Medical Device Packaging and Next Generation Tyvek® Maintaining Approval for Medical Devices and Sterile Packaging During the Transition

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Medical Device Packaging and Next Generation Tyvek® Maintaining approval for medical devices and sterile packaging during the transition

White paper

Abstract

A significant modification in the technology used in the manufacture of Tyvek® material found in a wide variety of medical devices and sterile packaging will now require manufacturers of currently approved Tyvek®-based products to re-evaluate them for continued compliance with applicable standards and regulations. This white paper presents the details of the production transition regarding Tyvek®, and summarises the likely steps necessary to ensure the continued recognition of previously approved medical devices and packaging that incorporate Tyvek® material.

TÜV SÜD Contents

1 INTRODUCTION 3

2 Medical Device Sterile Packaging Requirements and Standards 4

3 Tyvek® and Medical Device Packaging 5

4 The Tyvek® Medical Packaging Transition Project 6

5 Required Actions for Maintaining EU Notified Body Certification 7

6 Required Actions in Other Jurisdictions 8

7 Other Transition Considerations 9

8 How can TÜV SÜD help you? 10

About TÜV SÜD expert

Dr. Jan Havel Team Leader for Sterilisation and Biocompatibility, TÜV SÜD Product Service Dr. Jan Havel is a sterilisation product specialist and auditor for the Medical and Health Services group at TÜV SÜD Product Service. He serves as a team leader for TÜV SÜD experts in the validation of sterilisation processes, reprocessing, sterile packaging processes and biocompatibility testing for medical devices. Dr. Havel is an active member of the ASTM International’s Technical Committee F02 for Flexible Barrier Packaging and is Senior Product Specialist for the related topics and provides internal and external trainings for Sterilisation, Reprocessing, Packaging, Risk Management and Usability for Medical Devices.

2 Medical Device Packaging and Next Generation Tyvek® | TÜV SÜD Introduction

Tyvek®-brand polyethylene material manufacturers (SPMs) to file formal has been widely used by manufacturers notifications with their respective EU DuPont Company, the of certain medical devices and medical Notified Body or other national manufacturer of Tyvek®, device packaging because of its regulatory authorities in connection has transitioned to a resistance to microbial penetration with previously approved medical in sterile applications. However, the devices and packaging that incorporate modified manufacturing DuPont Company, the manufacturer of Tyvek® material. In addition, in some process in the production Tyvek®, has transitioned to a modified jurisdictions, manufacturers of medical of Tyvek®. manufacturing process in the production devices that pose the greatest risk to of Tyvek®. This modification will require patients may be subject to additional many medical device manufacturers testing in order to maintain their device (MDMs) and sterile packaging recognition.

TÜV SÜD | Medical Device Packaging and Next Generation Tyvek® 3 Medical device sterile packaging requirements and standards

The European Centre for Disease of initial sterilisation and packaging until validation, and affect the sterility, safety, Prevention and Control estimates that the time of use, thereby helping to or efficacy of sterile medical devices.” over four million patients in the prevent the spread of infection. Revalidation is required since packaging European Union (EU) acquire a characteristics or density could affect healthcare-associated infection each Under the requirements of the EEC the absorption or penetration of year, directly resulting in at least directives and the EC directive sterilising chemicals, the effectiveness 37,000 deaths and contributing to as applicable to medical devices, of the sterilisation process, the integrity many as 110,000 additional fatalities.1 packaging materials and systems used of package sealing or the safety of Since infections due to poor hygiene to preserve the sterility of medical sterilised devices. account for approximately 20 to 30 devices must conform to percent of all healthcare-associated the requirements of the EU’s harmonised ISO 11607 has become the infections, rigorous hygiene and version of ISO 11607, Packaging for internationally-accepted standard for sterilisation practices are a primary terminally sterilized medical devices. sterile packaging materials and systems focus of efforts to reduce overall Part 1 of the standard, ISO 11607-1, used with medical devices, and has infection rates in healthcare settings. addresses requirements for materials been adopted by medical device used in sterile barrier systems and authorities in most countries around Most medical devices and apparatus packaging systems, while Part 2, ISO the world. Although the U.S. Food and designed to come in direct contact 11607-2, covers validation requirements Drug Administration (FDA) does not with patients must be sterilised to for the manufacture and assembly of expressly require demonstrated prevent the unintended transmission packaging materials and systems. compliance with ISO 11607, the of infectious organisms. Typically, agency does accept evidence of sterilisation is achieved through the Of particular note in ISO 11607-2 is the certification to the standard in support use of specially-designed, non-reusable requirement to revalidate sterile of manufacturers’ 510(k) pre-market packaging materials that provide a packaging materials and systems submissions for the approval of new barrier against microbial transmission. when “changes are made to the… medical devices. This sterile barrier system effectively packaging materials or packaging maintains device sterility from the point processes which comprise the original

