Aseptic filling - fully automatic systems

Cellefill™

Overview

Vial filling machine and containment solution to fast track your cell, gene and biological therapies.

CellefillTM is a turnkey, small batch, vial filling machine with an integrated containment solution. This system has been designed by aseptic fill/finish experts Flexicon Liquid Filling and containment experts Franz Ziel.

As a fully integrated solution for the biopharmaceutical industry, Cellefill maximises production capabilities through recipe driven operation and delivers enhanced levels of process assurance to accelerate your time to market.

Cellefill optimises your batch security with highly accurate peristaltic pump performance and integrated environmental monitoring.

Our vial filling machines with integrated containment solutions maximise production of advanced therapy medicinal products (ATMPs) including cell and gene therapies (CGT), small batch pharmaceuticals and biologics.

Features and benefits

  • Fast track your cell and gene and biological therapies and futureproof for GMP compliance
  • Maximise production efficiency with recipe driven, remote set-up and no format parts for the entire vial range
  • Highly accurate, precision filling from micro volumes to 50 ml with better than ±1 % achievable at most volumes
  • Fully integrated environmental monitoring system in strategically risk-assessed locations
  • Reduced risk of batch loss with flexible in-process controls including 100% weight check with zero waste start-up
  • Integrated aseptic vial filling and containment solution reduces risk and cost
  • Expert guidance and support throughout your project, from initial enquiry through to installation, to after sales support and validation package expertise, we are your project partner every step of the way.

Technical summary

Accuracyachievable at most volumes ±1.0 %
Capacity1500 units/hour
StoppersISO standard or Lyo, 13 mm and 20 mm 
Cap diameter rangeISO standard or flip-top, 13 mm or 20 mm
Infeed and outfeed traysVial RTU compatible with SG EZ-Fill® and SCHOTT adaptiQ® trays 

Technical Summary table lists features available within the range. See ‘Specifications’ tab for model specific information.

Specifications

Technical specifications

Cellefill oRABCellefill iASPCellefill iBIO
Accuracyachievable at most volumes ±1.0 %achievable at most volumes ±1.0 %achievable at most volumes ±1.0 %
ApplicationSterile product protection of sensitive biologics, antibodies, cell protein or nucleic acid-based products Sterile product protection of sensitive biologics, antibodies, cell protein or nucleic acid-based products Hazardous biologics, individualised or live products requiring highest levels of cross contamination control or BSL2 containment. 
Barrier TechnologyOpen Restricted Access Barrier Double Wall Aseptic Isolator Double Wall Aseptic Isolator 
Batch Size10 - 10,000 vials per batch 10 - 10,000 vials per batch 10 - 10,000 vials per batch 
Capacity1500 units/hour1500 units/hour1500 units/hour
Cap diameter rangeISO standard or flip-top, 13 mm or 20 mmISO standard or flip-top, 13 mm or 20 mmISO standard or flip-top, 13 mm or 20 mm
Cleanroom ClassGrade B / ISO 7 cleanroom Grade C / ISO 8 cleanroom Grade C / ISO 8 cleanroom 
Filling Line TypeAseptic process filling line with manual disinfection Aseptic process filling line with automated VHP bio-decontamination Aseptic-containment process filling line. Automated VHP bio-decontamination providing protection of sterile products with aerosol containment features and optional post-production VHP cycle for inactivation of live product/biologic residues. 
Filling volume range Limited only by RTU vial size, filling volume range is from micro-volumes to 50 mlLimited only by RTU vial size, filling volume range is from micro-volumes to 50 mlLimited only by RTU vial size, filling volume range is from micro-volumes to 50 ml
Infeed and outfeed traysVial RTU compatible with SG EZ-Fill® and SCHOTT adaptiQ® trays Vial RTU compatible with SG EZ-Fill® and SCHOTT adaptiQ® trays Vial RTU compatible with SG EZ-Fill® and SCHOTT adaptiQ® trays 
Port typeCastus® alpha RTP 190 iCON, Sartorius Biosafe® 110 Monolever Castus® alpha RTP 190 iCON, Sartorius Biosafe® 110 Monolever Castus® alpha RTP 190 iCON, Sartorius Biosafe® 110 Monolever 
Power supply230/400 V 3 ph, 50 Hz 230/400 V 3 ph, 50 Hz 230/400 V 3 ph, 50 Hz 
StoppersISO standard or Lyo, 13 mm and 20 mm ISO standard or Lyo, 13 mm and 20 mm ISO standard or Lyo, 13 mm and 20 mm 
ValidationTurnkey Validation FAT, SAT IQOQ Turnkey Validation FAT, SAT IQOQ, PQ support for Isolator Turnkey Validation FAT, SAT IQOQ, PQ support for Isolator 
Vial SizeISO 2R - 50R ISO 2R - 50R ISO 2R - 50R 
Weigh Check20-100 % 20-100 % 20-100 % 
Throughput capacity up to 1500 vials/hour (based on batch size of 1000 vials/hour and dependent on customer configuration).
NTT process for de-bagging inner bag (oRAB model) or both inner/out bags (iASP/iBIO versions) 
Environmental monitoring: Integrated viable and non-viable, active and passive
Glove testers: optional accessory for all models
Automated hygrometer control system: Optional on iASP and iBIO models

