• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    MPO's Most-Read Stories This Week—Feb. 4

    MO SCI Acquires Assets of 3M’s Advanced Materials Business

    Neurent Medical’s NEUROMARK System Becomes Commercially Available in U.S. Markets

    Aspivix's Carevix Cervical Stabilizer Gains FDA OK

    Apyx Medical Submits 510(k) App for Renuvion APR Handpiece
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Deducing the Dual Reality of Elizabeth Holmes

    The Return of the AdvaMed MedTech Conference…Live!

    Material Matters: New Materials Call for New Thinking

    5 Ways to Maintain a Talent-Centric Mindset, Even During Economic Uncertainty

    The Changing Face of UK Medical Device Regulations: Most Recent Update
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Forefront Medical Technology

    Paragon Medical

    NDH Medical Inc.

    Arthur G. Russell Co. Inc., The

    JBC Technologies
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Onshoring Medical Device Manufacturing Can Strengthen Supply Chains

    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Forefront Medical Technology

    Paragon Medical

    NDH Medical Inc.

    Arthur G. Russell Co. Inc., The

    JBC Technologies
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Columns

    Packaging Design Considerations to Ensure a Safe, Sterile Medical Device

    Choosing the right packaging configuration for a medical device is critical to ensure safety and sterility to the end user.

    Packaging Design Considerations to Ensure a Safe, Sterile Medical Device
    Over the counter or in the operating room, aesthetics play an essential role in medical device packaging. Image courtesy of WuXi AppTec Medical Device Testing.
    Britt Jones, Manager, Chemistry & Package Testing, WuXi AppTec Medical Device Testing06.02.21
    Choosing the right packaging configuration for a medical device is critical to ensure safety and sterility to the end user. With so many competing priorities and elements to consider when getting a medical device ready to hit the market, even a significant factor like packaging could fall under the radar. Patient protection, device sterility, clear instructions, and hygienic presentation all play important roles in ensuring quality packaging and a successful and functioning medical device.

    In some cases, companies opt for standard offerings, but this can be limiting. Tailoring the packaging to the device ensures it is working for the product—not the other way around.

    To ensure manufacturers pass their packaging evaluation and end users receive a fully functioning, sterile, and presentable device, companies must understand potential risks and prioritize packaging design early in the device development process.

    Avoiding Compromised Sterilization
    Ensuring a medical device remains sterile until the end user needs it is imperative to patient safety and overall user satisfaction. Device packaging serves as an important barrier against unwanted exposure to bacteria and other potential contaminants. If the packaging design falters and allows a seal to break, the sterile barrier is compromised and the device is not useable. This mishap puts patients at risk and leads to the waste of what would have been a perfectly functioning product.

    Identifying risks that could lead to a compromised sterile barrier is something a testing partner can help with—however, there are factors to watch out for when designing packaging. Certain elements in packaging, such as any folds or channels in a heat-sealed poly packaging pouch, could lead to exposure and jeopardize the sterile barrier. Additionally, heavy or unnecessary packaging may lead to tears or dents in the material, causing issues with the integrity of both the sterility of the package and the device. Manufacturers can minimize the likelihood of a broken sterile barrier by designing the packaging with these risks in mind.

    For any sealed areas of the package system, a testing partner can confirm the accuracy of the manufacturer’s heat sealer using a bubble emission or a dye penetration test. These tests will detect if a package’s integrity is vulnerable. A testing partner can also put packaging through drop, compression, and vibration testing to assess whether the packaging configuration will negatively react to different distribution environments. Shipping and handling can be unpredictable, so it is crucial to ensure the packaging is up for the journey and will arrive to the end user fully intact with a functioning device inside.

    Prioritizing Protection
    To guarantee patient safety, make certain the packaging materials, enclosures, usability, and presentation are configured to the highest quality. The package design should strike a balance between providing adequate medical device protection with as few components as needed to conserve costs.

    To safeguard the medical device’s integrity and sterility, a well-versed testing partner with experts in packaging can help manufacturers determine an ideal packaging configuration by leveraging their vast exposure and historical expertise. While a standard, single-package configuration across multiple products might be appealing to streamline the decision and implementation processes, selecting the correct amount of packaging a device requires is essential to establish packaging quality. This is typically not a one-size-fits-all situation.

    Involving a testing partner will help manufacturers determine a reliable packaging strategy and save time. If the initial test results are less than ideal, testing partners can share their perspective on which factors to consider adjusting and provide support moving forward.

    The Role of Aesthetics
    In addition to ensuring optimal packaging performance, manufacturers also need to consider the experience component of delivering a device. The overall look of the packaging might not be as high of a priority as efficacy and safety, but visuals of a product can be just as important to the end user when selecting a product.

    Over the counter or in the operating room, aesthetics still play an essential role in medical device packaging. Sizing accurately can avoid crinkled or tattered packaging that, while technically sterile, look dingy and unappealing.

