CryoVault^® Bench Top Freezer

The CryoVault® Bench Top Freezer is a small-scale freeze and thaw system designed to complement the CryoVault® platform’s production-scale CV96 and CV300 systems. It supports process and product development by replicating representative freeze and thaw dynamics in small-volume stability containers (40 mL and 120 mL), requiring less footprint and process fluids. It features recipe-driven controls, live-test data logging, and can cool to -60°C and heat up to 40°C.

The CryoVault® Bench Top Freezer is used for small-scale freeze and thaw applications that support process and product development within the CryoVault® platform. It enables representative freeze/thaw solutions for stability testing and process development by mimicking the freeze path length and dynamics of production-scale containers, facilitating testing of biologics in small-volume stability containers (40 mL and 120 mL).

The CryoVault® Bench Top Freezer accommodates up to 10 CryoVault® stability containers of either 40 mL or 120 mL volume. It has physical dimensions of 15″ W x 18.8″ D x 12.9″ H (381 x 476 x 327 mm) for the heat exchanger and 16.73″ W x 15.75″ D x 28.35″ H (425 x 400 x 720 mm) for the temperature control unit. The system can cool containers down to -60°C and heat up to 40°C, weighing 95 kg and 28 kg respectively for the units.

The CryoVault® Bench Top Freezer uniquely replicates representative freeze and thaw dynamics of production-scale CryoVault® containers in a small footprint using 40 mL and 120 mL stability containers. It maintains the same freeze path length as larger systems, supports recipe-driven controls with pre-loaded at-scale water study recipes, and facilitates 21 CFR Part 11 compliance with tiered user access and Active Directory integration. It also features live-test data logging and auto-generated PDF reports.

The CryoVault® Bench Top Freezer integrates with the CryoVault® platform by supporting small-volume 40 mL and 120 mL stability containers, enabling freeze/thaw profiles that match production-scale CV96 and CV300 systems. It uses USB-powered heat exchangers and interfaces with Windows 10 PCs running dedicated software for recipe control, data logging, and report generation. The system supports Active Directory integration for user management, facilitating compliance and seamless workflow integration.

Yes, the CryoVault® Bench Top Freezer facilitates compliance with 21 CFR Part 11 regulations by providing recipe-driven controls, tiered user access with Active Directory integration, and secure data management including live-test data stored to CSV files and auto-generated PDF test reports. These features support regulated environments requiring traceability and data integrity in biopharmaceutical freeze/thaw process development.

The CryoVault® platform offers modular components that can be tailored to specific process needs. Meissner Filtration Products collaborates with customers to recommend the best configuration for their processes, including options for heat exchangers, temperature control units, and compatible CryoVault® stability containers (40 mL and 120 mL). This modularity allows customization of the Bench Top Freezer system to fit various freeze/thaw applications.

Commonly used products with the CryoVault® Bench Top Freezer include downstream filling and assembly solutions such as AccuFill™ Aseptic Filling Systems, Single-Use Filling Assemblies, and Single-Use Filling Needles. Upstream integration can involve the SGT (Single-Use Gauge Tee), while downstream capsule filling uses the Capsule Filling Bell.