Testing

Phillips-Medisize Honored as Finalist in the Medical Design Excellence Awards for Cologuard

Phillips-Medisize Corporation announced Tuesday that Cologuard has been selected as a finalist in the “diagnostic products and systems category” of the 18th annual Medical Design Excellence Awards (MDEA) competition. Finalists were officially announced in the May issue of Medical Device and Diagnostic Industry (MD+DI) magazine.

Learn about Changes to USP Packaging Chapters at Pharmapack North America

Several packaging chapters within the U.S. Pharmacopeia—including some mandatory ones—are now being revised and updated, which could significantly influence pharmaceutical packaging development and specifications (tests, methods, and acceptance criteria) of packaging components. These changes will be covered at the upcoming conference at Pharmapack North America on June 9 in New York City.

Automating Water-Vapor Transmission Rate Testing

MOCON Inc. (www.mocon.com) has introduced the PERMATRAN-W Model 3/34 G, a fully automated water vapor transmission rate (WVTR) testing system for packaging and other barrier structures.

Accelerated Ageing for Medical Device Packs: What Temperature?

The shelf life of terminally sterilised medical devices should be validated using both accelerated and real-time ageing, according to ISO 11607. As we've discussed before on this site, the Arrhenius equation is used to determine the rate of accelerated ageing. The version of this equation given in ASTM F1980 uses a Q10 factor of 2. This is saying that the rate of a chemical reaction is doubled for every 10°C increase in temperature. This increase in the rate of chemical reaction is accelerating the ageing.

New Dye Penetration Test Recently Published

A new test method for detecting channel leaks, ASTM F3039 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration, was approved at the last F02 meeting in Jacksonville, FL, and is now available from ASTM's Web site. The method is applicable for clear or opaque pouches made from materials such as film and foil. It could also be used with opaque blisters and cups with the same sensitivity, but they were not part of the initial scope.

Accelerated Ageing? Do My Test Packs Need to be Populated with Product?

Often during product development a device manufacturer will want commence packaging ageing studies before abundant quantities of product becomes available. After all to obtain five years Real Time Equivalence of Accelerated Ageing requires around 30 weeks in an environmental chamber. That is before testing even starts.

Preventing Packaging Failures Using FMEA

In Part 1, I introduced the FMEA methodology as a tool to prevent failures or defects in packages and reduce the risk of losing a customer or negatively impacting patients. It can be especially useful when “evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process” (source: Institute for Healthcare improvement University of Chicago).

Validating a Package/Seal Integrity Test Method

EN/ISO 11607-1 states that you should validate all test methods. Have you ever wondered just how do you validate a test method that is pass/fail?

ASTM Approves New Inspection System for Test Method F3004-13

PTI USA has been at work for several years to develop a more accurate and non-destructive method of evaluating the seal quality and integrity of pouches and flexible packaging. The result is their patented Seal-Scan technology. It utilizes non-contact airborne ultrasonic technology for seal integrity testing and seal quality analysis of pouches and flexible packaging.

Product Recall Due to Faulty Medical Device Packaging

The rapidly growing medical device market is creating fierce competition among MDMs. To be ahead in this race, it is important that time to market is less and MDMs stretch the limits of possibilities in this effort. Many times, this hurried approach may cause design flaws and may result in medical device recalls, which are real nightmares to the MDMs. Failure in the medical device packaging is also contributing to the product recalls.

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