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FINIA®
Fill and Finish System
Overview How It Works Materials Specifications

Finally, Finia.

Finally. The wait for downstream fill/finish automation is over.

Introducing the Finia Fill and Finish System, the first device of its kind to automate final formulation and the fill and finish step.

No longer do your lab specialists have to manually aliquot, cool, mix and seal final product bags. Finia automatically completes these tasks within a functionally closed single-use disposable tubing set using a guided user interface.

Automate Fill/Finish

Cell therapy developers and researchers no longer have to rely on a manual method for their fill and finish step. Single-use, functionally closed disposable tubing sets are designed for use with diverse cell types. Add Finia to cell therapy development processes to:

  • Reduce contamination risks by maintaining a functionally closed environment
  • Reduce the variability that can occur with manual processing
  • Customize final product volumes
  • Maintain product viability
  • Help facilitate cGMP compliance
  • Complete final formulation in under an hour

Reduce Variability

Take human error out of the equation by using Finia to automatically complete the tasks of aliquoting, cooling, mixing and sealing final product bags using a functionally closed single-use disposable tubing set. This minimizes contamination risk, ensures proper workflow and helps reduce processing errors. Your operators or lab specialists are free to focus on other aspects of the process.



Support cGMP Compliance

In conjunction with the server-based cell processing application, Finia’s data management and reporting capabilities meet the processing requirements of current good manufacturing practices (cGMP).

  • Manage and track access with user authentication
  • Record data throughout the process and produce end-of-run reports
  • Monitor process run data
  • Enforce desired workflow and track chain of custody through barcoding and central configuration

Process Optimization

From various cell types to final formulations to dosage ranges, Finia provides you the flexibility to customize many aspects of your fill and finish step using a guided user interface.

  • Customize formulations and dosage ranges from the outset
  • Adjust parameters to best prepare cells for immediate or future use
  • Help maintain product viability and reduce risk of wasted runs/product

How It Works


Finia: The first of its kind in automated fill and finish

Finia is an automated system that formulates and aliquots fluids, including cell suspensions, to enable cryopreservation. It consists of a device, a handheld barcode scanner, a monitor with a touch screen and functionally closed single-use disposable tubing sets.



  1. Optical barcode reader
    Helps maintain process workflow and track the product chain of custody.
  2. Touch-screen user interface
    Guides the user to ensure proper workflow. Customizable settings allow for varying formulations and dosage ranges.
  3. Final product bags
    Can deliver up to three identical doses in under an hour.
  4. Quality control bag
    Provides visibility into your final product.
  5. Mixing and cooling assembly
    Automatically adjusts product temperature.
  6. System pumps
    Distribute your cell and media into the product bags.
  7. Sealing valves
    Seal the final product and QC bags.
  8. Single-use disposable tubing set
    Minimizes contamination risk with functionally closed design.

The Finia Process Flow

Finia pumps up to three types of material through a tubing set and cools them to a specified temperature. The materials are then mixed to create the final product. The final product is aliquoted into individual product bags and a QC bag, and the lines to the bags are sealed. The aliquots are then ready for immediate use, testing or cryopreservation.

Touch Screen

The operator follows the guided on-screen instructions to load the tubing set, enter processing data, customize parameters, connect the material to the tubing set, and perform and troubleshoot the procedure.

Cell Processing Application

The stand-alone, server-based cell processing application manages the device and the procedure data. Procedure data is automatically transmitted between the system and the application while the system is in operation. Operators use the application to:
  • Specify processing protocols
  • Configure materials and the device
  • Define users and assign permissions
  • Track tubing sets and materials
  • Record alarms
  • Generate procedure reports


Let us help you maintain your device compliance with our IQ/OQ services.
LEARN MORE

Materials


On-Demand Webinar:
Downstream Processing Challenges in Cell Therapy Manufacturing

Finia Fill and Finish System Brochure

Specifications


EQUIPMENT

Surface space required: 0.45 m2 (4.8 ft2)
Minimum clearance: 30 cm (11.8 in) around the perimeter of the device
Weight:
Device: 66.9 kg (147.5 lb)
Monitor 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)

TUBING SET

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

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

ENVIRONMENTAL (device)

Operating environment: Indoor use only
Ambient operating temperature: 15.5 °C to 21 °C (60 °F to 70 °F)
Ambient operating humidity: 20% to 65%
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 targer per m3 of air sample
Disinfection: Surface and components of the device can be disinfected
Restrictions: Device is not for use in an explosive atmosphere
Shipping temperature: -20 °C to 60 °C (-4 °F to 140 °F)
Shipping humidity: 8% to 80%
Elevation: Up to 2000 m
Ingress protection rating: Ordinary protection only
Pollution degree: 2

ENVIRONMENTAL (tubing sets)

Storage temperature:
Long-term storage range: 0 °C to 25 °C (32 °F to 77 °F)
Permitted excursions: -29 °C to 0 °C (-20 °F to 32 °F) for up to 72 hours
25 °C to 50 °C (77 °F to 122 °F) for up to 6 weeks
Storage humidity: 0% to 75%

ELECTRICAL

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)
Electrical power requirements: 100 V AC to 240 V AC, 50/60 Hz, 10 A maximum
Installation category: II
Ethernet port: Port is electrically isolated

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