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.

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Polices and Procedures should be updated when you find out they are outdated, but until the change is made, they must be followed!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

Cell Phones in the Cleanroom

You’ll notice that I post a lot of material from articles in Pharmacy Purchasing & Products magazine. They have put a focus on USP 797 compliance that I haven’t seen in other magazines, probably because there is a lot of extra “stuff” to buy in order to get an IV room in compliance with USP 797 and to keep it that way. As a free publication about products and purchasing, it obviously makes its money through advertising, but I have found the articles to be excellent as well, especially those on USP 797.

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.

USP 797 Tip: Spread out Employee Competencies for Early Warning System

I liked this suggestion given by Eric Kastango in Pharmacy Purchasing & Products magazine’s Cleanrooms & Compounding supplemental issue in 2009:

The activities associated with hand hygiene, media fill, surface sampling, and gloved fingertip sampling are often misunderstood. The purpose of these quality elements is to demonstrate proper aseptic technique for compounding personnel…

Once all compounding and supervisory personnel—including pharmacists and technicians—have completed their initial training (regardless of their previous experience), these elements can be integrated into each employee’s annual or semi-annual training. It may be best to validate the competency of a few employees each month, avoiding a mass staff competency verification performed once a year. By dividing staff and performing these activities on a monthly basis, this process will also provide a baseline of microbial bioburden data for the controlled work areas. These data can serve as an early warning system to prevent processes, personnel, and/or facility operations from migrating out of a state of control.

By spreading media fill, glovetip, and surface sample competencies through the year, not only do you avoid the stress of doing them all at once, but perhaps more importantly you will know as soon as results are starting to creep out of range rather than waiting until the 6-month certification.

USP 797 Tip: Beyond Use Dating

USP 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 miss the “unless otherwise specified by the manufacturer” part of the section.

USP 797 Tip:Caulk Ceiling Tiles

From an article by Eric Kastango in Pharmacy Purchasing and Products magazine:

“Chapter 797 requires that ceiling tiles be caulked in place to ensure they do not move, become dislodged, or get damaged during cleaning. The presence of caulked ceiling tiles is especially important in negative pressure ISO Class 7 buffer areas to mitigate the introduction of dirty, unfiltered air from the ceiling plenum. This design element is an easily identified requirement and is frequently cited by board of pharmacy and department of health inspectors.”

February USP 797 Tip of the Day: Never mix hazardous drugs in a LAFW (laminar airflow workbench).

Never mix hazardous drugs in a LAFW (laminar airflow workbench).

Working in a LAFW does not provide any protection to the person using it. Hazardous drugs must be prepared in an appropriate ISO Class 5 EC.

Daily tips in February are from a document Eric S. Kastango produced in 2006.