Archive June 2018 XIX, No. 6

4 Questions to Ask About Prefilled Syringes

Here's what a compounding pharmacy consultant would want to know.

Christopher Smalley

Christopher Smalley, RPh

BIO

Scott LaBorwit, MD
INQUIRING MINDS What should you ask your compounding pharmacy about the prefilled syringes it produces?.

Before I would ever purchase prefilled syringes from a compounding pharmacy, I'd first ask the pharmacist a long list of questions. Aseptic filling or terminal sterilization? Have you done stability studies? Are you compliant with USP <797>? Are you a registered 503B facility?

The answers I received to these and a few other queries would determine which pharmacy got my business — and which I'd avoid like an outbreak of fungal meningitis.

Not that I'm in the market for prefilled syringes these days. You see, I was a sterile compounding pharmacist for more than 20 years in military hospitals. After retiring from the military, I worked for companies like Sanofi, Wyeth and Merck, where I saw firsthand the standards to which manufacturers are held. Now I'm a compounding pharmacy consultant, working with pharmacists to design, build and operate compliant compounding facilities. Yeah, you might say I've seen the compounding pharmacy industry from every side. But if I were in your shoes, here's what I'd ask a compounding pharmacy.

1. Aseptic filling or terminal sterilization?

You'll likely get this response: "Oh, we don't autoclave our syringes. We aseptically fill." I would be willing to pay more for terminal sterilization. The added assurance that all microbes are absent is worth a lot to me. Plus, the aseptic filling of injectable drugs is challenging.

I'd follow up with: "What kind of testing do you do to ensure that your operators have the skill to properly aseptically fill?" You'll want to hear that they test the gowning (and gloving) of their operators weekly and every several months perform a media fill with tryptic soy broth to be sure everyone's qualified. By the way, the New England Compounding Center (NECC), the compounding pharmacy that became the center of a scandal resulting from a meningitis outbreak, was aseptic vial filling the methylprednisolone for injection that was contaminated with fungi. Had NECC autoclaved their syringes, they would have destroyed the fungus.

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