Impact of Pharma Glass Extractables and Leachables on Drug Product Quality
Matt Hall, Ph.D., Technical Affairs Director
The composition of modern glass formulations considered generally suitable for parenteral packaging is restricted to a relatively small fraction of the periodic table. While the chemistry of pharma glass is relatively simple, there are still indirect and direct implications of glass extractables and leachables (E&L) for drug product safety, efficacy, and quality.
This webinar will discuss these indirect and direct mechanisms, including but not limited to: pH shift, chemically derived particulate, aggregation of API, chemical degradation of formulation components, and toxicology. These E&L implications will also be discussed within the context of modern pharma glass formulations and specific classes of drug products.
Corning Inc.
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US
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2015On CPHI since
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5000+Employees
Other Content from Corning Inc. (14)
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Brochure Corning Glass Tubing
Glass Composition & Chemical Resistance Classification, suited to supply high-quality clear and amber borosilicate glass tubing for pharmaceutical primary packaging -
Technical Data Corning® 33 Tubing
Chemical and Physical Characteristics for Corning® 33 Clear Borosilicate Glass Tubing -
Technical Data Corning® 51-A Tubing
Chemical and Physical Characteristics for Corning® 51-A Amber Borosilicate Glass Tubing -
Technical Data Corning® 51-C Tubing
Chemical and Physical Characteristics for Corning® 51-C Clear Borosilicate Glass Tubing with Cerium for Gamma Sterilization -
Technical Data Corning® 51-D Tubing
Chemical and Physical Characteristics for Corning® 51-D Clear Borosilicate Glass Tubing. Formulated for closed end ampoules upon request -
Technical Data Corning® 51-L Tubing
Chemical and Physical Characteristics for Corning® 51-L Amber Borosilicate Glass Tubing -
Technical Data Corning® 51-V Tubing
Chemical and Physical Characteristics for Corning® 51-V Clear Borosilicate Glass Tubing -
Webinar Sustainable Pharma: Advancing Climate Goals with Viridian® Vials
Jessica Buday, Product Line Manager, Velocity® and Viridian Vials
It’s been acknowledged that the pharmaceutical industry is a leading contributor to greenhouse gas emissions. In response, drug makers are setting aggressive sustainability goals and looking to suppliers to jointly combat this immediate and urgent problem. Achieving these targets will require several solutions, including improved approaches to pharmaceutical supply chain management. Primary packaging materials represent one area of opportunity for reducing emissions, where glass manufacturing is an energy intensive process and more than 100,000 tons of pharmaceutical glass packaging go to landfills each year.
This presentation will consider key stages in the life cycle of glass packaging, and the potential to reduce the environmental impact across the value chain. Strategies being employed by pharmaceutical glass suppliers to improve the sustainability of their products will also be reviewed, including Corn... -
Brochure Corning® Viridian® Vials
Viridian vials are a drop-in solution that can reduce manufacturing emissions by up to 30% and glass material waste by 20%, while enabling faster and safer fill-finish operations. An externally coated Type I borosilicate vial can improve quality and boost filling line efficiency, helping our customers increase production in an environmentally friendly package. -
Brochure Corning® Velocity® Vials
Made with Type I borosilicate glass and coated with Corning’s proprietary low coefficient of friction (COF) technology, Corning® Velocity® vials can improve overall equipment effectiveness (OEE) by increasing filling line efficiency and yield, helping to reduce manufacturing costs and accelerate the delivery of critical pharmaceutical products. -
Brochure Corning® Valor® Vials
Valor Glass Product Benefits: • Eliminates delamination • Reduces glass particulate generation • Resists damage and breakage • Prevents* cracks • Enables higher throughput through smoother filling line operations • Decreases total cost of ownership
*In laboratory testing, Valor Glass vials provided at least 30x protection against cracks than conventional borosilicate glass vials -
Brochure Corning® Velocity® RTU Vials
Corning® Velocity® RTU Vials with SG EZ-fill® Technology -
Brochure Corning® Borosilicate RTU Vials
Corning® Borosilicate RTU Vials with SG EZ-fill® Technology -
Brochure Corning® Valor® RTU Vials
Corning® Valor® RTU Vials with SG EZ-fill® Technology
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