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Infrastructure

We have an advanced infrastructure, which helps us in offering a flawless range of dry injectible powder products to our esteemed clients. Our unit's functioning zones are manned by a team of experts and the entire infrastructure is segregated into different departments for streamlining manufacturing, research & Development, packaging, storing, marketing and other related processes. Further, these departments are equipped with the latest equipment & technology that assist us in delivering a quality range of products to the customers.

Facility Highlights

  • Our critical manufacturing and filling is carried out under Grade A (class 100) with surrounding area of Grade B (class 1000).
  • Area is designed to have NOT LESS THAN 60 ACPH
  • Total production area is created with clean room G.I powdered coated sheets with walk-able false ceiling.
  • Additionally we have Class ONE LAC Raw Material store for storage of sterile raw material.
  • Air Handling Units (AHU's), Dehumidification Unit, Dust Extraction System and Temperature Controlling as per WHO GMP norms.
  • Movement of the material is made through dynamic pass box only.
  • Automatic Tunnel Line. PLC based washing, filling sealing and labeling machine line
  • Segregation of every critical processing activity in each zone, to avoid cross-contamination. Respective zones, areas and even uniforms marked with specific colors to ensure total segregation.
  • Total production area and microbiology lab is having PU flooring.
  • The installed production capacity is 240 vials per minutes
  • GMP CRITICAL soft wares used for HVAC AND WAREHOUSE MANAGEMRNT
  • All utilities are provided through service area.
  • Purified water system is double RO pass with EDI and UV to get optimum quality purified water which will be used as feed Water For Water for Injection (WFI) Under continuous loop system
  • Our in-house quality control department is independent, self-sufficient and capable of carrying out all tests.
  • The facility is dedicated for Cephalosporin group of sterile dry powder injection.
  • Environmental monitoring for differential pressure, humidity and temperature is monitored automatically with alarm system. Continuous record of the same is provided.
  • Considering the hazardous impact of industrial waste on our land and water, Finebiotics has established a modern Effluent Treatment (ETP) at the site for managing of waste disposal properly.
  • High power generators are available for full time back up of electricity to ensure the plant to run 24hrs operations uninterruptedly.
  • Quality System and Master Validation Plan is adhered