November 18, 2021
Particulate testing is required for medical devices to ensure patient safety, but there isn’t a lot of guidance available for how to perform particulate testing or what limits are appropriate. Here are four important things you need to know about...
See BlogApril 22, 2021
It’s not over just yet. Eclipsed for the past year by COVID-19, medtech’s long-simmering ethylene oxide (EO) controversy could soon flare up (again) as the industry grapples with alternative sterilization methods for its products. The U.S. Environmental Protection Agency (EPA)...
See BlogSeptember 16, 2019
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...
See BlogAugust 16, 2019
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...
See BlogOctober 28, 2014
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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