- Datum:
-
- Seminar
Container-/Closure-Integrity Testing - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
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
100% inline CCI Testing of Ampoules
- High Voltage inline testing: method description
- Integration in the production process
- Limits of the System
- Qualification of the System
- Validation
- Routine Operation
Residual Seal Force (RSF) & Headspace (HAS) Testing of Vials
- Setup of the testing System
- Usage of HAS in product Validation
- Statistical control by sampling RSF
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
