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Frequent Advisor
Posts: 75
Registered: ‎12-15-2010
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Does germicidal cleaning agent need to be sterile?

I am really hoping Eric will comment on this.  Does the germicidal cleaning agent used in the hood need to say it is sterile or just EPA registered?  (My final cleaning step is with sterile IPA.) I would really like to use an accelerated hydrogen peroxide product for cleaning the LAFWs since these products seem to be less harmful to people than the phenols, quats, etc. but I have not been able to find one marketed as "sterile."  I am also confused about the difference between PreEmpt RTU and Accel TB RTU.  Does anyone have experience with either product that they could share?  Thank you so much.

Expert
Posts: 1,152
Registered: ‎02-23-2010
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Re: Does germicidal cleaning agent need to be sterile?

[ Edited ]

Maureen,

 

Currently, there is no requirement in USP 797 for the disinfectant to be sterile.  EPA registration means that the detergent has been approved for specific antimicrobial/viral/etc activity.  In reading the cleaning and disinfecting section of USP Chapter <797>, it leads you to believe that only sterile IPA and sterile water for irrigation are required,  This is NOT true.  A germicidal detergent and water are required when performing cleaning activities.  I have attached a couple of articles that will provide you with a detailed explanation of what needs to be done.   Hope this helps. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Advisor
Posts: 14
Registered: ‎05-08-2014
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Re: Does germicidal cleaning agent need to be sterile?

The new PREempt product line will use the exact same Accelerated Hydrogen Peroxide (AHP) technology and
formulations that made Accel successful. PREempt has a new name, new look, and more relevant label language
but has the same features that the family of Accel products offered.

Advisor
Posts: 18
Registered: ‎07-21-2016
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Re: Does germicidal cleaning agent need to be sterile?

Has anyone heard of the FDA citing as an insanitary condition the use of AccellTB (or now PreEmpt) wipes because they are not sterile? We use this product as PART of our daily cleaning regimen as a germicidal detergent as from my understandings of readings, and posts and my questions, this is required so as to remove residue. Acidified 2% hypochlorite and sterile 70% IPA are not detergents. We also use PeridoxRTU and this can be used as a germicidal detergent if I am correct in my thinking but we use this as our monthly sporicidal agent and not daily.

Any advice, comments, suggestions are welcomed, please.

 

Thank you,

Patti

 

Advisor
Posts: 14
Registered: ‎05-08-2014
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Re: Does germicidal cleaning agent need to be sterile?

There is currently not a requirement in USP <797> or <800> to use sterile disinfectants, although it has been proposed in the revision.  You are correct that both PREempt and Peridox are germicidal disinfectants.  Both contain surfactants, making them cleaners and disinfectants.  They also contain wetting agents to keep them wet on a surface for the required dwell times.

Advisor
Posts: 18
Registered: ‎07-21-2016
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Re: Does germicidal cleaning agent need to be sterile?

Thank you for your reply. This is my understanding for other information i have read and from posts from Eric Kastango exactly about this item. I am glad to have confirmation.

 

Have you heard of the FDA citing its use as an insanitary condition because this happened to us. They came in awhile ago (Dec 2015). Upon followup (now), the only item they questioned, and cited us for its use, was the use of AccellTB as part of our cleaning regimen,  stating it created an insanitary condition because it is not sterile and develop spores  

 

Quote: "However, we still have the following concern regarding your disinfection program.... It appears AccellTB is not a sterile disinfectant. The use of a non-sterile disinfectant may introduce spore contamination into the aseptic processing area and is an insanitary condition. Your firm should address this concern..."

 

In our policy, we do not state that AccellTB (now PreEmpt) is our disinfectant. We describe it as a germicidal detergerent and our sterile disinfectant is sterile 70% IPA. When we use the AccellTB in our cleaning of the PECs, it is followed by sterile 70% IPA and our documentation shows this. 

 

Thoughts?  Anyone else hear of this product being questioned by the FDA? Expert opinions?
Thanks,

Patti

Expert
Posts: 1,152
Registered: ‎02-23-2010
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Re: Does germicidal cleaning agent need to be sterile?

