Technical specifications
| Cellefill oRAB | Cellefill iASP | Cellefill iBIO |
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 |
Accuracy | achievable at most volumes ±1.0 % | achievable at most volumes ±1.0 % | achievable at most volumes ±1.0 % |
Capacity | 1500 units/hour | 1500 units/hour | 1500 units/hour |
Batch Size | 10 - 10,000 vials per batch | 10 - 10,000 vials per batch | 10 - 10,000 vials per batch |
Power supply | 230/400 V 3 ph, 50 Hz | 230/400 V 3 ph, 50 Hz | 230/400 V 3 ph, 50 Hz |
Weight | 2900 kg | 5200 kg | 6430 kg |
Load per square meter | 605 Kg | 1085 Kg | 1090 Kg |
Barrier Technology | Open Restricted Access Barrier | Double Wall Aseptic Isolator | Double Wall Aseptic Isolator |
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. |
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. |
Cleanroom Class | Grade B / ISO 7 cleanroom | Grade C / ISO 8 cleanroom | Grade C / ISO 8 cleanroom |
Vial Size | ISO 2R - 50R | ISO 2R - 50R | ISO 2R - 50R |
Weigh Check | 20-100 % | 20-100 % | 20-100 % |
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 |
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 |
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 |
Validation | Turnkey Validation FAT, SAT IQOQ | Turnkey Validation FAT, SAT IQOQ, PQ support for Isolator | Turnkey Validation FAT, SAT IQOQ, PQ support for Isolator |
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 |
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.