Package and Product Integrity Blog

ASTM D3332-99, helping to determine the shock fragility of products.

DDL Product & Materials Division Applications Engineer, Amy Peterson, discusses ASTM D3332. ASTM D3332 is the standard test method for Mechanical-Shock Fragility of Products, using shock machines. Amy will help to explain the two different test methods that reside within the ASTM D3332 standard and explain how the data that is collected can help to determine where product damage occurs.

Pharma IQ is holding a conference focused on stability testing, September 14-16 in London, to discuss the many concerns surrounding pharmaceutical companies meeting regulatory requirements. The conference and workshops will focus on how pharmaceutical stability testing can help the pharmaceutical industry maintain high standards, while meeting time constraints and keeping costs at bay.

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Levi L., one of the product managers in DDL’s Product & Materials Testing division shows us how a guide wire test is conducted based on testing standard ISO 11070 Annex F, which is the fracture test. When tested in accordance with annex F, the guide wire, excluding the region of fixation and the first turn, shall show no signs of fracture, and coated guide wires shall show no flaking of the coating.

Patrick Nolan, President of DDL and Rick Roberti, Lab Manager for DDL East will both be attending the ISTA Transport Packaging Forum this week in Orlando, Florida. The Transport Packaging Forum is one of the premier events in the transport packaging industry. For those of us in the medical device industry, it is crucial to understand how the physical distribution and transportation of your products can affect the end user. Product integrity can often be compromised during the transportation stage of product distribution, often due to a lack of temperature monitoring solutions, temperature control, poor package design or non-compliance with packaging industry standards.

Some of the featured speakers at this year’s show for those of you concerned with package and product integrity topics will  include:

• Ed Church, Executive Director, ISTA and Brian Wallin, Engineer, Amgen – ISTA Standards for Temperature-Controlled-Products
• Greg Batt, Lecturer, Clemson University – Use of Simultaneous Three Axis Vibration in Simulation of the Transport Environment
• Dale Root, Lansmont Corporation – Constructed Probability, Applying Analysis Results in the Lab in Pursuit of Improved Damage Correlation
• Dr. S. Paul Singh, Professor, Michigan State University School of Packaging – Handling of Sea Containers in International Ports

Events like the Transport Packaging Forum are extremely valuable to packaging professionals that work in the medical device, pharmaceutical, life science and bio-tech industries, to ensure that we are continually learning from our peers.  Staying up to date on the ever changing world of packaging can ultimately affect how both the package integrity and  product integrity of these life saving, valuable products is treated.

How do changes in the transport packaging industry affect how your products need to be handled before reaching the end user?

Bill Hingle from TCP Reliable shows off a lightweight insulated shipping container and explains the different options for pack out configurations. Lightweight insulated shipping containers are used for the transportation of high value pharmaceutical products to ensure that during transportation, the drugs maintain their product integrity.