    Apart from the risk of a dented package deterring an end user, labeling also must be intact and clear for patient safety. Regulations set by the U.S. Food and Drug Administration (FDA) state that “all labels must be designed and applied to devices and containers so that the labels will remain in place and legible during the customary conditions of distribution, storage, and use.”

    Damage-prone material might not only result in poor user experience, but could also impact medical device usability. To confirm a device meets these expectations, a testing partner may also use simulated distribution to help manufacturers predict whether the label would rub off, become illegible, or move out of place under normal handling conditions.

    When designed strategically, manufacturers can guarantee safety for both the device and the patient. Fortunately, they don’t have to face this challenge alone. Medical device testing partners can guide manufacturers in choosing the proper packaging configuration for their device based on the product’s nature, planned sterilization methods, and intended use. Whether a company intends to use a standard configuration or take their own approach, taking the many factors at play in designing and testing packaging into consideration is critical to delivering a safe and successful medical device. 


    Britt Jones is the manager of package testing services for devices, biologics, and combination products at WuXi AppTec Medical Device Testing. He serves on the ASTM Committee on Packaging (ASTM D-10) and is a member of and certified by the International Safe Transit Association (ISTA) and the Institute of Packaging Professionals (IoPP). He can be reached at britt.jones@wuxiapptec.com.
    Related Searches
    • Packaging & Sterilization
    Related Knowledge Center
    • Packaging & Sterilization
      Loading, Please Wait..

      Trending
      • Study: Smartphone Therapeutic Helps Improve Fibromyalgia In Patients
      • CGM Devices Could Become Main Glucose Monitoring Solution In U.S.
      • Environmental Sustainability Becoming Increasingly Important To Medtech Industry
      • The Future Of Biomedical Engineering Advancements
      • A New Approach To Post-Market Surveillance
      Breaking News
      • MPO's Most-Read Stories This Week—Feb. 4
      • MO SCI Acquires Assets of 3M’s Advanced Materials Business
      • Neurent Medical’s NEUROMARK System Becomes Commercially Available in U.S. Markets
      • Aspivix's Carevix Cervical Stabilizer Gains FDA OK
      • Apyx Medical Submits 510(k) App for Renuvion APR Handpiece
      View Breaking News >
      CURRENT ISSUE

      January/February 2023

      • Struggling Suppliers in Electronics Manufacturing Services (EMS)
      • Machining & Laser Processing Have Huge Parts to Play
      • Medtech R&D Teams Must Be Creative & Resilient to Survive
      • Medtronic Neuromodulation President, Nnamdi Njoku, Interview
      • 6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
      • View More >

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      GOED Elects New Board Officers for 2023
      Aspire Hires Darrec Jones as VP of Business Development
      Pycnogenol Supplementation Linked to Better Hair Density in Menopausal Women
      Coatings World

      Latest Breaking News From Coatings World

      PPG Completes COLORFUL COMMUNITIES Project in Denmark
      10 Partners of the Automotive Industry Form JV, Cofinity-X
      BASF Recognized as Top Company for Supplier Diversity
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      MPO's Most-Read Stories This Week—Feb. 4
      MO SCI Acquires Assets of 3M’s Advanced Materials Business
      Neurent Medical’s NEUROMARK System Becomes Commercially Available in U.S. Markets
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Lilly 4Q Revenues Down 9% to $7.3B
      Bionova Expansion Project to Quadruple GMP Biologics Manufacturing Capacity
      Steriline Provides Fill-Finish Solution for Berkshire Sterile Manufacturing
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Pacifica Introduces Glow Baby Skincare Line
      Kohl’s Names Tom Kingsbury as Chief Executive Officer
      Mielle Unveils Haircare Bundles Inspired by Amazon Original Series Harlem
      Happi

      Latest Breaking News From Happi

      Grant Industries Names Mehran Ghadim Sales Manager, Canada
      Bio-Oil Celebrates Body Confidence Through Body Positivity Month Campaign
      Net Sales for Clorox Increase 1% for Q2 2023
      Ink World

      Latest Breaking News From Ink World

      Weekly Recap: Pigments, Inkjet Ink Market Reports Top This Week’s Stories
      Roland DGA Announces Key Changes to Leadership Team
      Ball Reports 2022 Results
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      MM Packaging adds first Nilpeter press for Dublin site
      Polytag develops new UV tag reading technology
      Enterprise Print Group adds Screen Truepress Jet L350UV SAI E
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      What You’re Reading on Nonwovens-Industry.com
      Kimberly-Clark Supports Period Poverty Initiative in Australia
      Suominen Reports Q4, Full Year Results
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      ODT's Most-Read Stories This Week—Feb. 4
      Toetal Solutions Secures $1.8 Million in New Financing
      Adrian Tyndall Joins Axogen's Board of Directors
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Weekly Recap: CES 2023, ams OSRAM and Celanese Top This Week’s Stories
      Zebra Provides East West Shrine Bowl with RFID Tracking Technology
      AAAS Elects Three ORNL Scientists as Fellows

      Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login