Biological Indicators Brochures

IFU

• 1410 Incubator Manual
  The Mesa Labs biological indicator incubator is designed for convenient and effective incubation of self-contained biological indicators requiring incubation temperatures of 37°C, 57°C, or 60°C.
• 1410 Quick Start Guide
  Mesa’s 1410 adjustable self-contained biological indicator (SCBI) incubator Quick Start Guide.
• 1450 Incubator Manual
  The Mesa Labs 1450 biological indicator incubator is designed for convenient and effective incubation of self-contained biological indicators requiring incubation temperatures of 37°C, 57°C, or 60°C.
• 1450 Incubator Quick Start Guide
  Mesa’s 1450 adjustable self-contained biological indicator incubator Quick Start Guide.
• 1480 Incubator Manual
  The Mesa Labs biological indicator incubator is designed for convenient and effective incubation of ProSpore Ampoule self-contained biological indicators requiring an incubation temperature of 57°C
• 1480 Incubator Quick Start Guide
  Mesa’s 1480 ProSpore incubator Quick Start Guide.
• 1501 Incubator Manual
  The Mesa 1501 Incubator is designed for single temperature incubation of Mesa’s ampoule biological indicators (MagnaAmp and 1ml ProSpore Ampoule).
• 1510 Quick Start Guide
  Mesa’s 1510 Ampoule BI Incubator Quick Start Guide.
• 1510 Manual
  The Mesa Labs biological indicator incubator is designed for convenient and effective incubation of ProSpore Ampoule (1mL) and MagnaAmp self-contained biological indicators requiring an incubation temperature of 57°C.
• 1700 Smart-Well Incubator Manual
  The Smart-Well® incubator is a valuable laboratory tool used for the rapid evaluation and automatic documentation of Smart-Read EZTest^® steam biological indicators (BIs).
• 1710 Smart-Well Incubator Manual
  The Smart‐Well^® incubator Model 1710 is a valuable laboratory tool used for the rapid evaluation and automatic documentation of Smart‐Read EZTest^® steam biological indicators (BIs).
• Apex Bare Ribbons
• Apex Discs
  Apex Biological Indicator (Reorder # HMV-091) for Gaseous Hydrogen Peroxide.
• Apex Discs – GR5 Series (9372)
• Apex Discs – NA5-152 (7953)
• DriAmp
  DriAmp^™ biological indicator culturing set with Releasat^® culture medium for demonstrating adequacy of dry heat sterilization.
• EZTest EO
  EZTest used in ethylene oxide sterilization.
• EZTest H2O2
  EZTest used in hydrogen peroxide sterilization.
• EZTest PPO
  EZTest used in propylene oxide sterilization.
• EZTest Steam
  EZTest used in steam sterilization.
• MagnaAmp
  Biological indicators for monitoring steam sterilization of liquids.
• Mesa Strip
  Spore strips offered from our Bozeman, Montana Manufacturing Facility.
• Metal Discs/Strips
  Metal discs and strips offered from our Omaha, Nebraska Manufacturing Facility.
• Metal General – Atrophaeus
  Metal discs inoculated with bacillus atrophaeus bacterial spores, offered from our Omaha Manufacturing Facility.
• OK Cycle
  The O.K. Cycle chemical integrator strips are designed for use in pre-vacuum steam sterilizers operating at 121° C and at 134°C.

