Validation of HVAC System in Pharmaceutical Industry


The HVAC system is an important part of a pharmaceutical manufacturing to maintain the required environment with desired temperature, RH, and air classification.


HVAC system Validation Tests

Air Flow Pattern or smoke pattern

- The test shall be performed in Rest as well as Dynamic condition.

- Video recording shall be performed for the airflow pattern test.

- The air should flow unidirectionally from supply towards the return air filter or grill within the room.


Frequency:

- Once in a year.


Air velocity/airflow measurement and calculation of air changes

- Calculate the ACPH is as follows:

Air changes per hour (ACPH) = Total CFM X 60

- Using Anemometer for air velocity

- The volume of the room is calculated and the air changes per hour are obtained by dividing the total air change by the volume of the room.

- A variation in air volume shall not be ±20% from the design CFM


Frequency:

- Once every six months.

- At Every Filter replacement.


Filter leak test

- For the leak test of the HEPA filter, aerosol calibrated photometer shall be used

- AHU system and the air velocity is checked at all the corners. In case it is found to exceed the upper limit, a gas cut (silicon) is used to decrease the leakage.


Note:

Earlier to carry out this test, DOP was used. But nowadays, it is replaced by the PAO (poly alpha olefin) taking into consideration the carcinogenicity of the DOP.


Frequency:

- Once every six months.

- At Every Filter replacement.


Viable monitoring (microbial monitoring) Passive /Active Air sampling

- To determine the viable particle count test by exposing the settle plate and air sampling in the defined areas.


Passive Air Sampling

- Plates shall be exposed on plate exposure stand at the pre-defined locations mentioned in individual format for each stream for not less than 4 hrs.

- Exposed plates shall be recovered after 4 hrs. of exposure and incubate at specified condition 20-25ºC for 72 hrs. Then 30-35ºC for 48 hrs.

- Plates shall be observed for any microbial growth after 5 days.


Active Air Sampling:

- The plate shall be recovered after sampling and incubate at specified conditions : 20-25ºC for 72 hrs. then 30-35ºC for 48 hrs


Frequency:

-Once in every six months for three consecutive days for ISO classes 5, 6, 7, and 8 at defined location. Continuous monitoring in critical / core areas.


Non Viable Particle count

Frequency:

- Once in every six months for three consecutive days at a defined location.

- At Every Filter replacement.


Differential pressure test

It is calculated by use of the manometer


Frequency:

For 3 days (Every six month) Continuous monitoring


Recovery study

Frequency:

- Once in a year.


Temperature and humidity control test

Frequency:

-For 3 days (Every six month) Continuous monitoring


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Resource Person: Hassan Hussein

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