Proof testing requires all samples to be tested at the end of each test interval to a specified failure point, then returned to the aging environment for continued exposure. Evaluate the package performance after accelerated aging relative to the initial package requirements.

Since these materials for the most part are polymeric in nature, their performance is related to the rate of degradation of their inherent structure and configuration over time. Accelerated aging is optional, but real-time aging is required when establishing an expiration date. This applies to all materials for which the above temperatures are greater than the ambient temperature. Meeker and Hahn, How to Plan an Accelerated Life Test—Some Practical Guidelines, vol 10, Milwaukee, WI, American Society for Quality Control, 1985. Gillen KT, and Clough RL, "Predictive Aging Results in Radiation Environments," Radiation & Physical Chemistry, 41(6): 803–815. DDL conducts both accelerated aging testing and real time aging testing to help establish shelf life and expiration dates for medical devices, packaging and products. It is important to remember that the protocol is based on the assumption that all materials in the study follow a zero- and first-order reaction-rate function, and that the supply of reactants remains constant over the study time frame.

Use of the simplified protocol for accelerated aging can represent a valuable means for device manufacturers to obtain critical performance and shelf-life data on new products.

MPT is an ISTA certified packaging test lab (ID Number ST-2339) devoted to the validation, testing and design of packaging for medical device manufacturers, pharmaceutical companies, biotech companies, and the diagnostic industry. The testing is conducted at higher than usual levels of stress—whether of temperature, humidity, radiation, temperature cycling, chemical environment, or other factors.

), along with additives such as antioxidants, inorganic fillers, plasticizers, colorants, and processing aids.

5. 3.

Accurate prediction of medical product shelf-life performance is critical. This test enables manufacturers to get their product to market faster. During the low-temperature conditioning, no test time is accumulated toward the ultimate shelf-life equivalency of the product. When establishing the accelerated-aging protocol, the environmental conditions selected should not represent unrealistic failure conditions that would never occur under real-time, ambient-aged conditions. Medical device manufacturers wishing to gather data on the shelf life of their products may subject their devices to long-term stability studies or accelerated aging studies. Gillen KT, Clough RL, and Wise J, Extrapolating Accelerated Thermal-Aging Results: A Critical Look at the Arrhenius Method, Albuquerque, NM, Sandia National Laboratories. In these cases, elevated temperatures may negatively distort the performance of the material at operating or storage conditions. As an example of the application of this formula, what test time in a 50°C oven would be required to achieve equivalency to 5 years of ambient shelf-life aging of a product at 22°C (i.e., T1 = 50°C, TRT = 22°C, Q10 = 2)?

Accelerated aging of polymers (time versus temperature), showing the time (in weeks) equivalent to 1 year of room-temperature aging when a polymer is heat-aged at a selected temperature (°C). Registered in England and Wales. Allowed HTML tags:

. One must be alert for reaction-rate changes over test time frames; in such cases, use of multiple test temperatures or alternate accelerated-aging methodology is recommended. For certain polymer structures, long-term performance may be influenced by the effects of humidity extremes. Lines and paragraphs break automatically. Cause negative results from integrity testing after aging intervals passed. In cases where differences in coefficients of expansion in mating parts could contribute to significant stress generation and part failure, temperatures need to be cycled through high (accelerated aging) and then low temperatures.

Care should be taken to identify—both qualitatively and quantitatively—all additives (e.g., antioxidants), fillers, and processing agents. The correct response is as follows: In other words, an oven test time of 37.5 weeks at 50°C would be equivalent to 5 years at 22°C ambient temperature (i.e., 7.5 weeks/year).

Define test conditions, room temperature (TRT), and accelerated aging temperature (TAA)., Biomimicry: How Nature Is Inspiring Better Medical Devices for the Future, Medtech Keynote Speakers Among Headliners at Virtual Engineering Week.

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. 11. Select the reaction rate coefficient of Q10 = 2, unless another rate coefficient has been previously determined experimentally. The high (accelerated aging) temperature is selected as described above in step 4, with the low (freezer) temperature < 5°C. The process works best when the chemistry of the degradation reactions is well understood, and when moderate aging temperatures are selected to minimize error factors and premature consumption of some reactants (e.g., antioxidants, radical groups) that may be sensitive to elevated temperatures.

"Standard Practice for Heat Aging of Plastics without Load," ASTM Report D3045, West Conshohocken, PA, ASTM.

Karl J. Hemmerich is general manager and corporate technical advisor at Isomedix Corp.'s gamma irradiation facility located in Sandy, UT. Because of the exponential effect, this can be conservative by orders of magnitude.

What Retirement? For any accelerated aging and ambient temperatures selected, the relationship of oven test time to shelf-life time is as follows: where T1 = oven aging temperature, TRT = room temperature (ambient/ use/storage), and Q10 = reaction-rate coefficient. Extracted information from ASTM F1980 testing may be used to support expiration date claims for medical device sterile barrier systems.

He was formerly president of Ageless Processing Technologies, a consulting firm specializing in the medical disposables market, and has also worked at Ivac Corp., Cutter Laboratories, and Becton Dickinson. The goal is to benefit both the patient—for example, through early availability of a life-enhancing device—and the company—by generating additional sales and market share—without exposing either to any undue risk.
(In some cases, a better match between the model and experimental room-temperature data can be achieved by modifying the 10-degree rule using an alternate temperature differential between 5° and 20°C that best fits the experimental data.). Following the steps listed above, develop a written test protocol specifying the accelerated-aging conditions (temperature, humidity, heat cycling, time), time frames, sample sizes, and specific tests to be undertaken at each test time interval. 2. Select an ambient temperature representative of actual product storage and use conditions (normally between 20° and 25°C). Age samples at TAA. This method, however, is only applicable when the selection of proof-test values does not weaken or compromise the product properties being examined. 4.

In addition, the product—in its final package—should be subjected to a minimum of one standard sterilization cycle. Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an …

Under such circumstances, one should consider performing aging under conditions of storage or use (ambient). He was a member of the task force that developed the technical information report for postirradiation of materials (ISO 11137). without any decrease in performance that may affect safety and efficacy when the products are used.


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