West Pharmaceutical Services Presentation: New Containment Solutions for Automated Aseptic Filling for Gene Therapy
Thursday, May 30, 2024 01:15 PM - 01:30 PM
Exhibit Hall - Theatre A
Global Showcase Presentation
Presenters
Combined expertise of West Pharma in containment technology and Cytiva innovative filling systems bring together valuable partnership to advanced pharmaceutical fill finish applications.
West Pharma’s New Product- Nested vials in tub ( NVIT) presents the 2mL and the 10mL ISO-like Crystal Zenith (CZ) vials packaged in a nested format designed to meet exterior dimensions specified in ISO 8362-1 standard. NVIT product follows conventional Pre-Filled Syringe nest and tub packaging configurations for pharma processing operations.
Accordingly, the NVIT presents CZ vials in a packaging configuration designed for broad compatibility with the Cytiva SA25 and various fill/finish equipment available in the market. The nest material and vial nest tub design offer many advantages such as a rigid structure to protect the vials during transit and promote machinability, a flat top surface to maximize the landing area for fill/finish equipment's automated fixturing to handle and position the nested vials; and the bottom vial pockets to facilitate lifting and desired operations such as crimping etc. The tub is further sealed with a breathable lid and enclosed in a non-breathable inner bag that serve as sterile barriers, capable of being removed manually, or with automated debagging machine fixtures. The design of the Cytiva SA25 and Microcell aseptic filling workcells was contingent on the availability of nested/tubbed RTU containers – such as West’s nested CZ vials – and nested/tubbed RTU closures. When combining the design features of nested containers and closures with those of Cytiva’s workcells, aseptic filling can be performed with process improvements such as the elimination of all indirect product contact surfaces and the elimination of particle-generating components used by conveyance tooling (vibratory stopper bowls and tracks, closure placement tooling, etc.)
Additional benefits will be discussed in this presentation, including the automation of aseptic filling to remove the need for human intervention.
Session Objectives:
• How aseptic filling can be improved, both by working with vials optimized for advanced therapies and by automating the process.
• Crystal Zenith (CZ) vials offer a market approved, reliable and versatile solution for the unique demands of advanced pharmaceutical applications.
• West Pharma’s New product NVIT- presents CZ vials packaged in a nested format that adheres to ISO standards, compatible with fill/finish equipment, and a robust protective packaging to ensure the integrity and efficacy of gene therapy drug formulations.
- Brent Lieffers, Senior Director, Innovation Advocacy, Cytiva, Canada
- Jim Thompson, Director, R&D, West Pharmaceutical Services, United States
Combined expertise of West Pharma in containment technology and Cytiva innovative filling systems bring together valuable partnership to advanced pharmaceutical fill finish applications.
West Pharma’s New Product- Nested vials in tub ( NVIT) presents the 2mL and the 10mL ISO-like Crystal Zenith (CZ) vials packaged in a nested format designed to meet exterior dimensions specified in ISO 8362-1 standard. NVIT product follows conventional Pre-Filled Syringe nest and tub packaging configurations for pharma processing operations.
Accordingly, the NVIT presents CZ vials in a packaging configuration designed for broad compatibility with the Cytiva SA25 and various fill/finish equipment available in the market. The nest material and vial nest tub design offer many advantages such as a rigid structure to protect the vials during transit and promote machinability, a flat top surface to maximize the landing area for fill/finish equipment's automated fixturing to handle and position the nested vials; and the bottom vial pockets to facilitate lifting and desired operations such as crimping etc. The tub is further sealed with a breathable lid and enclosed in a non-breathable inner bag that serve as sterile barriers, capable of being removed manually, or with automated debagging machine fixtures. The design of the Cytiva SA25 and Microcell aseptic filling workcells was contingent on the availability of nested/tubbed RTU containers – such as West’s nested CZ vials – and nested/tubbed RTU closures. When combining the design features of nested containers and closures with those of Cytiva’s workcells, aseptic filling can be performed with process improvements such as the elimination of all indirect product contact surfaces and the elimination of particle-generating components used by conveyance tooling (vibratory stopper bowls and tracks, closure placement tooling, etc.)
Additional benefits will be discussed in this presentation, including the automation of aseptic filling to remove the need for human intervention.
Session Objectives:
• How aseptic filling can be improved, both by working with vials optimized for advanced therapies and by automating the process.
• Crystal Zenith (CZ) vials offer a market approved, reliable and versatile solution for the unique demands of advanced pharmaceutical applications.
• West Pharma’s New product NVIT- presents CZ vials packaged in a nested format that adheres to ISO standards, compatible with fill/finish equipment, and a robust protective packaging to ensure the integrity and efficacy of gene therapy drug formulations.
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