Media CoverageNews - Packaging Validation Sessions at MD&M MinneapolisKaren Sams
Article Summary Web SightingsKaren Sams
Article Summary DDL Expands into New Environmental Testing Laboratory — Responds to Rapid Growth and Increased Demand for Environmental Testing ServicesKaren Sams
Article Summary Ddl Inc., which tests packaging for medical device products, plans to expand to the East Coast by the end of this year. The Eden Prairie-based firm, which has two testing laboratories in Minnesota and one in Southern California, is scheduled to move one of its sales representatives to Boston and hopes to start building a facility next year. Treat The Packaging As An AccessoryKaren Sams
Article Summary Packaging for medical devices play a key role in safely delivering specialized treatment to patients. Most single-use, sterilized medical devices can be opened with a high degree of confidence that it has remained sterile throughout storage, handling, and transportation. What makes packaging doubly important is that regulatory authorities recognize the critical nature of sterile barrier or primary package by considering them components or accessories to the medical device. This implies that packaging is almost as important as the device itself. And it is. If a package does not keep, for instance, a pacemaker sterile, patients will be put at risk. DDL Responds to Increased Demand for Medical Device Product TestingKaren Sams
Article Summary DDL Inc. testing services, a MN-based package, product & material testing laboratory, is responding to the needs of medical device manufacturers by expanding both its product test engineering team and its laboratory equipment inventory. The MN-based testing facility has grown its test engineering team with additional technicians and test engineers in order to replicate the dynamic and environmental hazards inherent in medical device transportation and daily operational environments. View from the Top - Interview with Pat NolanKaren Sams
Article Summary As medical device manufacturer’s face increasingly tougher scrutiny from regulatory agencies, they must do what they can to prevent possible causes for a rejection. This means ensuring the approval of every aspect of the submission, including the packaging. This month’s “View from the Top” speaks with [Pat Nolan, COO of DDL, Inc,] an expert on package testing and validation. Complying with EU Packaging Regulations Using ASTM International StandardsKaren Sams
Article Summary The world would be chaotic were it not for standards that allow the industrial community to simplify commerce. Standards promulgate a common language that promotes the flow of goods between buyer and seller and aids the common man by improving safety and safeguarding health. Some simple examples are; the use of nuts and bolts in both the metric or SI systems; a 92 octane gasoline that meets specific combustion ‘standards’ and state and federal regulations require that gasoline meet these standards so the consumer knows what he/she is pumping into their gas tanks; plugs (e.g. serial, parallel, RF) for connecting peripheral components to computers are all uniform worldwide for every type, make, and manufacturer of computers; medical devices are tested using standardized test methods so that performance specifications can be developed, and these same tests can be used to test the efficacy of similar or competing devices. Standards create order where there is disorder. What ISO 11607 revisions mean to you (Part 2)Karen Sams
Article Summary Medical device manufacturers must take care up front with contractors and vendors to determine roles and responsibilities in the entire package development and validation process. Most of the changes to the Standard will have little effect on how you design your packaging and sterile barrier systems for your devices. However, there are some nuances that will require additional testing and some subtleties for performing a final package system validation as described in Clause 6. |
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