Medical Device Link.

Originally Published PMPN February 2003

TRANSPORTATION PACKAGING

by Jenevieve Blair Polin, Contributing Editor

photo of transportation package testing courtesy DDL Inc.

When it comes to testing packaging for medical devices and pharmaceuticals, engineers have focused on integrity tests. Transport package testing, however, cannot be ignored. One reason may be the requirements, stated in 21 CFR and ISO 11607, that manufacturers must adequately test product packaging and document that it will survive distribution.

Another reason is that your package is going to be tested—one way or another, warns Dennis Young (Dennis Young and Associates Inc; Grand Rapids, MI), an independent consultant who provides transport package testing and consulting. One client is the International Safe Transport Association (ISTA). Young is ISTA’s associate director for membership.

“You have the option of testing it in a laboratory to find out in advance if it’s going to do the job, or shipping it to your customers and letting that be the test,” Young says. 

THE FOUR HAZARDS

Four hazards threaten every package as it is shipped and handled. They are shock, vibration, compression, and atmospheric variability (including temperature, humidity, and atmospheric pressure). Because PMP News has covered temperature and humidity concerns recently (See “Shipping Temperature-Sensitive Products,” PMP News, February 2002, and “Desiccants Boldly Go Where Moisture Hides,” PMP News, July 2002), this article focuses on the other hazards. 

“It’s a simplification,” says Young, “but handling is where we get most of our shock, transportation is where we get most of our vibration, and warehousing is where we get most of our compression or load.” 

Shock. Handling is not limited to the package itself. At the macro level, an entire shipping container may be handled by crane. At the intermediate level, a package may be part of a pallet load. These pallets are usually handled by automated or semiautomated equipment. Individual packages are most often handled by hand. Shock is measured as G force, with 1 G representing the normal force of gravity. The greatest shock, in most cases, occurs during individual package handling.

Vibration. Most vibration occurs during transport. Vibration may cause a package’s contents to settle, which makes them more vulnerable to shock and compression because of increased void space. Vibration may also cause migration of some types of packing materials, such as expanded polystyrene, cautions Mark Dawson, director of marketing, Ranpak Corp. (Concord Township, OH). Such migration may leave the product resting in the bottom of the box, relatively unprotected from shock.

Compression. “In-the-box packaging does two different things: One, it protects the product, but two, it maintains the integrity of the box,” Ranpak’s Dawson explains. Compression is the greatest hazard to box integrity, and void fill minimizes this risk. “Research shows that packers often use more void-fill material than necessary, just to be safe,” Dawson says. Ranpak manufactures the FillPak system to convert single-ply fan-folded kraft paper for top void fill. The firm recently introduced its AccuFill sensor array, which mounts over a conveyor. This system automatically determines and generates the amount of packaging needed.

Atmospheric Conditions. Next to temperature and humidity, variation in atmospheric pressure, particularly during air shipment, is the most common atmospheric hazard. Garry Newman, vice president of manufacturing and engineering, Air Packaging Technologies Inc. (APTI; Valencia, CA), says many manufacturers are unaware of the mandate for atmospheric testing in ASTM D6653-01. This standard describes a procedure for simulating high altitudes that can occur during shipping through a reduced atmo-spheric pressurization test. This should be done for any product that can be deleteriously affected by higher altitudes (i.e., lower atmospheric pressure). APTI exceeds the requirements of this standard by testing its Airbox for integrity at altitudes of 19,000 ft. (See the sidebar at right, “Smaller Boxes Spell Savings.”)

STANDARD TESTS

“The most important decision a manufacturer can make is to start testing—going from not doing any transport package testing to doing some sort of transport package testing,” says Young. The first step for a company just getting into testing, especially one that is seeing unacceptable damage levels to its shipped packages, is usually to contract with a third-party laboratory to test to a standardized protocol.

The test protocols commonly used for drug and medical device packaging are ISTA 1A (shock and vibration only), ISTA 2A (a four-hazard test with higher drop heights and more vibration than ISTA 1A), and ASTM D4169 (more complex than ISTA 2A, with drops from a variety of heights). A new choice, currently called ISTA 3AB, will soon be available. Now under development by a technical committee, this protocol will be demonstrated at ISTA’s Dimensions.03 conference (see sidebar on page 52).
There are about 300 ISTA-certified laboratories in the United States. Some product development service firms have these laboratories, and so do some package manufacturers.

Ranpak is one packaging system manufacturer with its own ISTA-certified laboratory. “We offer the lab services free of charge to our customers,” Dawson says. “We have three full-time packaging engineers on staff here who specifically work with customers to design packages.”

Dawson says some customers send Ranpak their product packaged in a competitive material. “Our engineers analyze it, cost it out, pack it in PadPak, take digital photos each step of the way on how to pack it in PadPak, and then provide a written report on how to pack it in PadPak. If desired, we can also test the product,” he adds.

Lansmont Corp. (Monterey, CA) is an equipment manufacturer that provides shock, vibration, compression, and drop testing equipment to companies worldwide. Lansmont also manufactures portable data loggers that can be shipped with packaging to re-
cord hazardous events. Dave Huntley is director of Lansmont’s Western Technical Services Group (Sunnyvale and Irvine, CA), which consists of independent ISTA-certified third-party test facilities that use Lansmont’s equipment and sensors. Three main operating groups (Instruments, Equipment, and Test Services) make up Lansmont’s Field-to-Lab Solutions.

