Process Engineering Capabilities (TAG)

TAG – Process Engineering Depertment Subject Matter Experts(SME) work toward API R&D Project to commercial scale manufacturing by performing lab scale simulation studies and process safety data generating of API process for scale up purpose.

Designs of Experiment

  • Systematic Experiment Design

RC1e/RD

  • Safety Study

FBRM

  • Crystallization Study/Particle Engineering

Easy Max

  • Simulation Study up 100ml

Radley’s Ready Lab Reactor

  • API Process Simulation Study - 1lt - 5lt & Lab Assurance

Dyno Chem Software

  • For Scale Up Simulation using Software to predict the Mixing & Other Parameters

Periodic Quality System Review

  • Process Feasibility
    Preliminary Process Safety Scalability Assessment to meet commercial Excellence
  • Lab Development & Optimization
    What-If Studies Proposal & Data Generation Thermal Screening (RSD/DSC) Calorimetric Data(RC1e) Unit Operation Generation for Commercial Scale Development Crystallization Process
  • PQ/ Lab Assurance
    Process Simulation Studies, Final Crystallization Assessment, Preparation of P&ID, Powder Safety(API) Assessment Report
  • Plant Validation
    Simulation Report using DynoChem Software Technical Support for Tech Transfer

TAG Value Addition

Process Engineering Assessment

  • Preliminary Process Assessment
  • What-If Study Proposal & Data Generation
  • Unit Operation & Data Generation for Scale-Up Feasibility
  • Implementation of DOE In-Process Development
  • Dyno Chem for Scale-Up, Process Excellence & Improvements
  • Develop Best Practices, Routines & Innovative Solutions to get Robust Process
  • Perform Process Simulations
  • Preparations of P&ID Equipment Selection & Plan
  • Preparation of Process Engineering Tech Transfer Document

Process Safety Assessment

  • Carry out Preliminary Process Safety Risk Check
  • Conduct Thermal Screening (RSD/DSC)
  • Generate Calorimetric Data (RC1e)
  • Process Simulation Studies
  • Preparation of Process Safety Assessment Report
  • Co-ordinate with Plant Tech Transfer Team for HAZOP

Crystallization & Partical size Engineering

Crystalization Process Development

  • Solvent Screening & Identification of Meta-Stable Zone width
  • Development of the Crystallization Process (Cooling, Anti-Solvent & Evaporative Process)
  • Perform Plant Simulation Studies with respect to Rate of Cooling, Mixing & Agetative Pattern
  • Crystalize Distribution Data with respect to Process

Particle Size Engineering

  • Particle Size Reduction through Down-size Technique
  • Particle Size Distribution (PSD)
  • D1 0, DS 0, D9 0/ Volume mean / Median /Mode. Bulk Density/ Tapped Density (Hausner Ration & Compressibility) Surface Area /XRD (%) Melting Point/ Morphology (Microscopic Image)
  • Polymorph Stability Data of final Optimized Product (Bench Top Analysis/ Accelerated Stability / DSC/ TGA)