PCD Directions for Use

• Population Assay Kit
  The following procedures have been provided with this kit and should be followed exactly when performing a population assay on Mesa Labs, Bozeman Manufacturing Facility biological indicators.
• ProChem B-D Bowie-Dick Type Test Packs
  Use once a day and at the beginning of each day.
• ProChem B-D 121 Test Packs
  The ProChem BD 121 Test Pack is for daily monitoring of pre-vacuum steam sterilizers operating at 121ºC for 11 minutes. The BD 121 is designed to operate in sterilizers with sub-atmospheric or trans-atmospheric cycles.
• ProChem Bowie Dick (BD) Test Sheets
  Run a shortened cycle (omitting the drying phase) to properly heat the sterilizer. Place a Bowie-Dick Test Sheet in the middle of a towel pack made to specification.
• ProChem EXT
  Place ProChem EXT in the most difficult to sterilize area of every package/tray to be sterilized. For larger packs, use multiple strips.
• ProChem Indicator Tape
  Affix tape to item to be sterilized. Tape may be used to secure packages or solely as an external process indicator.
• ProChem Steam Sterilization Emulator (SSE)
  Place a Mesa ProChem SSE strip in each pack, peel pouch or tray for sterilization. Place strip at a location in the packaged considered most difficult for steam to reach.
• ProChem SSI
  The ProChem SSI strips are designed for utilization in steam sterilization cycles operating at 132ºC (270ºF) for 3 minutes or longer.
• ProLine
  ProLine is a Biological Indicator Process Challenge Device (PCD) specifically designed for use in the validation or monitoring of Steam/EtO sterilization cycles of tubing ranging from 1/8” to 5/8” tubing ID.
• ProSpore2
  ProSpore2 Self-Contained Biological Indicator for steam/EtO sterilization cycles.
• ProSpore Ampoule
  Mesa’s ProSpore Ampoule is intended for use in the monitoring of saturated steam sterilization cycles at 121°C.
• ProTest
  ProTest is intended for use in the monitoring of saturated steam or ethylene oxide sterilization cycles.
• ProTest H2O2
  ProTest H2O2 is intended for use in monitoring the efficacy of hydrogen peroxide sterilization processes.
• Releasat (ClO2)
  Spore strips and culture media set to evaluate the efficacy of chlorine dioxide sterilization.
• Releasat (Gas)
  Spore strips and culture media set to evaluate the efficacy of ethylene oxide sterilization.
• Releasat (Steam)
  Spore strips and culture media set to evaluate the efficacy of steam sterilization.
• SmartRead EZTest Test Pack
  Smart-Read^® EZTest^® Biological Test Pack with Instant Readout Integrator is designed specifically for biological testing of 132°C (270°F) pre-vacuum steam sterilizers.
• SmartRead EZTest Steam
  The Smart-Read EZTest is a familiar self-contained color change biological indicator specifically designed for rapid evaluation in the Smart-Well incubator.
• Spore Strips
  Follow instructions for use and include several biological indicators with each cycle monitored. Place in the most difficult to sterilize chamber locations.
• Spore Suspension (Bozeman)
  Spore suspensions contain resistant bacterial spores for the inoculation of products used in sterilization cycle evaluation.
• SteriChart Steam
  SteriChart is a simple and convenient test for Steam Sterilization. Each bag/chart contains 5 test strips (1 each: Log 3, Log 4, Log 5, Log 6, and Log 7).
• SterilAmp 5230
  Biological indicators for monitoring low temperature steam sterilization.
• SterilAmp II
  Biological indicators for monitoring steam sterilization of liquids.
• SterilFlex
  Small, plastic biological indicators for monitoring steam sterilization of liquids.
• Wires/Threads/Sutures
  Follow instructions for use and aseptically place the wires/threads/polyester sutures into the sterilization load. Spore wires/threads/polyester sutures are designed to be used in areas with small lumen or areas where a spore strip will not fit properly.

Certifications

• ISO Certificate
• Certificate to Foreign Government
• 2015 FDA Registration

General

• ISO Certificate
• Chain of Custody Form for Materials to be Submitted to Mesa Labs for Testing (Omaha Facility)
• Chain of Custody Form for Materials to be submitted to Mesa Labs for Testing (Bozeman Facility)

