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Principles of sterilization – From A to Z

Introduction

Sterilization is a critical process in the pharmaceutical industry for the control of microbial populations. While most prevalent in the manufacture of sterile products it can be used in a variety of settings where microbes have potential impact on patients or products. Sterilization really isn’t that difficult, but inattention to science through excess criteria and constraints can make it an onerous task.
What’s the Objective?

• Removal of objectionables / specified microorganisms
• Control of microbial population
-Reduction in count
-Complete elimination
• It’s important to understand the real process need more completely than what this might otherwise suggest.

What’s the Target to be Sterilized?
[…]
What Process to Choose – 1

• There’s a fly in your living room, what do you use to kill it?
• A fly swatter
• A shotgun
• A piece of artillery
• Obviously we would use the fly swatter and that advice is appropriate in microbial control as well.
• We should use the process that best fits the target objective.
• Unfortunately, most practitioners in microbial control take the process to extremes as a matter of routine. That’s acceptable at times, but not always.

Microbial Control Processes

• Disinfection – a process that will eliminate infective organisms.
• Sanitization – a process will reduce the overall microbial population.
Depending upon the agent

What’s Wrong?

• Despite the maturity of the subject, the practice of sterilization within the global healthcare industry has descended into rote repetition of wrong headed expectations.
• Regulatory obfuscation and industry apathy have caused all manner of unnecessary complications and added patient risks.
• Rather than making products safer, we may have actually increased patient risk!

Why did it go Wrong?

• We’ve paid only limited attention to the basic science underlying sterilization.
• We’ve ignored the effect the various processes have on the materials.
• We have relied on overly simplistic models and ignored the core scientific principles upon which sterilization process must be
constructed.
• If we haven’t made it sterilization any safer or easier, we’ve sure made it dumber.

What are the Problems?

[…]
  • author: Agalloco James

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