This document discusses the user requirement specifications (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of heating, ventilation, and air conditioning (HVAC) systems used in pharmaceutical plants. The HVAC system must be qualified to ensure it is designed and installed properly and works as expected. The URS define the room temperature, humidity, and air cleanliness requirements. The DQ confirms the design meets the URS. The IQ verifies correct installation. The OQ tests the system operation. Finally, the PQ assesses the HVAC performance under normal operating conditions.

1. URS, DQ, IQ, OQ, PQ of HVAC system
Presented to –
Dr. Alka N Chaudhary
Associate Professor
Division of Pharmaceutical Sciences,
SGRRITS, Dehradun.
By –
Prashant Tomar
M.Pharmacy QAT 2nd Semester
SGRRITS, Dehradun.

2. Introduction
 Heating, Ventilation and air – conditioning (HVAC) systems are used in
pharmaceutical plat to prevent contamination and to provide
comfortable working conditions.
 HVAC are called Air Handling Units (AHU).
 AHU comprises of air supply, coarse filtration, heating or cooling and
HEPA filtration.
 Flow of air into the room may be horizontal or vertical.
 AHU producing class A (class 100 L), class B (class 100 T) & class C
(class 10,000) HEPA filters may be located in AHU.

3. Introduction

4. HVAC Qualification
 To ensure that equipment is designed as per
requirement, installed properly.
 Action of proving that any equipment works correctly
and leads to the expected results.

5. HVAC Qualification
Validation master plan
User requirements specifications
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
Re Qualification
Qualification
Validation

6. HVAC User Requirement Qualification
 Room Temperature & Relative Humidity.
 Clean Room Classifications for areas i.e. B, C or D.
 Single Pass or Re-circulated HVAC system.
 Room pressure / Air flow directions.
 GMP requirements,

7. HVAC User Requirement Qualification
 Capacity of HVAC depends on.
1. Room Volume.
2. No. of Air Changes Required.
3. Production / Consumption Data.
4. Seasonal Fluctuation.
5. Air classification of Rooms.
6. Future Development.

8. HVAC User Requirement Qualification
 Parameters to be defined in levels of Protection:
1. Filter type and position.
2. Air changes.
3. Air flow patterns.
4. Pressure differentials.
5. Contamination levels by particulate matter & micro –
organisms.

9. HVAC Design Qualification
 As per URS
 DQ must be as per
1. Class of cleanliness
2. Category of products to be manufactured.
3. Room design criteria
4. Reference to regulatory requirements
• It Should include
1. Functional Specifications
2. Technical Specification
3. Detailed Air flow Schematics
4. Detailed layout drawing of the system

10. HVAC Design Qualification
 Ensures that design
1. Meets URS
2. Details facility airflow and pressure cascade philosophy
3. Takes into account process & personnel flow
4. Details materials of construction
5. Details safety requirements
6. Details of all equipment and utilities

11. HVAC Installation Qualification
IQ includes –
 Manufacturers' equipment and workmanship verification.
 Calibration verification.
 SOP verification.
 Utilities connection verification.
 Change parts & replacement parts verification.
 Lubricant verification.
 Maintenance procedure verification.
 Lubrication verification.

12. HVAC Operational Qualification
 Air system balancing & pressure differential test.
 Air volume for non-uni-directional air flow terminal HEPA filter test.
 HEPA filter integrity test.
 Pressure differential stress test.
 Start up & shut down test.
 Control & monitoring device test.
 Air flow velocity & uniformity test.
 Air parallelism test.

13. HVAC Performance Qualification
PQ is similar to OQ but in PQ HVAC is assessed for its performance within the
area it is serving by simulating the process or by actually conducting it.
 Air system balancing & pressure differential test.
 Air volume for non-uni-directional air flow terminal HEPA filter test.
 HEPA filter integrity test.
 Pressure differential stress test.
 Start up & shut down test.
 Control & monitoring device test.
 Air flow velocity & uniformity test.
 Air parallelism test.

14. HVAC Performance Qualification
 Temperature – humidity control test.
 Air cleanliness test (Nonviable particle counting).
 Air borne bio burden test.

15. HVAC Performance Qualification

16. HVAC Performance Qualification

17. THANKYOU
ANY QUESTIONS