Brochures

• 1410 Adjustable SCBI Incubator
  The Mesa 1410 incubator is designed for convenient and effective incubation of Mesa self-contained biological indicators at 37 degrees C (Bacillus atrophaeus) or 57 degrees C and 60 degrees C (Geobacillus stearothermophilus).
• 1510 Incubator
  The Mesa 1510 incubator is designed for convenient and effective incubation of Mesa self-contained biological indicators at 57°C including MagnaAmp^® and ProSpore Ampoule 1mL liquid submersible biological indicators.
• Apex Brochure
  Apex biological indicator products are designed specifically for the pharmaceutical, food and medical device industries utilizing H202 vapor sterilization.
• Apex Discs Spec Sheet
  Using Apex biological indicators in a VHP (Vaporized Hydrogen Peroxide) process.
• Culture Media
  Soybean casein digest broth is recommended media (USP 24) for use with biological indicators.
• Custom BIs (Bozeman)
  Most commercially available biological indicators are designed for healthcare applications and are not well suited for many manufacturing situations.
• DriAmp
  The unique DriAmp^® biological indicator (BI) is appropriate for either high temperature direct air exposure or submersion in oils and other non-water based solutions where traditional paper strip indicators are difficult to use.
• EZTest
  EZTest is a self-contained biological indicator for monitoring steam, ethylene oxide, hydrogen peroxide, or propylene oxide sterilization.
• EZTest Test Pack
  The EZTest Biological Test Pack is a small, convenient, FDA 510 (K) notified product containing EZTest self-contained biological indicators.
• Industrial Use BI (Omaha)
  In addition to our line of healthcare BIs, Mesa offers a line of
  Industrial Use BIs to address the unique requirements of the medical device and pharmaceutical industries.
• MagnaAmp
  MagnaAmp is a self-contained biological indicators ampoule for monitoring steam sterilization of liquids in containers or washer sterilizers.
• Mesa Strips
  MesaStrip^® is a conventional paper strip biological indicator for monitoring steam, low temperature steam formaldehyde, ethylene oxide, dry heat, chlorine dioxide and gamma radiation industrial sterilization processes.
• Negative Controls
  ProSpore Ampoule and ProAMP are self-contained biological indicators for steam sterilization ideal for validating the sterilization of liquid loads, though they are also suitable for loads containing dry goods.
• OK Cycle
  ProChem OK-Steam Sterilization Multi-Spot Indicator.
• PCD Brochure – English Selection Guide
• PCD Brochure – Français
• PCD Brochure – Deutsch
• PCD Brochure – Español
• PCD Brochure – 日本人
• Population Assay Kit
  Our Population Assay Kit contains all the materials required to perform accurate population assays of Mesa Labs Bozeman Manufacturing Facility’s biological indicator products.
• ProChem Bowie-Dick (BD)
  Bowie-Dick type test packs.
• ProChem Chemical Indicators
  From indicator tapes and labels to Class 6 emulators, Mesa has a full line of chemical indicators for healthcare and industrial users alike.
• ProChem SSW
  ProChem SSW Steam Sterilization Integrator is a single use Class 5 Integrating Indicator which complies with ANSI/AAMI/ISO 11140-1:2005 and ANSI/AAMI ST60:1996.
• ProLine
  ProLine is a Biological Indicator system designed for use in the validation or monitoring of sterilization cycles of tubing ranging from 1/8” to 5/8” tubing ID.
• ProSpore2
  ProSpore2 is a self-contained Biological Indicator for use in either Steam or Ethylene Oxide (EO) sterilization. Each unit is made up of a plastic container with cap, a crushable glass ampoule with recovery media, and a paper disc inoculated with spores.
• ProSpore Ampoule
  ProSpore Ampoule and ProAMP are self-contained biological indicators for steam sterilization ideal for validating the sterilization of liquid loads, though they are also suitable for loads containing dry goods.
• ProTest Biological Indicator Test Pack
  ProTest BI Test Pack is a pre-assembled Process Challenge Device (PCD) with an Instant Readout Integrator which can be used to immediately release non-implant loads and for the emergency release of implants.
• ProTest Steam, EO and H2O2
  ProTest is a self-contained Biological Indicator for use in either Steam, Ethylene Oxide or H2O2 sterilization.
• Releasat
  Releasat^® is a biological indicator culturing kit containing MesaStrip^™ paper strip biological indicators and culture tubes of specially formulated soybean casein digest culture medium containing a color indicator which turns a dramatic yellow when spores grow.
• Releasat ClO2
  Releasat ClO2 is a biological indicator culturing kit containing MesaStrip paper strip biological indicators and culture media tubes specially offered for monitoring chlorine dioxide sterilization.
• Smart-Read EZTest
  The Smart-Read EZTest^® Biological Monitoring System allows an organization to release sterile product with true biological confirmation faster and easier than ever before.
• Spore Strips (Omaha)
  Mesa Labs offers a complete line of spore strips for sterility testing in various sterilization environments for both healthcare and industrial applications.
• Spore Suspensions (Bozeman)
  Spore suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of products or preparing custom biological indicators for monitoring steam, ethylene oxide, dry heat, hydrogen peroxide, radiation and other industrial sterilization processes.
• Spore Suspensions (Omaha)
  Spore Suspensions are diluted aliquots from our primary spore crop (batch).
  They are used to directly inoculate (and therefore challenge) a material or solution with a known concentration of spores.
• SterilAMP 5230
  SterilAMP II “5230” is a compact, self-contained ampoule biological indicator for monitoring industrial low temperature (110-118°C) steam sterilization of liquids in small containers.
• SterilAMP II
  SterilAmp^® II is a compact, self-contained biological indicator for monitoring industrial steam (121°C) sterilization of liquids in small containers.
• SterilFlex
  SterilFlex is a glass-free, liquid submersible biological indicator (BI) designed specifically to monitor thermally processed food products and for pharmaceutical manufacturing.

