Packaging Validation

Three-Day Webinar Series: Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes

Learn from the industry-leading experts at Nelson Laboratories in the three-day webinar series Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes including FDA, ISO, USP, and MDRs.

The experts at Nelson Labs are teaming with MD+DI to bring a live three-day webinar event that provides manufacturers of medical devices and pharmaceutical products with the most up-to-date regulatory updates, trends, and anticipated changes (including FDA, ISO, USP, and MDRs). Online registration is currently available on the MD+DI website. Many of those speaking contribute to committees that provide global guidance to safeguard patient health; each webinar will offer 15 minutes for audience questions with these experts. Details for each webinar are as follows:

OVERVIEW DAY 1

Title: Assessing Biocompatibility for Medical Devices: Updates, Trends, and Anticipated Changes

Date: Tuesday, 26 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Summary:

This presentation will discuss the recent and upcoming changes to regulatory documents and standards and how they will impact the overall biocompatibility assessment of medical devices. The presentation will include:

  • Discussion about how biocompatibility assessments are affected by the recent updates to the ISO 10993-1 document and the new European MDRs.
  • Anticipated changes to ISO 10993-18. Since the use of chemistry in the biocompatibility assessment of medical devices is gaining traction, the document that outlines how to use chemical characterization for these assessments is undergoing major revisions.
  • An overview of changes that are expected with the acceptance of in-vitro irritation testing.
  • A thorough review of the impact of the recently finalized ISO 18562 standard which specifically targets respiratory contact devices.

Presenters:

Thor Rollins, B.S., RM (NRCM)
Director, Toxicology and E&L Consulting

Matthew R. Jorgensen, PhD
Chemical and Materials Scientist

OVERVIEW DAY 2

Title: Sterilization Methodologies and Packaging Integrity Testing: Updates, Trends, and Anticipated Changes

Date: Wednesday, 27 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Summary:
Sterilization methodologies and packaging integrity testing are necessary to ensure patient safety. The sterilization portion of the webinar series discusses recent and upcoming changes to regulatory documents and standards such as:

  • Changes that impact steam, radiation, hydrogen peroxide, and ethylene oxide sterilization modalities.
  • What to expect in the new ISO document for hydrogen peroxide sterilization.

As part of the packaging presentation key points regarding the new European MDRs will be reviewed, including:

  • How medical device manufacturers can collect and document objective evidence of compliance for their packaging, look at designs that prevent microbial contamination at the point of use, and justify that the package is suitable for current use.
  • An introduction to a new leak-testing technology, Mass Extraction, that demonstrates container closure integrity in a non-destructive and rapid manner, will be presented. This new test meets the deterministic requirements as outlined in the newly published USP chapter 1207.

Presenters:

Martell K. Winters, B.S., SM (NRCM)
Director, Scientific Competency

Jason Pope, B.S., ASQ CQA
Senior Scientist

Wendy Mach, RM (NRCM), CQA (ASQ)
Packaging Section Leader

OVERVIEW DAY 3

Title: Cleanliness Testing for Medical Devices: Updates and Trends

Date: Thursday, 28 September 2017

Time: 11:00 AM Pacific Daylight Time (2:00 PM Atlantic Daylight Time)

Duration: 1 hour

Summary:

This presentation will cover the latest updates and current trends for medical device cleanliness testing. This webinar will include:

  • A review of the upcoming and highly anticipated orthopedic implant cleanliness ISO document.
  • A discussion about the testing considerations for certain additive manufacturing processes.
  • Guidance updates for reusable device validations.
  • An update regarding the reprocessing of single-use devices.

Presenters:

Alpa Patel, B.S., RM (NRCM)
Senior Scientist

Alexa Tatarian
Study Director III

Paul L. Littley, B.S.E
Consulting Manager

Non-Porous Packaging Validation

By Brandon Muhlestein, Packaging Consulting Study Director

Over the past few years, as medical device manufacturers look for new and innovative ways to package, sterilize, and market their products, the use of non-porous materials in packaging has become more and more popular. Similar to porous packaging, non-porous packaging also comes in a variety of options such as blister packs, all foil, all polymer (poly), and combinations of foil and poly. Since non-porous packaging has as many options as porous packaging, what criteria can manufacturers use to select one type of non-porous packaging material over another? When selecting a package, the most important thing to consider is the end use and purpose of the packaging. For example, if the product is light sensitive then a foil/foil pouch would be a more appropriate selection than a poly/poly style of pouch; as the foil/foil pouch would prevent light from affecting the contents inside. Other considerations include, but are not limited to: the sterilization method used the packaging process (i.e., vacuum or not vacuum sealed), the transporting or shipping method, and the actual contents that will be packaged.

Foil - Foil Pouch

Example of a Foil/Foil pouch

Non-porous packaging configurations must meet the same packaging requirements as porous packaging configurations. ISO 11607-1 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems, and packaging systems; provides the minimum requirements that terminally sterilized devices must meet regardless of whether the packaging is porous or non-porous. The standard states that a sterile barrier system must be able to maintain its strength, integrity, and microbial barrier until the end of the intended shelf life. However, some of the tests available to show that the packaging meets the requirements may vary slightly depending on which configuration and material combination are selected.

Before any testing can begin, the test protocol must be written and approved. The protocol usually includes; material selection justification, product details, sealing parameters, sample sizes, test methods, acceptance criteria’s, etc. Without a formal test protocol it is difficult to determine what to do, how to do it, and whether the testing was successful or not.

