APl raw materials

Fermasol™ Fermentation System for API Raw Materials

Application Overview

Fermasol™ Fermentation System is a professional industrial fermentation solution specially developed for fermented Active Pharmaceutical Ingredients (APIs) and pharmaceutical intermediates. It is widely used in the large-scale production of antibiotic APIs, amino acid pharmaceutical raw materials, vitamin intermediates, organic acid drug precursors, alkaloids, steroid intermediates and other biologically fermented pharmaceutical raw materials.

Most API fermentation processes are characterized by long cycle, high fermentation broth viscosity, high oxygen demand, complex metabolic regulation and high contamination risk. Targeting these industry pain points, Fermasol™ adopts customized tank structure, enhanced heat exchange system, high-efficiency stirring and oxygen supply configuration, matched with staged temperature control, segmented pH adjustment and intelligent fed-batch strategy. The system can effectively improve raw material substrate utilization, optimize microbial metabolic pathways, increase target metabolite accumulation and reduce by-product generation.

All wetted parts are made of pharmaceutical-grade 316L stainless steel and sanitary sealing materials, with crevice-free pipeline design and smooth inner wall. It supports fully automatic online cleaning and in-situ sterilization, eliminating residual cross-contamination risks, fully meeting pharmaceutical raw material production specifications and pharmacopoeia standards, and providing solid equipment guarantee for stable quality control of fermented API raw materials.

Core Performance Advantages

• Customized stirring, aeration and heat exchange configuration for high-viscosity, long-cycle and high-density API fermentation processes.

• Super high oxygen transfer efficiency, fully meeting the high oxygen consumption demand of antibiotics, vitamins and other strains.

• Multi-parameter linkage control and flexible feeding strategy to improve substrate conversion rate and unit output.

• Strict sanitary seamless design with automatic CIP/SIP function, reducing manual intervention and microbial contamination probability.

• Industrial-grade robust structure, supporting 24-hour continuous operation for large-scale API factory mass production.

• Complete DQ/IQ/OQ/FAT/SAT validation document package, convenient for production filing and regulatory inspection.

• Standardized modular design, easy installation, simple daily maintenance and low long-term operation cost.

Industry Application Value

Fermasol™ Fermentation System helps API manufacturers realize automation, standardization and large-scale upgrading of fermented raw material production. It solves the common problems of traditional API fermentation such as unstable batch quality, low conversion yield, high energy consumption and high batch loss rate. While improving product purity and batch consistency, it effectively reduces raw material consumption, labor input and energy waste.

The system fully complies with domestic and international pharmaceutical supervision requirements and pharmacopoeia standards, and is widely used in stable supply and export of high-quality fermented API raw materials. It helps pharmaceutical raw material enterprises optimize product structure, enhance core market competitiveness, and build a safe, stable and sustainable industrial supply chain for downstream pharmaceutical preparation enterprises.