The entire manufacturing complex is designed on the guidelines specified in the latest modular concept used in world-class drug manufacturing facilities, strictly in adherence to the USFDA and cGMP (Current Good Manufacturing Practice) requirements.

Modular design
The modular concept of manufacture meets regulatory guidelines that help arrest cross-contamination of pharmaceuticals. Only a select few pharmaceutical companies in the world, including Neopharma, practice this concept.

The modular concept allows only one product to be manufactured at a time, in one module, thus, effectively keeping away contaminants. Dedicated Air Handling Units [AHUs] fitted with Terminal HEPA filters, as per EU12 requirements are installed strategically to completely avoid cross contamination. This ensures the air entering the manufacturing areas and the adjoining corridors, are of Class 100,000.

Further, the AHUs are certified with Holland Eurovent Certification and fitted with dehumidifiers, which help maintain the humidity conditions suitable for moisture sensitive products.

With low pressure at the work site and high pressure in the corridor, a pressure gradient results in the constant movement of air in one direction - giving no room for any air contamination to come in from the other direction. Strategic placement of the inlets and outlets in the air-conditioning system eliminates dead pockets or areas with restricted air movement.

To further ensure absolute purity of the product, every worker undergoes two changes of clothing before entering the actual manufacturing area. Finally, since the gowning is colour coded, movement of workers from one module to another is restricted, thereby avoiding contamination altogether. Complete HVAC parameter control and data logging monitored from a remote BMS room.

Both plants have individual purified water generation units, ensuring that water from one plant does not enter the other at all. Raw water is pre-treated by passing it through a Multi Grade Filter [MGF] followed by a 'softening' treatment. Reverse Osmosis through multiple filter membranes follows and then electronic de ionization and ultra filtration - processes, which actually 'polish' the water and help it, meet the stringent USP 25 requirements.

All the water pipes are made of a sanitary grade of stainless steel i.e. SS 316L electro polished and welded by a computer welding process called 'orbital welding' which leaves a smooth internal and external finish; thereby eliminating any chance of microbial growth. The entire water system is further assisted by SCADA control with on-line controlling, monitoring and data recording of key parameters.



Manufacturing Process
Automated PLC controlled machines are used in the entire manufacturing process. This equipment is imported from Europe and incorporates product features like product recipe and data acquisition and is backed by a complete support system. The product does not come in contact with humans during the entire production process. Even the transfer of products - from one process to another - is done using lifting and tilting or vacuum transfer devices.



Effluent Treatment Plant: Creating a green environment
At Neopharma, conserving the environment is as important as the manufacture of pharmaceuticals. Not surprisingly, the treated water passes through an elaborate 'cleaning' system that effectively neutralizes all the harmful constituents - if any - and recycles the water for irrigation and landscaping use. The effluent treatment plant with Constant Transfer Process has extended aeration and filtration systems, which help it to meet the highest standards in environment friendliness.