Hi folks,

This Tiffacy being resurrection for so long time... Nice to say HI again to my all dearest folks here!!!

Being turning aorund by the issues on set up a cleanroom facilities in the medical devices manufacturing. What is the works and preparation works i need to do in the different stage of this cleanroom set up? As my company is decided to sub-contracted this cleanroom set up, how should I qualified this sub0contractor in order to perform a qualified services? What documents n report/ tests should my sub-contrator to provide me? Does any of my folks here have any cleanroom protocols to share with me? I would appreciate on your advise on these abovementioned issue.

:thanx:

Tiff

You may want to purchase these standards for cleanrooms:

ISO 14698-1
ISO 14698-2
ISO 14698-2/AC
ISO 14644-5
ISO 14644-7

They are about cleanroom requirements and contamination control. They may help you getting your head wrapped around the task at hand.

You will also want to have references supplied from the subcontractor, to evaluate perfomance and cooperation.

You will want to audit the subcontractor, they should have a Q-system.

You will want the subcontractor to provide documentation for the design of the cleanroom, HVAC-system, filters used, how many changes of air volume per hour, guaranteed minimum over pressure (the cleanroom should have its own air supply!), etc. Also a project plan, a requirement that you can decide who is not performing the work at your site, a project plan, and a requirement for daily compensation should the project be delayed.

Thanks for your help!!

Is there a comprehensive checklist for the documents and actions plan i should take in establishing this cleanroom 100k?

Thanks for your help!!

Is there a comprehensive checklist for the documents and actions plan i should take in establishing this cleanroom 100k?

You may find some help here:

ISO 14644-4 : Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up.

:thanx: is a great start!