Validation of hvac

In this slide contains definition, validation method of HVAC
Presented by: V NABI RASOOL (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur.

1. Validation of HVAC ( Heating Ventilation and Air conditioning) A Seminar as a part of curricular requirement for M. Pharm I year II semester Presented by V.NABI RASOOL. (20L81S0401). Department of Pharmaceutical Quality Assurance . 1

2. Content Table S.NO CONTENTS 1 Validation 2 Introduction to HVAC 3 Validation parameters of HVAC 4 References 2

3. Validation : Process of establishing documented evidence that demonstrate, the process/activity/test/procedure in the production/testing of pharmaceuticals that meet the desired level of compliance at all the time. Advantages: Decreases OOS/OOT. Reduces product Recall. Assures the quality of the product. 3

4. Heating, V entilation, and Air-conditioning systems (HVAC) HVAC include all the air filtration, electrical, and electronic devices required to create and maintain specific levels of cleanliness, temperature, humidity, pressure differentials, and airborne cleanliness in controlled environments. JSS College of Pharmacy, Mysuru

5. Function : JSS College of Pharmacy, Mysuru To condition(heating & cooling) To replace(make up, oxygen replacement) To Pressurize To clean(filter) the air in the environment

6. W hat is clean room ? JSS College of Pharmacy, Mysuru A room in which the concentration of airborne particle is controlled and which is constructed and used in a manner to minimize the Introduction, Generation and Retention of particles inside the room. A room in which other relevant parameters. e.g.. Temperature , humidity and pressure , are controlled as necessary.

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8. HVAC consists of : 1. Air conditioner 2. Air Handling unit 3. De-humidifier/heater 4. Filters 5. Dust extractors 6. Ducting (for delivery of controlled air) 7. Supply fans 8. Temperature, Pressure, Humidity sensors 9. Heating and Cooling coils 8

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10. Validation of HVA C JSS College of Pharmacy, Mysuru Different tests to be conducted: 1. Air Flow Pattern 2. Air Flow Velocity and Change per Hour 3. Filter Leak Test 4. Particles Count 5. Viable Monitoring 6. Filter Integrity Test . 7. Pressure Difference 8. Recovery (Temperature & Humidity) 9. Temperature and Humidity Uniformity Test 10. Fresh Air Determination

11. Air Flow Pattern JSS College of Pharmacy, Mysuru Take the titanium tetrachloride stick. Burn the stick. Place t h e b u r n i ng st i ck in f r o n t o f r u n n i ng Air Handling Unit (AHU) . Obser v e the fl o w of air with the help of s m o ke distribution in the room . The distribution of smoke should be uniform.

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13. Filter Leak Test JSS College of Pharmacy, Mysuru Place the VELOMETER in front of AHU unit. Next Check the velocity of air to the all corner of the AHU. The air velocity should be within the higher limit of HEPA filter. If there is air velocity is less than higher limit , a gas cut (Silicon)is used to prevent the air leakage.

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15. Particles Count : JSS College of Pharmacy, Mysuru On the air system before one hour of test operation. Take the suitable particle counter and operate it to check the particles in the room at non working operation. Collect the information from particle counter and fill them in the format.

16. 16 Operate the particle counter when work is on progress in the area. The particles should be count when more than one hour work has been progressed in the area. Record the data in the format. Operate the particle counter for all the room maintaining grade A, grade B, grade C & grade D.

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19. Pressure drop across the HEPA filters : The purpose of this test is to check the clogged or clean condition of the HEPA filters. Here the differential pressure transmitter(manometer) is connected to before and after the filters. Then check the status of the filter whether it is in cleaned condition or in clogged condition. If it is in cleaned condition there will be no pressure drop. 19

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21. Temperature and Relative Humidity test : Temperature and RH is checked and recorded in Static and Dynamic condition. Static Condition : All the machines are kept in switch OFF. Dynamic Condition :Machine with load are in run condition. Temperature and RH sensor Display units (Hygrometer sensor) are used and recorded and should meet the USER requirement specifications. 21

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23. Air Borne viable Particle monitering : It determines the air borne microbial contamination in the area. Pre incubated SCDA Media plates shall be exposed in Locations mentioned for 4 hours and incubated for 48 hours at 30 C to 35 C . Next 72 hours at 20 C to 25 C and record the results . SCDA plates shall be incubated once in 15 days to moniter the growth of anaerobic microorganisms . All the parameters which are performed in the area should meet the specifications . 23

24. References: Robert Nash and Alfred Watcher, Marcel Decker, Pharmaceutical Process Validation , 3 rd Ed. Edited by, 2003, pp.507-509. Agalloco James, Carleton J. Fredric ‘’ Validation of Pharmaceutical Processes ’’ 3 rd Ed.417-428. 24

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