Austar provides one-stop API process control system which complies with GMP, FDA and EMA requirements, including fermentation, extraction, purification, synthesis, crystallization, solvent recovery, etc. It is to guarantee product quality, improve manufacturing efficiency, lower production cost and ensure production safety by applying accurate and optimized control protocol.
1. Fermentation Process Control System
The detection and control of fermentation process parameters is to make the fermentation process meet strain growth environment requirements. It is to improve the fermentation unit and control product quality effectively by detecting and controlling fermentation broth, sterilization temperature, pH, dissolved oxygen, air flow, tank pressure, fermentation broth volume, agitation rotation rate, fed-batch fermentation, defoamation, etc.
2. Synthesis Process Control System
Chemical synthesis process has the features of complexity, fast reaction, anti-explosion and anti-corrosion. Based on above reasons, Austar chemical synthesis control system uses Batch to manage recipe and adopts online measuring instruments with reliable quality, high precision, anti-explosion and anti-corrosion to monitor manufacturing data and record the trend curve, so as to meet safety, usability and extension requirements and improve the synthesis control level.
3. Purification Process Control System
Purification is the most critical step of synthesis process. The crystal form, luster, purity, transmittance, uniformity of crystal directly affect product quality. The purification process control system is to improve product quality by accurately controlling temperature, pressure, liquid level, flow rate, pH, turbidity, etc. parameter of acid-alkali tank, acid or alkali adjustment tank, concentration tank, crystallization tank, etc.
4. Solvent Recovery Process Control System
The problems for solvent recovery include complicated solvent, high requirements on anti-explosion and anti-corrosion of equipment, instruments and systems, inconvenience site operation, and the high requirement on control accuracy of tower parameter. The control parameters of automatic control system on distillation tower and recovery tower during solvent recovering process mainly include: temperature (pressure of tower top and bottom), tower bottom liquid level, in/out/backflow flow rate, reboiler steam flow, etc. These parameters should be accurately controlled to ensure the recovery rate of the tower.