• 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
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    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
    EchoNous Partners with Samsung

    Solid Growth Forecast for Global Ostomy Devices Market

    KA Imaging's Reveal 35C Images Increase Lung Lesion Visibility

    Respira Technologies Appoints Brian Quigley as CEO

    Nikki Troiano Gainey Joins RIVANNA Board
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cooling and Melting the Pain Away

    What Are the Fundamentals of Go-To-Market Strategy in Medical Devices?

    Minding the Gap: How Harmonizing Quality Systems Pays Off

    Building Strong Partnerships Between Medtech and Surgeon-Learning Platforms

    Four Key Considerations for OEMs Transferring a Product Program
    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
    Trademark Plastics Inc.

    BMP Medical

    JBC Technologies

    Fusion Biotec Inc.

    Cirtec Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Buyer and Seller Tips on Mergers & Acquisitions for MPO Companies

    Medical Computing: COM Express Processes Real-Time Data at the Edge

    The Importance of Building Successful Supplier Relationships

    The Benefits of Outsourcing Innovation in Medtech Manufacturing

    Patching Healthcare Cybersecurity Risks in the Internet of Medical Things
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Trademark Plastics Inc.

    BMP Medical

    JBC Technologies

    Fusion Biotec Inc.

    Cirtec Medical
    • 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 Validations—Looking Beyond ISO 11607

    ...

    Packaging Validations—Looking Beyond ISO 11607
    Related CONTENT
    • Top 4 Challenges Healthcare Faces with Medical Device Information
    • 5 Medtech Trends Shaping 2017: Cybersecurity
    • FMI Opens New Cleanroom for Silicone Parts
    • Design Considerations for Using Reinforced Silicone Tube
    • 2. Johnson & Johnson
    Christopher Scott, Vice President, Eurofins Medical Device Testing10.05.17
    Most discussions on packaging validations for medical devices begin and end with ISO 11607: Packaging for Terminally Sterilized Medical Devices, and are laden with interpretations of how the two parts of this standard apply best to the unique aspects of any given device and packaging system. Although compliance to the standard is a requirement for CE marking of products in Europe, and ISO 11607 is on FDA’s list of recognized consensus standards, meeting the requirements of ISO 11607 does not ensure the complete obligations of FDA’s Quality System Regulations are fulfilled. Section 820.130 of Subpart K (Labeling and Packaging Control) of the regulations state, “Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.”

    ISO 11607 deals with ensuring the primary sterile seal integrity of terminally sterilized medical devices, which in many cases, accurately represents the highest risk of failure as a product makes its journey from the manufacturer’s warehouse to the point of use. When considering a titanium or stainless steel implant or instrument, it is easy to expect that the weak link in a shelf-life study or transit simulation will be the plastic film or tray in which it is being shipped, or the heat seal that establishes the sterile barrier of the packaging.

    In these circumstances, following the guidance of ISO 11607, and applying the appropriate ASTM, ISO, and ISTA standards will often satisfactorily address the packaging controls requirements of the Quality System regulation. As technology advances and designs of medical devices become more complex, however, the adequacy of adhering to this standard alone must be reconsidered. Beyond the necessity of ensuring an intact sterile barrier, the packaging is required to protect the functionality of the device itself.

    A thoughtful, risk-based failure modes and effect analysis (FMEA) for complex (or even not-so-complex) assemblies should consider the following questions:

    • Will the difference in the coefficient of thermal expansion between mating parts in my surgical instrument be impacted by a product that may be exposed to the back of a delivery truck in Arizona (potentially 140 degrees F) or a winter weekend in the trunk of a car in upper Michigan (potentially -40 degrees F)?
    • Will continuous road vibrations, as my product is shipped from Boston to Los Angeles by truck, cause any of the threaded components in my assembly to back out?
    • Will extreme temperature changes or high humidity cause my overmolded parts or surface coatings to delaminate?
    • Will my packaging ensure that all electronic connections in my device withstand the impact or jarring of a cargo plane landing?

