10 Evergreen Drive, Bozeman, MT 59715877.746.8883bicustomerservice@mesalabs.com
  • en
  • fr
  • de
  • es
FacebookTwitterYouTubeLinkedinWebsite
Biological IndicatorsBiological Indicators
Biological Indicators
AAMI & ISO Compliant Biological Indicators
  • Products
    • Biological Indicators
      • For Steam Sterilization
      • For Dry Heat Sterilization
      • For Ethylene Oxide Sterilization
      • For H2O2 Sterilization
      • For ClO2 Sterilization
      • For LTSF, Gamma, & PO sterilization
      • Apex Biological Indicators
      • PCD – Process Challenge Devices
      • All Biological Indicators
    • Incubators
      • Smart-Well Incubator
      • EZTest Incubators
      • ProSpore Ampoule Incubator
      • MagnaAmp Incubators
    • Chemical Indicators
      • Process Indicators
      • Air Removal (Bowie-Dick Type) Tests
      • Multi Variable Indicators and Integrators
    • Culture Media
      • Culture Media for Biological Indicators
      • Releasat Culture Media
    • Mail-In Spore Testing
    • Other Mesa Products
  • Services
    • BI Services
    • Temperature Mapping
  • Documents & Resources
    • Documents & Manuals
    • Spore News Newsletter
    • FAQs
    • Related Links
  • Videos
  • Blog
  • Contact
    • Contact Us
    • Find a Distributor
 
  • Products
    • Biological Indicators
      • For Steam Sterilization
      • For Dry Heat Sterilization
      • For Ethylene Oxide Sterilization
      • For H2O2 Sterilization
      • For ClO2 Sterilization
      • For LTSF, Gamma, & PO sterilization
      • Apex Biological Indicators
      • PCD – Process Challenge Devices
      • All Biological Indicators
    • Incubators
      • Smart-Well Incubator
      • EZTest Incubators
      • ProSpore Ampoule Incubator
      • MagnaAmp Incubators
    • Chemical Indicators
      • Process Indicators
      • Air Removal (Bowie-Dick Type) Tests
      • Multi Variable Indicators and Integrators
    • Culture Media
      • Culture Media for Biological Indicators
      • Releasat Culture Media
    • Mail-In Spore Testing
    • Other Mesa Products
  • Services
    • BI Services
    • Temperature Mapping
  • Documents & Resources
    • Documents & Manuals
    • Spore News Newsletter
    • FAQs
    • Related Links
  • Videos
  • Blog
  • Contact
    • Contact Us
    • Find a Distributor

Sterilization

November 4, 2016Biological Indicators BlogBy Lorrie Switzer

Sterilization

USP <1229> addresses the subject of sterilization.  As a general information chapter, it “provides an overview of the concepts and principles involved in sterilization (by various modes) of compendial articles that must be sterile.”   Included in this main document is information on:  validation of sterilization processes, establishing and justifying sterilization processes that rely on microbial inactivation, D-value and microbial resistance, biological and physical data, sterilization indicators and integrators, sterilization process development, and routine process control.

 In USP, sterility is defined “in probabilistic terms that establish an acceptable level of risk.  Sterility can be accomplished only by the use of a validated sterilization process under appropriate current good manufacturing practices and cannot be demonstrated by reliance on sterility testing alone.”   

 There are a few basic principles to consider in regards to your sterilization processes:  When you are developing your the process, make sure you choose the appropriate sterilization mode; take into consideration the compatibility of materials with your chosen mode; identify the parameters of your sterilization process to allow any microorganisms to be killed while maintaining the integrity of the materials being exposed in the cycle; confirm that the chosen equipment is able to operate within the identified parameters; use biological indicators to confirm that the parameters and expected lethality are in agreement; and continue to maintain and monitor the equipment and cycles to confirm conformance to the validated process.  

Let’s talk biological indicators!

Talk with one of our experts to get your questions answered and see how we can help you solve your BI pain points.


About the author

Lorrie Switzer

Lorrie Switzer is the Continuous Improvement Manager for Mesa’s biological indicator manufacturing facilities in Omaha, NE and Bozeman, MT. Since joining the company in 2010 (as a temporary employee in Assembly & Packaging), she has worked her way through various positions in the Quality Assurance department, ultimately helping to create her existing position. Lorrie holds a B.S. in International Business from Teikyo Post University.

Related posts
Type 2 PCDs
Mesa’s Most Resistant PCDs
April 17, 2018
PCDs
Confirming EO Sterility with PCDs
March 1, 2018
BIs for Every Application
Mesa’s Complete Biological Indicator Offering
February 22, 2018
Run a CI
Daily Sterilizer Monitoring Protocol
January 2, 2018
The Dental Profession is Changing
DSOs Becoming More Popular
November 30, 2017
EtO Sterilization
EtO Sterilization
November 21, 2017
The End of Oxyfume Blends
Learn all you need to know about how Mesa is changing its Certificates of Analysis to reflect the discontinuance of Oxyfume blends and the change to 100% ethylene oxide

Learn More

Have Questions?

Contact Us!

Testing Services
From 3rd party biological indicator verification to custom BI development, Mesa is your resource for specialized and professional testing services.

Inquire about testing >>>

Sign up for our newsletter!
Stay up to date on industry news, new products and product updates with our Spore News newsletter.
Who is Mesa BI?
Featured Articles
  • Control Over the Design Process
    Design Control
    July 5, 2017
  • Design Input
    Design Input
    July 28, 2017
  • Design Output
    Design Output
    August 4, 2017
About Us
  • About Mesa Labs
  • BI Relocation Information
  • Newsletter
  • Certifications
  • Corporate Site
  • Upcoming Events
  • Privacy Policy
  • Terms & Conditions
Contact
Bozeman Facility
10 Evergreen Dr.
Bozeman, MT 59715
877.746.8883

bicustomerservice@mesalabs.com

All European inquiries should be sent to
mesafrance@mesalabs.com

Find us on:

FacebookTwitterYouTubeLinkedinWebsite
© 2015 Mesa Labs, Inc. All rights reserved.
  • en
  • fr
  • de
  • es