Brochures

• Ampoule Media (Bozeman)
• Apex Stainless Steel Discs
• DriAmp
• Dry Heat Indicator Labels
• EZTest
• EZTest H2O2
• EZ Test Pack
• Indicator Tapes (Steam/EO)
• MagnaAmp
• MesaStrip
• MesaStrip ClO2
• Paper Spore Disc (Bozeman)
• Paper Spore Disc (Omaha)
• Polyester Suture (Omaha)
• ProChem Bowie Dick (BD)
• ProChem Bowie Dick 121 (BD121)
• ProChem Bowie Dick Sheet
• ProChem CI OK
• ProChem EXT
• ProChem SSE
• ProChem SSI
• ProChem SSW
• ProLine
• ProSpore2
• ProSpore Ampoule
• ProTest
• ProTest BI Pack
• Releasat
• Releasat Medium Only
• Smart-Read EZTest
• Smart-Well Printer Ink
• Spore Strips
• Spore Suspensions (Bozeman)
• Spore Suspensions (Omaha)
• Spore Thread
• Steel Spore Disc (Bozeman)
• Steel Spore Wire (Omaha)
• Steel Spore Wire (Bozeman)
• SterilAmpII
• SterilAmp 5230
• SterilFlex
• Tryptic Soy Broth (OMF)

Procedures

• BI/CI Records Log Sheet
• PCD Validation Guide
• Population Assay Procedure – Apex Products
• Population Assay – Metal Discs, Metal Strips, Wires (Omaha)
• Population Assay Procedures (Bozeman products)
• Population Assay – ProSpore Ampoule
• Population Assay – Sutures (Omaha)
• Population Assay – Spore Suspensions (Omaha)
• Population Assay -Threads and Paper Carriers (Omaha)
• Population Data Sheet
• Steam D-value Determination (Omaha)
  1. USP recommends using three specimens of the relevant biological indicator for determining a total viable spore count.
  2. Perform population count on three separate biological indicators and average counts.
  3. Mesa has validated that using 10 specimens of the relevant biological indicator gives equivalent results as the USP recommended three specimens.

Technical Reports

• Compare Three BI Types in Steam Processes: Spore Strips, Crushable Self-Contained, and Sealed Glass Ampoules
• DriAmp
• Extended Sterilization Cycles Impact on ProSpore Media
• EZTest Gas
• EZTest H2O2
• EZTest Steam
• MagnaAmp
• MesaStrip Gas
• MesaStrip LTSF
• MesaStrip Radiation
• MesaStrip Steam
• MesaStrip ClO2
• ProSpore Ampoule Media Performance In Extended Cycles
• Reduced Incubation Study ProSpore2 (EO)
• Reduced Incubation Study ProSpore2 (Steam)
• Reduced Incubation Study ProSpore Ampoule
• Reduced Incubation Study ProTest (Steam)
• Reduced Incubation Study Spore Strips (OMF)
• Releasat Gas
• Releasat Steam
• Smart-Read EZTest
• SterilAmp 5230
• SterilAmp II
• SterilFlex
• Storage Conditions upon and Resistance (D-value) of Spore Strip BIs Used in EtO Sterilization Monitoring
• Biological Indicators D-value and Population Verification/Assessment (Third party testing and assessment/verification testing results and what can and can not be done with this data.)
• Biological Indicators / D-value Verification (Provides information pertaining to the critical parameters necessary to perform a D-value assessment and why it may be so difficult to obtain a 3rd party verification of the D-value on Biological Indicators.)
• Micro-Lab / Medical Waste Sterilization Made Easier (Provides information on why one must use a sealed BI in waste sterilization and the easy way to accomplish such use.)
• Monitoring Bio/Med Waste Bags with Spore Strips as Biological Indicators and ‘False’ Negatives (It has been noted that a fairly large number of facilities use spore strips as their Biological Indicator (BI) for the monitoring of biowaste bags to be steam sterilized.)
• Steam Sterilization and BI Monitoring Liquid Loads (Information on liquid cycle sterilization, use of sealed glass ampoules, possible causes for a failed cycle and information on why the ampoule BI should sink in the liquid being sterilized and not float on the surface.)
• Sterilization Monitoring – Validation of Liquid Loads Managing Infection Control 2002 (Sterilization Monitoring and Validation of Liquid Loads in Steam Autoclave Cycles and the Importance of Appropriate BI Selection and Resistance.)
• Unique Cycles – Sterilizing Liquid Loads (With liquid loads there are no concerns about pre-vac air-removal or steam penetration as into a porous load, so why do so many problems occur with liquid media sterilization and BI lethality?)