Dr Martin Becker, Baxter Oncology
Roland Koch, Gasporox
Felix Krumbein, Head ECA Visual Inspection Group
Christof Langer, OSConsulting
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.
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:
- 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
- CCI testing of ampoules
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.
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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)
- Force Sensing Technology
- Capabilities and examples of the different Methods
- How to select the right method
- How to generate positive controls
Proposal for a 100% CCI Qualification Concept
- Regulatory requirements
- CCI Methods
- Composition and preparation of a qualification kit
- Execution and evaluation of the qualification
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
- 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