01-23-2017 09:27 AM
In the environment that I work in we use the terms triple clean and terminal clean interchangeably. We tend to refer or use this terminology if we have to clean our IV room when we have non-conforming results. I have heard quite a few people use this and am looking for clarification.
USP 797 does not mention anything to do with a triple clean or a terminal clean. Where did we come up with this? I have seen the phrase TERMINAL CLEAN used in the OR, however in my OR when they do a terminal clean they are not doing a triple clean, and only clean with one agent, one time....So , what does everyone else do? Are these phrases even applicable to pharmacy?
01-23-2017 09:48 AM
You are asking good questions. There have been a lot of discussion on this forum that will help. People use the term terminal cleaning and triple cleaning interchangeably. There is no definition to terminal cleaning but triple cleaning comes from my days working in a GMP operation where we cleaned all surfaces in our cleanrooms three separate but consecutive times. Twice with a germicidal detergent and once with a sporicidal agent. The chapter doesn't expressly talk about using a sporicidal agent for mold, fungi (hopefully not C.diff) and bacillus since our focus in on environmental contaminants in non-patient care areas like the cleanroom in a hospital. A triple clean is best practice and may be required if you have problems with microbiological growth. My interpretation of deep clean involves opening the bottom of a BSC or drip pan of a LAFW (if it has one) to get out all of the residue, dirt, and debris. It could also mean cleaning all surface of the room (daily and monthly cleaning as required by the chapter) at one time. I have attached an article to help give more detail on cleaning. Regarding your post about Peridox, you should call Tech Support at Contec and they can answer your questions. Hope this helps.
01-23-2017 09:53 AM
I appreciate the help - but just to clarify - what is your interpretation as far a sporicidal Agent? You are right I don't think the chapter talks about a sporicidal agent however I think one of the USP chapters does - perhaps something in the 1100's....so what is the USP interpretation of sporicidal? Or is sproicial just not necessary at all since it's not mentioned din 797 and the available products are really not even targeting fungal spores....
01-23-2017 10:08 AM
Chapter 1072 is the chapter you want to look at for more information. I attached a copy for you. A Sporicidal agent is one approved by the EPA as being effective spores. Sodium hypochlorite (various concentrations of bleach), SporKlenz and Peridox are examples of sporicidal agents that we should use in our rooms at least monthly (even though the chapter doesn't tell you this). It is based on experience with environmental excursions and FDA 483s issued to hospital pharmacies.
01-23-2017 10:24 AM
I do have one other question -- I was recently told my a microbiolgist that when doing a triple clean it is important to neutralize between each step. Historically i had used a Quat (germicidal), Accel TB( germicidal) and peridox (sporicidal ) and I had not neutralized in between.
I was told that it would create fumes and potentially lead to respiratory issues. I have not however found this information anywhere else...any ideas? I want to keep my employees safe but don't want to create extra work and I'm not even sure how you would neutralize in between,
02-11-2017 02:01 PM
We believe that a sporicidal agent is very important. When the FDA visited our facility, one of the first things that they asked for was to look at the C of A for our cleaning agents, esp. sporicidal. Alcohol WILL NOT kill spores. Our microbiologist told us that spores makes up a significantly larger percent of contamination in sterile environments than do bacterias, so you need to make sure that one of your cleaning agents will eliminate spores. FDA was very focused on this.