CUSTOMIZED TESTING

A more sophisticated type of transport package testing is focused simulation. In these tests, engineers create and ship dummy packages, identical in weight and packaging to the company’s product packages. These dummy packages contain data loggers—
battery-powered electronic devices that record dynamic events that occur during transport—such as those manufactured by Lansmont. After distri-bution, the packages are returned. The data are retrieved and analyzed. The engineers then use these data to create a customized testing protocol unique to this particular product, simulating the conditions it is likely to encounter during transport. It is then possible for a manufacturer to customize packaging to handle the predicted challenges. Manufacturers may collect and analyze their own data or partner with a consultant who provides this service.

“The advantage of using a generalized test is that it covers a wide range of possibilities. The disadvantage is some of those possibilities may not apply, so why develop a package for something that your product is not going to see?” asks Young.

Bill Brokob, technical center manager of Tuscarora Inc. (New Brighton, PA), agrees that package testing must be tailored to meet the specific needs of the product. “Packaging protection can be viewed as insurance: why pay for coverage you are not likely to need? The trick to developing an effective test protocol is in being able to replicate actual shipping damage in the lab, so you can work to eliminate it in the field. At Tuscarora, we concentrate on solving the customer’s problem in a material-neutral approach, giving them the most protection for their packaging dollar.”

Gerry Hock, president of GH Testing (Cincinnati and Phoenix), says that packaging engineers shouldn’t do “cookbook” transportation packaging testing. “We help customers look at all broad testing plans and then pick the testing plan best for them.” GH Testing performs testing according to both ASTM and ISTA standards.

DDL Inc.’s (Eden Prairie, MN) Pat Nolan says that “the most critical and difficult issue is determining what shipping unit to actually test.” DDL helps medical device and pharmaceutical manufacturers develop specific protocols for distribution testing. Its shock, vibration, and compression equipment provides all of the testing required under ASTM and ISTA procedures to simulate the hazards inherent in the distribution environment. “Since many medical device manufacturers do not configure their shipments in homogeneous products and quantities (e.g., same product in a 24-pack), but rather mix up products and have different quantities for every shipment, it is difficult to determine what to put through the test that represents a typical shipment. We help clients determine the best course of action.” 

Once companies know exactly what conditions their packages encounter, Young says most can reduce packaging costs by at least 15% without any increase in damage. “Unless you have a real damage problem in transit, you’re probably overpackaging. The question is, are you overpackaging by 1%, which would be fine, or are you overpackaging by 30% or 50%?
“There’s nothing wrong with reducing your packaging, even for critical products like medical devices, as long as you realize what hazards are presented by shipping, and you’re accounting for them. That’s good economic policy as well as good corporate citizenship,” Young adds.

Several companies, including Lansmont and Instrumented Sensor Technolog (Okemos, MI), manufacture transport data loggers. Some large medical device and pharmaceutical manufacturers have their own in-house testing laboratories and purchase their own data loggers.

DATA-LOGGING OPTIONS

Huntley explains the range of capabilities in Lansmont’s line of data loggers. Similar levels of sophistication are available from other manufacturers.

Lansmont’s most elaborate logger is the SAVER (shock and vibration environment recorder). It has 14 channels: 6 static channels (for slow-moving parameters, such as temperature, humidity, and pressure) and 8 dynamic channels (for detection of shock and vibration). These channels can record data from sensors placed at different locations within a box or load. The PAL 2000 (peak acceleration logger) measures just shock and temperature. This transport logger records only the largest 100 shock events during transit. 

The shock logger is for specialized applications. A very small recorder, the shock logger is embedded into a dummy product. It may be used for validating manufacturing lines for shock and vibration.

DATA ANALYSIS

Studies of the real-world environment are only useful if they have sufficient statistical power. Analyzing the data is key to an optimal testing protocol.

Trending. When considering the cost of monitoring real-world transport conditions, manufacturers are anxious to know how many trips will be required. There is no hard and fast rule; the answer depends on the preliminary data from the first 5 or 10 trips.
“When examining preliminary data, we are looking for trends,” says Huntley. “If we find consistent levels and content from trip to trip, we begin to have statistical confidence in the shipments measured. If we find the content and levels are all over the map from trip to trip, then we need a larger data population in which to identify trends. We also want to identify specific factors built into handling logistics that could account for the variance. If the same logistics and handling system are used, monitoring will identify the potential for similar events.

“The one thing you don’t want to do is develop test protocols at levels that are unrealistic,” Huntley continues. “These standards have real costs associated with them. Overtesting leads to overpackaging, and this can become costly. The key to this process is to buy the protection you need, and cut the costs you don’t.” 

Software. Companies that manufacture the data recorders supply proprietary software for analyzing the data after the devices return from their trips. Another option, which Young prefers, is to export the data from these types of software programs and conduct one’s own analysis using standard spreadsheet or statistical analysis software. 

Copyright ©2003 Pharmaceutical & Medical Packaging News