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FINIA® Fill and Finish System

產品品牌 / Brand:

 

Terumo BCT

 

產品類型 / Product Type:

 

Automating final formulation for cell and gene therapies

產品應用 / Application:

 

formulation for cell and gene therapies

相關網站 / Link:

 

https://www.terumobct.com/location/asia-pacific/products-and-services/Pages/cobe-spectra-apheresis-system.aspx

 

規格說明 / Specification:

 

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

  • Facilitate GMP compliance

  • 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

 

The Finia Fill and Finish System 1 :

 

  • 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: Volume

  • Material contact time

  • Temperature

  • Utilizes 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 either 10% or 2 mL (whichever is greater) of the user-
    defined target

  • Removes air to less than 2 mL per final product bag

 

System Volume Specifications

  • Volume accuracy: ± 2 mL or ± 10% of the target volume, whichever is greater

  • Product volume range: 20 mL to 174 mL

  • Material volume: Product volume plus 6 mL residual volume

 

Tubing Set Specifications

Finia 50 Tubing Set:

  • Quality control bag: 10 mL to 40 mL

  • Product bag 1: 10 mL to 28 mL

  • Product bag 2: 0 or 10 mL to 28 mL

  • Product bag 3: 0 or 10 mL to 28 mL

Finia 250 Tubing Set:

  • Quality control bag: 10 mL to 40 mL

  • Product bag 1: 29 mL to 70 mL

  • Product bag 2: 0 or 29 mL to 70 mL

  • Product bag 3: 0 or 29 mL to 70 mL

Equipment Specifications

  • Surface space required: 0.45 m2 (4.8 ft2)

  • Minimum clearance: 30 cm (11.8 in) around the perimeter of the device

  • Device weight: 66.9 kg (147.5 lb)

  • Monitor weight: 4.4 kg (9.7 lb)

  • Height: 78.5 cm (30.9 in)

  • Width: 88.9 cm (35.0 in)

  • Depth: 49.8 cm (19.6 in)

Environmental Specifications (Device)

Particle emission:

  • Fewer than 44,000 particles that measure 0.5 microns or larger per m3 of air sample

  • Fewer than 366 particles that measure 5 microns or larger per m3 of air sample