Tools for Testing Packages
These testing products can get your package evaluations going.
|Mocon's Skye 2000a combination burst and leak tester can test either closed or open packages.|
Package testing is both a science and an art. It involves science because you need to carefully control your testing conditions, measure and document results, and repeat processes consistently. It also involves art in that you can choose your own methods and apparatuses, as long as you validate them yourself and compile data demonstrating their sensitivity and repeatability.
The following systems can help device manufacturers test their packages for seal strength and package integrity. Some units are designed specially to meet standards like ANSI/ AAMI/ISO 11607-1997, "Packaging for Terminally Sterilized Medical Devices," or various methods from ASTM. All are designed to expedite package evaluations at reasonable costs.
TOOLS FOR STRENGTH
Designed to perform burst and creep tests in accordance with ASTM F1140-2000 and ISO 11607, the Test-A-Pack Model 2600 Control Console from Test-A-Pack Systems, Carleton Technologies (Orchard Park, NY), can handle burst, creep, and creep-to-burst testing. The 2600 automatically regulates air pressure to determine the seal strength of a wide variety of porous and nonporous packages. A burst test function automatically inflates the test sample until seal failure occurs, and a creep test feature checks package seals under sustained pressure. The creep-to-burst test sequentially checks minimum required seal strength and maximum pressure at burst. The 2600 includes a parallel printer port and an RS-232 serial output port for easy interface with a PC for data collection. Open-package and closed-package test fixtures are available.
Systems from Com-Ten Industries (Pinellas Park, FL) can help users meet seal- and seam-strength test specifications set forth by ISO 11607 and ASTM F88 medical packaging testing guidelines. A typical test involves cutting a strip from a package that has two free ends with a seal or seam in the middle. The free ends are placed in fixtures especially designed for packaging, thin films, plastics, or foils. The test is run according to a specific procedure or specification. As the test is run, the seal is peeled apart and force recorded. Some systems may simply display a peak force or more-advanced systems can determine an average force or a number of different peaks.
Affordable tensile and compression test systems range from automated, computer-controlled systems to hand-operated test stands, depending on your specific testing needs. For instance, Com-Ten's Digital Documentation Test System, an automated, motorized system, displays peak force and deflection and documents test speed. An optional printer for automatic test reports and graphs as well as test acquisition software are also available.
TOOLS FOR INTEGRITY
Intended to replace destructive test methods such as bubble and dye tests, the Qualipak 700–series from ITI Qualitek (North Billerica, MA) uses strain-gauge technology for use on the production line or in the laboratory. Holes as small as 10.0 µm can be detected in packages within a few seconds. Using statistical process control, results can help users track trends in the process for adjusting and maintaining packaging machines. Single- and dual-station package testers are available.
Using pressurization or vacuum techniques, the MDT-500C from T.M. Electronics Inc. detects changes in pressure if air leaks into or out of a surrogate test chamber. Holes as small as 5 µm can be detected in preformed lidded trays, blister packs, or pouches of common materials, including films, foils, and laminates. A fixture for testing bottles enables the unit to detect pinholes as small as 10 µm in sealed bottles. In-process testing detects leakage from pinholes, cracks, and seal and channel leaks without disrupting the production process. The tester also offers graphic results of individual tests, as well as SQC analysis of up to 500 tests in the data log.
The Pac Guard Model 500 from Mocon Inc. (Minneapolis) is designed to test porous medical device packaging at every stage of development. Employing a nondestructive test method to detect defects in rigid thermoformed trays and in the seal between the porous lid and the tray, the system relies on infrared-based sensing of a CO2 trace gas to identify defects. The Pac Guard can detect channels as small as 0.004 in. diam in the seal between the porous lid and the tray, and 0.002-in.-diam pinholes or cracks in the tray. Packages can be tested in less than a minute.
The Seal Integrity Monitoring System (SIMS) 1282+ Helium Leak Detector from Leak Detection Associates (Williamstown, NJ) uses a helium mass spectrometer. Packages are filled with helium on-line, then placed in a vacuum test fixture to measure the rate at which helium escapes from the package. A head space analysis module is then used to measure the concentration of helium in the package and report the actual leak rate.
Uson's (Houston) Series 4000 leak testers offer multiple test methods to perform leak, flow, vacuum, and functional testing on virtually any package. A transducer and signal- conditioning system allows the unit to achieve a resolution of 0.000003 psi. The newest addition to the series is Model 4600, which features a program sequence editor that allows users to customize test-step sequencing for complex test procedures. It eliminates the restriction of following fixed program steps, allowing users to develop their own test sequences. Various math functions can be inserted into the test sequence, permitting the testing of parameters previously not directly measurable.
The Test-A-Pack Model 2700 nonporous-package test system from Test-A-Pack Systems quickly and accurately verifies the integrity of nonporous, flexible packages. The 2700 system consists of a fully digital, automatic control console and a package test chamber available in various sizes. The control console regulates a vacuum source (sold separately) while providing test data on the display screen. The 2700 allows the user to display readings in inches or millimeters of mercury (gauge or absolute) and can also provide values in feet of altitude. The transparent vacuum test chambers can be used with or without water to detect leakage in the package seal or material. By adding water to the chamber for submersion testing, the exact location of any package leak can be observed by a stream of bubbles.
T.M. Electronics's Package Port system allows consistent penetration of flexible packages for seal strength and leak testing. The flexible Package Port allows the operator to simply and repeatedly insert the test probe into the package for restrained and unrestrained package testing. By attaching a double-sided adhesive disk to the package port and connecting the port to the package, a leak-tight path is created between the port and the package. The package- testing probe is then sealed inside the port as it is inserted, allowing the probe to maintain the leak-tight path.
Mocon Inc. offers the Skye 2000a, a combination burst (rupture) tester and leak (soak) tester used to predict shelf life based on leak rates of various packaging materials. The combination burst-and-seal-strength tester works with all types of packaging, including flexible or semirigid packages, canisters, tubs, and open- or closed-end tubes. Microprocessor-controlled, the system provides an accurate and reproducible measurement of package integrity and seal strength. This automatic test system quickly identifies (within approximately 15–30 seconds) high-stress areas and weaknesses of the package. It includes a closed-package fixture for pneumatically testing a variety of fully sealed packages or an open- package fixture for packages sealed on three sides.
|Test-A-Pack System's Model 2700 integrity tester is used to visually check for leaks or voids in nonporous packages.|
Acoustic microimaging (AMI) has recently been employed to help characterize the seal areas of pharmaceutical and medical device packaging. AMI systems, available from Sonoscan Inc. (Elk Grove Village, IL), can help with both package integrity testing and seal strength testing. AMI is a nondestructive inspection technique that uses very high frequency ultrasound that penetrates into and through materials to produce echoes from various depths within a seal region. The echoes are then collected and transposed into an acoustic image, which displays both bonded and disbonded internal features. The acoustic image offers the manufacturer a visual map of the seal region. The technique is extremely sensitive to air or gap-type defects such as voids, disbonds, delaminations, and porosity.
If you need your packages tested but lack the capital or volume to purchase your own equipment, you may benefit from using a third-party testing firm. Lansmont Corp. (Monterey, CA) can test packages according to ISO 11607 and various ASTM test methods and International Safe Transit Association test procedures. Comprehensive documentation on test results is typically provided by firms like Lansmont, helping you back your applications to FDA.