Existing facility modification of cleanroom

Engineering
1

Is there any procedure or guideline to modify existing facility of cleanroom, Three rooms are connected with one AHU and one of them have to modify as per requirement.

2

Modification in the cleanroom of existing facility shall be initiated through Change control,
which will trigger the following action task:
1.Master plan for facility modification
2.Execution of plan with modification/implementation
3.Risk assessment for the modification brought up
4.Requalification of machines(If applicable)
5.HVAC revalidation
6.fumigation
7.Media fill
8.Area release for sterile manufacturing

1 Like
3

First of all thanks sir for sharing, but just suppose we have one AHU cfm 9000 catering to 3 room each room required 3000 cfm and different products are running in each room & chances of contamination if we run other lines during this activity , futher we have to extend area of one room, demand of CFM will increase of that room to maintain ACPH. so I want to know how we can modify the Clean room. can we modify the clean room in this condition and please if you have any risk assessment related this please share.

4

Is there pharmaguidesline available for effervation tablets regarding pressure difference of classify area. What is pressure difference limit ? we have requires RH 15±5, Temp. 25=-5… Also suggest pressure increase what is effect in cleanroom

5

If you connect one ahu with 3 room there will be chances of cross contamination. it is not acceptable.

6

Dear we have filtration in ahu then again at room ends also so there’s no chances of contamination . We can connect one ahu with many rooms with different products…

7

I think u should read who guideline for hvac system

8

I know 10 micron 5 micron and .3 micron filter are used in ahu.you should validate the process that there is no chances of cross contamination.

9

So how we can measure the contamination in clean room if there’s chances.

10

Is there any procedure to check contamination if both lines are running with different product

11

Dear you don’t design of 3 room’s with respect to 1 AHU with different products each room.

12

Dear Arpit Patel,
In Effervescent Tablet manufacturing room, Differential pressure should be at least 20 pascal with respect to adjacent room. In low RH room it is recommended to maintain an airlock before the compression/packing room.

Thank you,
Md. Ishrat Islam Ronju