Injectable Plants (Small Volume)

Description

Injectable Plants (Small Volume)

Features

Custom integrated injectable process equipment for highest classified sterile formulation right from design, commission and validation.

  • Vessels, Valves & accessories in compliance up to Class 100 classified area.
  • SS Skid Mounted System.
  • Designing the sterile mixing vessels as per the highest cGMP standards with Design Qualification.
  • Clean environment manufacturing with Factory Acceptance Test facilities.
  • Providing custom required Automation as per MCA & 21 CFR Part 11.
  • Efficient Micro Filtration System of sterile application with pumping system.
  • Providing required sterile accessories.
  • Providing qualification documents like DQ, FAT & Protocols of IQ & OQ.
  • “CE” marked Equipments are offered with Third Party Inspection & All Electrical Control with ERTL Approval & Test.

Specifications

  • Sterile piping, valves and instrumentation.
  • Custom required Vessel agitation system, sterile Magnetic Agitator as required.
  • Mobile Auto CIP & SIP Units.
  • Skidded Systems with integrated piping, valves & Automation with inbuilt CIP/SIP System.
  • All contact parts SS 316L mirror polished to less than 0.5 Micron + electrpolished.
  • Zero Dead leg design for vessel and Flush bottom diaphragm valve.
  • Providing validated CIP & SIP devices without any shaded area in spray system.
  • Food grade Gasket conforming to FDA 21 CFR Part 177.2600.
  • Non-Contact parts SS 304 matte finished to less than 0.8 Micron.
  • Sterile sampling devices, cleanable & sterilizable.
  • SS Matte finished control panel.
  • GMP validated Magnetic Agitator with required mixing profile or top mounted compact agitator with sterile Mechanical Sealing systems.

Applicatrions

  • Injectable Small Volume Parenterals
  • Eye Drops
  • Nasal Drops
  • Sterile Oncology Products

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