How pinholes affect packaging
Dec 20, 2015
DuPont Tyvek's research associate Earl Hackett explains how a 25-µm hole affects sterile porous medical packages. Earl T. Hackettresearch associateDuPont TyvekWhenever engineers locate defects in medical device packages, they must go back and...
Validating test methods
Dec 20, 2015
ISO 11607, TIR 22, and ASTM all help manufacturers understand their package testing responsibilities. Any medical device package test that is used to support conformance with ANSI/AAMI/ISO 11607, Packaging for Terminally Sterilized Medical Devices...
Taking testing to the next level
Dec 20, 2015
More and more, the practice of nondestructive testing continues to lure cost-conscious manufacturers.By John ConroyNondestructive testing continues to be the Holy Grail for medical device and pharmaceutical manufacturers facing cost pressures and...
Regulatory focus: Measuring porous microbial barriers: Part II
Dec 20, 2015
The work behind ASTM International Standard Test Method F2638.By Paul F. Herman and Curtis Larsen,CPP, Fellow Editor’s Note: Longer, more-complete versions of Part I and Part II are being published in PMP News’s sister publication, MD&DI. To read...
Regulatory focus: Measuring porous microbial barriers: Part I
Dec 20, 2015
The work behind ASTM International Standard Test Method F2638.By Paul F. Herman and Curtis L. Larsen, CPP, FellowEditor’s Note: Longer, more complete versions of Part I and Part II are being published in PMP News’s sister publication, MD&DI. To...
Testing gets physical
Dec 20, 2015
FDA officially accepts physical integrity testing in lieu of microbial-challenge testing for whole packagesTesting the ability of a package to maintain product sterility has often been a dirty job. Literally. Engineers have stuck a whole package...
Package performance testing conundrum: Solved!
Dec 18, 2015
Risk to product efficacy will dictate choices in shipping simulation testing.The purpose of a distribution or transportation simulation test is to evaluate the performance of the complete packaging system. However, such testing is a conditioning...
Exposing the myths of tensile seal strength testing
Dec 17, 2015
The controversies regarding tensile seal strength tests need to be resolved.There is a major debate regarding the best way to perform tensile testing, inviting reaction from both packaging material suppliers and end-users. Everyone embraces the...
Inspecting heat seals on the form-fill-seal line
Dec 17, 2015
Non-destructive thermal imaging has transformed induction-seal analysis over the last year, and now the technology may be an option for heat-seal analysis, too.The Induction Integrity Verification System (I2VS) from DIR Technologies (which stands...
Stick with physical integrity tests
Dec 15, 2015
HealthPack hosted one of its largest--if not the largest--audiences ever last week in Albuquerque. While several speakers presented late-breaking updates on medical device packaging, such as the new TEQethylene HDPE blend from TEQ for...
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