Medical Device

Following the guidelines of ISO 11607, sterile medical devices and package systems must undergo a barrage of physical testing to ensure package integrity.  The repeatable results offered in a controlled laboratory lend to a high degree of confidence in patient safety.

Westpak has been supporting our Medical Device customers get their products to market for over 30 years.  We understand the steps needed to get there. If you need a protocol to outline testing, our Engineering Services team is happy.  We being by collaborating with you on the  product and package specifics, distribution environment, end user and any specific challenges.  Testing will follow the general guidelines of ISO 11607, many tests outlined below.

Accelerated Aging

Accelerated Aging

Accelerated aging is used in the medical device packaging industry to simulate the effects of time on a Sterile Barrier System to support shelf life claims and expiration dating. The accelerated aging process is extrapolated on a known relationship of reaction rates and temperature.

Properly applied in a package validation test plan (within ANSI/AAMI/ISO 11607 guidelines), this can result in a decreased time to market. For example, a Sterile Barrier System that is subjected to 40 days of accelerated aging at +55° Celsius has similar aging characteristics to a 1 year old sample per the Arrhenius equation. Accelerated aging data is recognized by regulatory bodies as an acceptable means to generate data quickly, but this data is only accepted until those tests can be correlated to “Real Time” samples.

Typical Procedures/Protocols
ASTM F1980

Typical Sample Size
Determined by the later performed Sterile Barrier tests such as Peel and Bubble Leak.

Temperature & Humidity Conditioning

Temperature & Humidity Conditioning

Environmental conditioning subjects package systems to temperature and humidity conditions expected in the distribution environment. Conditioning is commonly conducted prior to distribution package performance testing.

Exposure is conducted via a dedicated environmental chamber designed to maintain tight controls over both temperature and humidity as well as the rates at which these quantities are changed. The test levels chosen and rates of change between these levels are documented in the customer’s protocol and encompass what might be encountered during the actual distribution cycle.

Typical Procedures/Protocols

ASTM D4332
ASTM F2825
ISTA Series
ISO 2233

Typical Sample Size

Typical sample sizes range from 30 to 60 samples.

 

Distribution Testing

Distribution Testing

This portion of the testing is generally referred to as transportation or distribution testing. It is an attempt to bring the distribution environment dynamics into the testing laboratory in a controlled and repeatable fashion. The testing consists of a series of packaged vibration, free fall impacts (drop), compression, and possibly other tests that duplicate the hazards of the distribution environment in a repeatable manner.

Typical Procedures/Protocols

ASTM D4169
ASTM D7386
ISTA 2A
ISTA 3A
ISTA 3E

Typical Sample Size

Determined by the later performed Sterile Barrier tests such as Peel and Bubble Leak.

Sterile Barrier / Integrity

Sterile Barrier / Integrity

The integrity of medical device package seals can be tested by a dye penetration test conducted according to ASTM F1929, or a bubble emission test conducted on the entire pouch or tray according to ASTM F2096. Both of these procedures are qualitative tests and will result in a pass/fail determination and do not return a quantitative value.

To conduct the bubble emission test, the pouch or tray (Sterile Barrier System) is submerged 1 inch below a water bath surface and inflated with a pressure differential pre-determined by an induced controlled defect. Gross leaks in a non-breathable SBS are readily apparent. For breathable packages a steady stream of bubbles from a specific point will also indicate a possible path for microbial passage into the sterile interior.

The dye penetration test conducted according to ASTM F1929 consists of inserting a prescribed dye solution into the Sterile Barrier System and then rotating it causing fluid flow around the interior interface between two sealed surfaces of the package. Any defects in seals or “channel leaks” will be evident by the dye penetrating the narrow channel leak, which allows a graphic visual image of the potential problem.

Typical Procedures/Protocols

ASTM F2096
ASTM F1929
ASTM F3039

Typical Sample Size

Typical sample sizes range from 30 to 60 samples.

Seal Strength

Seal Strength

The purpose of the package strength testing procedures is baseline both pouch vendor and customer seals and later repeated to screen for undesirable changes negatively affecting the Sterile Barrier Systems (SBS) ability to maintain stability and the packaging system's ability to adequately protect the product. Note also that these are both quantitative tests.

The strength tests consist of the seal peel test according to ASTM F88 / F88M, and the burst test conducted according to ASTM F1140 / F1140M or ASTM F2054 / F2054M. Both are attempting to measure the strength and consistency of the seals on a pouch or tray containing a medical device, but have very different approaches. For the peel test, a 1 inch width section of the seal is pulled apart and the force of the seal strength is measured and plotted. In the burst test, the primary package is inflated with air pressure at a constant rate until the package fails or bursts. The fundamental purpose of both approaches is to prove the SBS hasn’t changed after sterilization, transit and storage.

Typical Procedures/Protocols

ASTM F88
ASTM F1140
ASTM F2054

Typical Sample Size

Typical sample sizes range from 30 to 60 samples.