What is ASTM F1980 and Why Should You Care?
For medical device packaging, one essential criterion is that the packaging you choose protects the device and maintains its sterile integrity over the shelf-life of the product. ASTM F1980 is the industry standard that governs accelerated aging studies used to evaluate the sterile integrity of the medical device and packaging over its intended shelf-life.
What is Accelerated Aging?
Accelerated Aging is the process by which sterile medical devices and their packaging are exposed to increased temperatures for a shortened period of time. By doing this, the contract manufacturer and OEM can evaluate how the packaging will age under equivalent normal conditions without having to wait for the full shelf-life period. This has a significant impact on speed to market for a new medical device and is standard practice in medical device packaging.
ASTM F1980, “Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices,” is the industry standard for accelerated aging. It is a specific test guidance established by ASTM International, an international standards organization.
The guide outlines the requirements and recommendations to test accelerated aging, including the appropriate temperature, time, humidity, and other test conditions. Experienced medical device contract packaging manufacturers should have the capabilities to do this in-house or at least have a good understanding of how the studies are conducted by a third party. In this way, they can evaluate the results and ensure that the test conditions adhere to ASTM F1980 standards.
Importance of Experience
At PRO-TECH Design, we have been conducting accelerated aging studies on our medical device packaging for over 10 years. Over that time, we have tested hundreds of medical devices in different packaging in our in-house testing chamber. This experience is invaluable to new customers who have never been through the process, as well as to veteran customers who are familiar with the process, but who may not have worked with a particular material before.
In either case, when an OEM is choosing a contract manufacturer, they should thoroughly evaluate the contractor’s experience level and study protocols to give them the peace of mind that their device will maintain its sterility and be protected over the shelf-life of the product.
What is the procedure for accelerated aging for medical devices?
Here are a few of the key steps involved in developing an accelerated aging test…
- Q10 Value – The process for accelerated aging starts with determining the Q10 value. This relates to “the rule of ten,” which is the factor by which the rate of spoilage increases when the temperature is raised by 10C. Q10 is used to predict the medical device’s shelf life under real conditions based on exposing the device to increased temperatures.
- Desired Shelf Life – The OEM and contract manufacturer work together to define the desired shelf-life of the medical device and package. How long do they think it will reasonably take for the device to be shipped and stored before it is used with a patient?
- Test Conditions – you also need to define the appropriate test conditions, including typical storage temperature, accelerated aging temperature, and humidity.
- Humidity – The most recent revision to ASTM F1980 takes into consideration the impact of humidity to the sterile barrier packaging. It is now strongly recommended to monitor and/or control humidity when conducting accelerated aging studies. As a result, aging chambers should be equipped with humidity monitoring devices. Relative humidity levels should be chosen carefully to avoid abnormal material changes. Typically, if the packaging materials are not impacted by humidity, it is acceptable to use ambient humidity.
- Test Duration – using these factors there is a calculation called the Arrhenius Equation to determine how long the test should be conducted
- Success Criteria – it is important to determine what success look like before beginning the accelerated aging test. At the end of the test duration, you will know what the benchmark is and whether you have successfully met the hurdle or not.
Real-Time Aging in Parallel
Even though you may use an accelerated aging test to go to market, the ASTM F1980 standard dictates that you also run a real-time test in parallel to confirm the results of the accelerated aging. This is done as a matter of practice and most experienced contract manufacturers will be well versed in how to conduct both real-time and accelerated aging studies.
Pre-Validated Packaging is when standard packaging has already been through accelerated and real-time validation testing. As a result, it can be approved for immediate use or with relatively minor testing.
At PRO-TECH Design, we find that many of our customers initially believe that they need custom packaging for their device, but when they see the trays and pouches that have been pre-validated, they are pleasantly surprised with the range of options, the cost savings, and the speed to market. And aging studies have been done for up to five years, providing peace of mind.
The majority of our customers end up choosing pre-validated packaging and are very pleased with the results.
ASTM F1980 FAQ
Can I conduct Accelerated Aging test on my own?
Yes, you can, but you may be opening yourself up to unnecessary risk if you do not have the proper experience and protocols in place to ensure that the testing is done properly. Experienced medical device contract manufacturers are adept at conducting this testing with different devices, various types of packaging and materials, and unique shelf-life requirements. And they typically include testing as part of their standard suite of services offered.
How can I determine if a Contract Manufacturer knows how to conduct Accelerated Aging tests?
Most will be extremely comfortable talking about their established protocols for accelerated aging testing. It is typically part of their validation studies and is offered as a service with their packaging development. To determine their experience level, it is often helpful to talk directly with their Quality Assurance team and to ask them about their experience, testing protocols, and to see their testing lab on a site tour.
How do you evaluate the ASTM F1980 test results?
Once a sample device and package has undergone accelerated aging conditions, its package integrity and physical properties will be compared against different aging time points. Comparisons include visual inspections (per ASTM F1886), and sterile integrity testing such as Bubble and Dye testing, and seal strength testing such as Peel and Burst testing. Again, experienced contract manufacturers should be familiar with these procedures, removing the burden from the medical device OEM.
Do most Contract Manufacturers do their own Validation Testing or do they sub-contract to a Third Party?
The answer is “it depends.” Each has their own level of expertise, but the more experienced contract manufacturers who have been developing medical device packaging for a while, often do their own testing in-house.
What other ASTM Standards are relevant for medical device packaging?
There are many ASTM standard tests and practices in common use for medical device packaging. Here are some that we conduct in-house…
- ASTM F88 – Standard Test Method for Seal Strength of Flexible Barrier Materials (Peel Test)
- ASTM F1140 – Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
- ASTM F1886 – Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
- ASTM F1980 – Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F2096 – Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
PRO-TECH Design & Manufacturing is a woman-owned full-service FDA- and ISO 13485-registered medical device contract manufacturing and packaging company headquartered in Santa Fe Springs, Calif.
Founded in 1980, PRO-TECH Design specializes in medical device contract assembly, contract packaging, sterilization management, and laboratory services. As a leader in the industry trusted by multiple Fortune 100 companies, the company has a presence in three key regional markets – California, Minnesota, and Texas.