Aug 10, 2023
1 min read
How do I do it? Starting to think about sterilization.
Navigating how to produce a sterile product can be seen as a challenging process but let's break it down into steps for your consideration. Some of these items may be done in parallel (e.g. selection of sterilization provider along with packaging definitions). While the sterilization aspires to be perfect science, the process to develop the process for your product can be a trial and error if one doesn't have experience.
Here is a visual from Sterilization of Objects, Products, and Packaging Surfaces and Their Characterization in Different Fields of Industry: The Status in 2020
Here are the steps we propose:
Reliability
What method can I use? If you look at the product materials this often indicates the best method to use.
Performance
Many materials drive the method. Steam and dry heat need materials that can withstand high temperatures.
Scalability
Packaging and its compatibility with the method.
Conformance Labeling
Labeling to ensure conformance during the process.
Sterilizer Selection
Contract Sterilizer selection, qualification, registration (FDA), commercial agreements.
24/7 Customer Support
Validation of the process to document effectivity and lethality.
Reliability
Are these tips helpful? Which do you prefer and why? Write a comment below. Your ideas will help enrich future content.
Performance
If it's too complex or confusing, feel free to ask for help anytime. We're here to guide you on your business journey.
Scalability
Any questions about our services? Please don't hesitate to:
Scalability
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WhitneyCaine
Aug 27
Comment analysis
Break down
Of the process,
Difficult
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Article Author
ToriDaniel
Publication Date
Aug 26, 2023
Article Excerpt
This is a great...
jalenmscrowensen980
Aug 24, 2023
What is the best way to decide which sterilization process is best for the my product?
Do these steps apply to non-medical devices?
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Kelsaey32thomasjames3
Aug 23, 2023
Is steam the future
of sterilization?
Something that is old
technology now?
Needs to be phased
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Nicolefurman39
Aug 23, 2023
Great Review About
Sterilization Methods
Confusing Concepts
For Many Companies
Nicolefurman39
Aug 23, 2023
Is EO undergoing
any changes?
Expected revenue
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Published on Aug 23, 2023
Question about sterilization
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juhatopi
Date Posted
Aug 23, 2023
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EO is the best for sure, not sure why you don't promote it more
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bakolib970
Publication Date
Aug 23, 2023
Topic of Discussion
Validation Again
What does Regulatory submissions involve?
Don't I already have all the approvals I need?
famat96602
Aug 18, 2023
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Why does packaging matter?
It just seems you are trying to charge me extra for something I do not need.
Can't you just sterilize?
I do not need packaging.
hebeko6563
Aug 18, 2023