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There exists “a great deal of misinformation” when it comes to accelerated aging of medical device packaging, said Curt Larsen of Spartan Design Group, LLC (952/380-1458), at the January 28 MD&M (Medical Design & Manufacturing) West Medical Device Packaging Conference in Anaheim, CA.
A medical device packaging track chaired by Randall Troutman (shown in photo), CPP, Oliver Medical Products, will take place from 9 a.m. to 4 p.m. Monday, Jan. 28, during the MD&M (Medical Design & Manufacturing) West Conference at the Anaheim Convention Center, Anaheim, CA. MD&M will be co-located with six other manufacturing shows at WestPack.
Validating heat sealers, dye penetration and burst tests, the consequences of designing packaging late in the product design process, and sterilization issues are among the topics that Jacob Kearns has answered in the past year on his "Medical Device Blog." Kearns is an engineer for a medical device company. Differing points of view may be shared on this blog.
If ex-lifeguard Christine Doolittle has her way, patients who are unconscious or not breathing may one day be rescued thanks in part to an easy-to-access prefilled syringe pack she developed as a prototype last year while earning a Bachelor of Fine Arts Degree in Industrial Design from the Savannah College of Art and Design (SCAD) in Savannah, GA. The package is not being sold commercially. The prototype was developed as part of a Design Initiative between SCAD and Eastman.
The results of Cardinal Health’s RFID pilot were presented at the Pharmaceutical Supply Chain Integrity conference, which was held in May and was sponsored by The Institute for International Research . Cardinal’s Pharmaceutical Technologies and Services (PTS) operations were recently divested and acquired by The Blackstone Group. This information was shared by Renard Jackson, formerly VP/GM Global Packaging Services of Cardinal Health, Dublin, OH, and now with PTS.
Attendees of the “Medical Device Distribution Package Testing” conference at MD&M West seemed to appreciate Jan Gates’ description of what medical device management wants from new packages. Those attributes include the following:
Jan Gates, principal packaging engineer at Abbott Vascular, offered the following advice during her presentation, “Medical Device Distribution Package Testing,” during Medical Device & Manufacturing (MD&M) West.
Beware drug abusers and diverters: Attempts to tamper with this pill container will result in the disintegration of its contents in a puff of smoke... It may sound like a far-fetched idea, but prototypes of the PillSafe, a drug container that causes pills to disintegrate if the unit is tampered with, are being tested at the University of Kentucky Center for Manufacturing. Anthony McEldowney, M.D., and Robert Muncy, D.M.D, formed R.A.M.M. LLC and collaborated with the university to develop a device that would reduce the abuse and diversion of highly addictive Schedule II narcotics.
Jan Gates, principal packaging engineer at Abbott Vascular, offered the following advice during her presentation, "Medical Device Distribution Package Testing," during the Medical Device & Manufacturing (MD&M) West show.
The Food and Drug Administration continues to be challenged by limited financial resources. That was one of the messages from Donald E. Marlowe, FDA agency standards coordinator, during his March 8 keynote address that launched this year’s HealthPACK medical device conference in New Orleans. “Packaging is one of the most important issues in designing medical products,” Marlowe told an audience that by unofficial count was about 160. He also said “packaging contributed to the largest number of product failures,” although not recalls. The problems included mislabeling and seal failures.
Compliance with ANSI/AAMI/ISO 11607-parts 1 and 2 involves more than crossing items off of a checklist. It requires a medical device company to understand its applications and processes, the ability to read, visualize, and understand both parts of the standard, and the development of a strategic plan. That was the message from Randall J. Troutman, CPP and senior engineering manager with medical packaging supplier Oliver Medical during a Feb. 15 presentation at the Medical Design & Manufacturing (MD&M) show .
Jan Gates, principal packaging engineer at Abbott Vascular, offered the following advice during her presentation, “Medical Device Distribution Package Testing,” during the Medical Device & Manufacturing MD&M West show.
Inducted into the Packaging Hall of Fame during Pack Expo International 2006, Edward Bauer elaborates on developments in pharmaceutical packaging materials in this Q&A with Healthcare Packaging.
