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Ten real-life problems package testing helped solve

Compiled by Christina Elston

Testing professionals recount problems or defects today’s methods helped them discover.

There is a tremendous amount of theory involved in medical and pharmaceutical package testing. But eventually those theories have to be translated into practice: real-life tests to solve real-life challenges. Here, 10 package-testing professionals explain how their programs helped customers arrive at solutions.

• A Hidden Weakness
—Jim Zynda, sales manager, Test-a-Pack, Carleton Technologies (Orchard Park, NY) 
About 10 years ago, we had a potential customer that was using tensile testing to check the seals on a lidded tray holding a surgical kit. The company invited us in to do a demonstration of our burst-test equipment and pulled samples off the shelf to be tested. Our demonstration showed that all of their packages had a weak spot right in the corner of the tray that had gone undetected because their tensile test didn’t cover the entire seal area. They had to recall two trailer truckloads of their product, and they very rapidly became a believer in our test method.

Companies are still facing the same issues today. Recently, we visited a medical device company that is currently using tensile testing on its packaging. After a demonstration, this company also decided to switch to burst testing, which they found to be more effective in terms of time and cost—requiring 15 seconds per package, rather than 15 minutes—and a more thorough way to test their seals.

• A Piercing Product
—Gregg Mosely, president, BioTest Laboratories (Minneapolis)
An offshore company manufacturing tubing sets found that its products were being contaminated with bacterial endospore formers and mold. The 10-ft-long tubing sets were arranged in coils and placed in preformed Mylar pouches with Tyvek strips down the middle of one side. Packages were then sealed.

Audits of the manufacturing facilities confirmed that validations across all sealing units were adequate and that the sealers in all lines were operating properly. We found no lot-to-lot quality variation in the pouch components and no failure of pouch seals during sterilization.
However, we noticed that the tubing in the pouches slightly overfilled the shipping boxes, which had to be compressed by operators during boxing, taping, and palletizing. Testing detected holes in some packages on the Mylar sides that were in proper juxtaposition to incriminate the sharp corners of the tubing clamps. The ultimate solution was to remake the injection molds for the clamps and rollers, eliminating the sharp corners.

• A Tricky Seal
—Wendy Mach, packaging section leader, Nelson Labs (Salt Lake City) 
One of our customers has a packaging configuration involving a preformed pouch with a chevron end, which is sealed after it is filled. The corners of the chevron part of the pouch have a slight seal to keep them from curling. The firm was experiencing spore contamination of their product.

When we exposed those packages to an aerosol challenge, we found that the corners actually trapped spores between the edge and the chevron seal. Then, when the seal was peeled, the trapped spores would fall onto the product. It increased the rate of failure.
The customer first sought to solve the problem by using an inner, unsealed bag and placing the bottom of the bag toward the peelable end of the pouch. However, this proved to be prohibitively expensive, so they are working on another solution, which might involve eliminating the corner seals on the chevron end of the pouch.

• Vicious Vibration
—Eric Joneson, vice president, technical services group, Lansmont (Monterey, CA) 
Recently a capital equipment manufacturer with a highly valuable and sensitive scanning product came to our company seeking help to eliminate damage being experienced in transport. We inspected historical damaged product and found that vibration input was the source of the damage.

We then fixtured the product rigidly to our vibration test system and performed a series of low-level sinusoidal sweeps, measuring the response of targeted components and locations to determine their resonant and amplification characteristics. This allowed the product engineers to implement structural improvements that mitigated some of those component responses.

The shipper planned to use air-ride truck trailers to transport the product. To mitigate vibration input, we created “floater deck” systems, consisting of a foam deck to which the product is rigidly mounted. We then placed it upon a skid or crate base, “tuning” the density of the foam and the loading configuration for maximum results. Our system proved to be successful, and the capital equipment subsequently traveled safely from point-of-production to the customer’s installation sites.

• Excessive Waste
—Melvin Miller, product and marketing manager, new business development, Uson L.P. (Houston) 
A medical device company using immersion testing had developed a protocol requiring the testing of 10 samples each time the operators started up any of the several lines in the morning, plus several times during each of the two shifts the lines were operated. Unfortunately, their chosen test method required the destruction of the package, and costs were adding up. Each package had a relative value of $1, and the company lost $60 each time all of the lines were tested, for a total cost of approximately $500 daily.

We suggested replacing the immersion test with a vacuum force-decay leak test method, which is nondestructive and nonsubjective. The method uses vacuum to expand the packaging inside a chamber. The package presses against a load cell, and the leak tester monitors any change in force exerted by the package. A large change would indicate a leaking package. Nonleaking packages are returned to the product line and sent on to consumers. For this company, switching to the vacuum force-decay leak test has resulted in an average daily savings of approximately $450.