    Shake, Rattle, and Roll
    Fortunately, addressing these design concerns does not require reinventing the wheel. The same approach used to precondition and subject parts to simulated distribution cycles for validation of sterile barrier integrity can also be used to assess the functionality of a device. In fact, in many cases, the demands of functional testing may be less daunting if the impact of shelf-aging can be assumed to have a negligible impact on the product’s performance.

    ISO 11607 serves as a guidance for subjecting packaged products to a range of conditions that might be encountered during storage and distribution, with the intent of subsequently assessing the primary seal integrity. This post-distribution analysis can include testing such as visual inspections (ASTM F1886), gross bubble leak testing (ASTM F2096), or dye penetration testing (ASTM F1929), to name a few.

    The representative distribution simulation that is chosen to challenge the packaging will likely be the same whether the objective is to assess the sterile seal or product functionality, unless the FMEA identifies a unique concern that pertains to product design that is not expected to impact the packaging itself, such as rapid temperature fluctuations or extended vibration at a specific frequency (potentially inducing the loosening of mechanically fastened parts). This distribution simulation can follow well-defined conditions as outlined in ASTM D4169, or standard distribution cycles described by the International Safe Transit Association (ISTA). Both of these standards use a menu of simulation vibration and compression cycles aligned with typical distribution scenarios, as well as elements of induced rough handling.

    Examples of these distribution simulations include ISTA Series 3A General Simulation Performance Tests for packaged products for parcel delivery system shipment weighing 150 lbs. or less, or ASTM D4169 Distribution Cycle (DC) 13, which simulates intercity air and motor freight (local, single package up to 150 lbs.) using large hydraulic platforms to replicate the amplitude and frequency of road and air travel. Rough handling simulations involve dropping packages according to specifically defined sequences from different heights onto the box faces, edges, and corners.

    In the lineup of tests that are required to support medical device submissions and design history files, few have received such colorful monikers as have been assigned to distribution testing—shake and bake; drop and vibe; or shake, rattle, and roll. Despite the fanciful descriptions, these test standards prescribe a robust and disciplined methodology, which is well documented and accepted by regulatory agencies around the world.

    Getting the Most from Distribution Simulations
    When developing the final package validation protocol, it is often possible to assess both the sterile seal integrity and product functionality using the same sample. In order to realize the cost and time savings, it is important to select a seal integrity method that will not interfere with the functional assessment. For example, a pressure decay leak method (ASTM F2095) or bubble leak test may be preferred over a dye test if the seal test is to be followed by a mechanical performance test.

    If package validation testing is outsourced to a contract laboratory, while functional testing is desired to be maintained in-house, then additional coordination and communication will be necessary to ensure testing protocols are appropriately cross-referenced and products are appropriately returned for subsequent performance testing.

    This option presumes the testing is deemed a relatively low-risk validation and the distribution cycle is not expected to significantly impact the functionality of the device. If, however, a moderate or elevated concern exists over whether or not environmental or transit factors will impact a product’s performance, then it is prudent to perform these studies earlier in the design process, as part of the verification phase. In this case, a partial distribution cycle, or environmental treatment that emphasizes the conditions of concern can be investigated more robustly to support passage of an earlier design stage gate.

    If a mechanical or product performance issue is identified during shipping simulations, the solution may be addressed through a packaging enhancement, such as a more rigid outer packaging shell, thermal insulating liner, more shock absorbent packing material, or the addition of a desiccant to the packaging system to reduce exposure to moisture for sensitive devices. Alternatively, the issue may force designers back to the drawing board to reevaluate the design of the device itself.

    Label Integrity
    One additional consideration for packaging validation that does not fall under ISO 11607, and is not addressed above, is the label integrity. Historically, the damage that two boxes or pouches rubbing against each other can cause to the label had been assessed by a simple visual inspection, whereby the primary endpoint was general readability or cosmetic acceptability. With Unique Device Identification (UDI) requirements, regulations demand that barcodes remain readable at the time of use. With the new UDI requirements comes an elevated need to assess the barcode scannability following distribution simulations.

    Like the product functionality testing, barcode scannability and human readability testing can be performed as part of a standard ISO 11607 package validation protocol, using the same samples that will be used for seal integrity testing. For this testing, however, the non-destructive barcode testing would precede the seal integrity portion of the study.

