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EQUIPMENT NEWS: Packaging and Assembly Equipment Validation Software Speeds Up Packaging Process Enhancements can shorten production times and increase safety In order to assist manufacturers in complying with the ISO 11607 standard requirements for packaging process development, equipment manufacturers are increasingly incorporating validation software and equipment into their machines. Rod Jennings of Van der Stahl Scientific Inc. says that his company's new pouch sealer "will incorporate real-time seal-integrity monitoring to enhance validation compliance." Enhancements to validation services can also "ensure the efficient and safe operation of our packaging solutions in the medical industry," says Michel Defenbau, president and CEO of This article looks at various validation additions to packaging machinery and also at equipment designed to speed up the packaging process. Enhancement Package for Validation Services validation service for its RS30 rollstock medical device packaging system surpasses FDA guidelines and includes a factory documentation package, multiple machine features, and installation qualification. "This enhancement service allows customers to significantly shorten time to productivity by ensuring
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Products & Services
Electronic and IC Packaging Services
Electronic packaging and IC packaging services perform the final stage of semiconductor device fabrication, places dies or boards inside of a protective package that provides connectors or pins for connecting to other devices.
Flexible Packaging
Flexible packaging conforms to the size and shape of the packaged item.
Packaging Machines
Packaging machines are used to package products or components, including equipment that forms, fills, seals, wraps, cleans and packages at different levels of automation.
Contract Packaging Services
Contract packaging services package and/or label products and materials produced by other companies on a contract basis.
Product Announcements
DDL Inc. - Medical Device Package Testing and Validation
DDL is your one-stop source for medical device package testing and validation - products, materials and packaging, as well as specific tests required for dangerous goods. (read more)
DDL Inc. - ISO 11607 Industry Standard
ISO 11607-01 is the foremost guidance document for validating packaging for terminally sterilized medical devices. Packaging must comply with ISO 11607-01 to ensure that the enclosed medical device is... (read more)
DDL Inc. - Package Strength Testing
In order to produce acceptable packaging on a daily basis and throughout a determined shelf life validation, it is important to evaluate the strength characteristic. (read more)
Parameter Generation & Control, Inc. - Validation Services
Parameter Generation and Control provides regulatory compliance and validation services to FDA regulated industries. Parameter provides the necessary service based on project requirements using the... (read more)
JAMAK Fabrication USA - Medical Packaging & Assembly
JAMAK is an ISO 13485 certified custom manufacturer of silicone components for Class I and Class II medical devices. We focus on providing personalized and responsive service to a wide assortment of... (read more)
 
Topics of Interest

The ISO 11607 standard is the foremost guidance document for validating packaging for terminally sterilised medical devices. In June 2006, important revisions were made to ISO 11607, which reinforce...

Environmental issues continue to exert great force on the packaging materials industry, and polyvinyl chloride (PVC) is still in the spotlight. Sengewald Medical Packaging product manager Michel...

A range of semi- and fully automatic packaging equipment includes three- and four-sided-seal pouch machines, blister-tray sealers, and constant-heat pouch sealers. Suitable for cleanroom use, the...

Risk-based compliance should also allow manufacturers to re-examine older, more holistic validation approaches, rather than fixating on individual components. "That's how it was done before...

Validating Medical Packaging at the Source Makers of packaging equipment increasingly supply validation tools to help customers meet international standards. As quality assurance requirements become...