500L Sterile Compounding Vessel With Magnetic Stirrer 316L SS Dual Duty Jacket For Biosimilar Preparation

500L Sterile Compounding Vessel with Magnetic Stirrer | 316L SS, Dual-Duty Jacket (2-8°C & SIP) for Biosimilar Preparation

Product Features This 500L sterile compounding vessel features a seal-less magnetic stirrer, automatic CIP/SIP integration, and a dual-duty jacket for 2-8°C chilling and steam heating, ensuring GMP-compliant mixing.

Technical Parameters

Product Usage Scenarios This vessel is specifically engineered for high-grade aseptic cleanroom environments within biosimilar and biopharmaceutical manufacturing facilities. It is ideal for continuous sterile processing lines where products must be strictly maintained in a 2–8°C cold-chain environment during intermittent holding and transmission stages.

Applications

• Formulation & Buffer Preparation: Gentle dissolution, dispersion, and homogeneous mixing of shear-sensitive biologic formulation components without foaming.

• Sterile Holding: Maintaining sterile filtered bulk solutions at a controlled 2–8°C with gentle agitation to preserve homogeneity and product stability prior to aseptic filling.

• Vaccine & Biosimilar Manufacturing: Handling critical therapeutics that require rigorous data logging, batch traceability, and electronic pass/fail evaluation.

Frequently Asked Questions (FAQs)

• Q: Does this vessel support automatic cleaning and sterilization? A: Yes, the vessel is designed for fully automatic, recipe-driven multi-stage CIP (Clean-in-Place) cycles utilizing spray balls, as well as SIP (Steam-in-Place) for steam sterilization up to 121–134°C.

• Q: How does the equipment protect temperature-sensitive biologics? A: The system is equipped with a dual-duty jacket capable of both steam heating and chilled operation. It reliably maintains the product at a controlled temperature of 2°C to 8°C using chilled water or glycol, ensuring cold-chain integrity.

• Q: Is the control system compliant with international pharmaceutical regulations? A: Yes, the integrated EU brand PLC and HMI control system complies with FDA 21 CFR Part 11 requirements, offering multi-level user access, electronic batch records, and continuous data logging with audit trails.

• Q: Why does this vessel use a magnetic stirrer instead of a standard mechanical mixer? A: The seal-less magnetic (mag-drive) stirrer eliminates the contamination risks associated with mechanical seals and provides gentle, variable-speed mixing to prevent shear damage and foaming in sensitive biologic formulations.