4 Medical Device Packaging and Next Generation Tyvek® | TÜV SÜD Tyvek® and medical device packaging

Originally developed in the U.S. by and mailing envelopes. be sterilised after packaging. Finally, DuPont in the 1950s, Tyvek® is an Tyvek® material is strong enough to engineered material comprised of The earliest application of Tyvek® to resist damage that could compromise non-directional fibres that are thinner medical device packaging occurred in the condition of previously sterilised than a human hair. These fibres are the early 1970s, a time when healthcare devices.3 bonded together with heat and facilities were increasingly turning to pressure (no chemical binders) and disposable medical devices as a way Due in large part to these unique spun into sheets using flash-spinning of reducing labour costs associated properties, Tyvek® has become an technology, a proprietary manufacturing with re-sterilising. DuPont researchers important packaging material option process. Tyvek®-based materials determined that Tyvek® was especially for sterile medical devices and is widely and packaging have the advantages well-suited as a packaging material used by device manufacturers of being light in weight while also for disposable medical devices, since worldwide. In addition to its application resistant to punctures or tears, as it provides greater resistance to in the packaging of medical devices, well as providing an effective barrier microbial penetration than medical Tyvek® is now also used to package against liquids.2 Today, Tyvek® is grade papers and other sterile disposable syringes and as a material used in a wide range of applications, packaging materials. Tyvek®’s in the construction of medical grade including vapour barriers in building permeability to air and gas also allows trays and pouches. It is even used as a construction, garments and shoes, for the infiltration of gas and ethylene packaging material for pharmaceuticals. and a variety of packaging material oxide, so that medical devices can

TÜV SÜD | Medical Device Packaging and Next Generation Tyvek® 5 The Tyvek® Medical Packaging Transition Project

DuPont manufactures a number of manufacturers of its plans to eventually its new manufacturing process to different styles of Tyvek® for the adopt a new flash-spinning technology determine its functional equivalence packaging of sterile medical devices, in the manufacturer of Tyvek® to help with Tyvek® material manufactured the two most popular being Tyvek® ensure the company’s capabilities to with the earlier version of flash-spinning 1073B and Tyvek® 1059B. Tyvek® meet anticipated future demand. technology. Testing conducted by 1073B is a robust packaging material According to the company, the change DuPont as part of the MPTP has offering increased resistance to in manufacturing technology would included assessments of the effects microbial penetration and greater potentially trigger the need to revalidate on the microbial barrier properties of protection against damage from heavy sterile packaging materials and systems the new Tyvek® from sterilisation, and devices or devices with sharp points. previously tested to the requirements from one year real-time aging and one, Tyvek® 1059B is a packaging material of ISO 11607. At a minimum, the three and five year accelerated aging.4 intended for use in sterile packaging transition to a new manufacturing applications for smaller medical technology would require manufacturers Under the MPTP, DuPont has also devices without sharp edges. As to update their documentation to worked closely with regulatory originally manufactured, both Tyvek® reflect the change and potentially to authorities in the EU, the U.S., China, styles 1073B and 1059B comply with adapt and revalidate the process. Japan, Canada and other countries. the material requirements of ISO The goal of these discussions has been 11607-1. Accordingly, medical device To aid medical device and sterile to provide regulators with testing data packaging comprised of either of these packaging manufacturers with the showing functional and biocompatibility two Tyvek® styles are presumed transition and possible revalidation of equivalence between Tyvek® produced compliant with material properties for packaging materials, DuPont launched under the new process and Tyvek® a sterile packaging as required under the Tyvek® Medical Packaging Transition produced using legacy technology. the EEC directives and the EU Project (MPTP) in 2011. Working in These discussions have also enabled directive applicable to medical conjunction with device and packaging DuPont to anticipate and address other devices, as well as applicable manufacturers, regulatory authorities, issues that could potentially create regulations in other jurisdictions Notified Bodies (including TÜV SÜD additional hurdles for manufacturers around the world. Product Service) and contract seeking revalidation of their packaging sterilisers around the world, the materials. In 2011, DuPont notified medical device company conducted extensive testing manufacturers and sterile packaging with Tyvek® material produced using

