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.
An ordinary autoclave can't sterilize syringes, but a pharmaceutical
autoclave most certainly can. The trouble with an ordinary autoclave
is that when you evacuate the steam, you replace it with compressed
air to keep the plunger from moving. Air over pressure is very difficult
to control. For prefilled syringes, you need to know how quickly the
solution is cooling and reduce the air pressure at the same rate so that
the plunger is not moving in or out. Think of it this way: If the solu-
tion inside the syringe barrel is boiling, there's no place for the pres-
7 4 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • J U N E 2 0 1 8
