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HVAC Validation In pharma Industries

HVAC VALIDATION



As per ISO guidelines for HVAC validation. In HVAC Validation  below points are determined and validated that they are in within range as per designed which will pass the respective ISO standard class acceptance criteria.

1)Air velocity and CFM calculation
2)Air changes per hour
3) Installed filter leakage test
4) HEPA filter integrity test
5)Air flow pattern test or smoke test
6)Partical count test
7)Total variable count
8) Temperatur and pressure monitoring
9) Temperature and Humidity recovery test
10) Fresh air calculation

All this points are determined recorded in documents.All this validation process done by validation contractors under observation of respective company Engineer.


 - Scan the area of the HEPA filter with probe of anemometer 6 inches from the filter face.
- For accurate velocity take the velocity of air at five place of filters ( Four corners and centre of filter)
- Record the air velocity in feet per minute at all point of filter face.
- Calculate the avarage air velocity of HEPA filter by sum of all velocity recorded then divide it with the number of velocity recorded.
- Calculate the area of HEPA filter face 
- To calculate the CFM multiply the average air velocity with the area of that filter. Result you will get is the CFM of that filter
- Do the same with the every filter available for CFM calculation.

- To calculate air changes per hour of room we have to calculate the CFM of that room.
- First calculate the CFM supply filter grill as mentioned in above how to calculate CFM.
- Then take sum all supply grill CFM available in that room then you get the room CFM.
- After that calculate the volume of room by multiplying room length, width and height.
- To calculate Air changes per hour multiply room cfm with 60 to get air changes per hour then divide it by room volume then you will get the Air changes per hour.

3) Installed Filter Leakage test:- 
- place the Velometer at the  front of  AHU unit. 
- check the velocity of air at the all corners of AHU units. It Should be within the higher limits the hepa filter.
- if there air velocity is more than the higher limits changes the gas cut to prevent the leakage.

- Generate the DOP or POA solution aerosol by using Aerosol generator by subjecting DOP/PAO at 20 psi pressure keep it in front of suction side of filter.
- Switch"ON" the photometer and allow to stabiilize for five minutes.
- Ensure that the 100% concentration is achieved at the all points of hepa filters.
- Scan the filter matrix and perimeter by passing the receptor probe 1 inches from the filter surface, aerosol partical passing through the HEPA filter should be within the specified limits which shows digitally on the photometer while scanning receptor probe on filter surface.

5) Smoke Test or Air flow pattern test:- 
- Take the titanium tetrachloride stick
- Burn the stick.
- Place the burning stick in front of the running Air handling Unit.
- Observe the flow of air with help of smoke distribution in the room.
- Make the air flow diagram chart for every room.

- Partical count done in two condition at rest and at running.
- For partical count test take suitable partical counter machine 
- Place the partical counter machine in the room at different locations for some time intervals and count the partical.
-  Collect the information from partical counter and record it in format.
- Do the same procedure for rest condition and for running condition.

7) Temperature and pressure monitoring:-
- Attach the data loger in the all rooms where the Temperature and pressure monitoring is to be done and start it in recording mode.
- Keep it for 1 day then collect the recorded data from the data loger.
- Then the check the recorded parameters are within the working limits.

8) Recovery Test:- 
- To take the temperature and humidity first record the current temperature and humidity parameters.
- Switch"OFF" the Air handling Unit, If the temperature is 21℃ then increase the room temperature by blowing hot air in the room by blower upto 40℃.
- Then start the air handling Unit and record the time required to recover the temperature from 40℃ to the normal running temperature limit.
- Update this time in the document.
- For Humidity Recovery test switch"OFF" the Air handling Unit,increase the humidity of room by spreading water in the room upto 80%- 90% humidity.
- Then start the air handling unit and record the time required to recover the humidity to its normal set limit.



Comments

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    چیلر جذبی از یک ابزوربر یا جذب­‌کننده برای ماده­ی اصلی کار خود استفاده می‌کند. نمک از بهترین جذب­‌کننده­‌ها برای این کار است و لیتیوم بروماید یکی از بهترین گزینه‌­ها برای این کار شناخته شده است. بنابراین در چیلرهای جذبی مخزنی برای نگهداری و عمل لیتیوم بروماید یا ماده­ی جاذب وجود دارد. علاوه بر مخزن ابزوربر یا جذب­کننده، از پمپ و ژنراتور یا مبدل حرارتی هم درون چیلرهای جذبی استفاده شده است.

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