    Process Changes and Revalidation
    Revisiting a package validation can be triggered by a number of factors and is most often associated with changes in packaging material suppliers, packaging line equipment or processes, or by a change in sterilization method. In light of performance considerations already discussed, it is important that any design or process changes to the device itself or the product labeling. Also consider whether that change may be sensitive to distribution chain rigors.

    A robust packaging validation program during the design and development phase will provide a helpful basis for future design and process changes, which should require a straightforward comparison study to assess any potential effects resulting from the change.

    Plan Ahead
    It is important to incorporate package testing into the project plan early in the design process. But all too often, tremendous focus is given to the device itself, while package validation remains an afterthought. As a result, project timelines can be thrown off at the eleventh hour due to an unexpected failure during validation testing that could have been avoided with a quick screening test earlier in the design process. This planning should involve the full design team, including logistics, warehousing, marketing, and sales, in order to fully anticipate what conditions a product may be subjected to as it progresses through the distribution chain from the production site to the end customer.

    Package validations are not only a regulatory requirement, but beyond that, the test methodologies employed can be a useful tool for ensuring a robust packaging system delivers the device sterile, intact, and in full functional condition for its intended use. 


    Christopher Scott is a vice president at Eurofins Medical Device Testing. With more than 25 years of experience in healthcare and medical device industries, Scott oversees operations for Eurofins Medical Device Testing. He has vast global experience in the development and commercialization of a broad range of medical devices. In his current role with Eurofins, Scott and his team serve as a partner for medical device companies in bringing their products to market through a comprehensive portfolio of testing services.
    Related Searches
    • assessment
    • implant
    • labeling
    • sterile
    Related Knowledge Center
    • Packaging & Sterilization
    • Testing
    Suggested For You
    Top 4 Challenges Healthcare Faces with Medical Device Information Top 4 Challenges Healthcare Faces with Medical Device Information
    5 Medtech Trends Shaping 2017: Cybersecurity 5 Medtech Trends Shaping 2017: Cybersecurity
    FMI Opens New Cleanroom for Silicone Parts FMI Opens New Cleanroom for Silicone Parts
    Design Considerations for Using Reinforced Silicone Tube Design Considerations for Using Reinforced Silicone Tube
    2. Johnson & Johnson 2. Johnson & Johnson
    Top 10 Challenges of the New MDR Top 10 Challenges of the New MDR
    Discussing the UL/Emergo Merger: A Q&A Discussing the UL/Emergo Merger: A Q&A
    Comparing cGMP Pharma vs. Device: Subpart A – General Provisions Comparing cGMP Pharma vs. Device: Subpart A – General Provisions
    House Calls House Calls
    Sharklet Technologies Announces Acquisition by Peaceful Union Sharklet Technologies Announces Acquisition by Peaceful Union
    Phillips-Medisize Names New VP Phillips-Medisize Names New VP
    NHS Barcoding: A Key Step Toward UDI NHS Barcoding: A Key Step Toward UDI

    Related Slideshows

    • Top 4 Challenges Healthcare Faces with Medical Device Information

      Top 4 Challenges Healthcare Faces with Medical Device Information

      Being cognizant of these healthcare issues/solutions may inspire device makers to develop their own solutions.
      Lee Ann McWhorter, Strategic Alliances Director, FDB Prizm 09.08.17

    • Digital Health | R&D & Design | Software & IT
      5 Medtech Trends Shaping 2017: Cybersecurity

      5 Medtech Trends Shaping 2017: Cybersecurity

      Cybersecurity risks will continue to threaten device innovation.
      Alex Butler, Manager, Medical Device Solutions, MasterControl 08.31.17

    • Contract Manufacturing | Tubing & Extrusion
      FMI Opens New Cleanroom for Silicone Parts

      FMI Opens New Cleanroom for Silicone Parts

      Medical silicone component manufacturer constructs 1,900 m² cleanroom and adds extrusion processes to company capabilities.
      Flexan 08.23.17


    • Cardiovascular | R&D & Design | Surgical | Tubing & Extrusion
      Design Considerations for Using Reinforced Silicone Tube

      Design Considerations for Using Reinforced Silicone Tube

      Solution offers a number of advantages, but designers need to consider the requirements of the specific application.
      Dan Sanchez, R&D Engineering Manager, Principal Engineer, Trelleborg Sealing Solutions 08.10.17

    • 2. Johnson & Johnson

      2. Johnson & Johnson

      ...
      07.26.17

    Loading, Please Wait..

