IQ Webinar: Challenges of Using Closed System Transfer Devices (CSTDs) with Biological Products
Challenges of Using Closed System Transfer Devices (CSTDs) with Biological Products
Thursday, 18 March
11:00 AM ET
Presented by the Closed System Transfer Devices (CSTD) Working Group of the IQ Biologics CMC Leadership Group
The intent of this public webinar is to discuss potential impact of CSTDs on drug product quality and to obtain stakeholder input on current clinical practices and CSTD performance variability.
Closed system transfer devices are supplemental engineering control measures that are used by pharmacists to mitigate potential exposure hazardous drugs. CSTDs are intended to mechanically prohibit the transfer of environmental contaminants to the drug product while also prevent the escape of potentially hazardous vapors to the environment. CSTDs are Class II medical devices subject to the 510(k) regulatory requirements. The development of USP ·800·, which references the NIOSH List of Hazardous Drugs, and increased concern about exposure to hazardous drugs has resulted in more widespread use of CSTDs. As a result, several compatibility concerns have come to the forefront, especially with respect to use of CSTDs with biological products. Furthermore, lack of clarity around the requirements of USP <797>, which governs sterile compounding, and USP <800> have resulted in confusion amongst many stakeholders about requirements and/or recommendations for using CSTDs. The purpose of this virtual panel discussion is to highlight the proposed changes to the NIOSH List of Hazardous Drugs, update stakeholders on the status of USP <797> and USP <800>, discuss concerns around compatibility of CSTDs with biological drugs, and address the interplay between these key aspects that impact how and when CSTDs are used.
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