FREE ONLINE WEBINAR: To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Attendance will be confirmed from the event's organizers.
DATE: June 23, 2022 | 3.00 PM - 4.00 PM CET
OFFICIAL LANGUAGE: English
ATTENDEES CAPACITY: 500 delegates
SUBMISSION LINK: https://attendee.gotowebinar.com/register/1591351089941711886
The event will be hosted within Go ToWebinar platform. Your registration request for this webinar will be submitted to the organizer for approval. You will receive information via email regarding your registration status.
Webinar Overview
An intact container closure system is the pre-requisite for a safe and sterile drug product. A critical step in understanding the biological safety and suitability of primary packaging is the ability to evaluate the potential of the container closure system to maintain a sterile barrier or to prevent leakage resulting in contamination or loss of the drug product. The container closure system protects the product from microbial contamination and also from exposure to gases or the loss of solvent. Container Closure integrity testing is a regulatory requirement and is performed during container closure system qualification, drug product manufacture, release, storage and shipment until the end of shelf life.
Different products and different container types require different testing methods. This webinar aims to give an overview of the different CCI testing systems by providing a systematic approach to applying these testing methods for CCI verification throughout drug product lifecycle. Strong of our expertise in the field, we will showcase valuable insights on how to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory requirements. Attendees can benefit by learning from real case-studies that will be highlighted during the event, to ensure the quality and protection of drug products.
Webinar Agenda
Introduction to CCIT
- CCI definition and regulation (USP 1207)
- CCIT definition and approaches
Probabilistic vs Deterministic approach
- Differences, advantages and drawbacks
- Deterministic and probabilistic test methods
CCI Test Methods in detail:
- CCIT along the product life cycle
- Tracer liquid (dye ingress)
- Microbial Ingress Test
- High Voltage Leak Detection
- Laser-based Gas Headspace Analysis
- Tracer gas detection (vacuum mode)
- Mass extraction
- Vacuum/Pressure decay
Method development and validation:
- The need for method validations
- Validation phases, key elements and parameters
Case studies
- Pressure decay for macromolecules
- Vacuum decay for larger volumes
Q&A
Your Expert
Tommaso Tancredi Alessandro Taroni
Project Leader at Eurofins BioPharma Products Testing divisione E&L and packaging testing.
