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Status:Closed    Asked:May 22, 2012 - 11:41 AM

which serie 2A or 3H used testing disposable medical devices packaged polybags/blisters/carton shipped on pallets?

We manufacturer sterile adminsitration sets and are wondering is the best approach is to use ISTA 2A or 3H. They are sterilized in polybags or blisters placed in carton on pallets and shipped all over the world, even in freight containers. Can you suggest which ship testing they should be conducted to ISTA 2A or 3H or another.

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This depends many factors, and more detail about your supply chain and packaged-product is required to make an informed suggestion. There are currently over 20 different ISTA Procedures and Projects. Some of these are basic tests: very non-specific in terms of the products, packages, and distribution systems to which they apply. Others, however, are quite specific, and are applicable only in certain situations. The procedures and projects, with short titles, are:
* 1A Packaged-Products weighing 150 lb (68 kg) or Less
* 1B Packaged-Products weighing Over 150 lb
* 1C Extended Testing for Individual Packaged-Products weighing 150 lb (68 kg) or Less
* 1D Extended Testing for Individual Packaged-Products weighing Over 150 lb (68 kg)
* 1E Unitized Loads
* 1G Packaged-Products weighing 150 lb (68 kg) or Less (Random Vibration)
* 1H Packaged-Products weighing Over 150 lb (68kg) (Random Vibration)
* 2A Packaged-Products weighing 150 lb (68 kg) or Less
* 2B Packaged-Products weighing Over 150 lb (68kg)
* 2C Furniture Packages
* 2D Packaged-Products Considered Flat for Parcel Delivery System Shipment
* 2E Packaged-Products Considered Elongated for Parcel Delivery System Shipment
* 2F Performance Testing of Shipping Containers for LTL Shipment National Motor Freight Traffic Classification Item 180 NCC/LTL
* 3A Packaged-Products 150 lb (70 kg) or Less for Parcel Delivery System Shipment
* 3B Packaged-Products for Less-Than-Truckload (LTL) Shipment
* 3E Unitized Loads of Same Product
* 3F Packaged Products for Distribution Center to Retail Outlet Shipment 100 lb (45 kg)
* 3H Performance Test for Products or Packaged-Products in Mechanically Handled Bulk Transport Containers
* 6-FEDEX FedEx Procedures for Testing Packaged-Products (Under or Over 150 pounds)
* 6-SAMSCLUB Packaged-Products for Sam’s Club® Distribution System Shipment
* 7A Open Reusable Transport Containers for Loads of 60 lbs (27 kg) or Less and Unitized for Shipment on a Pallet [Note: This is a PROJECT, not yet a PROCEDURE]
* 7B Closed Reusable Transport Containers for Loads of 150 lb (68 kg) or Less
* 7C Reusable Intermediate Bulk Containers
* 7D Thermal Controlled Transport Packaging for Parcel Delivery System Shipment
* 7E Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment [Note: This is a STANDARD and is subject to different certification rules. Click here for more details.]

The various tests can be organized in several ways, as follows:

By Series:
* 1-Series: Non-Simulation Integrity Performance Tests. Challenge the strength and robustness of the product and package combination. Not designed to simulate environmental occurrences. Useful as screening tests, particularly when used as a consistent benchmark over time.

* 2-Series: Partial Simulation Performance Tests. Tests with at least one element of 3-Series type General Simulation performance test, such as atmospheric conditioning or mode-shaped random vibration and at least one element of a 1-Series type non-simulation integrity test.

* 3-Series: General Simulation Performance Tests. Designed to provide a laboratory simulation of the damage-producing forces and conditions of transport environments. Applicable across broad sets of circumstances, such as a variety of vehicle types and routes, or a varying number of handling exposures. Characteristics will include simple shaped random vibration, different drop heights applied to the sample package, and/or atmospheric conditioning such as tropical wet or winter/frozen.

* 4-Series: Enhanced Simulation Performance Tests. In many ways similar to General Simulation tests, but incorporating the latest information on environmental hazards, and with test sequences based on user-defined descriptions of distribution means. Not currently in use, but under development.

* 5-Series: **Not currently an active Series** Focused Simulation Performance Tests. Guides to providing a laboratory simulation based on actual field measured hazards and levels.

* 6-Series: Member Performance Tests. Test protocols created by ISTA members to meet their particular purposes and applications. The tests may be completely original, or may be modifications or variations of ISTA Procedures or Projects, or other published and accepted tests. ISTA reviews and approves these tests, but primary responsibility for creation, validation, maintenance, revision and support rests with the originating member(s).

* 7-Series: Development Tests. These tests are used in the development of transport packages. They can be used to compare relative performance of two or more container designs, but are not intended to evaluate the protection afforded packaged-products.

By Distribution Mode or Type:
Any distribution mode; Individual packages weighing 150 lb (68 kg) or less: ISTA 1A, 1C, 1G, 2A

Any distribution mode; Individual packages weighing over 150 lb (68 kg):ISTA 1B, 1D, 1H, 2B

Individual packages, small parcel delivery mode: ISTA 3A, 2D, 2E

Individual packaged, LTL delivery mode: ISTA 2F, 3B

Unitized load, any distribution mode: ISTA 1E, 3E

Reusable systems, any distribution mode: ISTA 3H

Furniture packages: ISTA 2C

Non-unitized DC to retail: ISTA 3F

Development tests
Open container: ISTA 7A
Closed container: ISTA 7B
Intermediate Bulk Container (IBC): ISTA 7C
Thermal performance: ISTA 7D or ISTA 7E

To determine applicable tests for any given situation, the list may be narrowed down based on the above information. Then each individual Procedure or Project should be examined in detail to arrive at the one best suited.

Contact ISTA Headquarters for help with test interpretation ( / +1 517-333-3437). Assistance with test selection in specific circumstances and/or problem situations is available as a service from many ISTA labs, consultants, and members as well.

Source: ISTA Staff


May 22, 2012 - 11:55 AM

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