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Products

Bio Process

Pharmatech delivers process plants right from upstream process, media preparations, Fermenters & Bio reactors, Down stream process plants & Bio-waste, Deactivation System.

Basic Features

  • Cell & bacterial cultivations limits are designated & Manufacturing in compliance with latest cGMP guidelines
  • Product range from 10 liter to 50,000 liter as per cGMP & design standard of ASME/ PED/ CE
  • A wide selection of agitators from magnetic to powerful dispersion assuring best mixing performance for different products.
  • CIP/ SIP Integrated systems
  • Automatic / Semiautomatic systems in compliance with 21CFR Part-11 with SCADA & PLC

Applications

Vaccines
(Human & Veterinary)
Antibiotics
Recombinants
Hormones

Design, Construction and Validation features

  • Vessel: SS 316L, ASME coded, Electropolished to < 0.5 Ra
  • System design based on URS
  • DQ preparation for Fabrication and Software Complete suitability for in-line CIP and SIP
  • Dead Leg Free Design
  • Complete factory assembly with FAT
  • Preparation of validation packages: URS, FRS, HDS, SDS, FAT, IQ and OQ protocols
  • Compliance to all international cGMP criteria such as: 3A, ASME (BPE), USFDA, EHEDG, etc.
  • Compatibility of raising the bar from small batch to large batch with Part 11 compliance
  • Modular design with variety of options for customization

Features of fermenter assembly

  • Critical parts like harvest and sampling valves (sources of contamination) are zero dead leg valves of approved make
  • Peristaltic pumping system for dosing of Acid/Alkali/Antifoam
  • Utility service of water, clean air, pure and boiler steam, drain, chilled water supply and return, venting system etc...
  • Multiple sterile steam traps
  • Multiple ports with pH, DO, Temperature and other sensors
  • Thermal Mass Flow Controller for air if required
  • Resterilizable Air & Vent Filters
  • Open piping frame
  • Safety Valve & Rupture Disc
  • Automatic back pressure regulator
  • Exhaust line with Vent Condenser & Heater
  • Compact top or bottom drive unit
  • Efficient agitation system to provide optimum oxygen transfer rates and cell densities
  • Rotary spray ball for Manual/Auto CIP

Area of applications

  • Microbial Fermentation
  • Enzymes & Steroids
  • Microbial API
  • Monoclonal Antibodies
  • Antibiotics & Probiotics

Control Parameters

There are essential parameters to have precise control throughout the process. Those are pH, DO, Temperature, Foam, Feed, RPM, Pressure, Air Flow, CIP and SIP.

Automation

System control options range from manual, semi-automatic to fully programmable logic controller (PLC) with SCADA & DCS option Automation is in compliance with all current industry standards or 21 CFR Part 11, if required. Control system as per GAMP guidelines NEMA for control panel large touch screen interface with clear view of process parameters.

Forms

Process Equipments E-Catalogue
Catalogue
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