Aseptic filling - fully automatic systems

Cellefill™

Overview

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

Cellefill^TM是一个交钥匙,小批量,瓶填补ing 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

Accuracy	achievable at most volumes ±1.0 %
Capacity	1500 units/hour
Stoppers	ISO standard or Lyo, 13 mm and 20 mm
Cap diameter range	ISO standard or flip-top, 13 mm or 20 mm
Infeed and outfeed trays	Vial 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 oRAB	Cellefill iASP	Cellefill iBIO
Accuracy	achievable at most volumes ±1.0 %	achievable at most volumes ±1.0 %	achievable at most volumes ±1.0 %
Application	Sterile 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 Technology	Open Restricted Access Barrier	Double Wall Aseptic Isolator	Double Wall Aseptic Isolator
Batch Size	10 - 10,000 vials per batch	10 - 10,000 vials per batch	10 - 10,000 vials per batch
Capacity	1500 units/hour	1500 units/hour	1500 units/hour
Cap diameter range	ISO standard or flip-top, 13 mm or 20 mm	ISO standard or flip-top, 13 mm or 20 mm	ISO standard or flip-top, 13 mm or 20 mm
Cleanroom Class	Grade B / ISO 7 cleanroom	Grade C / ISO 8 cleanroom	Grade C / ISO 8 cleanroom
Filling Line Type	Aseptic 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 ml	Limited only by RTU vial size, filling volume range is from micro-volumes to 50 ml	Limited only by RTU vial size, filling volume range is from micro-volumes to 50 ml
Infeed and outfeed trays	Vial 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 type	Castus® 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 supply	230/400 V 3 ph, 50 Hz	230/400 V 3 ph, 50 Hz	230/400 V 3 ph, 50 Hz
Stoppers	ISO 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
Validation	Turnkey Validation FAT, SAT IQOQ	Turnkey Validation FAT, SAT IQOQ, PQ support for Isolator	Turnkey Validation FAT, SAT IQOQ, PQ support for Isolator
Vial Size	ISO 2R - 50R	ISO 2R - 50R	ISO 2R - 50R
Weigh Check	20-100 %	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

Literature

Brochures

Cellefill brochure (EN).pdf
PDF - 963.5 kb

Datasheet

Cellefill oRAB datasheet (EN).pdf
PDF - 254.5kb
Cellefill iASP datasheet (EN).pdf
PDF - 230.3kb
Cellefill iBIO datasheet (EN).pdf
PDF - 235.8kb

Advanced features

在扩大和repe Cellefill提供信心atability 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 (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	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	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	Format parts: Chutes, jaws and pistons The universal vibrator bowl accommodates both ISO standard 13 mm and 20 mm injection and lyophilisation stoppers
Capping	Choice of crimp capping or roller closure, both with force closure measurement 通用碗提供ISO标准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	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	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)
	Strategically located environmental monitoring for critical risk assessment combination of viable/non-viable and active/passive probes. Environmental monitoring package standard in all configurations