DDL is your one stop source for medical device testing and validation for products, materials and packaging. DDL has been a leader and innovator in the medical device testing industry since 1990. We offer single source solutions to medical device development engineers, Q&A and regulatory affairs professionals who are concerned that their devices meet all regulatory agency requirements. Medical device manufacturers are required to obtain 510(K) approval on each medical device and its packaging.
DDL performs Physical Package Integrity Testing (See Package Testing & Package Validation). The Testing services include:
- Package Leak Testing by Vacuum (ASTM D3079-02, ASTM D4991-94)
- Package Leak Testing by Dye Penetration (ASTM F 1929)
- Package Leak Testing by Bubble Emission (ASTM D 3078)
Package strength testing evaluates the strength characteristic to produce acceptable packages on a daily basis and throughout a determined shelf-life validation. It allows the medical device manufacturer determine that their process for sealing packages is consistent with their predetermined specification in the process validation.
The main culprit for poor package strength is the seal sealing parameters. If a proper process validation of the sealer is not performed, the medical device manufacturer can expect failure.
Package strength is the force required to separate two components of the package, for e.g. pouch, flexible lid or thermoform tray. These forces may be measured in pounds per inch width, as in the seal/peel test; or in pounds per square inch, as in the burst test method. Alone, these tests of package strength do not necessarily prove the integrity of the entire package. The seal width measured may be within the strength specification but may have a channel leak that could breach the package and negate its integrity.
Typical package strength testing includes:
- Package Strength Testing by Seal Peel Testing: ASTM F88-00
- Package Strength Testing by Burst Testing: ASTM F-1140-00
- Package Strength Testing by Peel Adhesion Testing: ASTM D 3330
DLL also offers clients Transportation & Distribution Simulation Testing Services (See See Package Testing & Package Validation)
Accelerated aging is performed on packaged medical devices to document a conservative shelf life and expiration times for products. Real time aging can be performed; however, products are often obsolete by the time a three-year expiration date is validated.
The European Medical Device Direction (MDD) implies that all sterile medical devices must have an expiration date. So documented shelf-life evidence must exist to substantiate those claims. Accelerated aging is based on a thermodynamic temperature coefficient formulated by Von`t Hof that states `for every 10 degree C rise in temperature the rate of chemical reaction will double.` But this formula was based on rate kinetics of a single chemical reaction, not on packages with various kinds of materials. So, its direct extrapolation to the aging of packaging materials must be used with caution.
Temperature selection for the accelerated aging should be determined by avoiding unrealistic failure conditions such as deformation due to melting. Real time aging must be performed in conjunction with any accelerated aging study to correlate the results found during accelerated
aging.
Tolerances for the temperature and humidity are provided to only ensure that the test chamber operates within a satisfactory range. Out of tolerance excursions (caused by opening doors for sample transfer; inserting moist samples into a dry environment, proximity of monitoring device to temperature and/or humidity source, etc.) for less than 6 hours for either temperature or humidity are acceptable and do not adversely affect the estimate for shelf life.
As regulators increasingly look for proof of pharmaceutical product stability throughout the supply chain, it is critical for manufacturers to ensure stable temperatures and endure handling from warehouse -- to transit -- to shelf.
- Thermal Performance Testing: From highly controlled cold chain package testing facilities DDL tests thermal packaging for pharmaceutical companies. Within 72 – 120 hours, DDL can conduct an accelerated stability test and develop a specification designed to inform clients of conditions that will push a thermal container out of the 2-8 centigrade (an indication that contents may loose active ingredients or even spoil) desired shipping and storage temperature.
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