Roland Koch
Gasporox
Referierende
Luigi Scaffidi
Boehringer Ingelheim Pharma
Jens Höllein
be integral
Christof Langer
OSConsulting
Highlights
- Pharmacopeial & GMP Requirements for CCI testing
- Overview CCI Testing Technologies
- Case Studies Boehringer Ingelheim
Zielgruppe
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.
Zielsetzung
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.
Programm
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.
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
Weitere Informationen
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.
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.
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.
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.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Robert Eicher (Operations Director), +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach (Organisation Manager), +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Dr Robert Eicher (Operations Director), +49 6221 84 44-12, eicher@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach (Organisation Manager), +49 6221 84 44-22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
Thu., 26 Nov. 2026, 09:00 - 17:15
Alle times mentioned are CET.
Alle times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Teilnehmerstimmen - das sagen andere über unsere Seminare:
