WMS is a state of the art pharmaceutical manufacturing facility designed and having 5000 Sq m of constructed area having European pharmaceutical production technology with fully closed clean room facility and SCADA controlled air and water system.
Fully automated preparation plant consisting of preparation tanks, tri-blender, sanitary pumps, liquid filtration unit and SS 316L distribution piping.
Touch screen HMI allows controlling and monitoring of process parameters.
Preparation plant equipped with system for CIP and SIP.
Preparation tanks equipped with sophisticated instrumentation and controls.
Bags Production – Form Fill Seal
Bag forming, filling and sealing performed are fully automatic and operates under LAF(Class 100).
Components in contact with product are made with SS 316L in accordance with GMP standard.
The primary film used are multilayer, transparent, DEHP & LATEX FREE with excellent water barrier property and assured for terminal sterilization at 1210 C.
Sterilization – Autoclave (Super-Heated Water)
Super-heated water Autoclave used for the final/terminal sterilization of IV solution bags ensures 100% product sterility.
Entire cycle of sterilization controlled by the PLC and 21CFR part 11 compliant software.
Vacuum overwrapping as per International Standard and as a protection during transportation.
HVAC & Clean Room
Self-leveling Epoxy flooring.
Modular wallsq & Special double windows.
Separate air locks for material entry and personal entry.
Temperature, humidity, air flow and differential pressure monitored and controlled by SCADA.
AHU system with terminal HEPA to provide clean laminar air.
Purified water should be Purified Water PW.
Purified Water (PW)
Fully automatic, completely drainable, operating at 200 C.
Heat sanitizable RO and EDI unit.
EDI system eliminating the use of chemicals.
SS 316L mirror polished and passivated storage tanks and pipe lines.
Sanitary user points, sampling points, and in-line instrumentation and controls.
Water for Injection (WFI) Systems
Fully automatic, operating at 800 C.
Energy efficient and self sanitizable vapor compression distiller.