GMP Reactors
GMP Reactors
GMP Reactors (Good Manufacturing Practice Reactors) are highly specialized vessels designed for industries where regulatory compliance, product purity, and process consistency are critical—especially in the pharmaceutical, biotech, chemical, and food industries. These reactors are engineered to meet strict GMP, FDA, and cGMP guidelines, ensuring hygienic design, traceability, and ease of validation throughout the production process.
At Harsha Engineers, we manufacture customized GMP-grade reactors that meet international standards and support high-quality production in sterile or semi-sterile environments. Built with SS316L or SS304 materials and mirror-polished internal surfaces (Ra < 0.4 µm), our reactors minimize the risk of contamination, support clean-in-place (CIP) and steam-in-place (SIP) processes, and provide complete documentation (DQ, IQ, OQ, PQ) for regulatory auditing.
These reactors include precision temperature control systems, PLC/HMI automation, sanitary fittings, and dust-free discharge mechanisms, making them ideal for handling APIs, sterile intermediates, and sensitive liquid or solid formulations.
Material of Construction (MOC): SS 304, SS 316, SS 316L (as per GMP standards).
Capacity Range: 50 Liters to 50,000 Liters (customizable).
Design Pressure: Full vacuum to 10 bar (or as required).
Design Temperature: -20°C to +250°C.
Type: Jacketed / Limpet Coil / Plain.
Jacket/Limpet Options: Single / double jacket with steam, hot oil, or cooling water circulation.
Agitator Types: Anchor, Turbine, Pitched Blade, Propeller, Paddle, Helical Ribbon (as per process requirement).
Drive System: Gearbox with motor, variable frequency drive (VFD) optional.
Seal Type: Mechanical seal / stuffing box.
Surface Finish: Mirror polished (Ra 0.28 to 0.4 µm) – internal, Matt or mirror finish – external.
Insulation: Cladded with SS / Aluminum sheet.
Mounting: Leg-mounted or skirt-supported.
Utilities: Steam, hot water, chilled water, or thermal oil heating/cooling options.
Compliance: cGMP, ASME, DIN, and international standards.
Chemical reactions can be carried out in GMP reactors under tightly controlled mixing, pressure, and temperature conditions. In accordance with GMP standards, they provide efficient heating, cooling, and mixing while maintaining sterility and contamination-free operation and are outfitted with agitators, jackets, or coils.
- Pharmaceutical manufacturing of APIs and formulation procedures.
- Culture and fermentation are examples of biotechnology.
- Food and Beverages: processing dairy and beverages, flavoring, and food.
- Chemicals and cosmetics: lotions, creams, and specialty chemicals.
- Ensures that global GMP standards are adhered to.
- Offers operations that are clean and free of contamination.
- Provides batch-to-batch uniformity and consistent product quality.
- Intended for simple cleaning, validation, and maintenance.
- Increases safety and process efficiency.
Conclusion
Harsha Engineers’ GMP reactors are designed to provide precision, safety, and regulatory compliance for industries where product quality and compliance with regulations are crucial. Our GMP reactors support seamless production and long-term operational reliability thanks to their flexible designs, long-lasting construction, and advanced features.