This webinar will cover various container closure systems used for freeze-dried products including vials and stoppers, bulk drying trays, and pre-filled syringes. Various aspects of the types of materials used, the specialized coatings available, and the configuration of the different systems will be discussed in relation to the impact on the products and the lyophilization process.
This seminar will cover the various container closure systems that are available for use with liquids, lyophilized products (bulk and single use), suspensions, emulsions, and bulk powders. As formulations get more complex, due to the chemical and physical instability of many of the new biologically based molecules (monoclonal antibodies, vaccines, etc.), the container closure systems have to adapt as well. Understanding how the container closure system can affect product stability, and knowing what options are available from the different manufacturers, is critical in ensuring long term stability and closure system integrity. In addition to discussing various vial and stopper configurations, specialized systems, including prefilled syringes, will be discussed along with the different specialized coating options that are available for these systems.
Why Should you Attend:
Choosing the correct container closure system is vital in ensuring long term chemical and physical stability of injectable drug products. Additionally, ensuring that system integrity it maintained over the lifetime of the drug is critical in ensuring that microorganisms do not compromise the product, as this can result in patient illness or death. There are several companies that make the various components that comprise a container closure system for a drug product, and all components are not created equal, nor are they all compatible. Care must be taken in choosing the correct components to ensure that a proper seal is achieved, and to ensure that the products contained inside don’t have a negative interaction with the container closure system components (physical or chemical). In cases where an interaction is observed, highly specialized formulations and coatings are available. New technologies such as prefilled syringes (liquid and freeze-dried) are now also widely used due to their ease of use and compatibility with kitting operations.
This seminar will discuss the components that constitute a complete container closure system including the various vials and stoppers that are commercially available. The various components that make up each of these systems will be discussed along with a brief discussion on manufacturing processes. In those cases where a basic container closure system will not suffice, time will be dedicated to discussing the various specialized systems that are available including specialized formulation components and specialized surfaces and coatings. Time will also be dedicated to discuss specialized delivery systems such as prefilled syringes (both liquid and lyophilized), as these constitute a large part of the market of container closure and delivery systems. Finally, a discussion will cover the various systems and methods of preparing and storing lyophilized bulk drug substances or excipients.
Objectives of the Presentation:
To guide in the understanding and performance of:
Who can Benefit:
- Vial types/formulations
- Vial leachables and extractables
- Vials and specialized formulations and coating
- Stopper types/formulations
- Stopper leachables and extractables
- Stopper and specialized formulations and coating
- Prefilled syringes
- Tray drying and specialized trays
- Learning how to identify the different types of vials and stopper for specific needs
- Understanding what types of special formulations and coatings are available and when to consider these
- Choosing a pre-filled syringe and things to consider for long term stability
- Understanding tray drying and specialized containers for bulk freeze-drying
This webinar will provide valuable assistance to those companies involved in the packaging of liquids:
Recorded Session - How it works
- Lyophilized Products
- Solid Pharmaceutical Dosage Forms
- Dried Foods.
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