OnlineCompliancePanel
Container – Closure Systems for Lyophilized Products
Instructor:

Product ID:
500061

Training Options
Duration: 60 Minutes
$288.00 Recorded Session
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Description:
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:
  • 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
Who can Benefit:
This webinar will provide valuable assistance to those companies involved in the packaging of liquids:
  • Suspension
  • Emulsions
  • Powders
  • Lyophilized Products
  • Solid Pharmaceutical Dosage Forms
  • Dried Foods.
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Instructor Profile:
Jeff Schwegman, Ph.D. is currently the founder and chief executive officer of AB BioTechnologies (www.ab-biotech.com) where he develops formulations, lyophilization cycles, determines residual moisture by Karl Fischer, and provides thermal characterization studies including freeze-dry microscopy and DSC. Additionally, Dr. Schwegman specializes in speaking and consulting in parenteral pre-formulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules. He also holds patents and develops new technologies within the lyophilization field. Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington Indiana, where he gained experience in analytical, formulation and process development. In 1999 he began graduate study in the Department of Industrial and Physical Pharmacy at Purdue University under the direction of Dr. Steve Nail, where his focus of research involved studying changes in the physical structure of biological molecules during lyophilization.

Dr. Schwegman received his PhD from Purdue University in 2003, and returned to Bloomington where he worked at Baxter Pharmaceutical Solutions as a Research Scientist in the Pharmaceutical Development group. In November 2005, he left Baxter and formed BioConvergence LLC with 3 other founders which specialized in developing new formulations and manufacturing processes for parenteral products. In February 2008, he left BioConvergence, which has become a successful company, to form AB BioTechnologies. He is currently the course Director for a 3-day course called Lyophilization Technology which he teaches through the Center for Professional Innovation and Education. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products.