1000L Pharmaceutical Compounding Tank AISI316L Biologic Preparation Vessel with Mag Drive Agitator & Auto CIP / SIP

Technical Parameters

Usage Scenarios Perfect for ISO-certified aseptic suites and vaccine manufacturing plants requiring rigorous contamination control. It seamlessly integrates into automated downstream filtration lines, specifically catering to cold-chain dependent biologics that demand strict 2–8°C holding parameters during process transfers.

Key Applications

• Biologic Formulation Blending: Executes homogeneous, low-shear mixing for sensitive APIs and buffers to prevent protein denaturation and eliminate foaming.

• Temperature-Controlled Bulk Storage: Acts as a highly secure holding vessel that preserves sterilized liquid integrity at 2–8°C prior to final vial, syringe, or cartridge filling.

Frequently Asked Questions (FAQs)

• Q: Can this tank be fully sterilized in place?
  A: Yes, it is fully equipped for Steam-in-Place (SIP) sterilization and automated Clean-in-Place (CIP) washing routines using 360° spray balls, minimizing manual operator intervention.

• Q: Is the stirring mechanism safe for delicate vaccines and proteins?
  A: Absolutely. The mag-drive agitator eliminates mechanical seals (a common contamination risk) and provides adjustable, gentle agitation to protect shear-sensitive formulations.

• Q: How does the system handle electronic batch records and audits?
  A: The integrated Eu brands PLC and touch HMI system is designed for regulatory compliance, ensuring secure data logging, multi-level user access, and comprehensive electronic audit trails.
  
  

  Regulatory Compliance & Validation Support

  Our equipment is engineered to meet strict international regulatory standards, ensuring seamless integration into your facility's quality management systems.

  • Complete Validation Documentation (DQ/IQ/OQ/PQ): We provide comprehensive validation protocols to support your regulatory submissions, including Design, Installation, Operational, and Performance Qualifications, alongside complete material traceability certificates for all product-contact components.

  • GMP-Compliant Sanitary Design: Built strictly to Good Manufacturing Practice (GMP) principles. The equipment features crevice-free stainless steel construction and is fully compatible with CIP/SIP (Clean-in-Place / Sterilize-in-Place) procedures to eliminate contamination risks.

  • Data Integrity & Traceability: Designed to support FDA 21 CFR Part 11 requirements. Our intelligent PLC systems feature secure multi-level user access, automated electronic audit trails, and real-time batch data recording that can be easily exported or integrated into your SCADA/MES systems.