Medical Devices

Medical Device Example

Medical Device products are those items used in the medical industry to help deliver high quality healthcare service in a wide variety of applications. Medical devices range from simple tongue depressors to complex catheters and implantable devices, such as implantable cardioverter defibrillators, and similar.

These devices have very important functions that can be life changing if accomplished successfully or life-threatening if not. Likewise, the package system must be of an extremely high quality and able to deliver a perfectly functional product in a sterile condition to the location where it must be used. In addition, the package must clearly identify the product contained within and be able to assist in the dispensing of that product into a sterile field, if required, using commonly known procedures.

The packaging for such products will focus on the containment, dispensing, sterile barrier, identification, and utility functions of the package to deal with the hazards present during distribution and storage. It is also important that the package system retain its functionality throughout the entire anticipated storage time. Validation of all of these functions within the package system demands a well thought out package test protocol including some or all of the following:

Package Functions Hazards & Sources Typical Test Procedures Typical Specs Westpak Capabilities
Protection from impacts Impact related damage from manual handling during storage, and transportation. Package freefall drop tests ASTM D5276
ASTM D3060
ASTM D3071
ASTM D5487
(8) drop test systems
Protection: from vibration induced scuffing and fatigue Label or container surfaces can become scuffed from transportation vibration resulting in illegible package printing, product scuffing, or similar. Random vibration tests ASTM D4278

ASTM D4169

ASTM F2497
More than (12) different vibration test systems and scuff test devices
Protection from temperature and humidity extremes Temperature and humidity extremes in storage and distribution can cause undesirable changes in the structure of the product or package system. High temperature and humidity extremes; Low temperature extremes ASTM D4332 More than (60) different temperature & humidity test chambers
Utility: ability to stack the packages for better space utilization Top load compression from storage and from stacking in vehicles Compression test to failure; Compression test, max load and release ASTM D642

ISTA procedure 2 and similar
(4) complete container compression test systems
Utility: the ability to resist pressure differentials from high altitude shipment Lower atmospheric pressure of higher altitudes, above 5000 feet by truck or in aircraft, can expand any closed system Expansion and over-pressurization of sealed containers or compartments, cracking of package components, etc. ASTM D6653 (4) complete vacuum test chambers
Sterile barrier: the ability to resist microbial challenge even after severe distribution excitation Distribution environment hazards may cause a compromise in the ability of a package to resist microbial penetration Tests are designed to see if the barrier of the package system can successfully resist microbial penetration ASTM F1929
ASTM F2054
ASTM F2096
ASTM F2559
ASTM F3039
ASTM F3078
All WESTPAK facilities are fully equipped to conduct the required testing and more
Convenience and sterile barrier: the ability of the pouch or tray to separate cleanly with a predictable level of resistance Many of the hazards during storage and distribution can negatively impact the ability of the package system to be open cleanly into a sterile field Peel testing of the seal areas and burst testing of the completed pouch or tray is very common. ASTM F88

ASTM F1140

All WESTPAK facilities are fully equipped to conduct the required testing and more

By subjecting your product/package system to the above suggested test procedures, or others, you will quickly validate the ability of the entire package system to perform its intended functions in the anticipated environments. Minor adjustments, major changes, supplier qualifications, material changes, or reevaluations can normally be accomplished at this point, prior to a devastating recall and its consequences. A thorough but cost effective package system evaluation prior to initial shipment is essential for products such as these.

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