Pharmaceuticals

Pharmaceutical Package Testing Example

Pharmaceutical products are those chemicals and compounds used in the healthcare business to help deliver high quality of life service. Pharmaceuticals range from simple aspirin and topical ointments to sophisticated drugs, materials and devices for critical applications.

The packaging for pharmaceuticals demand that the products be clearly identified on the package system, that the instructions for use are readily available and clear, that the products themselves be completely intact and ready for consumption or application, that the package system can be easily opened by the intended end-user, yet safe from the hands of children, and that the products be kept from harmful levels of humidity, temperature, U-V light, and any other type of harmful exposure.

The packaging for such products will focus on the containment, dispensing, identification, and utility functions of the package to deal with the hazards present during distribution and storage, and the requirements of the in-use environment. 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 causing pills, capsules, and similar to separate, or pulverize. Package free-fall drop tests ASTM D5276
ASTM D3060
ASTM D3071
ASTM D5487
(8) drop testers
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 D 4278

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 pharmaceutical form. 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 ASTM D6653 (4) complete vacuum test chambers
Utility: the ability of the package system to be opened by the intended user yet safe in children's hands 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 F1929
ASTM F2054
ASTM F2096
ASTM F2559
ASTM F3039
ASTM F3078
ASTM D3469
ASTM D3470
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 recall with its devastating consequences. A thorough but cost effective package system evaluation prior to initial shipment is essential for products such as these.