How to Prove a Sterility Assurance Level of 10⁶

PART 1: The OVERKILL Method(s)

Caramelization of Liquid Submersible Biological Indicators due to Extended Thermal Insult

VOL 11, ISSUE 5

Understanding Biological Indicator Grow-Out Times

Why Perform a D-value Study?

End-User or Third-Party Population Verification

End-User or Third-Party Resistance Verification

End-User or Third-Party Organism Identification and Purity

Apex^® EZTest^®: A Self-Contained Biological Indicator for Vaporized Hydrogen Peroxide Decontamination Processes

Vaporized Hydrogen Peroxide Isolator Decontamination in a World of Uncertainty: A Modern-Day Field Guide

Biological Indicator Incubation and Reduced Incubation Time (RIT)

Biological Indicators for Vaporized Hydrogen Peroxide Isolator Decontamination: Characteristics, Uses and Challenges

VOL 1, ISSUE 1

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

VOL 15, ISSUE 2

Product D-Value Study - Part 2, Heat-sensitive & Atypical Aqueous Liquids

VOL 15, ISSUE 1

Why perform a Product D-value Study? Part 1

VOL 14, ISSUE 2

The MeCo Solution: Improving Consistency, Accuracy and Robustness in SIP Validation

VOL 14, ISSUE 1

Sub-culturing a Positive Biological Indicator for Identification

VOL 13, ISSUE 3

Biological Indicators and the European Pharmacopoeia

VOL 8, ISSUE 2

The Problem with EP 7.0, 5.1.2

VOL 13, ISSUE 2

A Review of the Newly Revised ISO 11138 Series on the Manufacture of Biological Indicators

VOL 13, ISSUE 1

Biological Indicators and the United States Pharmacopeia

VOL 12, ISSUE 6

Introducing ExpoSure

Biological Indicator Selection

VOL 12, ISSUE 4

Product Profile: DriAmp Biological Indicator

Contract Studies

VOL 12, ISSUE 2

Process Challenge Devices

VOL 12, ISSUE 1

Biological Indicators and Their Relation to Standards Organizations

VOL 11, ISSUE 6

This Spore News article will explore several reported issues which are BI Impossible

VOL 11, ISSUE 5

Impact of Change from Oxyfume to 100% EtO

VOL 11, ISSUE 4

Delayed Incubation, Part II: The DriAmp Product

VOL 11, ISSUE 3

Resistance Analysis of Mesophilic Spores to Ethylene Oxide Sterilization

VOL 11, ISSUE 1

Taking the ‘‘Mystery” Out of Biological Indicator Storage

SEM Analysis of Vaporized Hydrogen Peroxide Biological Indicators

VOL 10, ISSUE 5

Sterilization Vocabulary

Vol. 10, No. 4

Effects of Delayed Incubation on BI Resistance

VOL 10, ISSUE 2

Total Viable Spore Counts

End User— Proper BI Placement During VH₂O₂ Decontamination Cycles

Using Replicate BIs to Evaluate Biodecontamination Cycles in Isolators

Parameters Affecting Vaporized Hydrogen Peroxide Biological Indicator Performance

Vol. 9, No. 2

Medical and Lab Waste Monitoring

VOL 9, ISSUE 1

Oxyfume® Blends vs. 100% EtO

VOL 8, ISSUE 5

CUSTOM BIOLOGICAL INDICATORS: Stop trying to put a square peg into a round hole!

VOL 8, ISSUE 4

BI Label Claim Verification Testing by Third Party, Part II

VOL 8, ISSUE 3

Caramelization or Darkening in the color of Autoclaved Liquid BI Ampoules

VOL 8, ISSUE 1

BI Label Claim Verification Testing by Third Party, Part I

Steam Sterilization of Liquid Filled Containers

VOL 7, ISSUE 4

Read Out Times of Smart-Read EZTest® Exposed at Elevated Temperatures

VOL 6, ISSUE 6

Defining Boundaries: The Beauty of a Self-Contained Biological Indicator (SCBI)

VOL 6, ISSUE 4

How Long Should BIs be Incubated?

VOL 6, ISSUE 2

The Biological Indicator Spore Population has Minimal Impact on Resistance Performance

VOL 5, ISSUE 5

The Most Important Letter in SteriliZation is Z

VOL 5, ISSUE 4

Glassine Packaged Vs. Naked Carrier D-values

VOL 5, ISSUE 3

Heat Shock/Heat Activation

VOL 5, ISSUE 2

Air Removal from the Sterilization Chamber

VOL 5, ISSUE 1

Spores Do Not Have an Intrinsic D-value

VOL 4, ISSUE 6

Verification Testing with Different Media is a Waste of Time

VOL 4, ISSUE 5

Will Biological Indicator Spores Contaminate My Production Environment?

VOL 4, ISSUE 4

Reduced Incubation Time, What’s the Point?

VOL 4, ISSUE 3

The Quest for the Perfect D-value

VOL 4, ISSUE 2

Why Use Biological Indicators in Routine Sterilization?

VOL 4, ISSUE 1

Impact of Culture Media on Biological Indicator Spore Recovery

VOL 3, ISSUE 4

Steam-in-Place (SIP), the Problems and a New Solution

VOL 3, ISSUE 3

What is the D-ifference in D-value?

VOL 3, ISSUE 2

Z-Value Calculation

VOL 3, ISSUE 1

Calculation of the Biological Indicator D-value and Kill Time for a Temperature not Specified on the Certificate of Analysis

Spores Don’t Lie… and Probes Don’t Always Know (or tell) the Truth

VOL 2, ISSUE 3

What does the Survival/Kill Calculation on the Certificate of Analysis Really Indicate?

VOL 2, ISSUE 2

Selecting a Biological Indicator with Appropriate Resistance Performance to Monitor a Validated Sterilization Cycle

VOL 2, ISSUE 1

How Much Variation Should You Allow When You Specify a D-value?

VOL 1, ISSUE 4

The Importance of 16S rRNA Bacterial Spore Identification

VOL 1, ISSUE 3

Product D-Value Studies: a Critical Tool When Developing a Sterilization Process

VOL 1, ISSUE 2

Biological Indicator for Monitoring Low Temperature Steam Sterilization