We are not very clean. We surely FEEL clean when we wash our hands, but if you look through a microscope, our skin is a rich ecosystem of bacteria, fungi and yeasts, living on top of microscopic mountains of loose hair, dead skin cells and other debris (sorry for being so graphic, but it is what it is…).
Cleanrooms on the other hand are clean. VERY clean.
So clean we have regulatory standards that specify just how clean they are. If you leave a Petri dish open inside a Grade A cleanroom, it would remain sterile for very long periods (well, at least it should, otherwise- Houston, we have a problem).
So how do we maintain them clean in spite of the… well, not-so-clean Humans that insist on working inside them to make Pharmaceutical Products?
That’s a very big challenge when making sterile products (like Vaccines, Eye drops and countless others). When you want to showcase how cool Pharmaceutical manufacturing is, you usually show the automatic filling lines and pill compression machines, and the absolute coolest- Blow-fill-seal lines.
What usually goes unnoticed are the funny-looking Humans in Astronaut suits standing next to these production lines, and doing an incredible amount of manual work, to ensure this entire thing runs properly, and paradoxically- to ensure the product remains sterile.
It’s amazing to see how much the industry has evolved since the previous inception of the GMP Annex 1. This document tells us how to make Sterile products and an updated version was recently released (after years of back-and-forth drafting efforts of the Regulatory authorities and the Industry).
Big thanks to Simone Biel, Dario Bonanni, Merck, Mercury and PDA Israel for inviting us to the seminar on Annex 1 and Single-use systems. It was a wonderful display of human ingenuity and technology, and the inspiration of this daily post...