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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

AAMI & ISO Compliant Biological Indicators

for sterility assurance

ExpoSure
200Apex

Apex Products
Biological Indicators

Biological Indicators

PCD SCBI (web)

PCD Products
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Mail-In Spore Testing

Which sterilization process do you use?

Steam

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Ethylene Oxide

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Dry Heat

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STERRAD®/H2O2

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ClO2

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LTSF & Gamma

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Relocation Complete

Mesa is currently undergoing a relocation of its BI operations as well as a consolidation of its products.

 

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Releasat Biological Indicator

Box and envelopes Screen

Case Study: Caoili Dental

See how Mesa Labs Mail-In Spore Testing Services helped Caoli stay compliant with California law.

Learn More

Recent Articles

Dental Handpieces

Reprocessing Dental Handpieces

In April of this year, the CDC reiterated the guidelines and recommendations regarding reprocessing dental handpieces. As many of these instruments can be contaminated with patient material, it is suggested that they be cleaned, and heat sterilized. Dental handpieces are considered medical devices and are regulated by the FDA. The handpieces that are not used…

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Type 2 PCDs

Mesa’s Most Resistant PCDs

Mesa’s Process Challenge Devices (PCD) are designed to help medical device manufacturers and contract sterilization providers efficiently and accurately confirm EO sterility assurance. All PCDs are identified by a N.X nomenclature. The N prefix delineates the polymeric film/pouch specification called a PCD ‘Type’. This type is indicative of a specific EO resistance range. The .X…

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PCDs

Confirming EO Sterility with PCDs

Mesa’s Process Challenge Devices (PCD) are designed to help medical device manufacturers and contract sterilization providers efficiently and accurately confirm Ethylene Oxide (EO) sterility assurance. Our convenient to use test pack replacement device provides greater EO resistance than almost all medical devices in most EO process cycles. Mesa’s PCD products are packaged in a controlled…

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Mesa Biological Indicators

Learn more about the vast line of biological indicators offered by Mesa Labs and more through our video series

View Videos >>>

Contract Testing Services

Mesa offers third-party confirmation of BI label claims, D-value and Z-value determinations, custom indicator development, autoclave cycle validation, and a variety of BIER vessel testing services for the medical device and pharmaceutical industries.

See our services >>>

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Mesa Validation Services

Mesa has created a service network specifically suited to provide in-house services to our customers. Whether your needs call for equipment repair, calibration or process validation, Mesa’s Global Services team is uniquely qualified to provide you with specialized service, expert protocol development and execution and complete validation services to suit every need.

View suite of services

PharmTech 100% vs. Oxyfume

As of Dec. 31, 2014, the United States Environmental Protection Agency Clean Air Act will prohibit the sale and use of HCFC-based (hydrochlorofluorocarbon) products in the US, and that will include Oxyfume ethylene oxide (EtO) sterilant blends such as Oxyfume 2000, often used by BI manufacturers for assessing BI EtO D-value label claims. To see how this change impacts the BI manufacturing community, read the complete, peer-reviewed article by signing up for Mesa’s Spore News newsletter today.

Access the article >>>

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Inside Biological Indicators

Overview

According to the International Organization for Standardization (ISO), a biological indicator is a test system containing viable microorganisms providing a defined resistance to a specified sterilization process. Biological Indicators (BIs) have been in use for several decades and are used in hospitals, food processing, tattoo parlors, dentist offices, pharmaceutical and medical device manufacturing, ambulatory surgical centers and anywhere else where validation and verification of an adequate sterilization cycle is required.

BIs come in many different shapes, sizes and configurations. Spore Strips have been in use for several decades and are still very widely used for a variety of sterilization processes. Self-Contained Biological Indicators (SCBIs) have become much more popular over the past 30 years, as they are more user friendly and often offer reduced incubation times. For situations where typical BIs are not appropriate, suspensions are widely used to directly inoculate product/substances and Mesa’s line of industrial use BIs are available to test the lethality of a sterilization cycle in a very specific area of a product or load.

Steam Indicators

Steam sterilization is the most popular type of sterilization and Mesa offers several different indicators to monitor the wide variety of items that are sterilized in steam. The variety of items being monitored is what has predicated the development of the variety of indicators that Mesa offers. Porous items (towels, hard goods, etc…) are easily monitored with Spore Strips while the use of test packs with SCBIs is ever increasing. Ampoule indicators are best utilized in liquid loads sterilization (bottles, media, etc…) and offer a variety of sizes for flexibility. Mesa also offers a complete line of Chemical Indicators including Class 5 (Integrators) and Class 6 (Emulators), Bowie-Dick type test packs and more.

Gas/ Ethylene Oxide Indicators

Ethylene Oxide sterilization is one of the most common sterilization methods for medical devices including specialty device kits used for specific surgical procedures. EO sterilization is most useful due to the fact that it uses a reduced amount of heat and is therefore safe for heat sensitive materials and devices.  Because of this, a completely separate type of biological indicator must be used for sterility assurance testing and monitoring. Utilizing a different species than our steam products, Mesa’s offers EO BIs as spore strips, SCBIs, test packs, suspensions, custom BIs and chemical indicators as well.

Dry Heat Indicators

Dry heat sterilization requires longer cycle times, higher temperatures and specialty biological indicators. Spore strips can be used in dry heat sterilization however as temperatures rise, charring becomes an issue and the indicator itself burns. Mesa offers a couple alternatives to spore strips with stainless steel discs and with its product DriAmp. DriAmp is an ampoule containing sand inoculated with spores which can withstand extreme temperatures. Additionally, Mesa offers chemical indicator labels for use with this process.

Specialty Indicators

Mesa has created a host of biological indicators for specialty sterilization processes including hydrogen peroxide (H2O2), chlorine dioxide (ClO2), low-temperature steam with formaldehyde (LTSF), gamma irradiation, propylene oxide and more.

Who is Mesa BI?
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Contact
Mesa Laboratories
877.746.8883
bicustomerservice@mesalabs.com
All European inquiries should be sent to
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