Cellefill oRAB dimensions

Description oRAB
Minimum required operational space 2000 mm
Footprint LOA 4330 mm
Footprint WOA 1800 mm
Height Overall 2760 mm

Cellefill iASP dimensions

Description iASP
Minimum required operational space 2000 mm
Footprint LOA 4470 mm
Footprint WOA 2400 mm
Assumed Height of Cleanroom 2737 mm
Height Above Cleanroom 2302 mm
Height Overall 5039 mm

Cellefill iBIO dimensions

Description iBIO
Minimum required operational space 2000 mm
Footprint LOA 5324 mm
Footprint WOA 2558 mm
Assumed Height of Cleanroom 2737 mm
Height Above Cleanroom 2897 mm
Height Overall 5634 mm

Advanced features

Cellefill provides confidence in scale-up and repeatability of your operation by combining the benefits of the FPC60 filling machine with an integrated Franz Ziel containment solution and a No Touch Transfer (NTT) debagging system.

With quick reference icons and provision of key guidance throughout the process, the advanced Cellefill interface is designed for an uncomplicated user experience, without compromise.

Facilitating remote set-up for filling, the data management system is fully accessible from any web device with access to:
· Real-time supervisory oversight
· Batch data retrieval
· Recipe creation

Designed for future regulatory requirement, Cellefill is compliant with EU and US GMP requirements including:
· 21 CFR part 11
· EudraLex Vol 4

With a centralised critical warning alert system, unified airflow studies, and strategically placed environmental monitoring probes and settle plates, Cellefill’s integrated design facilitates streamline validation and qualification improving your speed to market.

No-Touch-Transfer (NTT) is a GMP compliant process for debagging Ready-to-Use (RTU) vials, enabling loading of vials into the aseptic core while maintaining sterile integrity. Compatible with Schott adaptiQ® and SG EZ-fill® trays.

 

 

Flexible Modular Design

Module name Module description
No Touch Transfer
No Touch Transfer icon
No-Touch-Transfer (NTT) is a GMP compliant process for debagging Ready-to-Use (RTU) vials, enabling loading of vials into asepctic core while maintaining sterile integrity

There is an NTT process for de-bagging inner bags (oRAB model) or both inner/outer bags (iASP/iBIO models)
Infeed
Infeed icon
Tray turner for easy removal of vials from tray

A buffering turntable aligns the vials and moves them to the starting position of the walking beam
Filling
Filling icon
Peristaltic pump solutions with easy operation and high accuracy

Bottom up filling where filling nozzle raises along with fluid surface

Vial position sensors, prevents mis-filling and contamination of the filling environment

Up to 100 % in-line check weigh with zero waste start-up and in-batch dynamic calibration

Gloveless operation in the aseptic core
Stoppering
Stopper icon
Format parts: Chutes, jaws and pistons

The universal vibrator bowl accommodates both ISO standard 13 mm and 20 mm injection and lyophilisation stoppers
Capping
Capping icon
Choice of crimp capping or roller closure, both with force closure measurement

The Universal bowl accommodates both ISO standard 13 mm and 20 mm 'flip-top' and plain caps

Format parts: Chutes and crimping heads.

Rapid Transfer Ports and chutes for sterile transfer of stoppers and caps into the critical area
Reject
Reject icon
Automatic reject station transfers out of tolerance vials from the vial track down to the reject tray, based upon information relayed from any of the modules

Collection of vials to be sampled intra-batch
Outfeed
Outfeed icon
Vials collected in trays or loaded robotically into baskets (iBIO version only)

Finished vials can be removed without pausing production

Options for Rapid Decontamination Station (RDS) for closed container surface decontamination (iBIO version only)
Outfeed icon Strategically located environmental monitoring for critical risk assessment combination of viable/non-viable and active/passive probes. Environmental monitoring package standard in all configurations

Videos

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