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Full-Text Articles in Engineering

Final Design Report For The Bioburden Pre-Cleaning Device And Dr. Mark Rasnake At The University Of Tennessee Medical Center, Katherine Elizabeth Stiles, Megan Pitz, Kayla Franklin, Simran Dayal, Austin Bullock May 2019

Final Design Report For The Bioburden Pre-Cleaning Device And Dr. Mark Rasnake At The University Of Tennessee Medical Center, Katherine Elizabeth Stiles, Megan Pitz, Kayla Franklin, Simran Dayal, Austin Bullock

Chancellor’s Honors Program Projects

No abstract provided.


Purity Testing Protocols For Silicone Tubing, Csilla Kollar, Lise Tan-Sien-Hee Sep 2018

Purity Testing Protocols For Silicone Tubing, Csilla Kollar, Lise Tan-Sien-Hee

Single-Use Technologies III: Scientific and Technological Advancements

Silicone tubing products are widely used in critical biopharmaceutical processes including final fill and other aseptic operations that require high purity product contact components.

At Dow we have developed reliable and rigorous methods based on the industry standards for particulates, endotoxins and bioburden to test our Platinum-catalyzed silicone tubing family. The tests were conducted per the USP ‹788› Particulate Matter in Injection, the USP ‹85› Bacterial Endotoxins Test, and the ISO 11737-1 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products.

  • Method 2 Microscopic Particle Count Test of USP ‹788› was …