Risk Management of HVAC System in Pharma Industries

Author(s)

Kamakshi, Sharma, R.B.

Author's Affiliation

Abstract

Heating, ventilation, and air system encompasses heating, ventilation, and air conditioning, which is integral component of pharmaceutical facility functionality. The qualification of HVAC systems is done by using a risk based approach. The risk management program consists of four major components: risk assessment, risk control, risk review, and risk communication. All four components are essential. All the above methods should address the mentioned four basic components. Failure mode effect analysis (FMEA) concepts were used for risk assessment of a HVAC system to determine the scope and extent of qualification and validation in this present work. The HVAC is the “direct impact” system in the aseptic practice which directly affects the product quality and regulatory compliance. The level of risk associated with the HVAC system was assessed based on the impact and severity of the probable risk in aseptic practice in sterile manufacturing. After completion of the risk assessment the recommended actions were extended and verified against the qualification stages of the HVAC system. The various parameters to be evaluated for the validation of HVAC system include air flow pattern, air flow velocity, air changes per hour, filter leak test, particle count, viable monitoring, filter integrity test, pressure difference, recovery test for temperature and humidity, temperature and humidity uniformity, and fresh air determination. Validation of HVAC system involves systemized and assembled documents of functional specifications; design drawings, plans, and specifications; validation master plan; testing, adjusting, and balancing (TAB); and startup reports.

Keywords

Risk Management Program, Failure Modes and Effects Analysis (FMEA), Pharmaceutical Industry, validation

Cite This Article

Kamakshi, Sharma, R.B. (2015). Risk Management of HVAC System in Pharma Industries, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(3), 50-56.