    Trending
    • Monkeypox Outbreak Driving New IVD Device Development
    • M1 MedTech Announces Fall 2022 Cohort
    • Preceptis Medical’s Tympanostomy Tube System Cleared For Expanded Indications
    • Pulsed Field Ablation Tech Gaining Popularity
    • Edwards' PASCAL Precision Gains EU Nod
    Breaking News
    • EchoNous Partners with Samsung
    • Solid Growth Forecast for Global Ostomy Devices Market
    • KA Imaging's Reveal 35C Images Increase Lung Lesion Visibility
    • Respira Technologies Appoints Brian Quigley as CEO
    • Nikki Troiano Gainey Joins RIVANNA Board
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Parylene Coatings for Medical Device Technologies
    • Nearshoring Trends in Medtech Manufacturing
    • 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

    IFIC 2022 Food & Health Survey Highlights Eating Behavior Trends
    Icon Foods Appoints Operations and Marketing Leaders
    Annatto Tocotrienol Shown to Improve Weight Loss and Inflammation Markers in Patients with NAFLD
    Coatings World

    Latest Breaking News From Coatings World

    Birla Carbon, NREL Collaboration to be Presented at ACS Conference
    Coating Resins Market Worth $70.9 Billion by 2027: MarketsandMarkets
    PPG Appoints Brad Budde Vice President and Chief Digital Officer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    EchoNous Partners with Samsung
    Solid Growth Forecast for Global Ostomy Devices Market
    KA Imaging's Reveal 35C Images Increase Lung Lesion Visibility
    Contract Pharma

    Latest Breaking News From Contract Pharma

    GRAM to Fill and Finish Smallpox/Monkeypox Vaccines
    bluebird bio Wins FDA Approval of ZYNTEGLO
    Pace Life Sciences Acquires Meridian BioGroup
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Sephora at Kohl’s to Expand Sephora Presence to All 1,100+ Kohl’s Locations
    Emma Watson to Front New Fragrance Campaign for Prada
    The Estée Lauder Companies Delivers Strong Results in Fiscal 2022
    Happi

    Latest Breaking News From Happi

    Amorepacific, MIT Develop World's First Chip-less Wireless Electronic Skin Enabled by Semiconductors
    Maesa Launches Itk Skincare with TikTok Stars Brooklyn and Bailey McKnight
    Skin Delivery Formulation
    Ink World

    Latest Breaking News From Ink World

    Xeikon to Introduce TITON Food-Safe Dry-Toner Technology at Labelexpo Americas 2022
    Smurfit Kappa Employees Charity Cycle Across Europe
    ProAmpac’s Rocky Mount, VA Facility Receives ISCC Plus Certification
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    ePac makes big announcement, Avery Dennison debuts new technology and more
    Techkon USA announces latest handheld spectrodensitometer
    Maxcess China now manufacturing solid dies in Huzhou
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    INDA Appoints Director of Membership and Industry Relations
    Nexwear Acquires Incontinence Products Brand Lily Bird
    Because Market Expands into Retail Stores
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Theragen Receives Patent for Spine Fusion Bone Growth Stimulator System
    Study: BONESUPPORT’s CERAMENT G Can Help Save Infected Limbs
    Zavation’s Cervical Intervertebral Body Fusion Device Cleared by FDA
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    NREL, Birla Carbon Collaboration to be Shown at ACS Conference
    ORNL Celebrates Launch of Frontier, the World’s Fastest Supercomputer
    DuPont Names 2022 Lavoisier and Pedersen Award Medalists

    Copyright © 2022 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