Selection of Single-Use Components

Learning Level: Basic

Implementation of Single-Use Systems (SUS) starts with an effective selection of Single-Use components. This webinar highlights criteria to select and qualify Single-Use components. It expands on topics introduced in the ISPE Good Practice Guide: Single-Use Technology that lead to improved design and utilization of Single-Use systems in production processes. Like the Good Practice Guide, this Webinar provides guidance on the elements of selection and evaluation of Single-Use systems or components. The evaluation emphasizes risk management methods to identify the Single-Use components that are best qualified to meet the requirements of your processes. It is likely that Single-Use products are already in use in your processes. If so, was the selection and implementation a smooth undertaking? Join us to learn techniques applied in case studies that can help in your work.

Learning Objectives

  1. Understand the sequential and interactive steps in the selection and implementation of Single-Use Components. 
  2. Use of tools in the ISPE Good Practice Guide: Single-Use Technology to determine the critical validation attributes for Single-Use components applied in biopharmaceutical processes. 
  3. Use risk management to align the attributes of Single-Use systems and components with User Requirements. 

ISPE Good Practice Guide: Single-Use Technology


Speakers

Pietro P. Perrone, PE
Automation Process Engineer
Cytiva, Formerly GE Healthcare Life Sciences
Christopher J. Smalley
Compounding Pharmacist Advisor
ValSource