Sterile filling lines which consist of Ampoules, vials powder, vials liquid, and PFS recognizing the compliance with local and national requirements. Designing and building equipment that handles numerous sterile filling and packing processes with sterile isolators and containment isolators wherever needed.
Ampoule Line
Complete integrated line for ampoules consisting of washing, sterilizing tunnel, filling, sealing, Inspection and labelling. Key features:
- Servo control system
- 21 CFR Part 11 compliance /GAMP/ SCADA system
Vial Machinery
Washing – Vertical Rotary washing machine
Key features:
- Ultrasonic cleaning
- Auto drain Facility compliant
- Servo Control System
- Auto flushing of sanitary lines with WFI & sterile compressed air
- 21 CFR Part 11 compliance /GAMP/ SCADA system
Tunnel – Sterilizing and Depyrogenating
Key features:
- Drying – Sterilizing – Cooling – Stabilizing zone
- PID control
- CIP/SIP of Cooling zone
- Strip chart or paperless recorder
- 21 CFR Part 11 compliance /GAMP/ SCADA system
Filling – Vial Liquid /Powder Filling & Stoppering
Key features:
- In-process check weighing system
- Servo Control System
- oRABS/cRABS/Isolator Integrated
- Integrated VHP sterilization
- 21 CFR Part 11 compliance /GAMP/ SCADA system
Auto loading & Unloading System for Lyophilizer
Key features:
- Servo control system
- Equipped with containment process
- 21 CFR Part 11 compliance /GAMP/ SCADA system
Capping – Vial Cap Sealing Machine
Key features:
- Burr extraction system
- 21 CFR Part 11 compliance /GAMP/ SCADA system
External Wash – External washing for Vial /Ampoule
Key features:
- Isolator integration
- 21 CFR Part 11 compliance /GAMP/ SCADA system
Containment
Snowbell provides & supports pharmaceutical containment process used for protection of product, personal & environment for customized requirement up to OEB 5 Level.
Our containment systems range from simple glove box designs to fully integrated process systems which satisfy product OEL respectively. Snowbell can integrate any customized process like dispensing, sampling, reactor charging, discharging, milling, sieving, blending, granulation in API and Formulations.
We provide the Containment System for sterile high potent product by integrating our filling lines, equipped with VHP sterilization unit.
Key features:
- Automatic leak testing
- Dedicated AHU system with connecting valves
- CIP process support skid
- ERGO Model study
- Waste management
- 21 CFR Part 11 compliance /GAMP/ SCADA system
Triple Combi Filling Stoppering Machine
Triple Combi Filling Stoppering Machine
Snowbell do any combination for customized process in R&D. Along with Vial and Ampoules Snowbell provides an option to handle PFS filling and stoppering. Snowbell’s Triple Combi is a state of art machine.
Key features:
- Non-destructive in-line check weighing system
- Robotic Controls
- Servo based control system
- 21CFR part 11 /SCADA system
PFS & CARTRIDGES
PFS & CARTRIDGES
Pre-filled Syringes Filling and Stoppering Machine
Prefilled syringes are recognized as an efficient, reliable and convenient method for drug administration in healthcare Industry. Snowbell provide innovative machines for PFS filling, stoppering, plunger rod insertion and labelling operations following the Aseptic Guidelines.
Key features:
- In-process check weighing system
- Servo control controls
- Automatic handling of PFS
- oRABS/cRABS/Isolator integration
- 21 CFR part 11 compliance / SCADA system
Cartridges Filling & Stoppering Machine
Snowbell provide and support an intact process for cartridge filling sealing and capping. In aseptic conditions, we promote to have minimum manual interventions to the cartridges.
Key features:
- Nested / Non-nested infeed of cartridges with Automatic handling
- Nondestructive in-process check weighing system
- Servo control system
- oRABS/cRABS/Isolator integration
- 21 CFR Part 11 compliance /GAMP/ SCADA system
R&D
R&D
Combi Ampoule/Vial Filling Stoppering machine
Looking at the R&D pilot batch size requirement, Combi machine is one of the best solutions to resolve major issues for R&D scientist in terms of space and budget.
- | Daiichi Jitsugyo (America), Inc.
- | 630 776 2459
- | 630 875 0422
- | 939 A.E.C. Drive, Wood Dale, IL 60191
- | Rusty Nelson - Rnelson@djausa.com
