The revision of 797 has some very important changes which I detail in this video series on MyPharmacyEducation.com. Here’s one change that is easy to look over if you’re not looking closely; relating to the types of wipes you need to use when cleaning the PEC:

I came across a post this week on LinkedIn, from another pharmacist here in KY (Warren Finlinson, I’m looking at you) that started out with a simple question, “Should sterile disinfectants and cleaning wipes/pads be required for all CSPs?”

As I read through the post and comments there was something I realized that I actually didn’t notice at first glance. Devin Wallace, CPhT, pointed out that in box 7-1 and 7-2 in USP <797> it states (I bolded the text below, not like that in <797>):

Remove visible particles, debris, or residue with an appropriate solution (e.g., Sterile Water for Injection or Sterile Water for Irrigation) using sterile, low-lint wipers.

Box 7-1. & 7.2 Procedures for cleaning and Disinfecting the PEC – first bullet point in each box

USP Chapter <797> June 2019 Revision

Doesn’t this kind of just make sense though? In the most critical compounding area of your cleanroom, using sterile wipes seems like a no-brainer. But, there’s a few other things I’d like to point out. First, those two places noted, those are the only two places on the page where it mentions the use of sterile wipes; all others: just “low-lint.”

If we’re keeping score at home and following <797> to the letter, no more and no less (SIDE NOTE: I don’t recommend…using common sense to implement your own best (better) practices should be a part of your continuous quality improvement program), you would only be using sterile wipes inside the PEC and ONLY during the cleaning step.

Just to review, “cleaning” by definition, is the physical removal of particles and/or debris. For the next steps it does NOT mention “sterile,” only “low-lint.” The better practice in my opinion is anywhere in your critical, controlled areas (i.e. your cleanroom) use sterile wipers. Sterile cleaning and disinfecting agents would be the next step.

The “Agency” says…

If the fear of an FDA audit weighs heavy on your mind and keeps you up at night, you’ll want to take note of another process improvement step. Multiple 483s of compounding pharmacies mention the use of sterile wipes on the ISO 5 PEC that are being stored under ISO 7 conditions.

Okay, I’ve seen this quite a few times and the FDA definitely doesn’t like when you’re using something stored under a “lower” ISO class (i.e. ISO 7) that is going to be used in a “higher” ISO class (i.e. ISO 5) without wiping it off. But if we’re talking about the wipes themselves, how do we accomplish this? Easy: store the wipes in the hood (PEC).

And now the questions:

  • aren’t you supposed to NOT store “things” in the hood?
  • won’t this block airflow?
  • will we have to validate that with smoke studies?

True, possibly and probably a good idea.

Yes, generally speaking, you shouldn’t store “things” in the hood. However, a low profile container of pre-saturated IPA (or sterile water) wipes won’t be blocking much air and it would be very easy to demonstrate this with a smoke study during your semi-annual certification. (I receive NO compensation from EITHER of these companies for using these images, in no way is this a promotion!)

Texwipe
Berkshire

Another point I often like to make is that, again, cleaning is the “PHYSICAL” removal of…meaning you need to physically wipe off items by mechanical means (your hand) before introducing them into classified areas. I actually do this myself going over any threshold into another classified area (i.e. wipe down before entering anteroom, again before entering buffer and again before introducing into PEC). That’s to say that just spraying items with a disinfectant is not enough, you must wipe them off as well.

Is there something else worth mentioning about the revisions of <795> & <797>? Let me know!

Reach out! Contact me: seth@pharmacyinspection.com 

Always happy to help! #keepraisingthebar

About the Author:

Who dis? Me, Seth. 

Seth DePasquale is a pharmacist and co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. Seth is a 2002 graduate of Albany College of Pharmacy in Albany, NY and is a Registered Pharmacist in New York, Kentucky, Michigan, Oklahoma, Texas, West Virginia, Virginia, Alabama, Tennessee, Mississippi, Arkansas, Nebraska, Louisiana and Oregon.

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