An overview of the Validation Qualification of HVAC

An overview of the Validation & Qualification of HVAC System PART 1 PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA

LEARNING OUTCOME • After watching this Video lecture we are going to LEARN: • WHAT IS VALIDATION AND QUALIFICATION? • HOW THE QUALIFICATION OF HVAC IS DONE?

INTRODUCTION

INTRODUCTION Validation ensures about the accuracy of results being produced by any system. Maintenance of quality of products is of great importance, especially in the field of pharmacy as this field deals with drugs which directly affect the human body. Qualification is the action of providing that any equipment properly installed , works correctly & leads to expected results. ASHRAE defines The heating, ventilation, and air conditioning (HVAC) system which contains: üControl of air humidity. üControl of air circulations. üControl of air quality.

IMPORTANCE OF HVAC SYSTEM

IMPORTANCE OF HVAC SYSTEM HVAC systems are of great importance to architectural design efforts for four main reasons: • It requires substantial floor space for equipment and distribution. • HVAC systems constitute a major budget item. • The success or failure of thermal comfort efforts is usually related to the HVAC system. • Maintaining of appropriate thermal conditions through HVAC system operation is a major driver of building energy consumption.

VALIDATION OF EQUIPMENT

VALIDATION OF EQUIPMENT The equipment validation process generally covers the following steps: Ø Customer requirements or user requirement specification (URS) ØPreparation of design qualification (DQ) and its certification Ø Installation qualification (IQ) Ø Operational qualification (OQ) Ø Performance qualification (PQ)

VALIDATION OF HVAC SYSTEM

VALIDATION OF HVAC SYSTEM The validation of HVAC system usually involves the compilation of the documents like functional specifications – ØIQ - The goal of IQ is to verify and document the quality, installation, and integrity of HVAC system components. Design documents and literatures are used to design installation protocols. ØDQ - If particular equipment is to be fabricated as per the URS, then it is very essential to design detailed qualification document. It provides documented evidence that the design specifications were met.

• Now, please take a pause for 2 minutes to recapitulate the topics we have discussed, and try to answer the following questions: • What is validation and qualification? • What are the full form of IQ, DQ and explain these briefly.

CONTINUED… • OQ may be defined as: “Documented verification that the system or subsystem performs as intended throughout all specified operating range”. The equipment should be operated only when it passes the OQ Test. • PQ may be defined as: PQ should provide documented evidence that utilities, systems, or equipment and all its components can consistently perform in accordance with the specifications under routine use. Test results should be collected over a suitable period of time to prove consistency.

• IN THE NEXT VIDEO WE ARE GOING TO LEARN ABOUT • What are the methodology of HVAC system? • What are the applications of HVAC system?

Prepared by: Ms. Nilanjana Ghosh Mr. Fahaduddin Dr. Kishanta K. Pradhan Dr. Manik Ghosh PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA