The Package and Product Integrity Blog is the corporate blog for the TCP Family of Companies, including TCP Reliable, Cryopak, DDL and ATP. This blog covers topics about package and product integrity. The focus of the information covered in this blog is on the life science, pharmaceutical, cold chain and medical device packaging, as well as product industries.
Cryopak worked with Carolinas Cord Blood Bank at Duke University to develop a Cord Blood Shipper that would maintain between 4C-30C for at least 36 hours. This kit was designed so that no pre-conditioning was required for the system to function properly. The kits can be stored inside the expectant mother’s home and carried to the hospital on their delivery date. The doctor’s will then load the system with the required blood collection bag and tubes to be sent back to Carolinas Cord Blood Bank for storage.
Each kit was designed with an outer returnable plastic shell so that the systems could be reused numerous times and provide ample protection during transportation.
This kit is very unique in that it uses our new PIR panels and Exogel panels to maintain the required temperature ranges. Also, Cryopak designed a water filled pouch using our Flexible Ice Blankets to completely enclose the collected blood material to prevent any leaks and provide more protection to the collected blood samples.
Learn more about this project and how cord blood collection kits are helping to save lives.
Jean Bedard, CEO of ATP, a subsidiary of TCP Reliable/Cryopak, will be leading a workshop with TCP/Cryopak’s Technical Services Manager Anthony Alleva at IQPC’s 8th Annual Cold Chain Distribution for Pharmaceuticals Conference. The topic for Jean and Anthony’s workshop is Performing an Efficient Cold Chain Compliance and Process Gap Analysis.
Philadelphia Convention Center | September 20 – 23 | Philadelphia, Pennsylvania
The purpose of Gap Analysis is to assist pharmaceutical manufacturers, distributors or 3 PLs (3rd Party Logistics Providers) to help them identify gaps in their cold chain supply chain network or systems.
Jean and Anthony will be leading their workshop on Monday, September, 20th, from 2:30-5:30 pm.
What you will learn:
ASTM has recently issued a new standard which tests the mechanical seal strength for round cups and bowl containers with flexible peel-able lids. This test provides measured values for average seal strength, work and maximum seal strength when using a universal tester to separate the entire lid (cover/membrane) from a rigid or semi-rigid round container.
While the standard is specifically for round containers; oval, rectangular and circular containers with single or multiple cavities can be tested. The test applies to various industries including food, chemical and pharmaceutical. This test allows manufacturers of these containers to compare adhesives, seal methods and the affects of post sealing treatments such as aging or sterilization.
ASTM F2824 cites ASTM F88 which many of our customers are familiar with. F88 tests a portion of a seal and provides an actual seal strength picture of the portion of the seal under test. F2824 tests the entire seal by pulling the lid off at a rate of twelve (12) inches per minute while maintaining a peel angle of 45 degrees throughout the pull.
The 45 degree angle requires the test specimen to move during the test and in some cases requires a custom fixture to hold the container. DDL is equipped to carry out this test and has several methods to create custom test fixtures for the best test results possible.
“A good example that helps people envision this test is peeling the foil lid off of a yogurt container” says Al Gale, Sales Engineer for DDL’s Product & Material Division. “When you perform that simple act you can feel that the initial portion of the pull is harder than when you are in the middle of your pull and the pull gets harder again at the end. This is exactly what our universal test sees and records during the test.”
DDL, our medical testing services division recently came to a cooperative agreement with Pennsylvania-based CITECH, whereby DDL will be taking on testing that was formerly conducted by CITECH.
CITECH (Center for Information on Technology for Health) is an independent testing organization which has served the medical device industry since 1989. When CITECH President, Robert Mosenkis, decided to retire and close the business, he and DDL arranged for DDL to carry on with much of CITECH’s slate of medical device product testing.
Many of CITECH’s services already complemented our existing product and materials testing. By taking on some of CITECH’s business such as electrosurgical testing, DDL continues to expand its Product and Materials Division as well as assist CITECH’s clients with their testing.
“I wanted to be sure my clients were well taken care of. In the past, I have referred companies to DDL when CITECH was unable to meet their testing needs,” Mosenkis said.
We have been in the medical device testing business for almost 20 years and have been expanding our Product and Materials Division’s capabilities over the last five years in order to better serve the medical industry.
Bob will stay on, working part-time with us at DDL to offer his expertise and to help our transition into CITECH’s line of business.
In an ever changing regulatory environment for medical device manufacturers and vendors to the medical device industry, it is extremely important to know how changes are affecting packaging design considerations. Medical device packaging has come under more scrutiny from the FDA in the past few years and is causing MDMs to look closer at the requirements before designing, testing and manufacturing packaging for their medical device products. As a vendor to many medical device companies, it is our priority to monitor and educate ourselves on how the premarket notification process or 510 (k) works.
This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.
Package integrity is specifically mentioned in the FDA guidance documents for 510 (k) approval relating to Submissions for Medical Sterilization Packaging Systems. It is important that manufacturers understand these guidance documents before starting packaging testing, to ensure that time lines will be met and that any failed package validation doesn’t hold up the entire product development process.
Vendors also need to know how the FDA looks at packaging for terminally sterilized medical devices, so that they can have the proper expectations for working with medical device manufacturers.
Here are some of the aspects to consider when designing medical device packaging, in addition to a more strict regulatory environment.
Packaging for medical devices will continue to play an important role in the development of new medical devices. As technology continues to evolve, process for both MDMs and their vendors will need to be clearly defined so that they can maintain positive working relationships. In addition to issues with the regulatory bodies; sustainability, safety, ease of production and meeting the needs of a health care environment that is rapidly changing will be at the forefront of packaging design for medical device products.
What other aspects of medical device packaging need to be addressed in today’s health care environment?
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.
Continue reading ‘Pharmaceutical Stability Testing Can Ensure That You Meet Regulatory Requirements’
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.
Continue reading ’15 Frequently Asked Questions about ISO 11607-1′
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?
Click here to select the correct answer and enter yourself for a chance to win the iPod!
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.
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
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.
Twitter
Mark Francis
Pat Nolan