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FINIA®

FINIA®

FINIA®

Product catalog summary
Overview: The FINIA® Fill and Finish System is designed to automate the final formulation process for cell and gene therapies, replacing manual methods. It uses functionally closed, single-use disposable tubing sets suitable for various cell types.
Key Features:
  • Maintains a functionally closed environment to facilitate GMP compliance and reduce variability.
  • Ensures reproducible and accurate results, maintaining product temperature within 3 ˚C of the target.
  • Provides summary reports with planned and actual volumes, process alarms, and user-defined tolerance thresholds for volume, material contact time, and temperature.
  • Uses gamma-sterilized tubing sets and automatically seals final product and QC bags to maintain sterility.
  • Maintains cell viability above 95% and uniformity of cell concentrations within 5% for all bags.
  • Accurately fills bags within 2 mL of the target and removes air to less than 2 mL per bag.
System Volume Specifications:
  • Volume accuracy: ± 2 mL of target volume.
  • Product volume range: 20 mL to 174 mL.
  • Material volume: Product volume plus 6 mL residual volume.
Tubing Set Specifications:
  • Finia 50 Tubing Set: QC bag: 10-40 mL; Product bags: 10-28 mL.
  • Finia 250 Tubing Set: QC bag: 10-40 mL; Product bags: 29-70 mL.
Equipment Specifications:
  • Surface space: 0.45 m²; Minimum clearance: 30 cm around device.
  • Device weight: 66.9 kg; Monitor weight: 4.4 kg.
  • Dimensions: Height 78.5 cm, Width 88.9 cm, Depth 49.8 cm.
Environmental Specifications:
  • Particle emission: < 44,000 particles (0.5 microns or larger) per m³; < 366 particles (5 microns or larger) per m³.
Electrical Specifications:
  • Safety certifications: IEC 61010-1, EN 61326-1.
  • Power requirements: 100-240 V AC, 50/60 Hz, 10 A max.
  • Installation category: II; Ethernet port is electrically isolated.
Company Information: Terumo Blood and Cell Technologies is a medical technology company focused on blood and cell collection and preparation to treat diseases. For more information, visit TerumoBCT.com/Finia.
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Catalog excerpts

FINIA® -1

RUMO BLOOD AND CELL TECHNOLOGIES Automating your final formulation for cell and gene therapies You no longer have to rely on a manual method for your fill and finish step. The functionally closed, single-use Finia disposable tubing sets are designed for use with diverse cell types. Now you can: ■ Maintain a functionally closed environment ■ Reduce the variability that occurs with manual processing ■ Ensure reproducible and accurate final results ■ Maintain final product temperature to within 3 °C of the user-defined target ■ Provides a summary report with planned and actual volumes for all material and product bags and any process alarms or flags, including user-defined tolerance thresholds for: ■ Material contact time ■ Temperature Uses a gamma-sterilized, functionally closed tubing set Automatically seals the final product and QC bags to help maintain sterility Maintains cell viability of greater than 95% of the inlet cell viability Maintains uniformity of cell concentrations to within 5% for all product bags and the QC bag Accurately fills product and QC bags within 2 mL of the user-defined target Removes air to less than 2 mL per final product bag ■ Volume accuracy ± 2 mL of the target volume ■ Product volume range: 20 mL to 174 mL ■ Material volume: Product volume plus 6 mL residual volume GMP: Good Manufacturing Practices; QC:

 Open the catalog to page 1
FINIA® -2

Electrical Specifications Safety certifications: ■ IEC 61010-1 (Safety requirements for electrical equipment for measurement, control and laboratory use) ■ EN 61326-1 (Electromagnetic compatibility of electrical equipment for measurement, control and laboratory use) Equipment Specifications ■ Surface space required: 0.45 m2 (4.8 ft2) ■ Minimum clearance: 30 cm (11.8 in) around Electrical power requirements: 100 V AC to 240 V AC, Ethernet port: Port is electrically isolated Particle emission: ■ Fewer than 44,000 particles that measure 0.5 microns or larger per m3 of air sample ■ Fewer than 366...

 Open the catalog to page 2

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.