A Crystallizer comes to use in the production of an Active Pharmaceutical Ingredient (API). For the manufacture of a desired API, a reaction mass is prepared and sterilized through filtration. Once the reaction mass containing the desired API undergoes sterile filtration it is transferred into the crystallizer.
Crystallization takes place when product solution is mixed with solvent or any other chemical responsible for altering the behavior of product in terms of solubility or pH under controlled temperature and agitator speed (RPM).
BiOZEEN‘s Crystallizer is designed with the necessary piping and instrumentation for the flame proof area with a classification of Class 100, room temperature of 23±2 °C, and relative humidity less than 35%. The system is capable of crystallizing the product (semi synthetic penicillin) under aseptic conditions.
For optimal performance, our Crystallizer designs come with the following advantages:
- Minimum space requirement
- Optimized Crystallizer design
- Range: Currently have executed projects with 2000 & 4000 liters capacity, however the volumes can be customized to user requirements
- Floor-mounted structure
- Mechanical / Magnetic – low shear Agitator ( Top / Bottom Mounted)
- Flexibility in configuration to meet the budgets
- Design conforms to ASME BPE and GAMP 5 guidelines
- Material of construction
- Parts in contact with the media: SS 316 L
- Non-contact Parts: SS 304
- Internal surface Ra <= 0.6, Electro-polished
- Double wet mechanical seal
- Designed for easy access during operation and routine maintenance
- PLC control system
- Configurable control loops
- Safety features to protect the batch in case of any component failure
- The Crystallizer has provision for manual Sterilization-in-Place & Cleaning-in-Place