Medical Whiteroom Environmental Controls and Evaluation of Contact Plate Findings

[Aliveguy]

Greetings Cove Members,

My question is regarding a medical white room. We currently perform all the dress out and cleaning procedures prior to entering the room and perform daily cleaning procedures on the work surfaces. The products we use for cleaning (right now) vary from 99% alcohol to 70% sterilized alcohol with virtually no difference in our contact plate test CFU’s. I am trying to determine if what we are doing is even the correct thing to be doing. Should we be concentrating more on disinfecting or continue to sanitize? Thus far we have not tested the plates to see exactly what we are dealing with(Gene level only), but hope to do so in the near future. We have increased the number of CFU’s considered allowable until we can determine what a reachable and acceptable number for our application is. Nothing we seem to be doing is reducing the CFU count and was wondering if anyone can give me any suggestions on a product or direction I can look to understand what I am seeing and/or how to manage our cleaning process.

Thanks in Advance for your help !!

 

[MIREGMGR]

Nothing we seem to be doing is reducing the CFU count and was wondering if anyone can give me any suggestions on a product or direction I can look to understand what I am seeing and/or how to manage our cleaning process.

Are you making and/or packing medical devices to be sterilized? If so, and if you've already validated the cleanroom processes and a corresponding effective sterilization process, is there a reason why you are trying to reduce your counts instead of operating a stable process so as to maintain the conditions at which you validated?

The products we use for cleaning (right now) vary from 99% alcohol to 70% sterilized alcohol with virtually no difference in our contact plate test CFU’s.

Spores in particular cannot practically be killed by most sanitization materials without prior exposure to water to cause re-vivification. For that reason, 70% isopropanol is superior to (true) 99% isopropanol as a sanitizer, though 70% is still not very effective. I say (true) because 99% isopropanol is very hygroscopic, and rapidly absorbs atmospheric water if stored in a non-airtight or occasionally opened container.

In any case, isopropanol is not a particularly optimal sanitizer for gram positive bacteria, or outside a surface pH range of 5 to 8.

Lots of medical device makers operate successful processes with no greater understanding of microbiological and cleaning/sanitation issues than you have, once they're set up with an effective validated process. If however you feel that your organization needs more understanding of such issues, perhaps you could get some practical-industrial-microbiology training for someone. Or, you could hire a sanitization consultant/trainer to get you set up.

 

[Ajit Basrur]

Greetings Cove Members,

My question is regarding a medical white room. We currently perform all the dress out and cleaning procedures prior to entering the room and perform daily cleaning procedures on the work surfaces. The products we use for cleaning (right now) vary from 99% alcohol to 70% sterilized alcohol with virtually no difference in our contact plate test CFU’s. I am trying to determine if what we are doing is even the correct thing to be doing. Should we be concentrating more on disinfecting or continue to sanitize? Thus far we have not tested the plates to see exactly what we are dealing with(Gene level only), but hope to do so in the near future. We have increased the number of CFU’s considered allowable until we can determine what a reachable and acceptable number for our application is. Nothing we seem to be doing is reducing the CFU count and was wondering if anyone can give me any suggestions on a product or direction I can look to understand what I am seeing and/or how to manage our cleaning process.

Thanks in Advance for your help !!

Before I give my views on disinfection, let me bring to your attention two points -

1. 99 % alcohol will not kill micro-organisms as 70 % would do

2. why are you performing micro monitoring in a white room - its not a requirement !

For the CFU reduction, you should initially do microbiological evaluation of which organisms flourish on your work areas and then select those sanitisers that would help reduce them. There should also be rotation of disinfectnats to have an effective program.

Hope that helps !

 

[Aliveguy]

We are doing Contact Plate testing because we are Manufacturing a pouched product that is sterilized and want to keep our Bio-Burden under control.

I like your suggestion on the analysis of what we are dealing with and then treat that directly.

What Kind of analysis are we specifically looking to have ?? A Gene identification ??
Is there a name or identification to call this test, so when we request a quote for it, our Labs will know what we are wanting ?? Any help here wouldbe great !!

 

[The Specialist]

Have you looked into reduction of bio-burden by increased environmental and personnel controls such as;

HVAC filtration
Increased air change rate
RH control
Personnel hand-sanitising process or glove wearing
‘Masks’
Etc..?

Reduction of introduction of microorganisms will help keep your bio-burden down too.

At what point is your product sterilised?

 

[Aliveguy]

We have a very good HVAC system that limits airbourne particulated down to slightly better than an ISO Class 7 clean room. We do have a lot of people that go in and out and we think we have a good housekeeping and gowning procedure.
We also have a good positive pressure created, as our entry doors press open easily when accessed.

We are sterilizing our products at Sterigenics in North Carolina. Product does not stay exposed for too long in an open environment. It is either packaged as non-sterile for further processing by Kit packers, or immediately pouched for sterile product.

Thanks for your thoughts and if anyone would like to add to suggestions to keep a Robust Environmental Control program going...please do so.

 

[The Specialist]

Along with ISO 14644-1

Take a look at these example methods and procedure...

They may also help you.

 

[Ajit Basrur]

We are doing Contact Plate testing because we are Manufacturing a pouched product that is sterilized and want to keep our Bio-Burden under control.

I like your suggestion on the analysis of what we are dealing with and then treat that directly.

What Kind of analysis are we specifically looking to have ?? A Gene identification ??
Is there a name or identification to call this test, so when we request a quote for it, our Labs will know what we are wanting ?? Any help here wouldbe great !!

Bacterial identification either by manual or automated methods like VITEK could be helpful

 

[Aliveguy]

70% Alcohol vs 99% for Environmental Cleaning of Micro-Organisms


Hello Again,

We have heard that 70% alcohol is better than 99% for killing Micro-Organisms. I think we are on board with using the 70% again.

However, we were told to only use the 70% if it is sterile and filtered.
Is this really necessary and where can we get it at an economic cost ??
I think it makes sense to have it sterile and filtered, but would like some feedback from the experts (that is you !!!) on this subject to help justify the putchasing costs and usage needs.

Thanks in advance for you help...

Aliveguy ..

 

[MIREGMGR]

Re: 70% alcohol vs 99% for Enviro Cleaning... how about Sterile and filtered ??

we were told to purchase sterile and filtered 70% alcohol for this use. Is there any benefits to purchasing this sterile and filtered ??

Perhaps there is some aspect to your operations that a consultant on-scene would recognize as requiring such an approach. My view in a general Class-8-environmentally-controlled-area context, used for packaging of devices that subsequently will be sterilized, would be that an effective and cost-efficient approach is to alternate surface sanitation materials on a weekly basis between ordinary 70% isopropanol solution (i.e. rubbing alcohol grade, not sterilized and filtered) and commercial "quat" cleaner.

This assumes that the cleaned surfaces are inherently nonreactive, neutral pH, and not contaminated with nutrients, oils or cleaning detergents. This sort of weekly-alternating sanitizer approach helps to prevent surface contamination by microbes that can survive a single sanitizer, i.e. bacillus cereus is poorly killed by isopropanol.

I don't see the advantage of "sterile and filtered" sanitizers unless there is a requirement that the sanitizer in fact function as a sterilizer...in which case alcohols are almost certainly the wrong material choice, and complex issues such as personnel exposure and toxic surface residues must be considered.

Ordinary 70% rubbing alcohol is available inexpensively in bulk. "Quat" sanitizer, either concentrate or pre-diluted, is readily available as well from cleaning-maintenance materials suppliers.