A recent LinkedIn post by Cleanroom Contamination Control Expert, Morgan Polen, outlines the existing issues with the common Cleanroom Personnel Practices and Contamination Control designs.
Regardless of the Cleanroom Validated Specs and what the room is used for, and what those specs and the use it’s not all speculation without having the paperwork. Everyone’s definition of sterile must be compliant with the regulatory agency’s definition. As the commentary on the initial post says, you don’t need paperwork to see outdated Contamination control design and personnel practices.
As some of the former and current FDA consultants advise in the comments is that “The most important feature for contamination control is a barrier between the person and product.” This statement is something that we’ve been preaching for years now. We have met some resistance concerning the perceived “compliance” with USP 800 of the equipment (XLTC800) discussed below. For those that don’t know, USP800 is a pharmacopeia establishing guidelines for hazardous drug (HD) handling in hospital and independent pharmacy settings. The resistance met is not because anyone feels the approach inferior, to the contrary, all USP800 expert panel members, BOP executives and pharmacy directors we have presented to, pretty much unanimously feel that our XLTC 800 equipment, as a “stand alone” installation, yields a safer environment.
Among the comments of that original LinkedIn post, you can find a comment from a retired FDA and VA OIG inspector that states “The only Sterile Open Laminar Flow bench is the one that has just been cleaned but was never used.” In addition to that, regardless of the Brand name, model and specs of the Open hood, there are many contamination-related concerns about whether a BSC is better than horizontal LAFs. Most of these are completely irrelevant as the operator often seems to be working on the edge of the hood or even outside of it. Another FDA expert stated “I’ve walked into many pharmacies like this. After 40 observations, I quit. As Luis and other FDA stated, it’ll be interesting to see where FDA stops and states, “it’s time to start recalls.” I thought we would have improved by now.”
All these comments should not keep compounding pharmacies away from “sterile” compounding. The American Componding industry is stuck in the 20th century! Instead, compounding pharmacies should be more open-minded and consider all variables and all the risks of the personnel malpractices before developing their Contamination Control strategy.
To learn more about our XLTC 800 solutions, please take a look at our standard and custom Aseptic and Sterile application solutions. We’ve also done a study on how our XLTC800 compares against the current USP 800 regulations, you can find out more here.
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