Educational reference only. Not medical advice. Nothing on this site is for sale.
Latest
Sign in

Compounding, the whole story · Part 7: How a regulated compounding pharmacy works

Clean air, trained people, watched rooms

Lesson 5.7.2 · 7 min read · Advanced plan

What you'll learn

  • Sterile work happens in an ISO Class 5 device, often inside a pressure-controlled cleanroom suite.
  • Categories 1, 2 and 3 differ by where they are made and how long they may be kept.
  • Staff must prove aseptic skill through glove sampling and media-fill tests.
  • Air and surfaces are monitored for microbes, because problems must be caught early.

← Who writes the rules: USP <795> and <797> · All lessons in Compounding, the whole story · Beyond-use dates, sourcing and testing →