Fermentors / Bio-Reactors & Bio-Process Equipments

We are in the filed of Designing, Manufacturing, Supplying and Commissioning all types of Biotech Processing equipments including Fermentors and Bio-Reactors in standard Model as well as the Custom Process System requirements in fully Turnkey Integrated Package.

Our range of our Capabilities:

  •  System Design based on the URS.
  •  DQ preparation for Fabrication & Software
  •  Carrying out detailed Engineering with PFD, P&ID, Utility Design & Consumptions
  •  Fabrication Drawings, Assembly Drawings, 3D & Isometric Drawings, Welding details, SOPs
  •  Mechanical, Piping & Electrical specifications
  •  Instrument Index, Specifications
  •  Agitator Design & Specifications
  •  Software Development, SCADA, DCS, HMI Controls
  •  CIP & SIP Units design and integration system
  •  Skid / Platform & Support design
  •  Fabrication in clean environment
  •  Complete Factory Assembly and execution of FAT.
  •  Preparation of Validation Packages - URS, FRS, HDS, SDS, FAT, IQ & OQ Protocols.
  •  Supply and Supporting PAT
  •  Compliance to all International cGMP criteria like 3A, BPE 2008, USFDA, EHEDG etc.
  •  Automation in compliance with 21 CFR Part 11
  •  Sterile Run Testing at site
  •  Automated cleaning and sterilization
  •  Capability of Raising the Bar from small batch to large batch with Part 11 compliance.

 

Standard Features of Fermentor Assembly

 

  • Vessel : SS 316L, ASME coded, Inside EP to <0.5 RA, Free of Dead legs, Auto

Cleanable & sterilizable.

  • Resterilizable Sample Valve
  • Resterlizable Harvest/Drain Valve with quick connect fillings
  • Peristaltic Pumping System

 

 

 

 

 

  • Utility Service of
  • § Water
  • § Clean Air
  • § Pure Steam
  • § Boiler Steam
  • § Cooling Water/Chilled Water Supply & Return
  • § Drain System
  • § Venting System
  • Multiple Sterile Steam Traps
  • Multiple Ingold-type ports for RTD, pH & DO Sensors
  • Thermal Mass Flow Controller for Air
  • Resterilizable Vent Filters
  • Open Piping Frame
  • Safety ports
  • SS 316L Rupture Disc
  • Automatic Back Pressure Regulator
  • Exhaust line with Heat Exchanger & View Glass
  • Compact Top or Bottom Drive Unit
  • Efficient Agitation System
  • Light & Fill port with sanitary Tri-Clamp
  • Modular Design with variety of options for customization
  • Zero-Dead Leg sanitary fittings
  • Large touch screen Interface for clear view of Process Parameters.
  • NEMA for Control Panel
  • Control System as per GAMP Guidelines
  • Head Plate Ports for addition of Sensors
  • Double Mechanical Sterile Seal
  • High Level Foam Control

 

            

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