Sterility Assurance Matters to This ONE

I’m wondering if we often attempt to create a culture/behavior around Sterility Assurance by starting with the guidance documents, regulations, biology/engineering, and/or design level to make our case for the sterility assurance foundation. These are perfectly acceptable aspects of driving towards sterility assurance, but sometimes I wonder whether we have forgotten the incredible gift we have been given to work in an industry that produces formulations and devices and molecules and conjugates and therapies that change the trajectory of one’s life. I recognize we know it from a science level, but do we still embrace it with a passion of “how incredible is this” and do we help our colleagues remember and realize this blessing we have been given as well to work under this umbrella we call “Sterility Assurance”?

For many of us, these drugs or devices have been used by one of our neighbors, perhaps a friend, a family member and/or even by ourself. A medicine that has extended life, improved the quality of life, and most importantly, provided hope during a difficult time in one’s life.

For all of us that work in this industry that produces sterile products, drugs and devices tested for bioburden, and devices used for humans or animals that serve an important purpose, we should start our foundation with: What it does and How it does it.   Then we should take some time to explore who discovered the molecule, how did its function become identified, who thought of the novel idea of “attaching” it to another molecule to enhance its activity, what illness/diseases does it treat. I believe that if we can once again soak in the pure awe of what we are involved in, then the WHY of design, validation, sterilization, aseptic technique and assurance of sterility can be solidified in our daily activities and our desire for continuous improvement. What if the regulations, guidances, audits, observations, inspections could become essential tools for us to use to improve our craft and communicate our learnings to one another. Perhaps a little mushy and maybe naïve, but perhaps worth a try for us to rekindle our awareness of the products that we encompass.

If we do this, then each employee who manufactures a vial, syringe, bottle, bag, device can watch it as it goes through the production process and embrace a passion that sterility assurance matters to each one of those units. An intervention performed with minimal risk, the sterilization cycle validated successfully, cleaning and sanitization realized as a valuable step and not a chore, and all the information captured flawlessly in the release of that ONE UNIT can be a moment of pride. The continuous plastering of 483’s, Warning Letters, OAIs, etc., often related to sterility issues tells us that we are missing the “it matters to this one” message.

It is such a simple read and yet I often enjoy rereading the story written by Loren Eiseley, referred to as “the starfish story”. The young child taking the time to save as many starfishes as possible knowing how important it was to each one of them regardless of the challenge and how others may view his efforts. It has a message that can be utilized in so many ways and I find it has value as well in the arena of sterility assurance and each unit that we produce.

Thanks for giving me my “Jerry Maguire moment”.


Greg Gibb, Ph.D., microbiology, is an independent consultant for Quality Executive Partners, Inc. (QxP) and brings with him more than 30 years’ experience leading pharmaceutical/biotechnology partners to FDA compliance in operations. His expertise and experience focus on aseptic processing, quality control, quality auditing, change control, and GMP. Gibb has served in both technical and management roles in API and drug product production processes in the U.S. and internationally.

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