Distribution Testing: Prepare For Safe Transport

In this webinar on distribution testing for medical device packaging, Business Development Manager John Hodges is joined by packaging experts Wesley Herata and Victor Navarro to guide attendees through essential standards, methodologies, and planning considerations. Wesley leads the San Jose lab and brings experience in medical device manufacturing, while Victor specializes in ASTM and ISTA transit testing, environmental conditioning, and sterile barrier integrity.

The session focuses on ensuring packaging integrity during transportation by using recognized standards like ISO 11607, which outlines requirements for maintaining sterility through exposure to transport hazards such as shock, vibration, compression, and atmospheric conditions.

Two primary standards guide distribution testing: ASTM D4169 and ISTA. ASTM D4169 is FDA-recognized and allows customized, flexible test plans based on distribution cycles, assurance levels, and packaging types—though it may be costlier. ISTA standards, such as Series 3A, 3B, and 3E, offer test plans tailored to specific supply chains like FedEx and Amazon and are also FDA-recognized.

The webinar details how to scope a distribution testing project, starting with the choice between ASTM and ISTA. Factors like package design, material, shipping method, and product contents all influence test selection. Packaging layers—tertiary (outer), secondary (support), and primary (sterile barrier)—each play roles in protection and are evaluated accordingly.

Attendees also learn about real-world simulation through conditioning at various temperatures and humidity levels and testing methods such as manual drops, mechanical handling, and compression. These steps ensure product safety, compliance, and reliability in transit.