Fermentation systems for the pharmaceutical industry
CLA Fermentation systems for pharmaceutical use are developed for critical high-regulation processes, such as the production of microbial ferments, active ingredients (APIs), vaccines and biopharmaceuticals. Each plant is designed on URS to ensure full compliance with GMP regulations, complete control of process parameters and operational sterility.
Specifications
- Useful volume: 5 to 3000 liters, suitable for pilot batches and commercial production
- Magnetic stirring (from the top or bottom) to avoid contamination and reduce maintenance
- Internal finish: Ra < 0.5 µm, sanitary polishing to ensure cleanability and sterilizability
- Sterilization: CIP/SIP arrangement, with connection to utilities or on-board steam generator (optional)
- Regulatory compliance: PED 2014/68/EU – IQ/OQ documentation, FAT, SAT available
Process control and traceability
- PLC (optional) with recipe management, parameters, batch traceability
- HMI Panel touch screen operator with data recording and printing
- Electrical control panel with validatable interface
Standard Components
- Metering and heating liquid recirculation pumps
- Manual and automatic valves with steam cutting lines
- Sterile process gas filters
- Lid lifting system
Typical applications
- Bacterial and fungal fermentations
- Production of biopharmaceuticals, enzymes and active ingredients
- Fermentation of cell cultures (aerobic and anaerobic)
FAQ
Is it suitable for GMP production of biopharmaceuticals?
Yes, the materials, finishes, and sterilization systems are designed for pharmaceutical environments that comply with European and FDA regulations.
What parameters can be controlled?
pH, temperature, agitation, pressure, gas, fermentation time, with continuous process log via PLC.
Can the fermenter be integrated with a SCADA system?
Yes, it is set up for connection with SCADA and validable remote management.