Contamination Control News: Compounding the Problem

Question of the Week: When does owning not one but two slick websites make up for the absence of ethics in aseptic processing?

Answer: When it comes to a compounding pharmacy – never!

Yet Professional Arts Pharmacy, a compounding pharmacy based in Baltimore, MD, seems to think that it does. With a confidence-inspiring main website extolling the motto ‘Big enough to deliver. Small enough to care’ and an intimately confidential second one for hormone products, pharmacist Sam Georgiou – owner of both businesses – aims to attract customers who value not only personal service but also a pharmacy that’s prepared to go out on a legal limb. Fortunately for unsuspecting patients, the Federal Drug Administration (FDA) does not see the matter in these same terms.

According to the report from a brace of FDA inspections in March of this year, the company – which trades in compounding medications for both human and veterinary use – was cited for egregious violations of basic cleaning and disinfecting standards. And by ‘basic,’ we really mean BASIC – let’s take a look…

Sterile Solutions prepared without a Safety (or Hair) Net!

Reviewing the damning 6-page report issued by the FDA, you don’t have to read too far to encounter extremely disturbing observations. Let’s highlight a couple of the most horrifying health and safety violations noted by the inspectors…

In one of their ‘ISO 5 cleanrooms,’ technicians are tasked with the preparation of  injectable Glycine – an irrigant used to prevent clot retention. A sterile, nonpyrogenic aqueous solution, this product is intended for use in a surgical environment and is flushed through a patient’s body during prostate or bladder surgery. I think we can all agree that this solution absolutely must be perfectly sterile. Even more so because a ‘non-pyrogenic’ compound by definition must not contain anything that could induce fever. We’ll come back to this point.

However, within the ‘cleanroom’ environment, technicians were observed failing to adhere to some very significant SOPs for producing a sterile product. Some, for example, were observed wearing clothing that was not appropriate for their assigned tasks. One technician, the report details, not only wore non-sterile outer protection (mask, gloves, and shoe covers) but also had exposed hair and skin in the Entry Room, the Gowning Room, and in the Cleanroom. Not at all conducive to the production of a sterile compound within an aseptic environment! Clearly the company needs, at minimum, to revisit their SOPs on gowning practices.

And it’s not only the gowns but also the hoods!

Most industry insiders will agree that laminar flow hoods are a standard piece of cleanroom equipment. And, by following comparatively simple SOPs in respect of disinfection within the contamination-controlled environment, they are relatively easy to clean. Yet in inspectional observation #4, the FDA report zeroes in on Professional Arts Pharmacy’s perhaps idiosyncratic cleaning techniques, noting – for instance – that articles in the hood were not actually picked up to wipe underneath. Furthermore, it goes on to state that, where areas were cleaned, insufficient isopropyl alcohol was used in order to properly saturate the wipe and surface for the duration of the wiping. In fact, the inspector noted specifically: “By the completion of the cleaning, the surfaces did not appear to be wetted.” In addition, the same wiper was used to clean both the exterior and the interior of the laminar flow hood.

And, as a pièce de résistance, during those two fateful visits one inspector also noted ‘a white residue and a yellow residue on the stainless steel back [and] what appeared to be rust along the left hand side of the laminar flow hood.’ Let’s consider this for a moment.

Multi-colored residues and potential rust.

In an aseptic environment.

One that produces compounds guaranteed to be bacteria/fungus/toxin-free.

Used to treat patients who must not be exposed to infection and therefore fever.

Must do better, Professional Arts Pharmacy!

At our most charitable, we could imagine that this is a case of poor training. Perhaps the personnel at Professional Arts Pharmacy – whilst “friendly […] helpful […and] super-nice” (according to one Yelp reviewer) – just need to brush up on their technical skills? If that’s the case then we can all breathe a little easier knowing that these same errors will not be repeated after the company takes a long look at their SOPs. And, in case they’re looking for assistance in this, we’d like to refer Professional Arts Pharmacy to a couple of Berkshire’s own informative articles that will bring them back up to speed. Not sure about the correct usage and volume of isopropyl alcohol? We’ve got you covered at the Learning Center with our guide: Why is Isopropyl Alcohol the Choice for Cleanroom Cleaning? And what about best practices when it comes to using wipes? Folding is crucial and our ‘Proper Cleanroom Wiper Folding and Surface Cleaning Poster’ is an ideal asset for you to print out and keep for reference. Our resources are here for you, Professional Arts Pharmacy, and for any other compounding pharmacy in need of a skills brush-up.

Out on a Legal Limb: A Last Note of Caution

While we already shudder to think of the implications the FDA citations have for human health, one additional aspect of this case also bothered us. In a 2013 Yelp review a customer looking for treatments for her companion animal noted that “They also make stuff that is not FDA approved but that is legal in other countries.”

Make ‘stuff’ that is legal in other countries?

As Berkshire’s animal lovers commented: “If they can’t get the aseptic processing right, who knows what could happen to the poor animals?”

We’d love to know your thoughts. Please leave them in the comments section below!