USP 797 FAQ: Dating Multi-dose Vials

From Eric Kastango’s article in the recent Cleanrooms & Compounding issue of Pharmacy Purchasing & Products magazine (unfortunately, it doesn’t appear to be online yet – but several other excellent article related to USP 797 are available online):

There continues to be significant confusion regarding the storage period for multi-dose vials subsequent to their initial puncture. Many organizations have been cited by The Joint Commission, state boards of pharmacy, and departments of health for not discarding multi-dose vials after 28 days. The Multiple-dose Containers Section of USP Chapter <797> states that the “BUD for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives is 28 days (see Antimicrobial Effectiveness Testing <51>), unless otherwise specified by the manufacturer.” Many organizations have missed the “unless otherwise specified by the manufacturer” part of the section. The CDC’s Vaccine Storage and Handling Toolkit is an excellent resource on the storage and handling of vaccines. The CDC states, “a vaccine or diluent may be used up to and including the date on the vial unless otherwise stated in the product package insert.”

Use AutoPharm Remote Ordering to restock your clean room

Saw this on Jerry Fahrni’s Pharmacy Informatics blog today and thought I’d share the suggestion, as it addresses a major inconvenience that the USP 797-compliant cleanroom has created with the gowning and garbing requirements: moving in and out of the cleanroom to get supplies. Might not work for everyone, but for those with the right technology in place:

The AutoPharm software utilized by our carousels offers a function called “Remote Ordering”. Using the remote ordering function is really quite simple.

  1. Use the AutoPharm software to create a template containing items specific to the clean room.
  2. Create access to the template via any web browser (image 1 on the left below).
  3. Use the template to select items necessary to restock the clean room and place the order (image 2 in the middle below)
  4. The order appears in the the active orders queue in AutoPharm (image 3 on the right below). The order is pulled by the technician assigned to the carousel and taken to the clean room where it gets put away.

For more details, see the complete post on Jerry Farhrni’s blog:

Checklists save lives – why aren’t they used more in healthcare??

Checklists are used in many industries to make sure that multi-step procedures are done correctly and that no steps are missed. Airline mechanics use them, airline pilots use them, the military is full of them, even janitors use them to make sure they get each part of the bathroom clean. So why aren’t they used more in healthcare, when getting procedures right can literally be a life and death matter? Today’s Wall Street Journal article puts part of the blame on hospitals’ culture. If nurses and physicians were less concerned about politics they could save lives by using a simple checklist to prevent Hospital Acquired Infections.  

USP 797 deals with preventing infections as well. Do you use checklists to make sure things are done correctly? Maybe you should consider starting… how detailed are your compounding logs to make sure that each step is not missed? is everything getting cleaned the way it needs to, especially on the less-frequent weekly and monthly cleanings? automix pre-compound checklist? equipment calibration? the lists can go on and on…

Monthly Cleaning Checklist

Could a simple solution like a checklist make a difference for patient safety and USP 797 compliance in your cleanroom?

Weekly USP 797 Tip: Not all glove boxes are created equal!

This Week’s USP<797> Tip (week of 10/26): Not all gloveboxes are created equal! Compounding Aseptic Isolators, AKA glove boxes, must be placed in a ISO class 7 cleanroom unless you can prove that they can maintain a class 5 environment in dynamic compounding conditions outside of a cleanroom. The manufacturer should be able to provide this certification for you. If they can’t, look for a new manufacturer!

FAQ: Does my state require adherence to USP 797 regulations?

Clinical IQ has an interactive map on their website that allows you to see your state’s BOP position on USP 797 regulations. You can then drill down for more information including the direct reference in the state regulations addressing the topic. It also includes a CE requirements summary.

USP 797 State Map

As an example, here is what is listed for the state of Massachusetts:

Mass 797 Requirements

USP 797 FAQ: What are the requirements for the use of sterile alcohol (IPA)?

I’ve heard a lot of questions about when to use IPA versus bleach or other cleaning/disinfecting agents. Here is what the USP FAQ page includes on the topic:

30. Can vials be cleaned with alcohol swabs or 70% IPA wetted gauze pads?

Alcohol swabs must be sterile. 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 (see Cleaning and Disinfecting the Compounding Area).

31. Can nonsterile 70% IPA be used to disinfect surfaces other than those in the DCA (direct compounding area) of the primary engineering controls in the ISO Class 5, 7, and 8 areas?

Yes. The chapter requires that surfaces be cleaned with sterile water for irrigation or injection to remove any soluble residues with low-shedding wipes. This is followed by wiping with a residue-free disinfecting agent (such as sterile 70% IPA), which is allowed to dry before compounding begins. However, the Chapter does not require that the residue-free disinfecting agent be sterile.

33. How soon before going into the BSC (biological safety cabinet) do supplies need to be sprayed with sterile IPA?

If supplies are sprayed immediately before being introduced to the BSC the operator minimizes the risk of touch contamination that may occur if supplies are sprayed in advance.

34. We currently store syringes and needles in bins in the buffer area. Can we wipe every syringe down the day before and restock bins to get ready for the next shift or do we need to remove them from the buffer area? Do they need to be wiped immediately prior to use? Can we re-spray with sterile IPA in the buffer area?

Removing supplies from the buffer area on a daily basis is not required. If supplies are disinfected prior to use it minimizes the risk of touch contamination. Re-spraying with sterile IPA in the buffer area is acceptable.

35. Do you recommend spraying sterile IPA and wiping with something dry (like Texwipe) or using a pre-moistened sterile wipe? Does it matter?

Pre-moistened sterile IPA wipes are acceptable. Water-soluble residues can be removed with sterile water and low-shedding wipes. This is followed by wiping with a residue-free agent such as sterile 70% IPA which is allowed to dry.

37. Can bleach be used as appropriate cleaning agent and can diluted bleach be used exclusively as a disinfectant?

Bleach can be effective as a disinfectant but is inactivated by proteins. Bleach is not appropriate for disinfecting critical sites. Bleach is appropriate if followed by sterile 70% IPA wipe (see question #34) Consideration for the selection of cleaning agents should be given to the effect on surfaces and potential respiratory, skin, and eye irritation to the operator.

39. Are instant hand sanitizers adequate for use in the cleanroom?

Products for use in the clean room must be classified as a waterless, surgical hand antiseptic.

43. Are we required to use sterile IPA for everything, including cleaning carts before bringing them into the clean room or just for the actual compounding activities?

Sterile 70% IPA is required for critical sites. Other disinfectants may be appropriate for carts and other surfaces. Consider the effect on surfaces, material compatibility and the operator.

Weekly Tip (10/18/09): Free Educational Webinar Resource

This week’s tip: go to to view archives of webinars from expert Eric Kastango including “The Top 10 Gaps in USP 797 Compliance” and “The Use of Isolators in Compliance with USP 797.”

This link sounds like a shameless plug for Pharmacy OneSource’s Simplifi 797 product, but at the bottom of the page you’ll find a list of webinars unrelated to Simplifi 797 that hundreds of attendees have found very valuable. Those topics include:

– 09/09 Free Webinar “The Top 10 Gaps in USP 797 Compliance” with Eric S. Kastango
– 06/09 Free Webinar “Use of Isolators in Compliance With USP 797” with James T. Wagner

– 03/09 Free Webinar “Seven Deadly Myths of USP Chapter 797” with Eric S. Kastango
– 12/07 Free Webinar “USP 797 – Should vs. Shall” by Eric S. Kastango