
  • Non-viable particle count,
  • HEPA filter integrity,
  • The pressure differential across the HEPA filter,
  • Airflow visualization,
  • Recovery test,
  • viable particle count, except recovery study similar studies are done for  RLAFs (Dispensing and sampling booths).

In the processing area daily monitoring of differential pressure, temperature, and relative humidity. Microbial monitoring IS BEING DONE in the critical processing manufacturing area on a daily basis and weekly for noncritical areas, and daily in the microbiological section.

Air changes are at least 20-60 per hour in ISO-8 (100,000) classified area, of  ISO-7 (10,000) that is 60-80, ISO-6 (1000 surrounding LAF) air changes are 80 – 120, and in ISO-5(100 under LAF) that is 240-480 wherever applicable. Critical manufacturing areas have a positive differential relative to adjacent less clean areas to avoid cross-contamination. The return air is passed through the return air riser and 90% of it is again re-circulated with the intake of 10% fresh air every cycle. The return air risers are located in critical process areas. Filters are arranged in a series of 10m (return air filter), 05m (pre-filter), 03µ (fine filter), and 0.3m (HEPA filter) for critical areas and for non-critical areas filters are put in the series of 10m  5m and 3µ arrangements.