Shilpa Medicare Limited
Flow Chemistry Manufacturing

Flow Chemistry Manufacturing

Next-gen process intensification via continuous flow — safer, more efficient, scalable chemistry for APIs and intermediates.

Overview

Continuous flow chemistry enables reactions in a continuously flowing stream rather than traditional batch modes, offering superior process control, heat & mass transfer, safety, and scalability. Our platform spans from lab-scale development through validation and full manufacturing, aligning with cGMP standards and integrated into our CDMO services.

Manufacturing

Overview / Purpose

In manufacturing mode, our continuous flow processes are scaled to commercial throughput, fully GMP-compliant, with integrated controls, safety systems, and supply chain alignment. The process runs as a continuous stream, feeding upstream reactants and outputting finished material or intermediates in a controlled, monitored environment.

Capabilities & Key Activities

  • Scale-up architecture: "numbering up" reactors or scaling reactor dimensions
  • Real-time process control: integration of process analytical technology (PAT), feedback loops, alarms
  • Continuous purification / separation stages: inline quench, filtration, phase separation, continuous chromatography
  • Buffering strategies: holding loops or surge vessels to accommodate flow fluctuation
  • Quality assurance & batch tracking: continuous data capture, eBMR (electronic batch records), 21 CFR Part 11 compliance
  • Safety & containment: pressure control, heat management, containment of reactive or toxic intermediates
  • Changeover / cleaning in place (CIP): validated procedures optimized for minimal downtime
  • Throughput & yield optimization: maintaining high yield over long continuous runs
  • Documentation for regulatory filing: process flow diagrams, control strategies, validation summary, upstream/downstream integration

Manufacturing Benefits

Continuous manufacturing reduces variability, increases throughput, lowers cost per unit, and improves quality consistency. It also supports sustainable operation (less waste, less energy) and better safety for hazardous chemistries.