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.

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Polices and Procedures should be updated when you find out they are outdated, but until the change is made, they must be followed!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

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.

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.

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

• 22%   Meet/exceed all requirements
• 56%   Meet most requirements
• 15%   Meet some requirements
• 4%    Plan to address
• 3%    No plan for compliance

With less than a quarter of pharmacies currently fully compliant, here is the projected timeline to compliance for those not there yet:

• 31%   Within 6 months
• 32%  6 months – 1 year
• 23%  1-2 years
• 5%    2-3 years
• 9%   No plans for compliance

Any compliance approach should integrate the ‘loved-one’ rule, where staff are asked to picture loved ones as the recipient of the final CSPs, making the patients they may never meet more real.

One article I read last week online intrigued me: “Ask the Expert: Cell Phones in the Cleanroom”. The expert is none other than Eric Kastango, and his answer is that having cell phones (or MP3 players) in the cleanroom does not keep with the intent of USP 797  for two reasons. First, Appendix I states that only required materials should be brought into the cleanroom, which cell phones are clearly not. Second, it is recommended that procedures be performed in a manner to reduce the risk of touch contamination. When I was at the Baxa STAR Center receiving training, the instructors showed us how many particles a person creates just by walking by a hood. Imagine how many are created when a person is digging under their gown to fish out their cell phone or skip to the next song on their iPod. And you’ve heard studies about how many germs are on a phone’s keypad…

See the short article at http://www.pppmag.com/documents/V6N11/p15.pdf.