Distribution Simulation Testing

Background:

Properly designed packaging should insulate the medical product from shipping damage and significantly reduce the possibility of financial losses due to damage or product recalls. DROP, VIBRATION and COMPRESSION are variables that medical packages and products will experience when traveling from the point of manufacture to the sterilization facility, distribution center and to the healthcare facility.

Types of Tests:

DROP

These tests are used to determine the ruggedness of the medical package and the effectiveness of its interior cushioning ability, when the product/package system is exposed to impact during material handling operations. These types of abuses can be inflicted upon packages by equipment such as palletizers, sorters and conveyors commonly used in shipping/distribution facilities, or by manual stacking, loading and dropping.

Several test methods can be utilized:

Constant Height
Progressive Height
Safe Drop Height
Single Drop Height

VIBRATION

These tests are used to determine the ability of medical packages and products to withstand shock and vibration encountered during the course of transporting products. Stresses induced by vibration in the distribution environment can effect the palletized load, shipping container, interior primary packaging, primary package closure (seal integrity), product labeling and the actual product.

Several test methods can be utilized:

Repetitive Shock Test (Vertical Motion)
Repetitive Shock Test (Rotary Motion)
Repetitive Shock Test (Random Motion)

COMPRESSION

These tests are used to determine the ultimate compression resistance and long term stacking strength of both individual medical packages and their master shipping containers. Before a medical product (shipping unit) reaches its final destination, it is subjected to compressive forces from several different processes such as: manufacturer’s handling and warehousing, shipping, distribution warehousing, final shipping and point of purchase stacking. To move from one process to the next involves loading, surface or air transportation, stacking and un-stacking, an un-loading at various locations.

Several test methods can be utilized:

Constant Rate Compression Test
Constant Force Compression Test
Ramp-To-Load and Release Compression Test

Testing Methodologies:

ISTA Procedure 1A:

This test is designed to evaluate the performance of the package/product combination. It can also be used to compare the relative performance of various package and product design alternatives.

Testing Sequences and Types:

1^st Sequence:	Vibration, ASTM D-999 Fixed Displacement, Rotary or Vertical Linear Motion
2^nd Sequence:	Drop, ASTM D-5276 Free Fall Drop tester

ASTM D-4169-DC 13:

These Distribution Cycles are designed to provide a uniform basis of evaluating, in a laboratory setting, the ability of shipping units to withstand the hazards of distribution environment.

Note: Distribution Cycle 13 is the most commonly used cycle in the Healthcare Industry for packages weighing less than 100 Lbs. Other distribution cycles or custom cycles are also available.

Testing Sequences and Types

1^st Sequence:	Drop, ASTM D-5276 Schedule A, Handling
2^nd Sequence:	Compression, ASTM D-642 Schedule C, Vehicle Stacking
3^rd Sequence:	Vibration, ASTM D-999 Schedule F, Loose-Load Vibration
4^th Sequence:	Vibration, ASTM D-4728 Schedule E, Vehicle Vibration
5^th Sequence:	Drop, ASTM D-5276 Schedule A, Handling

Atmospheric Conditioning

In addition to the other tests mentioned above, it may be necessary to expose the medical products and packages to atmospheric conditioning in order to simulate particular field conditions that a packaged product or packaging component may encounter during its expected life cycle or testing cycle. The following standards apply to such activities.

ASTM D-4332:	Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
ASTM D-685:	Standard Practice for Conditioning Paper and Paper Products for Testing.