Product Contamination Risk Analysis

Hi Forum Friends,

Can any body help me in doing risk analysis for a change in the clean room entry procedure. I am planning to do some changes in the procedure (personnel only) and need forum members help in getting through the change.

Thanks in advance.

Raghu.

raghuramas said:

Hi Forum Friends,

Can any body help me in doing risk analysis for a change in the clean room entry procedure. I am planning to do some changes in the procedure (personnel only) and need forum members help in getting through the change.

Thanks in advance.

Raghu.

Click to expand...

Can someone help with this?

Thank you!!

Stijloor.

raghuramas said:

Hi Forum Friends,

Can any body help me in doing risk analysis for a change in the clean room entry procedure. I am planning to do some changes in the procedure (personnel only) and need forum members help in getting through the change.

Thanks in advance.

Raghu.

Click to expand...

Hi raghuramas,
Your question is actually about a revalidation of your room class after changes which are planned to be made. Your cleanroom was to provide a work environment meeting to a certain cleanroom class (say class 1000) and after you make changes per your plan for whatever reason (which I guess you have discussed and resolved with your cleanroom installation and commisioning agency) you need to get things back in place, run the AHU and the systems and validate once more if the room meets to class 1000 requirements. If work environment remains unchanged, there is no risk of product contamination due to cleanroom.

You should also perform process validation of your change. Though this is an AS9100 post you might find it helpful to look at the "Quality Management Systems - Process Validation Guidance" (Document # SG3/N99-10) published by the Global Harmonization Task Force (GHTF) found at http://www.ghtf.org/sg3/sg3-final.html.

GHTF is a working group for medical device industry but over the years I have found a number of their documents and guides have application in other quality management systems without having to reinvent the wheel.