Supporting Precise, Repeatable Package Testing

Versatile and more sensitive testers promise to lower downtime and product losses.
Package testers with multiple testing modes and higher sensitivity offer OEMs with a diversity of medical packaging systems the ability to test packaging faster and with more precision.
For performing the package integrity and seal strength tests required by ISO 11607, Packaging For Terminally Sterilized Medical Devices, TM Electronics Inc. (TME; offers the BT Integra-Pack Intelligent Package Tester.
With features including automatic mode for “out-of the box” burst testing parameter definition and new technology for testing large packages, the unit supports 20% higher resolution in the detection and quantification of package defects.
In whole package leak testing compliant with ASTM F-2095-07e1, the test performs to a resolution of 0.001 psig (pounds per square inch gauge), significantly better than earlier systems. Resolution in pressure decay leak testing is defined as the smallest pressure difference, or decay, the instrument can consistently detect during a predetermined test time, advises Stephen Franks, TME’s executive vice president.
“University studies have indicated that extremely small holes may allow biological contamination that may compromise the product. Device manufacturers have to evaluate the packaged product and determine where the line is between a good package and one that may be compromised, to minimize the risk of product contamination throughout its handling and shelf life,” Franks says.
“The BT Integra-Pack’s improved sensitivity provides more flexibility in setting appropriate specifications and reliably detecting defects,” Franks says.
Testing systems with higher sensitivity also support greater process control such as for sealing operations in high-speed production.
“High-speed packaging processes—and complex packaging designs—leave the device manufacturer vulnerable to significant loss if a process problem is not detected quickly. As packaging processes such as sealing have become more sophisticated, OEMs’ need greater detection levels to control these processes. You are providing a lower cost product by lowering downtime and product losses,” Franks says.
BT Integra-Pack can be programmed for burst, creep, and creep-to-failure seal strength testing of the whole package seal area for either porous or non-porous packaging, in compliance with ASTM test methods F-2054, F-1140, and for whole package leak integrity testing of non-porous packaging, per ASTM F-2095-07e1.
Device manufacturers are faced with setting up testers to cope with more materials in a processing day. To minimize the work involved in parameter input, the BT Integra-Pack features automatic testing as well as new support for testing large packages.
Packages can be tested without laborious test parameter input. A unique feature of the BT Integra-Pack is
automatic seal strength burst testing in the “automatic” text mode which eliminates time-consuming parameter input. The unit reacts to package size during pre-fill and runs the test appropriately with a pre set ramp rate. The user only need input their pass fail criteria, if that has been established, Franks explains.
For seal strength testing of large porous packages, the unit features a high flow capacity probe with a test stand with an expanded range of probe motion.
“As new package designs have evolved, many are required to be of large physical size, or to have large areas of porous materials such as Tyvek or thinner gauge materials that flow air during seal strength testing.
“Previous testers, including our BT-1000, required what was generally seen as an unacceptably long time to fill and test these packages. The BT Integra-Pack has addressed the issue by adding large-capacity air handling—up to 15 cfm—and by using a linear output algorithm control system for ramp rate control. The Pre-fill mode available in the BT-1000 was designed into the Integra-Pack, Franks says.
“These standard functions allow the user to define and save programs in the instrument that cover a wide range of applications, regardless of package size or material. During shifts where multiple packs are being manufactured and tested, the operator need only touch the display and choose the appropriate program for the item under test,” he adds.
The BT Integra-Pack features robust process documentation and quality control, with standard 32 MB memory and a memory card slot. USB and RS232 ports and an Ethernet port enable electronic storage and data retrieval.
Data are maintained under 21 CFR Part 11 compliance so that no data record can be altered in the instrument. When the instrument is locked, validated test programs are protected in the instrument to ensure consistent application of the appropriate test and specifications for each product, Franks says.
“Remote data transmission and storage limits the risk of operator error and provides the MDM with complete record keeping for regulatory requirements,” says Franks.
“Manufacturers are required to drill deeper than ever to show that they have complied with their validation methods. As the old proverb says ‘if you can’t measure it, you can’t control it.’ Knowing a manufacturing process has gone out of control—and when it has gone out of control—prevents process losses and possible recalls.”
As particular testing requirements arise with new packaging designs, new instrumentation with help meet the emerging needs. Testing equipment designs that are more compact and versatile will help eliminate the need for multiple instruments on the production floor and lower production costs, Franks says.
“An important goal we at TME are working toward is improving ease-of-use of the instrument by the operator. The BT Integra-Pack’s electronic capability simplifies usage with ‘out of the box’ (automated) performance, and the ability to lock in hundreds of test programs and switch from product test to product test with only a touch,” Franks says.
As a solution with versatile performance in non-destructive testing, TME offers the Solution-C pressure/vacuum chamber test system. The unit features customized fixtures to maximize sensitivity with options such as dual switching and multiple test ports to minimize test time.
These non-destructive tests are being used primarily for whole package leak integrity testing.
“Once a package has a product sealed inside, the MDM will prefer to not destroy the package during testing. Even if the product inside is not damaged, reprocessing the device adds cost to the product. The TME Solution-C provides a high-resolution, non-destructive whole package leak integrity test for non-porous packages for which there is significant advantage to preserving ‘good’ product. In the vacuum testing application, the system is compliant with FDA consensus standard ASTM F-2338.”
Whether using an FDA consensus standard as a guide for the design of a particular test or not, the user must follow a procedure for validating the test method chosen with the particular product/package to be tested. Toward that end, TME will supply the client with a procedure for using and qualifying a test system with their package, Franks says.
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