HVAC/clean Room Validation in Pharma or Medical Device Industry
clean room Validation

HVAC/Cleanroom Validation is provided by conducting a series of tests to qualify if a controlled environment is performing in accordance with process requirements and the applicable regulatory guidelines.

Process parameters and controls are determined during the validation of any process or system. Only installing HVAC (Heating Ventilation and Air conditioning) 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.

HVAC/clean room Validation facilitates to find out the deviations incurred in the system and the design during the process over the time. 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 Regulatory Audits. Validation also reduces the risk of non-compliances with regulatory standards. HVAC and clean room validation helps to determine the worst case and risks that may arise during the manufacturing of the quality products. It also helps to investigate the deviations caused during the process of manufacturing. The risk of the regulatory non-compliance is minimized after this type of validation process. Deep study and understanding of the whole system and equipments are made possible due to the validation. Validation reports help the quality teams to ensure the consistency of established processes/ systems. Above all these reasons, regular HVAC and clean room Validation are the most important statutory requirements in Pharmaceutical or medical device Industry. The production capacity of manufacturing units can be optimised by reducing the chances of rejection on account of bad quality. 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, regular validation of HVAC/ clean room is a mandatory requirement.

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