MesaLabs
  • Our Solutions

    • Sterilization & Cleaning Monitoring

      • Products

        • Biological Indicators & Accessories

        • Chemical Indicators

        • Cleaning Control

        • All Products

      • Services & Consulting

        • Sterilization Cycle Development & Validation

        • Contract Laboratory Testing

      • Knowledge Center

        • Resource Library

        • White Papers

        • Training & Events

        • Videos

        • FAQs

        • Customer Support

        • Request a Quote

    • Mail-in Spore Testing

      • Products

        • Testing Services Packages

        • In-Office Testing Products

        • Chemical Indicators

        • All Products

      • Services

        • Check Test Results

      • Knowledge Center

        • State Dental Regulations

        • Industry Insights

        • FAQs

        • Customer Support

      • Shop Online

    • Continuous & Process Monitoring

      • Hardware

        • Continuous Monitoring Panels & Sensors

        • Process Monitoring Data Loggers

        • All Products

      • Software

        • Continuous Monitoring Software

        • Continuous Monitoring Software Downloads

        • Process Monitoring Software

      • Services

        • Validation & Calibration Services

        • Data Logger Calibration & Repair

      • Knowledge Center

        • Resource Library

        • FAQs

        • Customer Support

        • Request a Quote

      • Shop Online

    • Renal Care Quality Control

      • Products

        • 90XL Technician Meter

        • pHoenix XL Reference Meter

        • Solutions - Conductivity, pH, Neo Care, NIST-Traceable

        • Care & Calibration Stations

        • All Products

      • Services

        • Equipment Calibration & Repair

      • Knowledge Center

        • Resource Library

        • FAQs

        • Customer Support

        • Request a Quote

      • Shop Online

    • Occupational Health & Safety

      • Gas & Air Flow Instruments

        • Mesa Defender Series (Volumetric Accuracy ±1%)

        • Mesa FlexCal Series (Volumetric Accuracy ±0.5%)

