Medical Device Packaging Validation

DuPont’s Tyvek Transition: Are You Prepared?

Tyvek Transition

By: Craig Fisch, Study Director, Nelson Laboratories

With DuPont’s Tyvek transition looming, manufacturers should consider performing a packaging validation as part of their implementation strategy.

Nelson Laboratories has been working with the new Tyvek material, testing it according to the ASTM F2638 method, for several years. DuPont has committed to help make this transition process seamless for sterile packaging manufacturers (SPMs), medical device manufacturers (MDMs), and the healthcare industry, carrying the lion’s share of time, money, and resources associated with establishing functional equivalency. For most manufacturers, the transition will not justify a full packaging re-validation – DuPont’s functional equivalency letter may provide much of the necessary justification.

Throughout the Tyvek transition, manufacturers need to be asking, Is the new Tyvek material functionally equivalent once implemented in my unique packaging configuration? A consult with a qualified testing partner early in the implementation process may help manufacturers properly answer this question.

A packaging validation will generally include three components: integrity testing, strength testing, and microbial barrier testing. The options for strength and integrity remain the same, but manufacturers have a new option when it comes to microbial barrier testing – ASTM F2638, Standard Test Method for Using Aerosol Filtration in Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier.

ISO 11607 Packaging for Terminally Sterilized Medical Devices indicates all sterilizable medical packaging materials need to provide an effective microbial barrier. The method traditionally used to determine if packaging materials meet this requirement has been ASTM F1608, Microbial Ranking of Porous Packaging Materials, and DIN 58953-6.  But the lesser known ASTM F2638 is well suited to testing the filtration efficiency of the new Tyvek material, and should be considered as a viable test option.

ASTM F2638:

  • Intended for porous package testing
  • Is performed using a wide range of flow rates to more accurately mimic real-world exposure
  • Provides quick test results (same day)

ASTM F2638 is a nice addition to the family of package testing methods, as it tests materials at real world flow rates. Or in other words, the standard recommends rates that are more representative of the level of exposure the packaging might endure in a real world setting. It also offers immediate results. Unlike test methods which use live organisms to test filtration efficiency, and therefore need an incubation period, ASTM F2638 uses particles, which means evaluation is based on particle counts which need no incubation, giving a speedy result.

Nelson Labs offers clients unique access to both ASTM filtration efficiency test methods (ASTM F1608, and ASTM F2638), and has the experience and resources to perform the lesser known ASTM F2638 test.  Contact Nelson Laboratories to discuss your package testing needs – sales@nelsonlabs.com, 801-290-7502. You may also be interested in watching Developing Your Packaging Validation and Plan, a complimentary on-demand medical device packaging webinar.

About Craig Fisch: Craig Fisch is a Study Director at Nelson Laboratories. Craig is an expert in ASTM F2638 material qualifications and container closure integrity (CCI) testing. Since 2012, he has overseen integrity testing (ASTM F1929, ASTM F2096, CCI by Dye Immersion), microbial barrier testing (ASTM F2638), and the accelerated and real time aging processes (ASTM F1980) in Nelson Laboratories’ packaging department.

Accelerate Your Time To Market With Nelson Labs Accelerated Aging Testing!

Nelson Labs Accelerated Aging Promotion

Accelerate your time to market with Nelson Laboratories, Inc. medical device packaging validation services. For a limited time we are offering an accelerated aging discount of 28% off list price! To take advantage of this special promotional rate, contact your Nelson Labs sales representative for a quote at 801-290-7502, sales@nelsonlabs.com, request a quote, or submit samples.

PACKAGING VALIDATION OFFER:

  • Samples delivered to Nelson Laboratories for accelerated aging tests between 16 Sep 2014 and 31 Dec 2014 are eligible
  • Accelerated Aging discounted to $25/day (that’s a $10/day discount, or 28% off list)
  • Receive an additional 5% discount on post-aging packaging validation tests
  • Promotion valid for up to 3 years accelerated aging chamber time (generally 19.5 weeks)
  • Restrictions apply, see qualifying test parameters below

QUALIFYING TEST PARAMETERS:
Nelson Labs offers multiple chambers and parameter ranges to meet your needs. For our promotional event we have four parameters available. Promotional rate includes sample sizes up to 10 cubic feet. Sets larger than 10 cubic feet or requiring customized chamber temperatures are not eligible.

  • Parameter #1: 55 ± 4°C, 50% RH
  • Parameter #2: 60 ± 4°C, ambient RH (20-40%)
  • Parameter #3: 40 ± 4°C, ambient RH (20-40%)
  • Parameter #4: 30 ± 4°C, ambient RH (20-40%)
  • Submission window: 16 Sep 2014 – 31 Dec 2014

NELSON LABS PACKAGE TESTING SOLUTIONS:
Nelson Labs offers a wide variety of medical device packaging validations including but not limited to:

  • Package Types: Porous Packaging, Non-Porous Packaging, & Poly/Tyvek Tray Validations
  • Packaging Strength, Integrity & Shelf Life: Accelerated Aging, Real-Time Aging, Transportation & Distribution Simulation, Bubble Emission, Burst, Whole Package Integrity, Seal Peel, Dye Migration, Microbial Ranking, and more.

To learn more contact Nelson Labs’ sales at 801-290-7502, sales@nelsonlabs.com.

ABOUT ACCELERATED AGING:
The Accelerated Aging test simulates real-time aging of porous and non-porous materials. This test enables manufacturers to get their products to market faster. Nelson Laboratories performs this test in compliance with ASTM F1980 and ISO 11607 “Packaging for terminally sterilized medical devices.” Note that while accelerated aging is optional, real-time aging is required when establishing an expiration date.

QUESTIONS? VISIT NELSON LABS AT THESE UPCOMING EVENTS:

About Nelson Labs: Nelson Laboratories is a leading provider of testing and consulting services. We know that every test matters and requires solutions that improve patient outcomes. We call it The Science of Success™. It means working with clients to ensure the safety and efficacy of every product. Learn more at www.nelsonlabs.com.