6 Medical Device Packaging and Next Generation Tyvek® | TÜV SÜD Required actions for maintaining EU Notified Body certification

The exhaustive and detailed efforts Currently, it appears that the its Notified Body about every taken under the auspices of DuPont’s requirements for maintaining EC- planned changeover from legacy MPTP have now provided medical certification issued by an EU Notified Tyvek® to new Tyvek® by submitting device and sterile packaging Body will involve the greatest effort a substantial change notification. manufacturers with a clear path for for medical device and sterile packaging The aforementioned submission of maintaining existing approvals of sterile manufacturers. The legal a substantial change notification packaging materials and systems manufacturer or the authorised applies for all certified medical made of Tyvek® in most jurisdictions. representative is obliged to inform devices regardless of their class.

Required actions for maintaining EU Notified Body certification

1 2 3 4

CONCLUSION ISO 11607-2 NBOG BPG 2014-03

Initiate a formal Document the rationale for If further testing is Update the applicable change assessment accepting the functional deemed appropriate, medical device design and risk assessment equivalency conclusions identify and complete file with all relevant process consistent of DuPont’s testing and the specific testing that documentation, with the requirements protocol assessment as must be conducted; including a Significant of ISO 11607-2 and they apply to their specific Change notification. NBOG BPG 2014-03; product; and

In the case of Class III medical devices, manufacturer’s submitted data is Regardless of the risk class assigned manufacturers will be required to sufficient to support the changeover to to a given device, medical device submit their updated medical device the new Tyvek® material. and sterile packaging manufacturers design dossier and Significant Change must also concurrently review and notification to their respective EU For lower risk devices categorised as evaluate the provisions of their quality Notified Body immediately upon the Class Is, IIa and IIb, manufacturers management system for continued completion of the above steps. The will be required to submit a significant compliance with the requirements of Notified Body will then review all change notification and supporting ISO 13485, Medical devices - Quality submitted documentation and make documentation to their respective EU management systems - Requirements a determination whether the Notified Body for review. for regulatory purposes.

TÜV SÜD | Medical Device Packaging and Next Generation Tyvek® 7 Required actions in other jurisdictions

Below is a brief summary of the current transition status in other key jurisdictions:

United States In October 2015, the U.S. FDA has affirmed the functional equivalence of Tyvek® styles 1073B and 1059B produced with the new technology.5 With affirmation of functional equivalence, the modification will simply be interpreted as a change in material lot, and medical device and sterile packaging manufacturers will not be required to file amended 510(k) applications for currently approved devices in most cases.

China China’s Food and Drug Administration conducted its own independent testing in 2013 on Tyvek® manufactured with the new technology and has concluded that “For the DuPont ‘Tyvek®’ products manufactured with DuPont’s latest flash-spinning technology and current manufactured DuPont Tyvek® products, all the testing results meet the criteria of functional equivalence and non- inferiority under the DuPont Validation Protocol.”6 Therefore, no additional testing is required.

Japan Japan’s Ministry of Health, Labor and Welfare (MHLW), in conjunction with the Pharmaceutical and Medical Device Agency (PMDA), recommends that medical device manufacturers review and update relevant documentation as necessary, and submit a change notification to authorities. The change notification is not expected to result in a subsequent audit or investigation. 7

Canada Health Canada has developed a unique notification process to specifically address the Tyvek® changes. Under this process, manufacturers of Class III and Class IV medical devices using Tyvek® affected by the manufacturing technology change must submit to Health Canada written notice attesting that the configuration and sterilisation process identified in DuPont’s testing is directly applicable to their product. Manufacturers of Class III and Class IV devices are only required to submit a Medical Device License Amendment Application in cases where differences in the packaging configuration or sterilisation process could negatively impact device sterility over the stated shelf-life.8

8 Medical Device Packaging and Next Generation Tyvek® | TÜV SÜD Other transition considerations

Despite their comprehensive scope, The notification received by DuPont products is required to maintain the functional equivalence studies from the U.S. FDA affirming the compliance with applicable regulations conducted by the MPTP do not functional equivalence of transition and requirements. Prompt attention address every potential variable in and legacy Tyvek® in October 2015 to transition requirements will enable how Tyvek® may be used in a specific signals the beginning of commercial manufacturers to quickly incorporate application. For example, some sterile sales of the transitioned advanced new Tyvek® into their production packaging manufacturers may prescribe material. The company announced processes, reducing the risk of sterilisation using chlorine dioxide, a that starting January 2019 all 1059B production interruptions and helping to sterilisation modality that differs from and 1073B will be Transition Tyvek®; ensure the continued flow of product those evaluated under the MPTP. In Legacy Tyvek® products will be to customers. such cases, medical device and sterile discontinued. packaging manufacturers will likely be required to conduct additional For these reasons, medical device and testing to demonstrate functional sterile packaging manufacturers are equivalence with legacy Tyvek® in urged to complete the regulatory connection with a specific use in a review process to determine whether currently approved product. revalidation testing of their specific

TÜV SÜD | Medical Device Packaging and Next Generation Tyvek® 9 How can TÜV SÜD help you?

