Sterile filling lines which consist of Ampoulesvials powdervials 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.

Ampoules
Vials
Containment
Combi
Pre-Filled Syringe
R & D

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

Washing – Vertical Rotary washing machine
Vertical rotary vial washing machine designed to process Vials / Ampoules / Cartridges internally and externally with multiple washing media. Integrated with Decartoning station at Infeed and sterilization tunnel at outfeed with automatic controls.

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

An advanced Sterilizing & Depyrogenation tunnel is used for handling Vials, Ampoules & Cartridges.  Highly precise instrumentation and mechanical filter assemblies in tunnel to suit with aseptic guidelines.

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

Accurate filling of product (Powder/Liquid) to achieve the desired output with versatile filling mechanism viz., Filling Syringes, Peristaltic pump, Time Pressure Dosing or Mass Flow System based on the physical & chemical characteristics of product.

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

Automatic Lyo loading and Unloading system for Lyophilizer
Loading & unloading of filled and stoppered vials in Lyophilizer without human intervention under sterile conditions.

Key features:

  • Servo control system
  • Equipped with containment process
  • 21 CFR Part 11 compliance /GAMP/ SCADA system

Capping – Vial Cap Sealing Machine

Capping – Vial Cap Sealing Machine
Rotary sealing arrangement synchronized with cap feeder assembly with identical sealing heads to achieve desired output.

Key features:

  • Burr extraction system
  • 21 CFR Part 11 compliance /GAMP/ SCADA system

External Wash – External washing for Vial /Ampoule

External Wash – External washing for Vial _Ampoule
External washing machines are designed to clean the external surface of vials with various washing media. A drying section is provided to dry the washed vials.

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

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

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

cartidges filling

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

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.