Patti,

 

If your pharmacy was tagged by the FDA, you are stuck in using sterile disinfectants because of your insanitary condition finding.  Unless it PreEmpt container says it is sterile, it will not satisfy the FDA issue.  

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Advisor
Posts: 18
Registered: ‎07-21-2016
0

Re: Does germicidal cleaning agent need to be sterile?

I have no idea what that means Eric. Sorry for my ignorance. The FDA can simply say "use a sterile disinfectant" and then we are stuck with that, even though it does not say that in USP 797? I am so confused. Does a "sterile germicidal detergent" exist? Our PeridoxRTU does not say "sterile" and the FDA did not mention this. They only singled out the use of AcellTB (which is now called PreEmpt). Our 70% IPA is sterile.

 

I really do not understand this at all. Sorry if my frustration is coming through. Do you know what sterile disinfectants there are on the market? Other pharmacies use this product -- I just dont understand this. I am also going to reach out to our Contec Cleanroom rep to see if he has heard this before. I am trying to do the right thing and now it seems the rules just changed and I had no idea.

 

Thanks so much. 

Patti

 

 

 

The PreEmpt website says this:"

Applications

Ideal for use on environmental surfaces in pharmaceutical and life science cleanrooms, labs, and other cGMP facilities (meets USP 797)"

Expert
Posts: 1,152
Registered: ‎02-23-2010
0

Re: Does germicidal cleaning agent need to be sterile?

Patti,

 

The FDA rules supersede USP 797 rules when the pharmacy gets visited and issued an insanitary observation.  There are different rules for pharmacies under USP 797 than there are for compounding facilities that get inspected by the FDA because the FDA does not inspect to USP 797 but GMP.  What did the pharmacy agree to do for the FDA to address their observation?  Did the pharmacy agree to use a sterile disinfectant?  You need to research Steris, Contec, and Veltek products that are sterile and are used in the GMP world.   

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Advisor
Posts: 18
Registered: ‎07-21-2016
0

Re: Does germicidal cleaning agent need to be sterile?

Hi Eric,

 

I have reached out to the Contec and just spoke with their representative and the division manager will be calling me back. We are not cGMP facility but a 503A pharmacy. We did not agree to use sterile disinfectants in our response and reiterated that we follow USP 797 and are 503A. We sent them our policy and procedures on our cleaning regimen and after almost 2 years, their response is that the one issue they have with our process is with the use of AccelTB. 

 

The Contec cleanroom rep stated that PeridoxRTU is both sterile and a germicidal detergent/sporicidal so I guess we can eliminate the use of PreEmpt and change to daily use of the PeridoxRTU but this doesnt seem right to be using a sporicidal daily? And if we use the Sterile peridox in our ISO 7 buffer rooms, is it now no longer sterile? I cannot really quite understand the logic here.

 

So if other 503A compounding facilities or even hospital sites are using PreEmpt (or similar agent) as a germicidal detergent as one step in their cleaning regimen can now be cited for insanitary conditions? I guess the inconsistency in application of the rules is getting to me since I worked and still work at the local hospital in my area and see both sides. My background is in home infusion for 12 years and hospital pharmacy for 10 years and now compounding pharmacy for the past 2 working in compliance. This is frustrating for me.

 

 

I did just speak with the Healthcare division business manager at Contec regarding this issue. It was an interesting conversation. I am awaiting documentation, whenever it is completed, from the Contec Microbiologist who is formulating a response for people in situations such as ours. He called in a "disinfectant rotation document" and said it will be ready to send to me in a few days. I look forward to getting this document.

 

As an option, he confirmed that we could elminate the use of PreEmpt and replace with daily PeridoxRTU, although he feels it is not necessary and if our EM is showing a state of control. But, if we do need to go this route, he said in his opinion, then you do NOT need to replace the monthly peridox with anything else. He said, however, that some inspectors may then require rotational of agents which is not required either. He said the inconsistency of the application of these rules is an issue and understands my concerns. Just wanted to share this with you since I just got off the phone with him and before I sent back a response. 

 

Thanks as always for your response. I know you can't definitively answer my issues but I do appreciate you being out there and responding to my questions. Thanks again for all you do!

 

Patti