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On-Demand Webinars

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Radiation Sterilization of SVPP: RTU and fill/finished. Do not default to 25 kGy – 40 kGy

Examples will be presented for radiation sterilization of RTU SVPP as well as terminal sterilization of fill/finished items. A critical...

Extractables & Leachables Testing of Single-Use Systems for Production

Leachables in pharmaceutical products could originate from manufacturing items (filters, bioreactors, etc.) used in the production process. With the increasing...

Virucidal-Efficacy Testing for Submission to Regulatory Agencies

Virucidal-efficacy testing is a type of testing that is used to determine the effect of disinfectants or antiseptic products on...

Big Changes to ISO 10993-1: What Is Happening to the Main Biocompatibility Standard Now?

In 2018 TC194, which is the ISO committee for biocompatibility, released a new version of 10993-1. This new version focused...

Polymer-based, Pre-filled Syringes designed to Minimize the Aggregation Risk of Sensitive Biodrugs

Biopharmaceutical drugs offer new therapeutic solutions to numerous human diseases and conditions. However, with this comes the risk of efficacy...