Originally Published EMDM October 2002
PRODUCT UPDATE
Validating Medical Packaging at the SourceMakers of packaging equipment increasingly supply validation tools to help customers meet international standards.
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| A 15-mm-wide test strip of material is sliced off using the ht 150 SCD's integrated cutter and is inserted into a clamping device. The seam is then pulled apart by the device at a precise speed of 200 mm/min to determine its tensile strength. |
As quality assurance requirements become more stringent, manufacturers must take into account a range of processing variables, including those affecting the ability of a packaged device to meet safety and efficacy requirements. By initially setting the proper parameters and validating the equipment, package inspection time can be reduced, output increased, and quality ensured. In the case of heat sealing equipment, for example, the use of dependable controllers can help engineers to verify "that bags coming out of the sealer have been sealed within [established] tolerances," says John Lewitt, vice president of sales for Emplex Systems Inc. (Toronto, ON, Canada). "That's what validation is all about—knowing the right parameters have been used to close a bag or tray."
Recently developed packaging equipment integrating features designed to ease validation are profiled in this article. The accompanying capsule articles in this section highlight an array of packaging equipment, materials, and services suited for medical device applications.
Validating Heat Sealing Equipment
"Validation, and thus quality assurance, begins with the packaging," says Christian Wolf, general manager at Hawo GmbH (Obrigheim, Germany), a supplier of sealing and welding equipment. The company has developed a validatable impulse sealer that can help users comply with ISO 11607 and EN 868-5 requirements for packaging processes, validation, and process control. The hm 460 V sealer is equipped with digital controls and maintains a continuous record of temperature, sealing pressure, and sealing time by means of a serial interface connected to a computer.
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The
Seal Check ht 150 SCD from Hawo GmbH allows users to perform a tensile
strength test on heat-seal seams in accordance with ISO 11607 and EN 868-5..
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The company has also designed a testing device that can help manufacturers to validate heat sealing equipment. ISO 11607 and EN 868-5 stipulate that a package's seam strength before and after sterilization be at least 1.5 N for a 15-mm-wide strip. This can be determined by means of a tensile-strength test.
In the past, this test was often conducted in off-site laboratories; continuous process control also requires that the heat sealing equipment be validated at the manufacturing site. The Seal Check ht 150 SCD "enables such measurements to be performed easily at any location, regardless of the type or functional characteristics of the device used to produce the [heat-sealed] seam," explains Wolf. "A test performed using this device gives precise information on the breaking force of the sealing seam and thus rules out subjective interpretations," he adds.
The machine has an integrated cutter that slices off a seam sample. The sample is then inserted into a clamping device, which pulls it apart at a precisely set speed of 200 mm/min to measure the amount of tensile strength that is required. The data can be saved for continuous process control, enabling users to regularly validate their sealing equipment.
Real-Time Monitoring of Seal Integrity
Also designed to ease validation compliance, a pouch sealer from Van der Stähl Scientific Inc. (Wrightwood, CA, USA) incorporates real-time seal-integrity monitoring. The Model MS-350 monitors the temperature of the heat platen to ensure that tolerances are within the set-point range. The unit does not rely on air pressure; constant repeatable pressure is delivered by means of a robust electronic solenoid.
A menu-driven Hitachi microprocessor makes sure that dynamic pressure is applied to the pouch and constantly monitors servo pressure at the seal bar. The unit can also operate in autocycle mode, which allows the machine to be set in 0.1-second increments for up to 5 seconds.
"Our seal-watch system monitors pressure and temperature and will alert the operator if the machine is unable to deliver set-point parameters," says Charles Webb, director of sterile packaging. "These proprietary software functions monitor the critical sealing operation to be certain that no medical device inadvertently arrives in the surgical theater with its sterility compromised," he explains.
Enhanced Validation Package
Packaging and process validation enhancements for rollstock medical device packaging systems were recently introduced by Multivac Sepp Haggenmüller GmbH & Co. KG (Wolfertschwenden, Germany). The features, which include a factory documentation package, multiple machine functions, and installation qualification, reportedly surpass US FDA guidelines.
"This enhancement service allows customers to significantly shorten time to productivity by ensuring problem-free validation of the installation, operational parameters, and package process," says president and CEO Michael Defenbau.
The R530 rollstock medical device packaging system notably is equipped with measurement and control redundancy. Monitoring control sensors with independent redundant sensors enables a backup warning system to alert operators to potential problems that can affect a system's uptime.
Prior to shipment, each machine undergoes a documented factory checkout process to ensure that the customer receives the specified features, capabilities, and sequence of operations. The documentation includes a software validation certificate, factory acceptance testing records, calibration certification of instruments used in manufacturing, and certificates of accuracy for all sensors used on the machine.
More Products:
Tolas Health Care Packaging
Medipack AG
UFP Technologies
Multivac Sepp Haggenmüller GmbH
and Co. KG
S-Y-M Products Co.
Doyen Medipharm Ltd.
Flexible Medical Packaging Ltd.
Emplex Systems Inc.
Hawo GmbH
DuPont Medical Packaging
SIG Pack Systems AG
Van der Stähl Scientific Inc.
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