An important part of the package testing is the transportation and distribution testing (i.e. ship testing). This testing is conducted to show that the shipping container and shipping system provide adequate protection to the sterile barrier inside. The most commonly used ship-testing standards are; ASTM D4169, ASTM D7386, ISTA 3A, and ISTA 2A. Ship testing subjects the shipping container to a series of tests that simulates what the container could see throughout the actual distribution process. For example, compression testing would simulate warehouse and vehicle stacking; shock testing would simulate a drop from a conveyer belt or when handling; and vibration testing simulates the shock of traveling (over roads, rail, or through the air). Remember, that testing the packaging and distribution process in a lab setting is more controlled than performing the test in a non-lab setting or under normal shipping conditions. When selecting a standard, make sure that it is recognized by the regulatory body you are planning to use as they may require testing to follow a specific standard, or justification as to why the test method was selected.

After the shipping tests have been completed, the next step will be to test the sterile barrier to determine whether the shipping container or system provided adequate protection. This is usually when the actual package testing begins. This testing is classified as baseline, or T= 0, because the data represents how the sterile barrier functions as it would arrive at the end user. The testing incorporates, at a minimum, one test from each of the three previously mentioned categories (strength, integrity and microbial barrier). There are a few standards that have been developed specifically for non-porous packaging systems. For the integrity category, ASTM F3039 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration; was developed as the preferred standard for performing the Dye Migration test on non-porous packaging systems. This standard is applicable to packages that are either clear or opaque. In 2015, ASTM F2981 Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air; was released as a way to prove that the materials being used in the non-porous packaging system are truly non-porous and thus meeting the microbial barrier requirement of ISO 11607-1.

At the same time the baseline packaging testing is being performed, the accelerated and real-time aging should be started. The table below breaks down the basic differences between accelerated vs. real-time aging:

Table

The purpose of any aging study is to show that the sterile barrier can be maintained through its intended shelf life. Package testing will need to be performed not only at the baseline time point, but also at the end of its intended shelf life. In shelf-life studies longer than two years, adding an interim time point, or two, reduces the risk of a failed validation. For example, if the product’s shelf life is expected to be five (5) years and you wait until the very end of the accelerated aging to test the packaging, if there is a failure there is a high chance of having to start over or repeat the testing. This can be both a significant cost and time issue. However, if you had tested the packaging at interim time intervals (i.e. 2, 3, and 4 years), you could fall back to the last point in time that the testing passed and introduce the product with that time point as an initial shelf life.

Once all of the testing has been completed, the data needs to be reviewed to determine whether or not the device passes. This is accomplished by compiling the data from all of the different test phases and comparing it to the sample acceptance criteria listed in your protocol, and evaluating any change over time that may have occurred. Assuming the data is acceptable, the next step would to be file with the FDA or other regulatory body; and once cleared, go to market.

Non-porous packaging has become a flexible, cost-effective alternative to its porous counterparts. However, the testing for these packaging solutions will need to be as rigorous and comprehensive as that for porous packaging options.

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.

ISO 16775: The Medical Device Packaging Professional’s Latest “Must Have”

Medical Device Package Testing. Learn more at www.nelsonlabs.com.

Medical Device Package Testing. Learn more at www.nelsonlabs.com.

By: Jennifer Gygi, Nelson Laboratories, Inc. Packaging Department Scientist, SM (NRCM)

If you are involved in the packaging of medical devices, your primary standards reference has probably been the International Organization for Standardization (ISO) 11607 publication for packaging design and validation. However, this standard was lacking much of the detail and guidance many packaging engineers were seeking; therefore ISO recently published a new standard, ISO 16775 – Packaging For Terminally Sterilized Medical Devices – Guidance On The Application Of ISO 11607-1 And ISO 11607-2, a comprehensive guide to all things packaging.

The new standard references the fundamental concepts outlined in ISO 11607 but takes it to the next level, providing practitioners additional detail.  More specifically, ISO 16775 highlights what makes a sterile barrier system (SBS), what the SBS requirements are, design considerations, materials selection, labeling issues, and package assembly to name a few.

ISO 16775 also details common packaging configurations and applications, and walks users through the entire package testing process step by step. From creating the validation plan to installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) on the sealing equipment, to testing final product/packaging for strength, integrity, and microbial barrier properties over time, ISO 16775 has you covered.

Where ISO 11607 speaks in generalities, ISO 16775 gives specifics. The meat of the document is found in the 19 appendices covering topics including but not limited to:

  • Guidance for health care facilities for creating SBS and performing validations
  • Selection of materials, design input, risk analysis tools, and sampling plans
  • Using contract packagers
  • Establishing processing parameters
  • Failure investigations, and design feasibility

ISO 16775’s appendix even includes example forms / checklists that can be used for IQ, OQ, and PQ  validations.

How ISO 16775 May Affect You

ISO 16775 is a “must have” for medical device packaging professionals.  It covers not only pre-formed SBS systems, but addresses many of the challenges unique to health care facilities, with extensive information on wraps and containers.

If you are experienced in medical device packaging, ISO 16775 will be a review of topics you are already familiar with, supplemented by new and valuable insights.  If you are a newcomer to packaging, this document is your new best friend.  ISO 16775 is a great reference to add to any library.

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.

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.