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		API
		Finished Dosage Forms
		Lab and R & D Setup
		High Potent

Client Name	: -	Dr. Reddy’s Labs (DRL)
Project Location	: -	Vizag, India
Facility Type	: -	Hormones (High Potent)
Project Duration	: -	18 months
Project Cost	: -	Rs. 80.00 million
Services Provided	: -	Basic Engineering, Detailed Engineering, Procurement Assistance, Site Supervision, Commissioning Assistance, Validation Documentation

Key Project Features:

The Hormone Manufacturing facility was constructed on an existing site of DRL
Area of production block is approx. 1500 sq. meters
The batch size was 50kg/month
The facility has two dedicated self-contained modules from bulk manufacturing to powder processing

Project Execution:

The starting material has an OEL limit of 500 ng/cu.m. Based on this risk assessment and containment policies were decided. The facility layout were prepared to meet the current GMP requirements of USFDA.

Spectrum provided an unique solution for charging of material to various reactors minimizing capital cost and at the same time meeting the requirements of stringent exposure limits.

Being a high potent facility the pressure differential was the most critical part in HVAC design.

Necessary Isolators and RTP’S were used to minimize exposure of operators to the high potent material.

Dedicated detoxification reactor is provided to detoxify the effluent before discharging it to a common effluent treatment plant.

Achievement:

The design, execution, commissioning & validation of the whole plant were done in a record time of 9 months.