A sink with water in an ISO Class 7 Cleanroom

[eileenr]

Hello Everyone,
I am currently in the process of turning back on a class ISO 7 cleanroom. I have sourced the Validation engineer and have sourced the cleaning people. The cleanroom was used 5 years ago by another medical company and they have a sink with potable water actually in the cleanroom. Most people who have come into the cleanroom have said "have it removed". But because we are a small start up company and we are not sure what our customers needs may be down the line, I am trying to keep as much in the cleanroom as possible. How big of a headache is it going to be for me to keep this water source in the cleanroom and would it just be better to have it removed prior to validating the system.
Kind regards
E.

 

[Pads38]

Re: ISO 7 Cleanroom

A company I previously worked for had a cleanroom with sink. Indeed the sink and water formed part of the manufacturing process. It fed a deioniser and a water still, the outputs of which were used in final cleaning of product.

The cleaning water had to be monitored for bio-burden but I do not remember any difficulty with the presence of the sink. There was a separate sink in the 'gowning' area for hand washing. One FDA inspection did call up the need for a formal procedure for the de-scaling of the water still but I don't remember any other difficulties.

 

[Ronen E]

Re: ISO 7 Cleanroom

A company I previously worked for had a cleanroom with sink. Indeed the sink and water formed part of the manufacturing process. It fed a deioniser and a water still, the outputs of which were used in final cleaning of product.

The cleaning water had to be monitored for bio-burden but I do not remember any difficulty with the presence of the sink. There was a separate sink in the 'gowning' area for hand washing. One FDA inspection did call up the need for a formal procedure for the de-scaling of the water still but I don't remember any other difficulties.

Yes, I've seen similar things in the pharma world (lotions and potions, class 8 cleanroom).

To the OP - my opinion is keep the sink and the piping but seal (reversibly, preferably outside the cleanroom) the water supply and the drainage, until such time that you actually need it in the cleanroom for production purposes. Keeping it active is not worth the trouble unless you really need it.

Cheers,
Ronen.

 

[eileenr]

Thank you both for your feedback, I think I will keep the sink in place and close off the water mains from outside the cleanroom
I really appreciate the advice.
E

 

[Ronen E]

Thank you both for your feedback, I think I will keep the sink in place and close off the water mains from outside the cleanroom
I really appreciate the advice.
E

I intentionally wrote "seal". Simply shutting off the water supply might not be enough, because the length of piping still open to the cleanroom may harbour all sorts of contamination. I also recommend sealing the drainage, for similar reasons. If I was in your place, I would also take away all parts that are easily removable (faucet etc.).

Cheers,
Ronen.