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Author: Jennifer Gygi





September 16, 2019

Mass Extraction makes FDA Consensus List

The Mass Extraction test is a container closure integrity test (CCI) primarily used for detecting small leaks in rigid containers such as vials, syringes, and auto-injector drug delivery systems.  Mass Extraction is a deterministic test which is on the UPS...

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August 16, 2019

Building Distribution Test Plans In Accordance to ASTM D4169

Transportation and Distribution testing is required for all shipping containers used to transport medical devices. This is important as the shipping and distribution environment presents hazards (i.e. shock, vibration, compression, altitude, temperature, and humidity) that can be detrimental to the...

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October 28, 2014

ISO 16775: The Medical Device Packaging Professional’s Latest “Must Have”

If you are involved in the packaging of medical devices, your primary standards reference has probably been the International Organization for Standardization (ISO) 11607 publication for packaging design and validation. However, this standard was lacking much of the detail and...

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