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Injectables Plants

Pura-Sys Pharma Pvt. Ltd. offers custom integrated; innovative and efficient process technology for injectable plants applications in complete compliance with WHO, USFDA, ASME (BPE) with highest classified sterile application right from the designing to the commissioning stages on Turnkey bases.

We can offer complete plant comprising:

  • Designing the sterile mixing / manufacturing vessels as per highest cGMP standards with system requirements suitable to the best of applications.
  • Provide custom Automation as per 21 CFR Part 11
  • Filtration for the injectables with necessary cartridge filters and sanitary pumps as of been required.
  • Custom required vessel agitation from top or Bottom entry magnetic stirrers; necessary sterile seals; sterile sampling points and fitments.
  • Providing qualification documents like DQ, IQ & OQ.
  • Sterile piping, valves instrumentation for necessary atomization.
  • Mobile Auto CIP & SIP Combo Units with complete traceability and printing facility.
  • The characteristic of our injectable plants like crevices and dead leg free surfaces with 0.5 µ ra inside EP and outside Matt finish; assembled with complete 100% Darin ability with flush bottom Diaphragm valve suitable for CIP & SIP with food grade Gaskets compliance with FDA 21 CFR Part 177 -2600 with Bottom Entry Magnetic Stirrer System with Sterile Double Mechanical Seal & Vacuum Powder addition to the system & on going process.
  • GMP validated magnetic stirrers with required mixing profile with sterile mechanical seal.
  • Skidded Systems with integrated piping, valves & Automation with Inbuilt CIP/SIP System.

Unique features at PPPL been exercised are:

  • In house team for design; fabrication & welding activities.
  • Traceability for each material been documented.
  • No dead legs with cGMP practices through out the unit.
  • Provision for CIP / SIP devices.
  • Zero Dead Leg (ZDV) & flush bottom valve.
  • Supported & Documented by DQ/IQ/OQ.

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