ASTM F1608

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 –, 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.

ASTM Committee Meeting Updates for F02 and D10

Robert Haley, Packaging Department Manager, Nelson LabsMicrobial-Ranking

The American Society for Testing and Materials International (ASTM) Committee Meeting for F02 and D10 committees was recently held in Lansing, Michigan.  During the F02 meeting, there were discussions for potential round robin studies and upcoming changes to several standards. Nelson Laboratories is particularly interested in helping with the changes associated with the ASTM F88 and F1608 Standards.

Proposed changes to the ASTM F1608 – Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) – resulted in part from work performed by members of Nelson Laboratories. The changes will be highlighted during the next ASTM F02 meetings to be held in Belfast, Ireland in the fall of 2014.

The committee for ASTM F02 is seeking to perform a round-robin study for the ASTM F88 – Standard test Method for Seal Strength of Flexible Packaging Materials (Peel Test).   While participating in this study, Nelson Labs will conduct a seal peel test on rigid containers with flexible lids. Our results will be compared to the results of other labs participating in the study, to show repeatability and reproducibility of the outlined test.  The results will then be added to the precision and bias section of the standard.  The committee is currently working towards developing a standard protocol.  After the protocol has been finalized, labs to be involved in the testing should be determined.

During the D10 committee meetings, information was presented from an inter-lab study regarding the vibration section of the ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems.  The current cycles are outdated due to new technology in the transportation industries.  The changes would bring the ASTM D4169 standard closer to more realistic shipping cycles.

Additionally, during the spring meetings a tour of Michigan State University (MSU) School of Packaging was arranged. The purpose of the tour was to show the facilities that MSU’s new students are exposed to when developing their education in the packaging field. These facilities are also a source of developing new technologies in the packaging field.  I would like to thank the Faculty and Students of MSU for hosting the ASTM F02 and D10 meeting.  They did a great job hosting the meeting and demonstrating the new technologies being study in the field of packaging.