Medical Device Packaging

Healthpack Conference 2018 Wrap Up

By: Wendy Mach, RM (NRCM), CQA (ASQ)

This year’s Healthpack® Conference included a wide range of topics and speakers that covered everything from the past, present, and future of the packaging industry. With a majority of the attendees being from both the medical device manufacturers and material suppliers, the opportunities to share and learn were plentiful and exciting.

This year’s highlights included the always popular Nurses Panel.  Manufacturers have the opportunity to subject prototype packaging to local nurses and, through a moderator, listen to their interaction and comments as they open the units. The biggest takeaway for this year was a “dislike” of locking dispenser boxes that frequently lead to difficulties opening the packaging, and the opportunity for finger cuts when opening.

The industry survey included questions on packaging that related to a company’s focus, what types of packaging tests most companies perform to meet the ISO 11607 regulations, and how packaging fits into a company’s organization. It was clear to see from the responses that the focus and awareness of packaging in the medical device industry is growing but still continues to be considered one of the last steps in the design process.

As the European Union (EU) prepares for the update of the Medical Device Regulation (MDR) to be fully implemented in May 2020, a thorough review of the implementation dates, changes to be expected and the impact to sterile packaging was discussed.  As the due date approaches, the AAMI Packaging group (ISO TC 198/WG7) is working diligently to bring the ISO 11607 document into alignment with the MDR regulations.

One of the most interesting topics presented was Smart Packaging and its possible uses for the future.  With the increase of available conductive inks, the possibility of capturing real data throughout a package lifecycle is not just a possibility – but a reality.  This data can be used in so many ways from remote sensing to interoperable communication.  Envision a device label that can provide real time data to a device manufacturer regarding the actual distribution environment it traveled. The development of test cycles could be based on real data rather than established standards that represent worst case situations; this actual usage data can represent extreme conditions for many companies.

Other topics covered included a very informative discussion on material selection with regards to flexible packaging, a panel discussion on seal strength testing, and the FDA regulatory perspective with regarding to sterile barrier testing.  Last but not least was a discussion of seal strength differences between EN 868 and ASTM F88.

Overall, everyone walked away from this year’s conference with a background of where the packaging industry was, what is currently being worked on, and then a glimpse of what the future may hold.

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.