- 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
Expectations of a GMP-Inspector regarding to Container/Closure Integrity Testing
- Regulatory documents on container / closure integrity testing (an overview)
- Testing methods for CCIT & validation strategies
- Current situation on CCIT in pharmaceutical industry & challenges
- Inspection findings & experience
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)
- Force Sensing Technology
- Capabilities and examples of the different methods
- How to select the right method
- How to generate positive controls
Case Study: 100% Testing of Vials
- System setup
- Validation
- Routine operation
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
Integrity Testing of Prefilled Syringes
- Sampling plan
- He-leak testing
- Limitations of the He-leakage test
- Cross validation with mCCI