Shilpa Medicare Limited
Flow Chemistry Validation

Flow Chemistry Validation

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.

Validation

Overview / Purpose

Validation ensures that the continuous flow process is reproducible, robust, and meets regulatory requirements. We confirm consistency across runs, define acceptable operating ranges, and generate validation reports and process performance data suitable for regulatory dossiers.

Capabilities & Key Activities

  • Process qualification: repeated validation runs under worst-case conditions
  • Robustness testing / Design of Experiments (DoE): variation of critical process parameters (flow rate, temperature, pressure, mixing)
  • Residence time distribution (RTD) studies: to confirm plug flow behavior or characterize dispersion
  • Inline and offline sampling / analytics: monitor purity, conversion, and impurity profiles
  • Comparison to batch benchmarks: matching or exceeding yield, impurity control, and throughput
  • Documentation & regulatory deliverables: validation protocols, reports, deviation handling
  • Stability / shelf life studies of intermediates or final API as required

Regulatory Compliance

To satisfy regulatory authorities (FDA, EMA, etc.), validation ensures that flow processes are consistent, demonstrate control, and are fit-for-purpose. Well-designed validation helps reduce risk in scale-up and commercial runs.