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weliconPlant Overview

manu1Located in a serene, pollution free environment in T.T.C MIDC, Navi Mumbai, part of Greater Mumbai-financial capital of India , is strategically and centrally, very close to JNPT port which is the largest Indian port handling almost 60% of country’s export traffic worldwide. Bionext Pharma is a WHO-GMP approved dedicated facility for LIQUID ORALS potentially catering to domestic as well as export markets. The facility structure is a combination of pillarless building and an adjacent building with a combined built-up area of 35000 sq. ft. housing all the requisite departments of Quality Assurance,Quality Control, Manufacturing, Stores(RM, PM, BSR), Product R&D, Regulatory Affairs, Purchase, Accounts and Utility Area .

 

Some Salient Features of the Facility are :


  • Dedicated Formulation-Liquid Oral plant that eradicates cross contamination and mix-ups.
  • Sufficient built up area that caters to all requisite cGMP norms for areas required for RM, PM, IN-PROCESS and FINISH GOODS.
  • State of the Art Facility with unidirectional and minimal MMI (Man Machine Interface).
  • In-House Testing Facility for Chemical, Instrumentation and Microbiological Analysis.
  • Close loop manufacturing with Vacuum Material Transfer System.
  • Fairly Huge Capacity Manufacturing Vessels with 316-L moc and bottom mounted stirrers / homogenizers supported by requisite ancillary equipment’s and utilities that operate in tandem with each other and interlocked for any malfunction.
  • CIP (Cleaning In Place) system for effective cleaning of manufacturing vessels with DM Water only.
  • Automatic High Speed packing line with design speed of 200 bottles / min supported by all latest tools for visual inspection.
  • Water System consisting of automised purification generation system of capacity 2000 lt / hr and distribution system.
  • Dedicated HVAC systems for Critical and Non-Critical areas with 100000 classification.
  • 3-Tier Electrical Safety System with Inverter and DG Backup.
  • Air-Tight Clean Room light fixtures, electric panels, air curtains, UV-lights provision.
  • Flush Windows and Doors with Air-Locks wherever necessary.
  • Maintenance free Polished Tile walls, Puff Partitions and Ceiling.
  • Seamless solvent – free epoxy flooring with appropriate covings and drain traps made of Stainless Steel.

This modern and well equipped facility is equally supported by trained workforce, technical staff, knowledgeable and experienced field management and a Visionary Executive Board. Quality Systems are implemented with check points at every concern stage well supported by technology, management, communication tools of Vision Systems, ERP and In-House Mailing and IP systems respectively.