We have one of the largest capacities in the world to manufacture highly potent compounds with Occupational Exposure Limit (OEL) in the range of 0.1-1 μg/m3 (OEB 5). Our facilities are audited by US FDA and regulatory bodies.
We offer manufacturing of high potent compounds supported by special unit operations like micronization and spray drying. Our facility is designed to give output as low as 100 gm to multi-tons.
Our approach for high potent handling 
Overview of our High Potent Sites and Features:
We provide high potent API manufacturing services from 3 sites based out of India. All sites are inspected by US FDA and other reputed regulatory bodies. Some of the key features of sites are as listed below:
- Multipurpose facility with various sized reactors
- Isolator technology in place for containment to handle OEB 5 compounds
- Hastelloy ANFD with isolators
- Facility for milling, blending and packing under isolation techniques with isolators
- Analytical instruments (HPLCs, GC, FTIR, UV-Vis, polarimeter and microbiology laboratory)
- Cleaning-in-place (CIP) practiced under the closed condition
- Separate effluent detoxification reactor
Material Handling
We take utmost care in handling highly potent materials at every stage of the manufacturing journey.
- cGMP compliant isolator systems (OEL 0.1µg/m³) for highly potent raw materials, intermediates dispensing, charging, filtration and drying, and packaging
- Reaction mass transfer through closed loop lines
- Rapid transfer ports for solid material transfer
- Dedicated warehousing: The warehouse is specially designed for handling high potent raw materials in both solid and liquid forms. A SAP-integrated barcode system logs proper storage
HVAC and Utilities
- HVAC system with zone classification to avoid cross-contamination
- Differential pressure system with temperature and humidity control
- HEPA filtered air
- Multiple utilities (cooling tower water, hot water, chilled brine, nitrogen, compressed air and steam)
Production Blocks and Unit Operations
The manufacturing process starts with reaction, sampling, workup, and isolation, followed by filtration and drying operations. The facility also has special unit operations across all the modules ranging from material removal into the canister, layer separation, drying, rotation evaporator, spray drying, and micronization. All modules have ANFD and micronizers in SS packing isolators.
Dedicated QC
All the analysis steps, such as in-process, intermediate, and complete, are performed in a dedicated QC lab designed to handle high potent molecules. The QC lab is equipped with a weighing and sample preparation isolator. The samples are analyzed using various equipment such as HPLC or GC. The QC lab relates to Empower 3 servers and all the data related to in-process, intermediate, and complete analysis steps are transferred to SAP through LIMS software.
Detoxification
Our manufacturing processes follow not only the highest quality but also sustainability standards to protect the environment and our workforce. The effluents are treated and processed in detoxifying areas, as per regulatory standards.
Why Aurigene Pharmaceutical Services?
One of the largest capacities in Asia- 3 US FDA inspected cytotoxic GMP facilities
Variety of unit operations in containment
Highest standards of safety
Experience in manufacturing 50+ high potent compounds
Dedicated high potent R&D facility allowing for faster development and technology transfer
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Hyderabad R and D Center
Bangalore R and D Center
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Resources
JUNE 28, 2022
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