Industry Standards

Below is a summary of the main standards, the latest revision year, and comments regarding changes compared to the previous revision.

ASTM F1929: STANDARD TEST METHOD FOR DETECTING SEAL LEAKS IN POROUS MEDICAL PACKAGING BY DYE PENETRATION

Latest Revision: 2023
Previous Revision: 2015
Westpak’s Standard Committee’s Comments:

Changes do not affect testing; the change allows for other manufacturers/brands to be used for the dye penetration solution.

ASTM F3039: STANDARD TEST METHOD FOR DETECTING LEAKS IN NONPOROUS PACKAGING OR FLEXIBLE BARRIER MATERIALS BY DYE PENETRATION

Latest Revision: 2023
Previous Revision: 2015
Westpak’s Standard Committee’s Comments:

Percent ranges were added to the wetting agent and carrier.

ASTM D4332: STANDARD PRACTICE FOR CONDITIONING CONTAINERS, PACKAGES, OR PACKAGING COMPONENTS FOR TESTING

Latest Revision: 2022
Previous Revision: 2014
Westpak’s Standard Committee’s Comments:

This new revision has no procedural changes that would affect testing – only editorial.

ASTM D4169: STANDARD GUIDE FOR PERFORMANCE TESTING OF SHIPPING CONTAINERS AND SYSTEMS

Latest Revision: 2022
Previous Revision: 2016
Westpak’s Standard Committee’s Comments:

Changes involved the Vehicle Vibration (Air) profile; Low, Medium, and High levels replaced Assurance Levels, and the frequency range was updated to 1-200 Hz.

ASTM F1980: STANDARD GUIDE FOR ACCELERATED AGING OF STERILE BARRIER SYSTEMS AND MEDICAL DEVICES

Latest Revision: 2021
Previous Revision: 2016
Westpak’s Standard Committee’s Comments:

Coverage expanded to include the medical device. Manufacturers must determine the effect of moisture on materials and decide if humidity should be controlled during accelerated aging testing; if uncontrolled, a justification should be written. Appendixes X3 regarding humidity as a test component was updated.

ASTM F88/F88M: STANDARD TEST METHOD FOR SEAL STRENGTH OF FLEXIBLE BARRIER MATERIALS

Latest Revision: 2021
Previous Revision: 2015
Westpak’s Standard Committee’s Comments:

This new revision has no procedural changes that would affect testing – only editorial.

ASTM F1140/F1140M: STANDARD TEST METHOD FOR INTERNAL PRESSURIZATION FAILURE RESISTANCE OF UNRESTRAINED PACKAGES

Latest Revision: 2020
Previous Revision: 2013
Westpak’s Standard Committee’s Comments:

This new revision has no procedural changes that would affect testing – only editorial.

ASTM D5276: STANDARD TEST METHOD FOR DROP TEST OF LOADED CONTAINERS BY FREE FALL

Latest Revision: 2019
Previous Revision: 1998 (Reapproved 2017)
Westpak’s Standard Committee’s Comments:

Change affects drop testers with steel surface, which must be ½ in (13mm) thick and firmly anchored to the mass described in section 5.1.5.2. The length and width of the impact surface shall be the same or less than the width of the rigid mass. The impact surface shall be integral with a mass at least 50x that of the heaviest test container.

ISTA 3A: GENERAL SIMULATION PERFORMANCE TEST PROCEDURE FOR PARCEL DELIVERY SYSTEM SHIPMENT 70 KG (150 LB) OR LESS

Latest Revision: 2018
Previous Revision: 2008
Westpak’s Standard Committee’s Comments:

Two product definitions were added (Fragile Products and Liquids). A sample size of two (2) or more packaged-product samples is recommended for Fragile and Liquid product types. A leak test was added, to be conducted on products containing liquids.

ASTM F2825:  STANDARD PRACTICE FOR CLIMATIC STRESSING OF PACKAGING SYSTEMS FOR SINGLE PARCEL DELIVERY

Latest Revision: 2018
Previous Revision: 2010
Westpak’s Standard Committee’s Comments:

The changes include updating the scope which does not affect testing.

ISTA 3B: GENERAL SIMULATION PERFORMANCE TEST PROCEDURE FOR PACKAGED-PRODUCTS FOR LESS-THAN-TRUCKLOAD (LTL) SHIPMENT

Latest Revision: 2017
Previous Revision: 2013
Westpak’s Standard Committee’s Comments:

Added identification of items related to Orientation of packaged-product. Max top-load weight of 600 lbs eliminated.

ASTM D4728: STANDARD TEST METHOD FOR RANDOM VIBRATION TESTING OF SHIPPING CONTAINERS

Latest Revision: 2017
Previous Revision: 2006
Westpak’s Standard Committee’s Comments:

The changes include updating of references and appendices which do not affect testing.

ASTM D7386: STANDARD PRACTICE FOR PERFORMANCE TESTING OF PACKAGES FOR SINGLE PARCEL DELIVERY SYSTEMS

Latest Revision: 2016
Previous Revision: 2012
Westpak’s Standard Committee’s Comments:

Changes were made affecting testing, namely to Section 11.4, Schedule D3; Section 12.3, Test Method D5265; and Section 13, Schedule J.

ASTM F1929: DYE PENETRATION TEST METHODS

Latest Revision: 2015
Previous Revision: 2012
Westpak’s Standard Committee’s Comments:

This new revision has no procedural changes that would affect testing – only editorial.

ASTM F2054/F2054M: STANDARD TEST METHOD FOR BURST TESTING OF FLEXIBLE PACKAGE SEALS USING INTERNAL AIR PRESSURIZATION WITHIN RESTRAINING PLATES

Latest Revision: 2013
Previous Revision: 2007
Westpak’s Standard Committee’s Comments:

This new revision has no procedural changes that would affect testing – only editorial to add “M” to the title of the standard.

ASTM D6653/D6653M: STANDARD TEST METHODS FOR DETERMINING THE EFFECTS OF HIGH ALTITUDE ON PACKAGING SYSTEMS BY VACUUM METHOD

Latest Revision: 2013
Previous Revision: 2001
Westpak’s Standard Committee’s Comments:

This new revision has no procedural changes that would affect testing – only editorial.