04-13-2011 11:53 AM - edited 04-13-2011 02:21 PM
Thanks for joining our presentation with Eric Kastango and Alice Weissfeld, "What's "Bugging" You About USP 797 Environmental Sampling?"
Have a question for Eric or Alice? Post them here and they will be answering your questions as best they can.
04-13-2011 02:43 PM
Here is a question from our live presentation:
Q: USP <797> does not outline the frequency for surface sampling. What recommendations do you have? Are your recommendations based on risk level of compounding?
04-13-2011 03:47 PM - last edited on 04-13-2011 03:49 PM by HeatherQ
Where can we purchase the agar contact plates shown in the presentation?
The following vendors sell contact plates for surface or gloved finger-tip sampling:
Hardy Diagnostics: 800-266-2222
04-14-2011 09:22 AM
I understand that proposed changes to USP 797 include the use of malt extract agar for airborne contaminant testing? Will that apply to surface and fingertip sampling too? If not, why? Also... I cannot seem to find a copy of the proposed changes on the USP website. Can you provide a link to these changes?
Thanks for the enjoyable presentation yesterday.
04-15-2011 09:01 AM
Thanks for your kind words. If you visit http://www.usp.org/USPNF/pf/ and register to access Pharmacopeial Forum for free, you can go to PF 36(3) and look for the revisions. There should be additional changes in the coming months.
04-18-2011 05:58 PM
At the bottom of page 54 of "Compounding Sterile Preparations: ASHP's Video Guide to Chapter <797>" there is a table entitled "Maximum Time That a Container Can Be Used". One of the listed containers is "Pharmacy Bulk Package", which I know includes such things as frozen antibiotics or pre-diluted bags of Ranitidine. I work at a pediatric hospital where we frequently compound dilutions of drugs in bags which we use to draw up our batches. Would these bags, which generally consist of a medication added to a bag of either D5W or NS, fall under the classification of Pharmacy Bulk Package when determining the length of time they can be used, based on <797>? If not, how would you determine exactly how long one of these bags can be used? There is stability, but not sterility, info on these kinds of admixtures available.
04-20-2011 09:35 AM
In my opinion, surface sampling should be integrated with employee media fills and then once a month to see how effective your cleaning process is. This will give you an objective metric to provide employee feedback.
05-04-2011 01:02 PM
While discussing the spectrum of Environmental sampling , was any discussion of end product testing? ANd frequency ( it probably correlates to risk of CSp compounding)
Also Eric you briefly touched on TPN compounder tubing changes, does USP 797 address or is this a a specific vendor supplied or recommendation
05-18-2011 11:48 AM
I am not sure I agree that frozen antibiotics or pre-diluted bags of rantidine fall into the category of Pharmacy Bulk Packages (PBP). The official USP definition of a PBP found in USP Chpater <1> Injection is:
A Pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes. The closure shall be penetrated only one time after constitution with a suitable sterile transfer device or dispensing set
which allows measured dispensing of the contents. The Pharmacy bulk package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
Designation as a Pharmacy bulk package is limited to preparations from Nomenclature categories 1, 2, or 3 as defined above. Pharmacy bulk packages, although containing more than one single dose, are exempt from the multiple-dose container volume limit of 30 mL and the requirement that they contain a substance or suitable mixture of substances to prevent the growth of microorganisms.
Where a container is offered as a Pharmacy bulk package, the label shall (a) state prominently “Pharmacy Bulk Package—Not for direct infusion,” (b) contain or refer to information on proper techniques to help assure safe use of the product, and (c) bear a statement limiting the time frame in which the container may be used once it has been entered, provided it is held under the labeled storage conditions.
I would consider those dosage forms as single dose containers that could be used for up to six hours in a hood when used to prepare subsequent CSPs. This issue is one of many under consideration by the USP Compounding Expert Committee.