05-09-2017 09:18 PM
Some facilities in my area are being cited due to using one alcohol swab on more than one vial or port. They are being told one swab per surface, even if there are multiple vials of the same drug. We are expecting to be visited in the next few months and right now we are using one swab on more than one surface since it is still wet enough to have sufficient contact time. Is there a reference that states this is OK or NOT OK?
05-10-2017 08:13 AM
There is no reference for one wipe per vial and I believe it is TJC who is citing people. It is bull**bleep** because there is no data to support any specific practice. If wipes are being used and they are sterile, then, in my experience it is fine. Inspectors, surveyors, and auditors are focusing on the wrong things when inspecting pharmacy operations. Time to do a study to test what is best practice.
05-12-2017 05:30 AM
On the topic of alcohol pads, we are wondering if the outside of each individual alcohol swab package must be wiped with sterile 70% isopropyl alcohol when being placed into the hood (moving from ISO7 to ISO5 environment). Thank you!
08-11-2017 07:41 AM
Is there a specific amount of times a swab can be used when wiping vials? A JC surveyor told us one swab, one wipe only. She told us that if you swab more than once, then the "contaminants" removed fromt the swab will transfer to the second surface your are wiping. This does not make a whoel lot of sense to me since these swabs are soaked in IPA, but I wanted to clairfy since this was brought up during a recent survey.
08-11-2017 11:03 AM
Since the packaging is essentially a paper type product, wont wiping the product down with IPA possibly risk compromising the packaging, thus compromising the intgerity of the product inside (the IPA swab). My facility is not wiping down the alcohol swap packaging for this reason.
08-12-2017 02:46 PM
The packaging can be wiped down. The key when handling anything inside of the ISO Class 5 PEC is that all packaging and components are not sterile so after handling them as part of your prep, disinfect your gloved hands and allow them to dry prior to doing any aseptic manipulations. This behavior is key to protecting the product/CSP and ultimately the patient. Hope this helps.
02-14-2018 09:50 AM
Hi all (Hi Eric!),
Thought I would chime in here. We just had a mock Joint Commission Survey and this alcohol wipe question must be on a checklist of questions to ask. She asked if we used 1 wipe per vial and per bag. I replied we used a sterile wipe as long as there was still wetness to the critical site - usually 3-4 vials/bags. She said this was something we could be cited for and provided this from USP 797 :
Wiping with small sterile 70% IPA swabs that are commercially available in individual foil-sealed packages (or a comparable
method) is preferred for disinfecting entry points on bags and vials, allowing the IPA to dry before piercing stoppers with sterile
needles and breaking necks of ampuls. The surface of the sterile 70% IPA swabs used for disinfecting entry points of sterile
packages and devices shall not contact any other object before contacting the surface of the entry point. Sterile 70% IPA wetted
gauze pads or other particle-generating material shall not be used to disinfect the sterile entry points of packages and devices.
I said to her that our tech was preparingto make 250 vials of a sterile product and her response was that it was an excessive amount of wipes to open and she would get back to me. Anyway didn't hear back and I am just wondering how you would open 250 wipes keeping trash to a minimum while at the same time maintaining glove sterility. Any thoughts or suggestions? I'm going to research to see if there are bulk packages of alcohol wipes.
Winchester Medical Center
02-14-2018 07:11 PM
Unfortunately, the TJC is taking a literal interpretation of one wipe to one vial, which is unreasonable in my opinion. Not sure there is a way to get around this one. We don't know how many times an IPA wipe can be effective but technically, once it touches a vial septum, it is no longer sterile. Hope this helps.
02-21-2018 03:27 PM
Thanks Eric....not exactly what I wanted to hear!
Can you or anybody else share some suggestions when compounding hundreds of vials? I know spraying is a no-no and we certainly do not want to harm the HEPA filter.