        • Mesa BGI DryCal Metrology Series

        • All Products

      • Accessories

        • Mesa Defender Series Accessories

        • Mesa FlexCal Series Accessories

        • Mesa DryCal Pro Software

      • Services

        • Equipment Calibration & Repair

      • Knowledge Center

        • Resource Library

        • Videos

        • FAQs

        • Customer Support

        • Request a Quote

      • Shop Online

    • Environmental Controls & Air Quality

      • Equipment

        • Mesa BGI Ambient Particulate Air Samplers

        • Mesa BGI Air Flow Calibrators

        • Mesa BGI Personal Sampling Cyclones

        • Mesa BGI Environmental Cyclones

        • All Products

      • Software

        • Mesa BGI Companion Software

      • Accessories

        • Environmental Accessories

        • Industrial Hygiene Accessories

        • Filter Media

      • Services

        • Equipment Calibration & Repair

        • Equipment Rental

      • Knowledge Center

        • Resource Library

        • Videos

        • FAQs

        • Customer Support

        • Request a Quote

      • Shop Online

    • Torque Testing

      • Products

        • Semi-Automatic Torque Testers

        • Manual Torque Testers

        • All Products

      • Accessories

        • Torque Testing Accesories

      • Software

        • TorqueIQ Process Control Software

      • Services

        • Gold Bottle Magnetic Torque Verification

        • Equipment Calibration & Repair

        • Upgrade/Trade-In Options

        • Torque Rentals

      • Knowledge Center

        • Resource Library

        • Customer Support

        • Request a Quote

  • About Us

    • Our Purpose

    • Mesa Brand Family

    • Executive Team

    • Careers

    • Investor Information

  • Contact Us

  • Resource Library

    • Certificate (COA) Finder

    • Regulatory Documents

    • Instruction Manuals

    • Product Specifications

    • Product Technical Reports

    • Safety Data Sheets

  • Our Solutions

    chevron
    • Sterilization & Cleaning Monitoring

      • Products

        • Biological Indicators & Accessories

        • Chemical Indicators

        • Cleaning Control

        • All Products

      • Services & Consulting

        • Sterilization Cycle Development & Validation

        • Contract Laboratory Testing

      • Knowledge Center

        • Resource Library

        • White Papers

        • Training & Events

        • Videos

        • FAQs

        • Customer Support

        • Request a Quote

    • Mail-in Spore Testing

      • Products

        • Testing Services Packages

        • In-Office Testing Products

        • Chemical Indicators

        • All Products

      • Services

        • Check Test Results

      • Knowledge Center

        • State Dental Regulations

        • Industry Insights

        • FAQs

        • Customer Support

      • Shop Online

    • Continuous & Process Monitoring

      • Hardware

        • Continuous Monitoring Panels & Sensors

        • Process Monitoring Data Loggers

        • All Products

      • Software

        • Continuous Monitoring Software

        • Continuous Monitoring Software Downloads

        • Process Monitoring Software

      • Services

        • Validation & Calibration Services

        • Data Logger Calibration & Repair

      • Knowledge Center

        • Resource Library

        • FAQs

        • Customer Support

        • Request a Quote

      • Shop Online

    • Renal Care Quality Control

      • Products

        • 90XL Technician Meter

        • pHoenix XL Reference Meter

        • Solutions - Conductivity, pH, Neo Care, NIST-Traceable

        • Care & Calibration Stations

        • All Products

      • Services

        • Equipment Calibration & Repair

      • Knowledge Center

        • Resource Library

        • FAQs

        • Customer Support

        • Request a Quote

      • Shop Online

    • Occupational Health & Safety

      • Gas & Air Flow Instruments

        • Mesa Defender Series (Volumetric Accuracy ±1%)

        • Mesa FlexCal Series (Volumetric Accuracy ±0.5%)

        • Mesa BGI DryCal Metrology Series

        • All Products

      • Accessories

        • Mesa Defender Series Accessories

        • Mesa FlexCal Series Accessories

        • Mesa DryCal Pro Software

      • Services

        • Equipment Calibration & Repair

      • Knowledge Center

        • Resource Library

        • Videos

        • FAQs

        • Customer Support

        • Request a Quote

      • Shop Online

    • Environmental Controls & Air Quality

      • Equipment

        • Mesa BGI Ambient Particulate Air Samplers

        • Mesa BGI Air Flow Calibrators

        • Mesa BGI Personal Sampling Cyclones

        • Mesa BGI Environmental Cyclones

        • All Products

      • Software

        • Mesa BGI Companion Software

      • Accessories

        • Environmental Accessories

        • Industrial Hygiene Accessories

        • Filter Media

      • Services

        • Equipment Calibration & Repair

        • Equipment Rental

      • Knowledge Center

        • Resource Library

        • Videos

        • FAQs

        • Customer Support

        • Request a Quote

      • Shop Online

    • Torque Testing

      • Products

        • Semi-Automatic Torque Testers

        • Manual Torque Testers

        • All Products

      • Accessories

        • Torque Testing Accesories

      • Software

        • TorqueIQ Process Control Software

      • Services

        • Gold Bottle Magnetic Torque Verification

        • Equipment Calibration & Repair

        • Upgrade/Trade-In Options

        • Torque Rentals

      • Knowledge Center

        • Resource Library

        • Customer Support

        • Request a Quote

  • About Us

    chevron
    • Our Purpose

    • Mesa Brand Family

    • Executive Team

    • Careers

    • Investor Information

  • Contact Us

  • Resource Library

    chevron
    • Certificate (COA) Finder

    • Regulatory Documents

    • Instruction Manuals

    • Product Specifications

    • Product Technical Reports

    • Safety Data Sheets

White Papers

  1. Home

  2. caret-right icon

    Our Solutions

  3. caret-right icon

    Sterilization & Cleaning Monitoring

  4. caret-right icon

    Knowledge Center

  5. caret-right icon

    White Papers

  6. caret-right icon

    VOL 12, ISSUE 3

VOL 12, ISSUE 3

Contract Studies

By Paul Nirgenau

Mesa Laboratories Contract Studies Department provides valuable assistance to customers in verifying the sterility of their products. This Spore News gives an overview the services the Contract Studies Department can provide.

D-value Analysis on Liquid Pharmaceutical Products

Mesa Labs performs steam D- and Z-value analysis on pharmaceutical products using Geobacillus stearothermophilus, or Bacillus subtilis “5230” spores for heat sensitive products. Onionskin glass ampoules containing the pharma product and 106 spores are manufactured and exposed to gradient cycles in a steam resistometer (formerly referred to as Biological Indicator Evaluator Resistometer (BIER) test systems). Four ampoules per cycle are exposed, and population assays are performed immediately after exposure. The D-value for liquid pharmaceutical products is calculated using the Survivor Curve Method.

