Cleanroom Cleaning Agents for cleaning a Class 7 Cleanroom

[WisdomseekerSC]

Does anyone have a list or recommendations for chemical cleaning agents for cleaning a Class 7 cleanroom (floors, walls, contact surfaces, etc.)?

Parts will be further processed and sterlized by OEM. We are looking to minimize foreign objects (particulates) debris embedded in part during extrusion process and surface contaminates. We do not 'clean' the parts, but we do blow-off (anti-static)/wipe-off (lint-free) visible surface contaminates during inspection process prior to packaging. Parts are USP Class VI plastics (biocompatible). I have ISO 14644-5.

Cleaning agents will need to be free of material derived from animal origin.

 

[Ronen E]

Hi,

I have several comments on your described set-up but I'll hold back for now (unless you're interested) and focus on your original question. To be able to answer it I need a little clarification though. You wrote "chemical cleaning agents", then related also to aspects of particulate matter cleanliness and maybe other sorts of contamination. So, are you mainly looking to
- remove unwanted chemicals (which?) from the surfaces;
- further reduce particulate matter presence; or
- reduce micro-organism presence levels on the surfaces?

Cheers,
Ronen.

 

[Ajit Basrur]

Does anyone have a list or recommendations for chemical cleaning agents for cleaning a Class 7 cleanroom (floors, walls, contact surfaces, etc.)? <snip>

While you respond with Ronen's great questions, you could also refer to United States Pharmacopeia (USP) 1072 DISINFECTANTS AND ANTISEPTICS that gives some good info

.

 

[WisdomseekerSC]

Mainly looking for routine cleaning supplies recommended for cleanroom level production area use.

We had a customer in a supply audit recommend we have a list of what we consider approved cleaning supplies for use in the cleanrooms. We make parts for multiple Industries...my focus is on the medical...so minimizing residue left behind by cleaning agents is desirable.

We manufacture the parts in a Class 7 clean environment and then have a separate attached cleanroom for inspection and packaging, also a Class 7.

We are controlling particulates (non-viable) currently. No customers have required bioburden reduction to date (mostly because they further process our parts and clean prior to sterilization). We do wipe down contact surfaces with alcohol to minimize potential microbial contaminates (viable particulates) as a preventive measure.

We have approved suppliers for our cleaning supplies in general, but not specifically a list for cleanrooms. Prehaps those more knowledgable about cleanroom operations can provide some advice. :

 

[Ninja]

Assuming you mean ISO 7 (ye old Class 10,000 room) we simply use water, IPA and Acetone. Simple and Cheap, with little to no residue.

Specifically for the Acetone, be sure to test it on surfaces first. many clean room items (flaps, wall coverings, glove boxes, etc.) may be damaged by Acetone. IPA and water are generally non-destructive for most plastic stuff.

 

[MIREGMGR]

Acetone is highly flammable, in addition to having some degree of breathing toxicity. That's not to say it shouldn't be used, but I'd think you'd want to have a documented basis for not having special precautions in regard to its flammability, i.e. a fire evacuation plan commensurate with the physical size of fire that would result if a non-safety-container of acetone in the space (quart? gallon?) was dumped after igniting.

We do wipe down contact surfaces with alcohol to minimize potential microbial contaminates (viable particulates) as a preventive measure.

No single disinfectant (of reasonable nature) will kill all organisms of common concern. In a single-disinfectant environment, surviable organisms can over-populate due to absence of their natural competitors, possibly enhanced by genetic adaptation over time due to "survival of the fittest" in a partial-kill environment.

We use 70% isopropyl alcohol/30% water daily for a week (the commonly available commercial blend--note that this blend is much more effective as a commercial disinfectant than 92% isopropyl/8% water, because the latter does not re-vivify spores nearly as well), then "quat" solution (quaternary ammonium compounds in water) for a week, repeating. This combination kills essentially all organisms, and prevents genetic adaptation.

 

[Ninja]

Acetone is highly flammable, in addition to having some degree of breathing toxicity. That's not to say it shouldn't be used, but I'd think you'd want to have a documented basis for not having special precautions in regard to its flammability, i.e. a fire evacuation plan commensurate with the physical size of fire that would result if a non-safety-container of acetone in the space (quart? gallon?) was dumped after igniting.

Point understood and well taken...but I can't help the...

Oh, please! It's freaking nail polish remover. I've got a quart of it under my bathroom sink! They used to soak your coffee beans in it to make decaf...oh, please!

Rant over...make sure it's stored in properly marked diamond label bottles that cost more than the friggin' acetone does, and then keep the proper paperwork that costs more than the friggin' cleanroom does...

OK, now rant actually over...

 

[Ronen E]

They used to soak your coffee beans in it to make decaf...

Are you sure?... I believe it was (is?) Methylene Chloride.

I wouldn't use any Ketone for surface cleaning because of their aggressiveness towards many polymers. There are so many more suitable alternatives.

 

[Ronen E]

Mainly looking for routine cleaning supplies recommended for cleanroom level production area use.

Typically, "cleanroom cleaning supplies" are focused on reducing bioburden and particulate matter potential presentation to the product. However, I'm still not sure that's your focus in this case.

We had a customer in a supply audit recommend we have a list of what we consider approved cleaning supplies for use in the cleanrooms.

Having a list of approved cleaning agents is a very good practice.

We make parts for multiple Industries...my focus is on the medical...so minimizing residue left behind by cleaning agents is desirable.

Addressing any residues from the cleaning agents themselves should be a no-brainer if you pick any that are traditionally used for this purpose. Typically the manufacturer's labeling would inform you if there are any concerns and instruct how to address them effectively. I would have been more concerned with residues from other (non-medical) production processes, if equipment is shared. If you're looking to remove non-particulate matter that might be adhered to the surface, it's important to first comprehensively characterize what you're dealing with, so that you can identify the right cleaning agent(s).

We do wipe down contact surfaces with alcohol to minimize potential microbial contaminates (viable particulates) as a preventive measure.

As a side note, alcohol is not the best microbicidal option for hard surfaces (I also sign up to MIREGMGR's recommendation to use 70% concentration rather than higher ones; an additional reason being that with 30% water make-up it takes longer to evaporate and thus affects the surface for longer). With "chemical" surface cleaning in mind, alcohol may be an effective agent for some fat-based / organic matter, however, it may be totally ineffective in other cases. It all depends on what you're trying to remove.

***

Whichever cleaning agents / methods you choose, make sure to validate the cleaning method before commissioning it.

Cheers,
Ronen.

 

[v9991]

I agree with MIREGMGR & also Ronen E;
I believe that merely having a list of cleaning agents would not be adequate;
Here's few references which could help. You can assess for relevance/need....
Current Industry Trends -Including Cleaning and Disinfection trends, Disinfectant Validation Trends, and Current Warning Letter Activity

The Scope of Validation for Cleanroom Disinfectants and Cleaning Agents

http://www.microtestlabs.com/documents/wp_Cleaning-Validation.pdf
http://pharmacie.hug-ge.ch/ens/conferences/fs_cleaning_validation_krk08.pdf