04-08-2010 12:21 AM
I had such good luck getting an answer to my question on viable air sampling that I thought I would give it another shot. Hopefully, I'm not pushing my luck!
USP 797 states that gloved fingertip sampling shall (read MUST) occur immediately after exiting the ISO Class 5 environment. The gloves, of course, must be sterile gloves. Now, the question to which I have yet to see a practical answer, is a multi-parter.
We only have CAIs for our Class 5 environment. I have read that the sterile gloves must be worn over the CAI gloves. I know that is going to be somewhat difficult, donning sterile gloves over the CAI gloves while ones hands are in the CAI gloves and there is no one to assist you (as in surgery). But, let us assume that we can pull the sterile gloves over the CAI gloves.
Now we must perform a gloved fingertip sampling. USP 797 states that the sampling must be done after a compounding session before the gloves are disinfected. USP 797 further states that the sampling must be done after exiting the Class 5 environment. It is not to be done inside the Class 5 environment.
So, we remove our hands from the CAI gloves in order to exit the Class 5 environment. However, our (once) sterile gloves that we placed over the CAI gloves are now laying inside the Class 5 environment. How can we accomplish the gloved fingertip sampling outside the Class 5 environment?
The only possible way I can see would be to have someone place the media plate inside the pass-through chamber, the operator opens the chamber from inside the CAI and, without removing the media, reaches into the chamber and presses his fingertips onto the plate. But, with the chamber now open to the Class 5 environment (and possibly extending into the Class 5 environment on a slide-out tray from the chamber so it can be reached with both hands) is the sampling really occurring outside of the Class 5 environment?
Now, just a short question about surface sampling. USP 797 states that "Surface sampling shall be performed in all ISO classified areas on a periodic basis." What period of time should we consider as "periodic"? I have seen that interpreted as anywhere from once a week to once every 6 months. What would be the most appropriate period?
Thank you for your help.
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04-12-2010 11:54 AM - edited 04-12-2010 11:54 AM
I cannot find your chapter reference that sampling needs to occur immediately after exiting the ISO Class 5 environment. Due to the nature of an isolator, gloved fingertip sampling needs to occur within the ISO Class 5 buffer chamber. You want to avoid having a media plate in the main buffer chamber while working with patient preparations. Glove Fingertip and surface sampling should be considered personnel-related metrics that allow you to evaluate the aseptic technique, routine disinfection of gloves and surfaces of compounding personnel (see attached article). I recommend that you conduct these two activities during annual or semi-annual personnel media fills.
04-13-2010 10:10 AM
Thank you, Eric. You have been very helpful in clarifying the sampling issues I had. I also reviewed the chapter carefully trying to find a reference to the glove fingertip sampling having to be performed outside the Class 5 environment. As you said, not there.
I did, however, locate the source from which I got the idea. I have a copy of the article I downloaded, however, I can't find it's source. I had assumed that it was "official" because at the end of the article is printed a copyright symbol followed by "The United States Pharmacopeial Convention All Rights Reserved". That line also appears at least once in the body of the article. I have attached a copy and perhaps you can identify its source.
Robert Martin, PharmD
04-14-2010 02:21 PM
You are quite welcome. Thanks for sending me the document. This document is old, copyright 2006 and contains language from the proposed changes that were never approved. I believe this document came from a vendor site but you need use the current chapter as your reference document. There are lots of legacy documents on the Internet that is not current or accurate. Be careful and verify your sources.
05-13-2010 09:20 PM - edited 05-13-2010 09:20 PM
Three-time cleaning means performing three separate cleaning events (floors, walls and ceilings) using a germicidal detergent twice followed by the use of a sporicidal agent like bleach.
Re: the slit in the gown, I do that to prevent my gown sleeve from getting pulled up from under my gloves.
06-02-2015 03:18 PM
I have a question and apologize if this has been answered somewhere and didn't notice yet. I have been collaborating with my colleauges trying to figure out the number of glove samplings within/use of positive pressure CAI. I've found in the 797 chapter under the paragraph "Asceptic Work Practice Assessment and Evaluation via Personnel Glove Fingertip Sampling"....where is says "
"Sterile contact agar plates shall be used to sample the gloved fingertips of compounding personnel after
garbing in order to assess garbing competency and after completing the media-fill preparation (without applying sterile 70% IPA)"
Ok,..it's my understanding that when 797 indicates ISO 5 environments saying PEC that this (pre and during media fill sampling if you will with 2 x 2 samples for both hands = 4 total glove samples) INCLUDES CAI's as well as LAFW's and BSC's? Am I correct in interpreting that this sampling is the same for ANY/ALL PEC's? Because the confusion we're having is the fact that it's a CAI, that only 1 set (garbing competency) is required.
and thank you in advance for your input on this!
06-02-2015 08:40 PM
Thanks for the insightful questions. There are issues/conflicts in the chapter as we continue to embrace its requirements and figure out how to implement it. Not sure there is only one garbing competency for users of CAIs. Technically, the chapter says that garb is required unless the manufacturer provides evidence to support not using it. Taking that statement at face value, is any garbing competency required other than donning sterile gloves within the main chamber of the isolator? I can tell you the intent was to ensure that people were properly performing hand hygiene and garbing activities including the donning of sterile gloves regardless of the PEC being used. The chapter needs to be modified to reflect the waivers given to CAIs and properly describe the requirements. PPE needs to be worn when working with hazardous drugs so garbing competency can be done when working in a CACI. The gloved fingertip sampling is required x 3 with ZERO CFUs on both hands and then after the media fill based on the risk level frequency (annually for low/medium-risk, and semi-annually for high-risk) regardless of the PEC used. Hope this helps.
08-17-2015 03:23 PM
Is there a process that anyone follows for remembering to check the samples that are put in the incubator instead of signing into OneSource everyday? I have other technicians that are doing the environmental sampling but they do not let me know when the samples are placed in the incubator. By the time i notice they are in there, the time has already passed for the due date. Any suggestions would help!