The low volume of product, use of onionskin glass ampoules, and square wave steam cycle of the resistometer generates data that can be used for multiple volume configurations if the time to temperature is known for each volume. If this information is not known, D-value analysis can also be performed with direct inoculation into the customer’s product configuration.

D-value Analysis on Pharmaceutical Stopper/Piston/Vial Components

Inoculating the septum or most difficult location of the component to sterilize, D-value analysis is performed using the fraction/negative method with 10 or 20 components per cycle. Components are exposed to gradient cycles in a resistometer, aseptically cultured, and monitored for growth. D-values are calculated using either the Limited Holcomb-Spearman-Karber or Stumbo-Murphy-Cochran method.

D-value Analysis on Custom Biological Indicators

Mesa Labs can perform resistance testing on custom biological indicators. Analysis can be performed using the customer’s specified inoculation location, or Mesa can determine the most resistant inoculation location. In the past, we have performed resistance testing on syringes, powders, membranes, medical devices, lumens, and Process Control Devices.

Bioburden Resistance Testing

Spore forming bacteria that has been identified by the customer can be sent to Mesa Labs on a plate or slant. The bacteria will be grown targeting a 108 population, harvested, and inoculated into WFI (Water for Injection) or product ampoules. D-value analysis is conducted using the Survivor Curve Method.

Third Party Verification

Verification of D-value, Survival/Kill time, population, purity, and microbial identification listed on the Certificate of Analysis can be performed on other manufacturers’ biological indicators.

Custom Studies

We can work with you to design a study around your product and sterilization method. Mesa can perform testing in steam, ethylene oxide, dry heat, and VHP processes.

About the Author

Paul Nirgenau graduated with a B.S. degree in Environmental Science from Creighton University. He has worked at Mesa Labs since 2004. He has held positions in Research and Development, Contract Studies and is currently the Contract Studies Manager. Paul is Bozeman’s resident Eagle Scout and accomplisher of the impressive 2200 mile hike of the Appalachian Trail.

Topics: Contract Studies ,   Failure Investigation ,   Specialty Biological Indicators ,   BI Selection ,   Resistance ,   Third Party Testing ,   Population ,   Identification ,   Incoming Inspection ,   Label Claim Validation
Recent Posts
Why BIs Survive a Validated Cycle A Review of the Newly Released ISO 11138-8 Standard on the Validation of a Reduced Incubation Time for Biological Indicators Product D-Value Study - Part 2, Heat-sensitive & Atypical Aqueous Liquids Why perform a Product D-value Study? Part 1 The MeCo Solution: Improving Consistency, Accuracy and Robustness in SIP Validation Sub-culturing a Positive Biological Indicator for Identification Biological Indicators and the European Pharmacopoeia

Subscribe now

Full of expert takes on industry trends and the latest technical education offerings. Spore News gives you the insight you need to prepare for what's next.

MesaLabs

Our Solutions

  1. Sterilization & Cleaning Monitoring
  2. Mail-In Spore Testing
  3. Continuous & Process Monitoring
  4. Environmental Controls & Air Quality
  5. Occupational Health & Safety
  6. Renal Care Quality Control
  7. Torque Testing

About us

  1. Our Purpose
  2. Mesa Brand Family
  3. Executive Team
  4. Careers
  5. Investor Information
  1. Sterilization & Cleaning Monitoring
  2. Mail-In Spore Testing
  3. Continuous & Process Monitoring
  4. Environmental Controls & Air Quality
  5. Occupational Health & Safety
  6. Renal Care Quality Control
  7. Torque Testing
  1. Our Purpose
  2. Mesa Brand Family
  3. Executive Team
  4. Careers
  5. Investor Information
  1. Contact Us

    Corporate Headquarters
    Mesa Laboratories, Inc.
    12100 West 6th Ave.
    Lakewood, CO 80228

    303.987.8000
    customerservice@mesalabs.com

Connect with us

Follow us on Facebook Follow us on LinkedIn Follow us on Twitter Follow us on Facebook
©2022 Mesa Labs, Inc. All rights reserved. |   Terms, Conditions & Privacy Policy   |   Cookie Settings
©2022 Mesa Labs, Inc. All rights reserved. Terms, Conditions & Privacy Policy