Roland Koch
Gasporox
Referent:innen
Christof Langer
OSConsulting
Jens Höllein
be integral
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
Different products and different container types require different testing methods: this event aims at giving an overview of the different CCI testing systems which are applied during production and as part of the quality control system. Apart from technical aspects the regulatory requirements on CCI testing will be highlighted as well as the applicability of inline and offline testing.
Background
An intact container closure system, which is the sum of packaging components that protect the dosage form, is the pre-requisite for a safe and sterile drug product. The CC system protects the product from microbial contamination and also from exposure to gases or water vapour or the loss of solvent. Container Closure integrity testing is therefore a regulatory requirement and it is part of the whole life cycle of a sterile drug product.
Initially this testing was performed as part of the initial Development of the packaging system and the system’s suitability verified in stability studies including on-going stability. Over the years, the expectation was raised to perform batch by Batch verification with latest trends to 100% inline or offline testing wherever possible.
We will discuss and answer questions like:
We will discuss and answer questions like:
- What are the current and upcoming GMP- and compendial requirements in the US / EU / RoW?
- Will container closure integrity testing change to 100% inline testing?
- What does the Annex 1 require?
- How do we have to define ’tight’?
- How to set up and defend a CCI control strategy
- Which testing technologies are available and suitable?
- CCI testing of vials
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)
- 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
Hidden Defects in CCIT and their effects on Stability and Sterility
- The formation of defects that affect stability
- Detection of hidden defects
- Clogging
- FDA & CCIT in Lieu of Sterility
- Hidden defects with possible effect on sterility
Residual Seal Force (RSF) & Headspace (HSA) Testing of Vials
- Setup of the testing System
- Usage of HAS in product Validation
- Statistical control by sampling RSF
Weitere Informationen
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily Display.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily Display.
Timing and Duration
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Contacts
Questions regarding content:
Dr Robert Eicher (Operations Director), +49 6221 84 44 12, eicher@concept-heidelberg.de
Questions regarding organisation:
Ms Julia Grimmer (Organisation Manager), +49 62 21 84 44 44, julia.grimmer@concept-heidelberg.de
Dr Robert Eicher (Operations Director), +49 6221 84 44 12, eicher@concept-heidelberg.de
Questions regarding organisation:
Ms Julia Grimmer (Organisation Manager), +49 62 21 84 44 44, julia.grimmer@concept-heidelberg.de
Recording from 27/28 November 2025
Duration of Recording: 4 h 50 min
Teilnahmegebühr
| ECA-Member*: | € 1190,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1240,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager"
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E-Mail: info@concept-heidelberg.de
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