"The vision of process engineering is the greatest inspiration in the setting-up of state-of-the-art Bulk Drug, KSMs, and DIs facilities as it opens up avenues for exceptional success unparalleled in other disciplines.”
The processes employed vary with materials and their physical forms but in all cases the bulk drug manufacture domain relies on sophisticated mass production techniques to make active pharmaceutical ingredients (APIs) in bulk quantity.
Process engineering design determines effectiveness, occupational health and safety, and quality of the manufacturing processes, all of which are essential interrelated concerns.
Comprehending and planning for the chemical processes for drug development, choice of equipment, Process Flow Diagrams (PFDs) and Piping-and-Instrumentation Diagrams (P&IDs), Raw material, intermediate and final product storage and inventory control, Kinetics and thermodynamics of reactions, Control system implementation, Measurement and control of temperature, pressure, flow rate, and other important parameters, Hazard identification and mitigation in relation to chemical processes, Emergency Action procedures, Quality Control Tags, Pilot testing of processes to determine the feasibility of scaling from the laboratory to production, Scaling up of equipment for large batch production from small model versions, Waste disposal methods that are as environmentally friendly as possible, Compliance with Good Manufacturing Practices for safety and quality of drug products, Documentation and reporting to fulfil legal obligations, Process improvement in efficiency and cost along with control and offer improvements placement feedback.
We have experience in setting up below facilities
Generic API
Bulk Drugs, KSMs & DIs
Sterile API
Bulk Drugs, KSMs & DIs
Speciality Chemicals
Bulk Drugs, KSMs & DIs
Hi-Potent API
Bulk Drugs, KSMs & DIs
Intermediates
Bulk Drugs, KSMs & DIs
Solvent Recovery Manufacturing facility
Bulk Drugs, KSMs & DIs
Fine Chemicals
Bulk Drugs, KSMs & DIs
Hydrogenation Halogenation Reactions
Bulk Drugs, KSMs & DIs
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