FEATURED ARTICLES

• Mastering Ethylene Oxide Sterilization: Your Comprehensive Field Guide

  Whether you're refining existing protocols or developing new ones, this guide serves as a valuable resource for ensuring safe, effective, and compliant sterilization outcomes.

• Choosing A PCD Configuration For Your Cycle

  Ethylene Oxide (EO) sterilization is essential for medical device safety. Explore how Process Challenge Devices help validate and monitor EO processes with precision across a wide range of applications.

• Enhancing Ethylene Oxide Sterilization Processes

  PCDs are patented devices designed to meet the demands of EO sterilization. Gain insight into how they support process development, validation, and monitoring with reliable, reproducible performance.

• Ensure Safety And Compliance With A Guide To Sterilization Validation

  Sterilization validation is vital in pharma and medical device manufacturing to ensure product safety and regulatory compliance. Explore essential principles, best practices, and frameworks for effective implementation.

• Specific Sterilization Method: Best Practices And Common Pitfalls

  Validating sterilization methods like steam, VH₂O₂, and EO is essential for safety and compliance. Learn best practices, avoid common pitfalls, and optimize your validation strategy effectively.

• What Is A Bowie-Dick Test And Why Is It Important?

  Effective sterilization is vital in manufacturing. Discover how the Bowie-Dick test ensures vacuum sterilizer performance, safeguards patient safety, and strengthens your sterility assurance program.

• Understanding D-values: A Simplified Explanation For Busy Professionals

  D-values are essential for ensuring sterility in pharma and medical device manufacturing. Explore a simplified concept that helps professionals optimize sterilization processes and ensure product safety.

• The Ultimate Guide To Biological Indicators

  Discover why biological indicators are the gold standard for sterilization validation in pharmaceutical and medical device manufacturing, as well as how choosing the right one ensures safety, compliance, and product integrity.

• 5 Biggest Sterilization Challenges Facing Manufacturers

  Sterility is non-negotiable in pharmaceutical and medical device manufacturing. Discover the top five sterilization challenges facing manufacturers today and the proven strategies to overcome them while ensuring compliance and safety.

• Why Perform A D-Value Study? Reference Review

  Understanding how a product influences microorganisms' resistance is crucial. Read about relevant standards and references as well as recommendations for performing product D-value studies.

• Reducing Risks In Your SIP Validation Cycles

  Utilizing tape for positioning during Sterilize in Place (SIP) validation can introduce numerous issues. Explore the top eight reasons why tape should be avoided during SIP validation cycles.

• How To Prove A Sterility Assurance Level Of 10⁻⁶

  Explore the Biological Indicator/Bioburden (BI/BB) method for achieving sterilization of products along with the prerequisite studies needed to develop the sterilization process.

• 6 Reasons To Use Biological Indicators During Your Sterilization Cycle

  Understand the importance of biological indicators, and learn why they should be integral to any comprehensive sterilization program.

• Annex 1 Compliance Guidelines For Biological Indicator Users

  Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators.

• Caramelization Of LSBIs Due To Extended Thermal Insult

  Learn about liquid submersible biological indicators (LSBI), including the three basic LSBI formats, and how caramelization due to long sterilization cycles affects the media's ability to promote spore growth.

• Product D-Value Study - Part 2, Heat-Sensitive And Atypical Aqueous Liquids

  How can your organization use this critical tool when developing your sterilization process for heat-sensitive products and low F0 cycles?

• Why Perform A Product D-Value Study?

  Follow a discussion on non-heat sensitive aqueous liquid product sterilization and the use of the Overkill method and Bioburden/BI method.

• Product D-Value Studies: A Critical Tool In Sterilization Process Development

  Learn about what questions to ask when developing a sterilization method and a critical tool that can help guide your decisions.

• Biological Indicators And The European Pharmacopoeia

  Here, we review the information concerning biological indicators in European Pharmacopoeia General Chapter 5.1.2, which is more detailed and covers a wider scope than the previous version.

• Why Biological Indicators Survive A Validated Cycle

  We review what to do should you ever find yourself in the situation where the probes indicate conditions that would render killed BIs, yet the units are testing positive.

• Biological Indicators For Vapor Hydrogen Peroxide Isolator Decontamination

  We highlight vapor hydrogen peroxide (VH₂O₂) biological indicators (BIs) including necessary physical characteristics of the BI unit, BI types, proper BI placement, and challenges encountered.

• A Guide To Vaporized Hydrogen Peroxide Isolator Decontamination

  This field guide uses current published resources to provide clarity and direction regarding best practices for validating decontamination processes using VH₂O₂.

• Proper Biological Indicator Placement During Vaporized Hydrogen Peroxide Decontamination Cycles

  We discuss the three general BI types used for monitoring the VH₂O₂ cycles and directions on their proper placement in the isolator.

• Using Replicate BIs To Evaluate Biodecontamination Cycles In Isolators

  We discuss the concept of using triplicate biological indicators (BIs), not as a reaction to having obtained an unexpected growth-positive BI in your vaopr hydrogen peroxide cycle, but as a proactive measure.

• Parameters Affecting Vapor Hydrogen Peroxide Biological Indicator Performance

  We review the potential benefits and difficulties of using Vapor Hydrogen Peroxide (VHP) in decontamination and sterilization.