• An Unusual Bottle Shape
—Stephen Franks, executive vice president, T.M. Electronics Inc. (Boylston, MA) 
One of our customers needed to perform nondestructive, high-resolution, quantitative leak testing on sealed pharmaceutical bottles. The customer’s rectangular and square bottles provided no shoulder for a chamber seal tester, and typical machined cavities would allow a large void volume that reduced test sensitivity. A new technique was needed to provide small-void-volume test cavities to increase the sensitivity needed to detect very small leaks.

The TME Solution Chamber Leak Test System was modified to address the customer’s issues. The tester detects air leakage when a differential pressure is created on the test part inside a closed chamber, providing leak detection resolution to 0.0001 psi. To solve the problem of unique bottle shape, we created three-dimensional CAD solid models of each of the bottles to be tested using new, proprietary technology. We manufactured precise cavity inserts with controlled void volumes that optimize the sensitivity of the chamber leak-testing process. This new method of highly customized cavity manufacture solved both of our customer’s problems.

• An Unnecessarily Tough Test
—Hal Miller, president, PACE Solutions LLC (Warren, NJ)
An orthopedic manufacturer was experiencing primary-blister cracking after its transportation and distribution testing. Its standard performance test protocol, ISTA 2A, called for a general random vibration test and 10 free-fall drops from 38 in. This is a very robust test.

After reviewing its distribution environment, we decided to perform ISTA 3C, a general simulation performance test for parcel delivery. The company typically used FedEx to deliver orders directly to hospitals. The ISTA 3C procedure incorporates a specific random vibration spectrum for this environment and employs only six free-fall drops from 15 in. and one 30-in. drop. This protocol is more indicative of this distribution system.

The firm’s packages passed the protocol, and it has been using it ever since. The key lesson here is that it may not be necessary to redesign or “beef up” the package at additional time and expense, but instead to use realistic protocols and tests that meet package needs.

• An Insecure Insert
Mark Escobedo, chief technologist, Westpak (San Jose, CA)
We had a client that produced a catheter device that was secured to a chipboard insert and placed inside a pouch constructed from Mylar on the front and Tyvek on the back. The pouch was placed inside a chipboard container, and five chipboard containers were packed inside a shipper. When the shippers were subjected to 48 hours of conditioning, followed by impact, compression, and vibration tests, punctures were found on the Mylar side of some pouches.

Since there was no evidence of damage caused by conditioning and compression, we suggested subjecting one group of catheters to impact tests and one to vibration. Following an impact in the end-down orientation, a puncture in the Mylar side of the pouch occurred in 90% of the pouches. The chipboard insert was allowing movement within the pouch, causing the catheter to pierce the bottom of the pouch. A redesign of the chipboard insert to hold the catheter more securely solved the problem.

• Harmful Leachables
—Jennifer L. Riter, manager, technical customer support and business development laboratories, West Pharmaceutical Services, Inc. (Lionville, PA)
Recently, West Pharmaceutical Services worked with a pharmaceutical company to test an aqueous-based protein product. Testing was performed over the shelf life of the product at specified time points and conditions.

The drug product was packaged with a butyl stopper with a barrier fluoropolymer film on the plug of the stopper. West implemented and validated several analytical test methods to assess the presence of leachables within the product. West tested the drug product stability samples over several months and detected several leachables from the rubber formulation in the drug product.

Leachables can interfere with medical diagnostic tests, increase the impurity level of a drug product to an unacceptable level, and increase the toxicity of a drug product. They may also react with one or more drug product components.

Because of the potential impact leachables may have had on the protein product, the company was forced to reassess the packaging currently in use. To minimize leachables in drug products, pharmaceutical companies should consider appropriate packaging needs as soon as a drug enters clinical trials.

• An Unacceptable Risk
—Jack Richtsmeier, business development manager, Sonoscan Inc. (Elk Grove Village, IL) 
A large medical device company was trying to decide whether to transfer a product from its European division into the United States. The firm used our technology to test foil lid seals on a bottle and ultimately found the seals to be of poor quality. The number and consistency of failures was so great that they chose not to bring the product to the United States. By screening the product, they were better able to make an educated decision and eliminate the potential liabilities associated with poor product quality.

In another case, a company needed to optimize the process of sealing a saline pouch at high speeds in a wet environment. The pouch was used to help calibrate a system used for blood analysis. Sealing a pouch at high speed in a wet environment is a difficult process, and Sonoscan helped them optimize it before transferring it to their European division. The technology provided immediate and direct feedback to help them make adjustments and optimize the process.

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