血液成份分離機 / COBE SPECTRA

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

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