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   Experience
 
Biopharmaceutical Project in India
Role : -  – Basic Engineering
– Process Engineering
– Review of Detailed Engineering
– Site Management
– Commissioning
– Validation Support
      

Mahendra Sarvankar – (GM Operations - Spectrum Pharmatech Consultant Pvt. Ltd.) has vast experience of 18 years in Pharmaceutical Industry. Mahendra has B. Tech in Pharmaceutical and fine chemicals from University Department of Chemical Technology (UDCT) one of the Premier Institute in Chemical Technology In India.

Mahendra has worked with Wockhardt Limited during 1998 – 2007. During this period he has worked on various biotech projects of Wockhardt.

Mahendra was involved in setting up pilot plant for Manufacturing Human Insulin.  This facility was the first r-DNA Insulin facility out of US and Europe. The yeast based expression system was used to manufacture Insulin.

The facility was created for manufacturing Insulin for clinical trials, and process validation. The facility was designed to meet regulatory requirement of USFDA.

The live culture handling areas such as Microbiology, Sterility testing, Inoculum preparation, Seed train, Fermentation and first stage of downstream processing was a contained area thus minimizing hazard to operator from exposure to Genetically Modified Organism (GMO)

All gaseous vents were scrubbed / filtered to ensure GMO does not escape to the environment. All used glass wares were decontaminated by sterilizing before sending out of the contained area. All garments used in contained area were decontaminated by autoclaving before sending out of the facility. All liquid waste was sent to kill tank where the same was deactivated by sterilization.

Downstream processing involved Expanded Bed chromatography, High speed Centrifugation, Chemical conversion and High Pressure chromatography.

Final steps involved Sterile Crystalisation, Filtration, Drying and Packing.

All ancillary areas such as buffer solution preparation, RM dispensing / mixing were connected to the facility with separate Men entry thus preventing intermingling of personnel working in contained area and other areas.
   
 
 
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