The course will give an overview on how to develop a container closure system for parenteral products. Starting with setting up of a product profile of the final product container, all aspects will be covered like selection of materials, assessment of container closure systems, specification and documentation of components and entire systems. In addition, current hot topics such as glass delamination and container closure integrity testing will be discussed.
For all topics of the agenda presentations will be given. The participants are invited to add own experience, ask questions and offer issues to be discussed within the group and/or with the trainer. The intention is to work in an open workshop-like atmosphere.
Who should attend?
- Scientists in Drug Product Development
- Scientists/ Engineers in Packaging Development
- Regulatory Affairs Experts
- Set-up of a target product profile of a container closure system
- Select appropriate container closure materials, components, and systems
- Apply the appropriate regulations and standards to container closure systems for parenteral formulations
- Prepare a development plan of a container closure systems from the early development until market phase
- Specify container closure system regarding technical aspects and regulatory requirements
- Understand compendial requirements and quality as well as technical standards regarding container closure components and systems