Webinar Tomorrow: Decreasing Costs in your Sterile Compounding Operation without Sacrificing Quality

There is a tremendous amount of pressure on pharmacy leadership to cut operating costs in their departments and many compliance elements of USP 797 are viewed as expensive and ripe for replacing or ripping out. Eric S. Kastango, MBA, RPh, FASHP will provide the attendees with actionable ideas that will improve the efficiency of your sterile compounding operation which will result in decreased costs without sacrificing quality.

Wednesday, May 9, 2012 1:00 PM – 2:00 PM EDT

Click here to register for the webinar.

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How to Clean and Disinfect a Glovebox (CACI)

This month’s issue of Pharmacy Purchasing & Products includes an article from Luci Power, MS, RPh, and Eric Kastango, MBA, RPh, FASHP, addressing the proper approaches and processes for decontaminating “gloveboxes” – compounding aseptic container isolators. There seem to be a lot of rumors and misunderstandings regarding gloveboxes and what is required to care for them. The article goes into detail on the best practices for changing gloves, cleaning, and disinfecting the chamber.

Click here to see the complete article. If you have a CACI, follow the manufacturers recommendations for cleaning – this article will prove a valuable additional reference.

Coated vs. Corrugated Cardboard and Insubordiantion

On the Pharmacy Operations Blog from Pharmacy OneSource that I mentioned in an earlier post, there was an interesting thread  last week that highlighted an issue that I hear about from time to time: boxes in the cleanroom, as well as a more important issue of compliance to policies and procedures.

One person posted a question raising a concern that a technician had taken a coated cardboard box into the cleanroom that had the lid ripped off, exposing shredded cardboard underneath the coating. The tech was told to remove the box due to concerns about introducing extra particles. The tech repeated the offense a couple days later, stating that he “did not agree enough to comply”. The question was, “Am I correct (that torn cardboard should not be allowed), or am I going overboard?”

A follow-up post suggested that they allow coated cardboard in their cleanroom, but not corrugated cardboard – a position that I hear often.

Eric Kastango’s reply addressed two issues. First, concerning the box question, he suggested that if they had an operating buffer area that met USP 797 requirements, he wouldn’t anticipate that they should be particularly concerned (pun intended!) with a coated box that had a ripped off lid (see an earlier post addressing a related question about using printers, pencils, etc. in the cleanroom). However, his second point was that if the facility’s Policies and Procedures do not allow this type of boxes in the cleanroom then it is not up to the  technician to determine if they agree or not. If they do not comply, they should be disciplined accordingly.

Polices and Procedures should be updated when you find out they are outdated, but until the change is made, they must be followed!

The original forum thread can be found here (requires a free membership).

Eric Kastango’s webinar: “Understanding USP 71 Sterility Tests and Extended BUD”

Eric Kastango just did a webinar on Wednesday titled “Understanding USP 71 Sterility Tests and Extended BUD.” You can view an archive of the webinar at http://rph.com/webinars/.

Excellent Blog about Pharmacy Operations

I know its been a while since I posted last… summer is finally kicking into gear here in Seattle and life seems to get so much busier! I just got back from a camping trip with my wife and 3 daughters. But you’re not here to read about my personal life…

I highly recommend you check out the Community Forum that Pharmacy OneSource has recently started. Among other topics, it has a great section on Pharmacy Operations that includes lots of Q&A about USP 797, and usually the answers come directly from Eric Kastango. Check the forums here.

USP 797 FAQ: How large does the ante-room need to be?

From USP’s FAQ on USP 797 page:

126. Is a large ante-room required, or would a small vestibule for hand washing and donning of protective garb be sufficient? In other words, could there be an IV work room that is unclassified where the computer input, unboxing and storage of IVs takes place outside of an ante-room to reduce the square footage of space required to be ISO 7 or 8? The IVs would still pass into the buffer area through the vestibule that is the ante-room.

USP does not define the process flow requirements. A small ante room that simply facilitates hand hygiene and gowning is adequate.

California Compounding Regulations FAQs Being Sought

Just received this email from the California State Board of Pharmacy:

Compounding Regulations FAQs Are Being Sought

The California State Board of Pharmacy announces that at its Enforcement Committee Meeting  on June 16 in Sacramento,  a question and answer session will be held to discuss the Board’s Implementation of 16 California Code of Regulations Sections 1735-1735.8, Pharmacies That Compound, and Sections 1751-1751.8, Pharmacies That Compound Sterile Injectable Medications.  These requirements will go into effect on July 6, 2010.

Questions for the Board’s Enforcement Committee to answer about the compounding regulations may be submitted in advance to Susan.Williams@dca.ca.gov.  Questions and anwers developed will be posted on the board’s Web site in the future, so those individuals submitting questions do not need to attend the meeting.  Not every question submitted may be answered by the committee.

Please click on this link to view the Enforcement Committee Meeting agenda:

http://www.pharmacy.ca.gov/meetings/agendas/2010/10_jun_enf.pdf