ISO 7 and 8 Clean Room Cleaning

[SpiderMonkey]

Hey everyone. I am looking for some guidance/help on cleaning of ISO 7 and 8 Clean Room. Particularly on schedules of cleaning and extent of cleaning.

-How often should floors be mopped?
-How often should ceilings and walls be wiped down?
-What are the appropriate cleaning solutions for mopping?

A little background. We are a contract manufacturer of Class I-III devices and components. We have less than a dozen clean rooms. Half at an ISO 7 cert and the others at an ISO 8. We have current mopping and cleaning schedules in place and have not had any particulate, bioburden or other environmental testing alerts or actions.

We are improving our mopping buckets to the 2 bucket system and are looking for other improvements and efficiency gains in the process.

I don't want to bias opinions or guidance with what our current schedule is just yet.

Please let me know your thoughts on what is appropriate and if there is any industry guidance that you are aware of or specific regulation which outlines room cleaning requirements.

 

[Ajit Basrur]

Welcome to the Cove

Have you referred the ISO 14644, Cleanrooms and associated controlled environments — Part 5: Operations?

Annex F is very informative and provides lot of guidance around cleanroom cleaning.

Specifically, to answer your questions, its up to the organization to define a plan. Since your particulate and microbiological values are well within control, your cleaning schedules and cleaning process seem to be effective. Any additional improvements are just a bonus

 

[Ninja]

I am not in medical...only electronics...but I work with cleanrooms frequently.

For Cleanroom class, there is no requirement to clean at all...just to maintain particle count below threshold. (It's about the air)
Cleaning is a tool, not a requirement.

For any requirements for Bioburden...that's its own issue that I'm not qualified to discuss.

We had a 10K sqft class 100,000 (ISO8) room, and a 100sqft 10K (ISO7) room.
In the years (>10yrs) that I worked there and managed the rooms, we never once cleaned the walls.
Floors were vacuumed (HEPA Vacuum) twice a month, and mopped once a month on single bucket.

I don't think you're fighting so much against requirements as much as being responsible...and kudos to you for that.

To my knowledge (outside of the medical community), there are no industry guides or requirements for cleaning practices...only guidelines for which products to use...written by the folks who sell those products.

Monitor your air, and be proactively responsible for the products you assemble, manufacture and handle. Look for ways things can go wrong and head them off.