Accelerated Aging

Accelerated Aging Package Testing

By: Pal Khangaldy & Wendy Mach

The Packaging Department at Nelson Laboratories is often asked by manufacturers “What do I need to do to validate my packaging?” or “What package testing do I need to have performed in order to comply with regulations?” There is not a one-size-fits-all answer to these questions as unique product, packaging, and sterilization combinations require unique testing combinations. However, there are some basic testing concepts that apply to all product and package types: expiry testing; strength, integrity, and microbial barrier testing; and package distribution testing.

FDA and Accelerated Aging

ChamberFDA requires testing to demonstrate that the packaged product will maintain its integrity and sterility when stored over time, and this testing is required to establish an expiry date. Tests that meet these regulatory requirements are accelerated aging testing, real-time aging testing, or a combination of both. It is important to note that accelerated aging testing does not replace real-time aging testing. In a perfect world with unlimited time and resources, manufacturers would only conduct real time aging tests. However, this type of testing is not practical for manufacturers that need to quickly get their product on the market – they do not have the time to put a package system on the shelf for two or more years and await the results. Because of this, accelerated aging was developed as it meets the testing requirements by FDA.

Accelerated Aging Testing

The concept behind accelerated aging testing: Increasing the temperature escalates the chemical reaction rate of the samples and results in deterioration of materials which simulates artificial aging. Every 10°C increase in temperature doubles the reaction rate. This concept is based on the Arrhenius equation and is explained in further detail in ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier System for Medical Devices.

There are limits to this equation, as increasing the temperature too high can prematurely destroy the product/package system. Test temperatures should not exceed 60°C. The temperature used most often in the industry for accelerated aging is 55°C and is the temperature Nelson Labs recommends.

Next Steps

Strength, integrity, and microbial testing verify that the packaging is intact after aging tests. These types of testing are the topics of our next blog post. For more information on real-time or accelerated aging testing, contact your Nelson Labs Account Manager or our Service Center via ServiceCenter@NelsonLabs.com or 801-826-2088.

 

 

 

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.