The HVAC system consists of an air handling system with filters, and temperature and humidity control capabilities. Temperature limit is not more than 25 ºC and humidity is not more than 55%. The system is constructed of sealed ductwork, with 10µ pre-filters, , 5µ MV filter in the AHU plenum.
The HVAC system is designed to provide the quality of air required for each operation at the site of individual operations. The air handlers and delivery module are installed to permit access for maintenance purpose. The design allows for pressurization of production areas and thereby provides complete segregation of the dust.
All the filters are checked periodically once in six months for efficiency (DOP Test) and for air velocity by out side agency. Bag efficiency is not less than 99% and HEPA efficiency is not less than 99.997%.
Heating and air conditioning are provided to optimize worker comfort and to provide humidity control, where necessary, for the heading of raw material and in process and finished product.
Re-validation is done when any significant change carryout or any change in parts/systems/or modification area etc. We have frequency of re-validation is six month.
There is no chance of contamination. Air pass throw 0.5µ filter in manufacturing areas. Air curtain is provide in all entrance area. Each system functions independently with different operating characteristic. The dust collection is monitored across the filter and the filters are cleaned periodically and change in products with oil-free compressed air. Dust collection system is located out side the facility i.e. in service area with cartridge type filter for trapping the dust, the trapped dust is disposed.
All employees are given training in the fundamental requirement for sanitation and hygiene. Each critical area is cleaned and maintained by following written down standard operating procedure. The procedure specifies the objective, frequency of cleaning, materials and concentration of various disinfectants to be used and the method to be followed for cleaning.
The personnel involved in manufacturing operations are specially trained for the job(s), they will be doing and for cGMP concepts. They are provided with clean apprens, gloves, masks, etc., and they are required to follow the standard operating procedure for entry-exit in the manufacturing areas.
Validated cleaning procedures for equipment and areas are followed. Pest and Rodent control, disinfections and rodent control in the premises is done through service contracts, at predefined frequency. The hygiene and sanitation levels of environment and personnel are regularly monitored by QA.