Pharmacy OneSource Blog

Your Sterile Compounding Questions Answered by Eric S. Kastango

Posted on 04/28/16


Our Pharmacy OneSource forums have been a useful resource for those involved in compounding to get insight from compounding peers. Eric S. Kastango RPh, MBA, FASHP, also monitors the forums and has answered questions on compounding, ranging from ISO 5 conditions to beyond use dating. Eric has served on the USP Sterile Compounding Committee and Council of Experts.

Here are some of his responses to your forum questions:

After puncturing and withdrawing from a multi-dose vial (while inside LAFW), does the compounder then have to cover the top of the vial with a foil cover (we call it a diaper) before removing it from the LAFW?

Kastango: The MDV has preservatives in it so as long as you use it according to package insert directions, you are good. Think of an insulin vial when you are trying to figure out how to safely use an MDV. Patients use them all the time, and as long as the septum is disinfected before use and good aseptic technique is used, there aren't any special handling instructions. Read full thread here.

I understand that low/med risk level medial fill testing must be done annually and high risk level must be done semiannually.  Does high risk level testing cover all three levels with one test or is it necessary to perform a separate test annually for low/med risk level testing?

Kastango: Doing a high-risk level media fill will require you to use of non-sterile TSB and make it sterile. You can most certainly design a media fill procedure that incorporates all of YOUR common high-risk level compounding actions in addition to those associated with low and medium-risk level compounding activities. Read full thread here.

Looking for some guidance when using a sporicidal agent in the cleaning of the hood. Contact time of the particular brand of wipes that we are planning to use is 10 minutes.  Does this need to be followed by a single wiping of sterile water or sterile IPA?  

Kastango: Following by wiping with Sterile IPA.  You don't necessary keep it on the surface for 10 minutes.  Those times assumes soiled areas (with blood, protein and other blood or body fluids) so you can minimize those times and verify your disinfectant's activity via surface sampling. Read full thread here.

I see that USP 797 recommends cleaning ISO Class 5 environments at the beginning of each shift, after 30 minutes of continuous compounding, spills and contamination occurs. My questions is, if an ISO Class 5 work area is not going to be used for a 24-hour period, must it still be cleaned on the day it is not to be used?

Kastango: If you aren't going to use it for an extended period of time, leave it clean (after using a germicidal detergent and water) and when you are ready to start using it, wipe it down with sterile IPA. Cleaning on the weekends is not necessary in my opinion. Read full thread here.

In the current chapter USP 797, it states "Glass and metal devices may be covered tightly with aluminum foil, then exposed to dry heat in an oven at a mean temperature of 250° for 30 minutes to achieve sterility and depyrogenation (see Dry-Heat Sterilization under Sterilization and Sterility Assurance of Compendial Articles <1211>and Bacterial Endotoxins Test <85>). Such items are either used immediately or stored until use in an environment suitable for compounding Low-Risk Level CSPs and Medium-Risk Level CSPs.”

Is there a specific storage requirement - area for storage and time limit? Can someone explain what this means? Does this mean it needs to be stored under ISO 5 conditions (environment suitable for compounding Low-Risk Level CSPs and Medium-Risk Level CSPs.”)?? I do not see any reference in the proposed chapter as well for storage of these items. Indeed, even the FDA guidance for industry - Sterile Drug products produced by Aseptic Processing -cGMPs) under section VIII "Time limitations" are vague.

Kastango: Technically, each pharmacy needs to verify the storage period of their sterilized/depyrogenated glassware.  I would interpret this language as saying that processed glassware needs to be safely stored in no less than an ISO Class 7 buffer area. Read full thread here.

Can anyone provide guidance as to where overstock of items used in garbing (face masks, booties, gowns, etc) should be stored? It is supposed to all be stored in ISO 7? Does it state the requirements anywhere? I do not recall ever reading where these items need to be stored. Is the warehouse not an appropriate place, even if in manufacturer bags and/or plastic bins?

Kastango: All of these supplies are stored in warehouses before they get to you.  They need to be stored in a dry and protected area where they can't be contaminated.  Overstock should not be stored in your ISO classified areas. Read full thread here.

What is the minimum required frequency to do surface sampling in ISO5, ISO7 and ISO8 areas? Current USP797 says: Surface sampling shall be performed in all ISO classified areas on a periodic basis.

Kastango: You are correct. There isn't any specific frequency for surface sampling. You can look at the proposed USP 797 for recommended frequencies. Since it is an easy and inexpensive quality metric, I would do it weekly for high-risk level operations and monthly for low and medium-risk level operations. This is my personal best practice recommendation. Hope this helps. Read full thread here.

You can visit the Pharmacy Practice forum to read more and participate in the sterile compounding discussions happening among your compounding peers.

usp 797 success 

Topics: Sterile Compounding

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Heather Quitos is the Digital Marketing Manager for Pharmacy OneSource.