Container-/Closure-Integrity Testing - Live Online Training
Thursday, 26 November 2026
Course No. 22712
Speakers
Roland Koch
Gasporox
Luigi Scaffidi
Boehringer Ingelheim Pharma
Christof Langer
OSConsulting
Highlights
- Pharmacopeial & GMP Requirements for CCI testing
- Overview CCI Testing Technologies
- Case Studies Boehringer Ingelheim
Target Group
This conference is directed at specialists and executives from the areas engineering and production and QA dealing with the implementation and operation of systems for the container/closure-integrity testing of sterile medicinal products.
Objectives
Ensuring an intact container closure system is essential for maintaining the sterility and quality of injectable drug products. As regulatory expectations evolve, CCI testing has moved from early development studies toward routine batch verification and, increasingly, toward 100% inline or offline control.
This seminar provides a clear overview of current CCI technologies, their technical principles, and their application to different product and container types. Participants will gain an understanding of global GMP and compendial requirements (EU, US), Annex 1 expectations, and how to define and justify a robust CCI control strategy. Practical examples for vials and ampoules, as well as the advantages and limitations of various test systems, round off the program.
The course equips attendees with the knowledge needed to select appropriate CCI methods, meet regulatory expectations, and implement effective testing strategies in development, production, and quality Control.
Programme
Container Closure Integrity Testing of Sterile Drug Products – Requirements, Expectations and Exaggerations
Container Closure Integrity during Development, Qualification and Stability Testing
Regulatory, Pharmacopoeial and GMP requirements
System integrity versus container damages
Patient risks – do we need batch by batch testing?
Industrial best practices
Overview of Container/Closure Integrity Testing Technologies The presentation gives a complete overview of the different aspects of leak testing to do CCIT in the pharmaceutical production. The systems presented can be used for the CCIT of Vials, Ampoules, Syringes, BFS, IV Bags, Blisters etc.
Leak, Leak rate and the relevant physical units
Leak Test Methods
Pressure change methods (vacuum, pressure and LFC)
Head Space Analysis using TDLAS
Helium Leak Test and other Mass Spectroscopy Systems
High Voltage Leak Detection (HVLD) – 100% testing of ampoules
Force Sensing Technology
Capabilities and examples of the different Methods
How to select the right method
How to generate positive controls
Leak Testing: Concept and Implementation at Boehringer Ingelheim
Overall CCIT concept at the Ingelheim site
Standard leak: production, areas of application
Differentiation between the basic test methods (probabilistic vs. deterministic; inline vs. offline, etc.)
Tests at the Ingelheim site (from bubble test to microbiological tests to headspace analysis)
Qualification strategy for vacuum decay testing
CCI testing of Vials: Temporary Defects
Impact on stability & sterility
Detection of hidden defects
Holistic approach
How to avoid CCI issues
Further Information
Technical Requirements Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT) ECA Members € 1.090 APIC Members € 1.190 Non-ECA Members € 1.290 EU GMP Inspectorates € 645 The conference fee is payable in advance upon receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
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