Critical Quality Attributes - Validation of an Automated Glassware Washer and Depyrogenation Tunnel
Complimentary
Learning Level: Intermediate
Time: 1000 - 1100 ET
Session Length: 1 hour
Presented by Antonio Ortiz and Cecilia Pierobon, contributors to the Aseptic Processing Critical Quality Attributes blog series endorsed by the ISPE Sterile Product Processing Committee, this session continues the committee’s mission to deliver practical, science-based guidance for the qualification and validation of critical equipment and processes in sterile pharmaceutical manufacturing.
The blog series that inspired this webinar addresses essential topics such as the qualification of automated washers, autoclaves, glassware washers, and depyrogenation tunnels. These resources aim to strengthen industry knowledge and promote standardized, lifecycle-driven approaches to equipment and process validation.
Why Lifecycle Validation Matters
A lifecycle approach ensures systematic qualification by reinforcing process understanding during design and qualification phases and encouraging ongoing monitoring to maintain effectiveness and consistency.
What You’ll Learn in This Webinar
We’ll focus on two key processes that enable sterile manufacturing facilities to deliver glass vials meeting pre-determined critical quality attributes:
Validation of an Automated Glassware Washer
Learn the procedures and technologies that guarantee glassware is cleaned to the highest standards. We’ll review a science-based, standardized approach for equipment qualification (IQ/OQ) and process qualification (PQ) for automated glassware washers.
Validation of a Depyrogenation Tunnel
Discover how controlled heat treatment eliminates bacterial endotoxins, ensuring product sterility and quality. Gain insights into the lifecycle approach to validation, with emphasis on Process Design and Process Qualification, and receive practical recommendations for implementing a robust qualification strategy.
Learning Objectives
- Understand validation principles for glassware washers and depyrogenation tunnels, supported by current industry regulations, good manufacturing practices, and the speakers' experience in the pharmaceutical industry.
- To learn of the best practices for global compliance for qualification of the equipment and the process using automated glassware washers and depyrogenation tunnels using the lifecycle approach.
- Takeaway actionable insights for the validation process to employ in your own manufacturing facilities.