TÜV SÜD Product Service GmbH is sterile packaging manufacturers available digitally for a fee of 850 EUR one of the five EU Notified Bodies step-by-step through the evaluation plus VAT and can be used by companies that participated in DuPont’s MPTP, and revalidation process. TÜV SÜD’s for all their medical devices affected and has issued a guidance letter Tyvek® Transition Submission Form by the transition. on the transition for compliance provides an effective blueprint for with EU requirements. TÜV SÜD navigating the transition process, For more information about TÜV SÜD’s has also developed a generic digital and is an efficient and cost-effective Tyvek® Transition Submission Form, Tyvek® Transition Submission Form method for achieving continued please contact your local TÜV SÜD that will take medical device and compliance. The questionnaire is representative.

10 Medical Device Packaging and Next Generation Tyvek® | TÜV SÜD GlossaRy of aCronyms EU – european union MPTP – medical packaging transition project FDA – food and drug administration PMDA – pharmaceutical and medical device agency MDM – medical device manufacturers SPM – sterile packaging manufacturers MHLW – ministry of health, labor and welfare

footnotes [1] “Healthcare-associated infections,” European Centre for Disease Prevention and [6] “Validation Report of Functional Equivalence and Non-Inferiority for the DuPont Tyvek® Control, updated 5 May 2015. Available at http://ecdc.europa.eu/en/healthtopics/ Medical Packaging Transition Project,” issued by CFDA-Jinan Quality Supervision and healthcare-associated_infections/Pages/index.aspx (as of 31 August 2015). Inspection Center for Medical Devices, 24 December 2013. Bi-lingual text available at http://www.dupont.com/content/dam/dupont/products-and-services/packaging- [2] “Product Handbook for DuPont Tyvek®,” E.I. du Pont de Nemours and Company, May materials-and-solutions/medical-and-pharmaceutical-packaging-materials/documents/ 2002. Available at http://www.dupont.com/content/dam/dupont/products-and- CFDA-Jinan%20Final%20Report%20on%20MPTP%20Material.pdf (as of 31 August 2015). services/fabrics-fibers-and-nonwovens/industrial-fabrics/documents/DPT_Tyvek®_ Product_Handbook.pdf (as of 31 August 2015). [7] For further details, see “DuPont Tyvek® Transition Project: Japan Regulatory Guidance Update,” DuPont 1 June 2015. Available at http://www.dupont.com/content/dam/ [3] For additional information on the history of Tyvek® in medical device packaging, see dupont/products-and-services/packaging-materials-and-solutions/medical-and- “Tyvek® — Advancing the Science of Protection in Medical Packaging,” DuPont website, pharmaceutical-packaging-materials/documents/Japan%20Guidance_June%20 2015. Available at http://www.dupont.com/products-and-services/packaging-materials- 1%2C%202015.pdf (as of 31 August 2015). solutions/pharmaceutical-packaging/brands/tyvek®-sterile-packaging/articles/science- of-protection.html (as of 31 August 2015). [8] “Notice to Sterile Medical Device Manufacturers: Health Canada Requirements for Manufacturers Relating to Manufacturing Change to Tyvek® 1073B and 1059B,” Health [4] The complete results of DuPont’s testing of the new Tyvek® is available at www.transition. Canada. Available at http://www.dupont.com/content/dam/dupont/products-and- tyvek®.com (as of 31 August 2015). services/packaging-materials-and-solutions/medical-and-pharmaceutical-packaging- materials/documents/NOTICE%20TO%20STERILE%20MEDICAL%20DEVICE%20 [5] “U.S. FDA Affirms Functional Equivalence of DuPont Tyvek®”, DuPont, 5 October 2015. MANUFACTURERS.pdf (as of 31 August 2015). Available at http://www.dupont.com/products-and-services/packaging-materials- solutions/pharmaceutical-packaging/brands/tyvek®-sterile-packaging/press-releases/ fda-tyvek®-functional-equivalence.html (as of 4 December 2015)

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