Medical Device Link.

As you seek to develop packages that ensure product safety and integrity during storage and transport (with an eye on keeping costs to a minimum, of course), it pays to know something about your distribution environment. But how much do you need to know?

Collected field data more accurately reflects actual shipment conditions, but such collection is time intensive and costly. Generalized testing profiles are faster and may be based on updated information, but do they reflect the specific conditions your package encounters?

And, what testing methods should you use?

Presenters at Dimensions.07, The International Forum on Transport Packaging, held in Orlando, described several packaging development scenarios where product and package integrity was established and costs reduced.

Abbott Nutrition, Abbott Laboratories (Columbus, OH), used a combination of methods to test primary, secondary, and transport packaging for an 8-oz screw-top plastic container for its Ensure nutritional drink. The plastic bottle replaced a nonreclosable can. After the new packaging launch in 2003, a second project phase aimed at cost improvement. Two optional box-style packages were evaluated for performance with stress testing.

Alan Crawford, principal packaging engineer, medical nutritional packaging development, Abbott Nutrition, said testing methods chosen for the Ensure packaging needed to ensure speed to market while minimizing the risk of package failure.

"Speed-to-market can pay off handsomely. The challenge when changing to a new package is to manage the risks. The new package and the subsequent cost-improved package had to maintain acceptable package integrity and acceptable appearance at point of sale," Crawford said.

"You have to determine the best means of making that assessment to provide a high level of assurance of long-term performance, but with minimum elapsed time and resources," he said.

By testing "just right," a company can avoid over- and undertesting and enable quick market delivery with an acceptable level of package-failure risk, Crawford said. Abbott's testing drew on three evaluation methods: expert knowledge and rigorous logic that helps determine the tests and the amount of testing, actual shipment testing, and lab distribution stress simulation.

An evaluation of actual shipments of test samples without instrumented monitoring showed minimal effect on the proposed packaging. But assessment through this approach is risky, because there can be significant variation in distribution stresses from shipment to shipment, Crawford noted.

Lab simulation with established profiles is controlled and repeatable and can be performed more quickly, with performance assessment completed in hours rather than days. Abbott subjected packing to ISTA tests (3E, 3F, 3A) in an Abbott simulation lab. "Laboratory tests may not exactly duplicate the distribution environment, but the results are generally good enough to aid in decision making," he said.

The Ensure packaging initially featured a strong corrugated box with full FOL flaps that supported most of the stress test load, protecting the plastic bottles. In the phase-two box redesign, Abbott qualified a package using lighter-weight corrugated material that put more of the stacking load on the bottles.

The same ISTA tests were used in testing the two boxing options, both of which put more vertical stacking stress on the bottles. A corrugated tray with a shrink film overwrap and a wraparound box with RSC economy end flaps made from a lightweight (32 ECT) corrugated were evaluated. Stress Engineering Services (Mason, OH) was selected to perform an accelerated simulated stacking-stress analysis in which bottles were subjected to 130° F temperatures for six weeks. Testing showed the bottles could withstand anticipated warehouse stacking load without buckling or cracking with either package. Abbott chose the RSC end flap design--where the box provided only modest compression support--as it could be more quickly executed with modification of existing case packers. The reduced-strength corrugated box was implemented in 2005 with no reports of increased damage. Package costs were reduced in excess of $1 million.

In summary, Crawford emphasized these points: Understand the distribution environment and that it is dynamic; test to simulate the environment; ISTA methods include accelerated tests for objective assessment that minimize risks; and additional accelerated test methods and outside help are available.

Amgen Inc. (Thousand Oaks, CA) performed field data collection to develop vibration and temperature profiles to assist in package development for liquid-suspended protein drug products shipped in insulated containers.

"Amgen is a data-driven company. We began four years ago developing new profiles in order to ensure compliance and more importantly to serve our patients. To defend our packaging with regulators, we wanted to develop profiles based on our own measured data. The goal is to simulate in the lab as close as possible our real-world shipment environment," said Brian Wallin, engineer, Amgen.

For creating vibration tests standards, trucks were continuously monitored for 30 days traveling Amgen delivery routes. Air routes were monitored with vibration instruments affixed to LCD containers and with pressure loggers to indicate when planes were in flight. Random vibration profiles were created using the data. A lane characteristics study was performed to create a worst-case test transportation lane, after which a testing sequence was defined.

Wallin said Amgen's profiling established a high confidence level in ISTA profiles. (Amgen adopted two truck profile modes from ISTA 3A.) But "the airplane data were not consistent with prior profiles and validated why Amgen must collect its own data. Amgen's air data exhibited significantly lower amounts of vibration than the ASTM air profiles," he said.

Wallin said that Amgen does not perform accelerated testing because its studies have shown that accelerated lab test data do not match actual shipment data. "It does not work for Amgen products. This is an example of why engineers need to do their due diligence to understand where industry profiles come from, what they mean, and how they apply to their business," he said.

Amgen can simulate the environment more closely by running heat and cold and pressure profiles simultaneously the vibration profiles. Ray Cowland, senior engineer, reported on Amgen's development of heat and cold profiles for qualifying shippers for global distribution.

To develop ambient thermal profiles, recording devices were fixed to corrugated noninsulated containers. UPS handled shipments that were sent domestically using two-day air service. Global profiles that covered global temperature extremes were developed based on two sets of domestic ship data and historical data obtained from NASA.

"Qualifying shippers to the thermal profiles allowed Amgen to use the same insulated shippers for shipping to different locations, since the ambient profiles used cover the limits of heat and cold exposure that the package is expected to encounter," said Cowland.

Since adoption of the qualified shippers, nonperforming and returned packages have dropped to 0.3% from 30%, saving millions of dollars, he said.

While shippers of pharmaceuticals and medical devices are being challenged to justify their packaging, these examples show that appropriate testing can result in reduced costs, besides patient safety assurance.

David Vaczek
Senior Editor