Manufacturing & Packaging Articles

  1. The Importance Of Medical Device Packaging 6/13/2022

    When designing or considering the manufacturing process for a medical device, there’s an element that often gets left until the last minute; packaging. The right packaging used can reduce costs, potentially optimize the sterilization processes, and aid in the manufacturing process.

  2. When Does Automated Assembly Make Sense? 6/13/2022

    To mitigate costs, timeliness, and other factors, in order to produce a safe, effective, innovate medical device means assembly has to be part of the concept phase, to determine if full automation is the solution. 

  3. Biological Indicators And The European Pharmacopoeia 5/10/2022

    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.

  4. Why Biological Indicators Survive A Validated Cycle 5/10/2022

    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.

  5. Flexible, Modular Manufacturing When One Size Doesn't Fit All 5/5/2022

    Current drug delivery devices need to be more mobile, less intrusive, and cost-competitive. Learn how flexible, modular manufacturing aims to solve these challenges.

  6. Biological Indicators For Vapor Hydrogen Peroxide Isolator Decontamination 4/20/2022

    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.

  7. A Guide To Vaporized Hydrogen Peroxide Isolator Decontamination 4/20/2022

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

  8. Using Replicate BIs To Evaluate Biodecontamination Cycles In Isolators 4/20/2022

    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.

  9. Parameters Affecting Vapor Hydrogen Peroxide Biological Indicator Performance 4/20/2022

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

  10. Vision And Paperless Ops Make Northeast Scientific A MedTech Industry Leader 2/28/2022

    Managing all the documentation for the many devices Northeast Scientific remanufactured was complex and prone to errors. A modern manufacturing execution system allowed them to manage documentation by eliminating paper.