Compliance responsibilities that were clearly outlined in section 4.4 of the current standard have been omitted from the new International Standards Organization (ISO) 11607-01. Therefore, confusion may arise over certain areas of responsibility such as:
• Who should test the packaging suppliers’ seals?
• Who is responsible for validating package sealing equipment?
• Who is responsible for evaluating the biocompatibility or other material characteristics such as microbial barrier properties?
High-altitude transportation of goods has created unique problems in maintaining the integrity of the packaging. Ground transportation through higher elevations and air transportation via cargo and feeder aircraft with either partial or no pressurization results in a high incidence of reports of packaging failure. Packages sealed at or near sea level will experience an increased pressure differential on the seal/closure/finish with exposure to higher elevations. This pressure differential can cause leaks.
For the past four years, Michigan State University’s School of Packaging has been involved in studies to determine the effects of simultaneous vibration and low pressure on package integrity. These projects, funded by the Federal Aviation Administration and conducted by the Consortium of Distribution Packaging Research, aim to identify problems with existing packages and develop new test methods that can reduce the number of leaks in air shipments. Among the test results were the following:
• Wide-mouth samples (>28-mm) leaked more than narrow-mouth ones.
• HDPE bottles leaked more than glass bottles: 30.3% vs 20.6%, respectively.
• The average failure rate (leaks) for the entire study was 25.4%.
• Closure back-off was not observed in any of the leakers. This was verified by putting aligned ink marks on the cap and bottle, then testing for misalignment.
• Higher failure rates for the HDPE samples can be attributed to several effects: larger tolerances in finish specifications for plastic bottles and closures as compared to glass bottles and phenolic closures; the effect of temperature and creep; and that plastic bottles tend to “panel” (buckle inward)
when the headspace air escapes, taking product with it.
• The overall failure rate for a liner made from a PE foam core between two PE sheet layers was 91 leakers out of 270 samples tested, or 33.7%; 22.2% for PVC liners. A larger percentage of PVC liners with paperboard backing showed swelling and delamination during the test, resulting in package failure and leaks. The overall failure for linerless closures was 20% of the 270 samples tested.
• Recommended application torques on closures, consistent with industry practice, do not prevent leaks.
• Leaks were observed in samples that retained a residual removal torque after the test, so the closures retained some tightness.
If validation documentation is done earlier, the Factory Acceptance Test (FAT) can be a simple procedure, but not always.
“It used to take only a couple of hours to make sure things were running properly during a factory acceptance test, but today it can take eight to 10 weeks to put the equipment and software through the necessary challenges to demonstrate that it will meet today’s quality compliance standards,” says Bikash Chatterjee, COO of consultancy Pharmatech Associates.
“We need to make sure that the equipment will meet all the user and functional requirements, which means we spend more time at the factory where it’s more efficient to fix things in the supplier’s factory than on the customer’s shop floor,” he says.
“Some customers are doing FATs in factories and are there for weeks on end,” says Dave Schuh, VP of sales and marketing at MGS Machine Corp. “But the challenge is to understand the full scope of the FAT requirements, and fit it within the scope of work up front so that everyone wins.”
The pharmaceutical industry responded to the FDA's cGMP report with Process Analytical Technology, or PAT, a system to design, analyze, and control manufacturing and packaging processes through timely measurements of critical quality and performance attributes. The goal of PAT is to understand and control the processes with the assumption that quality cannot be tested into products, but rather should be built into systems by design.
“All packages are tested,” says Ed Church, executive director of ISTA (International Safe Transit Association). “The question is, will the package be tested by you so you see the results, or tested by the real world where your customer will see the results?”
Church’s remarks stem from a May 10 conference on package testing in Rosemont, IL, during the Contract Packaging Services Expo.
“Global commerce is about more than damage prevention,” says Church. “It also involves control of packaging and shipping costs, as well as reduction of waste.”
There are many levels of testing, from simple to complex, but any testing is better than none, according to Church. While field tests and basic guidelines for specifying material construction can help, laboratory testing creates a miniature universe where the tester has control and can observe, up close, variables and results, not only for basic hazards such as shock, compression, and vibration, but also atmospheric testing of temperature, moisture, and high altitude (low pressure). The latest in lab testing is vibration under vacuum, which reveals leakers some tests never uncovered.
