Package and Product Integrity Blog

Save the Date! DDL and Cryopak will be hosting their Fall Package Testing and Cold Chain Packaging Seminar and Interactive Workshops, October 11-12 at our east coast laboratory and manufacturing facility in Edison, NJ.

Package Testing Presentation Topics:

• Distribution Simluation by DDL’s Packaging Engineer, Peter Johnson

• Test Method Validation by our Director of Operations, Corey Hensel

• Materials Used in Your Sterile Barrier System for Shelf-Life Products

Package Testing Workshops Sessions:

• ASTM F88 – Peel Seal Testing

• ASTM F2096 – Bubble Leak Testing

• ASTM F1929 – Dye Leak Testing

• ASTM F1886 – Visual Inspection Testing

Cold Chain Packaging Presentation Topics

• Use of Thermal Modeling Software

• Thermal Transportation Package Design

• How thermal modeling is used in transport packaging design work

• The effects of engineered phase change materials in package design

Cold Chain Packaging Workshop

• Assembly of a cold chain pack out

• How the thermal package is readied for testing

To learn more about DDL and Cryopak’s Fall Packaging Seminar, please visit the event page below for further details and to register.

Register for DDL/Cropak’s Fall Package Testing and Cold Chain Packaging Seminar >>

By Patrick J. Nolan, President of DDL, Inc. and Karen K. Greene, VP of Sales/Technology at Life Packaging Technology.

ISO 11607, the foremost guidance document for validating packaging for terminally sterilized medical devices, was revised early in 2006.  The updated ISO 11607-1 standard contains revisions to package validation requirements including sample size, labeling, documentation and testing methods.

DDL has received many questions from medical device manufacturers and package engineers regarding the  ISO 11607-01 standard.  Here are 15 of the most frequently asked questions.

1) Is it necessary to re-do previous validations to comply with the new standard?
NO! You will not have to re-do any validations that have already been completed or are in process. I would recommend that any future validation incorporate the provisions of the new standards.

2)  Is it a recommendation or a requirement for testing to be conducted on a product produced at “worst case” parameters not at nominal?
This will be a requirement. The thought process here is that if the sealing machines are operating within the control parameters established, but at the high or low extremes of the range, then there are many packages being produced that might meet production quality requirements but may not possess optimized seal integrity relative to the dynamics that will occur during shipping and handling.

3) Why is testing performed at every step of packaging?  Current practice usually combines processes and only tests at certain points.
Performing seal strength and integrity testing at points at every step of the packaging validation process helps to determine the root cause of any failures. If these interval tests are not done and only left until the end, and a failure is found, it is very difficult to determine at what point and under what stress the failure actually occurred in order to take corrective action.

Read more »

Each quarter, DDL introduces a new “Packaging Quizzler” to test your knowledge with a medical device package testing question and a chance to win an iPod. At the end of each quarter, we will do a drawing from all of the people that answered the question correctly for an iPod.

Here is this quarter’s question:

Which of the following test(s) can be performed to prove package integrity throughout your package validation?

• A) Visual Inspection (ASTM F1886) & Burst Testing (ASTM F1140)
• B) Bubble Leak (ASTM F2096) & Seal Strength (ASTM F88)
• C) Dye Penetration (ASTM F1929) & Visual Inspection (ASTM F1886)
• D) Both A & B
• E) None of the Above

Click here to select the correct answer and enter yourself for a chance to win the iPod!

Here is part 3 of our 7 part series on Medical Package Design, from Life Packaging Technology‘s Karen Greene. In part 3 we look at why medical device manufacturers should be evaluating how their competitor’s medical device packaging is performing for their customers, both positively and negatively.

Packaging Essential #3: Evaluation of similar or competing devices

The value of evaluating similar or competing devices may appear to be obvious but is not rigorously put into practice.    Identify your key competitors and/or comparable devices and get yourself out into the clinical setting and determine what your target customers love and hate about these packages.  Inquire about every facet of the packaging design and request your customers to prioritize their top 3 requirements for the package.

Considerations

• labeling for product identification, directions for use, bar coding and inventory management requirements
• examination of existing storage systems for integration
• ease of use of package/device
• package size as it relates to storage and use
• packaging materials utilized(primary, secondary, tertiary packaging systems)
• Is it imperative that the package is see-through and why?
• Does the primary sterile barrier package impede removal and aseptic technique?
• Does a coiled device present a significant hurdle to good clinical application because the device has taken an unacceptable “set”?
• Does the package facilitate one-handed opening and removal?
• If the device is a procedural kit, are all the expected and necessary components contained within the kit package?

You will not have the time or resources to gather a statistically significant data set on these package design considerations but the value of a first hand experience in the clinical setting including a dialogue with the clinical staff on their input and the reasons for their opinions will prove invaluable towards a successful package design.  As a packaging design professional, you will be able to quickly discern what will or will not work based on first hand clinical input.

The article series, 7 Essentials for Successful Medical Package Design was written by Karen Greene, Vice President of Sales and Technology at Life Packaging Technology LLC.

Testing for package integrity is often times one of the most important factors for many medical device manufacturers getting FDA approval for their products. There are many considerations to make by the packaging engineer in determining the best way to design, test and get approval for medical device packaging. In part 1 of a 7 part series on packaging essentials, we will take a look at packaging design requirements.

Packaging Essential #1: Packaging Design Requirements

It is imperative to define the packaging system in order to produce a successful package design .  The packaging engineer/designer must collaborate with project team members to create a packaging design requirements document which provides a clear expectation of the function, limitations, special features, aesthetics, product/company branding, cost limitations, size limitations, sterilization method, labeling requirements, hospital/clinic storage requirements, case count and possible adverse conditions of use and/or distribution and storage.   Do not limit your consultation to your Marketing and product development representative.    Valuable and detailed input can be obtained from the clinical team member, the end user, such as the clinical nurse, the O.R. technician, the Cath Lab technician, and the physician.  Also, consult your field sales representative for insight into competitive products.  Plan a trip to a local clinical site to see first-hand the environment in which your packaged device will be deployed.  Pre-arrange a visit and you will find a warm reception from the clinical staff as people love to provide their opinions.

Do you collaborate with all of the necessary parties involved in producing your package design?

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?

As a medical device manufacturer, one of the most important steps in the FDA approval process for a device is evaluate each package’s ability to protect the product inside throughout the handling, distribution, and storage environment.

The manufacturer must demonstrate that, under the rigors of distribution, storage, handling, and aging, the sterile package integrity is maintained at least for the claimed shelf life of the medical device or product.

There are many important questions you should be asking your packaging engineers internally, if you do your own testing, or that you should be asking of a third party testing laboratory. Here are 5 questions to ask a medical packaging engineer before you conduct your next package testing project.

1. Which technical standards does your testing laboratory comply with?
2. Are the standards that we are currently using or about to utilize in compliance with ISO 11607?
3. What are the material characteristics in the package design?
4. How is the device sterilized?
5. What is the worst case packaging configuration to use for a final package performance validation?

As a medical device manufacturer, what other questions do you make sure to ask of your packaging engineers in house, or of your preferred testing laboratory?