Manufacturing & Packaging Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Bring Us Your Toughest Challenges 2/4/2022

    At Knowles Precision Devices, we purposely avoid commodity components. What we thrive on is doing the hard things. We handle the specialty components that go in systems that cannot fail and that operate at extremely high voltages, temperatures, or frequencies.

  7. Medtech Manufacturing: From Disruption To Evolution 12/16/2021

    Medical device manufacturing is a complex industry, so figuring out what areas to digitize can be difficult and different for every company. Here we explore different ways medical device and diagnostic manufacturers are embracing digital tools to maximize the value of ever-increasing data, as the industry pivots from crisis mode to evolution.

  8. Vital Signs Of The Medical Device Industry 10/1/2021

    The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond. As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive.

  9. What To Look For When Choosing A Medical Device (CMO) 9/17/2021

    ​Choosing the right CMO, with the qualified capabilities and experience your device needs prevents problems such as high failure rates, cost over-runs, misalignment on critical quality requirements, which could lead to missed deadlines and the loss of speed-to-market. 

  10. Manufacturing Transfer Requires Cross-Functional Leadership, Resources, And Open Communication 9/17/2021

    When a top-30 medical device original equipment manufacturer needed to close a legacy facility producing a Class III implantable device as part of its consolidation strategy, it opted to explore oursourcing rather than an in-house option.