Pharmaceutical and Nutraceutical

Pharmaceutical Engineering is all about the industrial processes, in which raw materials are converted into useful dosage form or API or Excipients. We can resolve the issues and improve the process with the help of basic fundamentals of engineering.

We monitor pharmaceutical unit operations such as; Granulation, Compaction, Coating, Size Reduction, Size Separation, Drying, Mixing, Material Flow, Material Handling, Flow of Heat, Evaporation, Filtration, Segregation, Crystallization, Distillation, Centrifugation etc.

We always study & set the CPPs properly to achieve desire CQAs.

Many factors effecting the CPP & CQA such as; Temperature, Pressure, Moisture, Humidification, De-humidification, pH, Static Charge, Viscosity, Particle Size etc. are very important to control during process.

Accordingly, we offer end to end support to Pharmaceutical, Nutraceutical and Speciality Chemical Industries.

We take all the responsibilities from lab development stage to the successful commercialization of the product.

Our technical team will complete the assigned tasks without compromising product quality & project timeline.

Productivity Improvement

  • We find out the critical factors responsible for less productivity, resolve it with innovative ideas and target the increase in productivity by many folds.

Process Improvisation

  • We improvise your large volume legacy product for quality improvement and cost reduction.

Process Optimisation

  • Product quality should be built during development stage instead of troubleshooting in commercial stage.
  • During product development it is recommended to optimise/challenge the process for robustness.
  • Proper optimisation will save your valuable time in future commercialisation by avoiding un-necessary troubleshooting / wastage of human, machine & material cost / delays in batch deliverance etc.

Process Validations

  • We perform Process Performance Qualification (PPQ) for new product for dossier submission in regulatory agency.
  • We do PPQ for increase in batch size, change in area/equipments, Site Transfer, Loan Licence, Contract Manufacturing etc.
  • With the help of scale up factors (such as Tip Speed, Froude Number) and scientific justification we can modify scale dependant parameters for product set up with or without post approval filling requirements.

Technology Transfer

  • We offer technology transfer of products during each phase. Technology Transfer with help of scale up factors (Tip Speed/Froude Number) increase the success rate against traditional systems;
  • We do feasibility studies, scale up studies to ensure smooth transfer of products from lab scale to commercial scale.
  • We handle Technology Transfer for Contract Manufacturing locations, Loan Licence Manufacturing site, Site Change, Area/Equipment changed within company.

Troubleshooting

  • We handle trouble shooting at the stage of Development, Optimisation, Exhibit, Validation, Technology Transfer as well as in routine commercial.

Upgradation & Automation

  • Upgradation of machinery/process/systems & Implementation of New Technology/Automation etc

Post Approval Changes

  • We handle post approval changes in approved products according to regulatory norms (e.g. Annual Reportable/CBE0/CBE30/ PASS/ Variations fillings).
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