Why HVAC (Heating, Ventilation, & Air Conditioning) is an important statutory requirement in Pharma or medical device Industry?

Every Pharma Company in order to establish its commitment towards the production of quality drug must have a designated, well maintained HVAC facility in manufacturing area. The Drugs & Cosmetic Act 1940 and Rules 1945 also require the pharma companies to have well designed and installed HVAC in manufacturing, filling & packaging area to control temperature, humidity, air flow and contamination.

A set Temperature is required to control as effective blending of ingredients in drug manufacturing process may got affected by change in temperature. Also the working of equipments and machinery generates lot of heat which is to be controlled for providing good working conditions. Bacteria, Fungi, virus and other pathogens grows rapidly in warm and humid environment and thus controlled temperature and humidity is must for production in pharma companies.

In order to avoid any contamination, installation of filters along with required air flow is mandatory. Filters control the number and size of air particles present in a closed area within the accepted level of quality standards.

As a matter of fact certain areas require a separate independent Air handling unit from adjacent areas to ensure the above parameters can be established and any cross contamination can be avoided.

Why regular HVAC/clean room Validation is important statutory requirement in Pharma or medical device Industry?

Only putting in a HVAC system isn't always completely effective until a regular validation has been carried out to confirm that the installed system is running as per the set parameters and design. Validation means checking, verifying, or confirming the accuracy of a process or system or facility. After performing validation a documented evidence of the findings in form of reports are kept for record which are very important at the time of Audits. Validation reports helps the quality teams to ensure the consistency of established processes/ systems.

The results of validation also helps the maintenance team to take preventive measure on time before the breakdown of the system along with planning the annual maintenance program of the system. HVAC Validation facilitates to find out the deviations incurred in the system and the design during the process over the time. Validation also reduces the risk of non-compliances with regulatory standards. The production capacity of manufacturing units can be optimised by reducing the chances of rejection on account of bad quality.

It is important here to mention that regular validation of HVAC/ clean room is a mandatory requirement under various regulation viz. FDA (food & Drug Administration), Schedule M of Drugs & Cosmetic Act 1940 and Rules 1945, MHRA (Medicines and Healthcare products Regulatory Agency of UK) and ISO.

When should the clean room validation for pharma companies be done?

As per Schedule M of The Drugs & Cosmetic Act 1940 and Rules 1945 ( a ) Particulate monitoring in air – 6 Monthly

(b)   HEPA filter integrity testing (smoke testing) – Yearly

(c) Air change rates – 6 monthly

(d) Air pressure differentials – Daily

(e) Temperature and humidity – Daily

(f) Microbiological monitoring by settle plates and/or swabs in aseptic areas – Daily, and at decreased frequency in other areas

Note : The above frequencies of monitoring shall be changed as per the requirements and load in individual cases