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By Andrew Walsh, Thomas Altmann, Joshua Anthes, Ralph Basile, Alfredo Canhoto, Ph.D., et al. | The ASTM E55 Cleaning Team collaborated with F04 Medical Device Committee members to develop a science- and risk-based standard for cleaning process development, validation, and monitoring. They found the commonly used three-level criticality system inadequate and derived new, data-driven levels. This article discusses each level and how they can guide the selection of risk reduction and control measures. |
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| Delivering Market Success For Pharma Partners From Concept To Patient | Article | By Shari Krusniak and Patrick McLoughlin, West Pharmaceutical Services, Inc. | The development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies. |
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| Four OEM Benefits For RFID-Enabled Medical Devices | Article | By Nick Iandolo, HID | RFID technology has changed the ways in which OEMs fabricate, distribute, and market modern medical devices and provides medical facilities and their patients with real and measurable benefits. |
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