SVP preparations refer to sterile liquid injectable preparations with a volume of 1-50ml, which are mainly used to inject drugs directly into the human body (such as vein, muscle or subcutaneous), with the characteristics of rapid onset, precise dosage and high bioavailability. Its production needs to meet the stringent standards of sterility, no pyrogen, and visible foreign matter control.
Vessel Volume | Vessel Design Pressure | Vessel Design temperature | Temperature control accuracy | Stirring speed | Weighing accuracy |
50/300/500 L | 0.4Mpa | 150℃ | ±1℃ | 0~400rpm | 3‰ |
Performance Features:
1.The liquid mixing vessel incorporates a bottom-mounted magnetically driven agitator, ensuring leak-free operation with enhanced evenly mixing and efficiency.
2.The system adopts 3D modular design, offering a compact and aesthetically-pleasing structure with space-saving configuration.
3.The system can achieve fully automated control of production, Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP) operations.
4.Compliant computerized functions including flexible formula management, electronic signatures, electronic records and audit trails, etc.
5.Configurable with on-line analytical instrumentation (e.g., pH,O3, conductivity) to achieve controllable production of key process parameters.
6.Critical components utilize premium European/American brands, ensuring operational reliability and long-term performance stability.
Basic Functions | Optional Functions |
CIP (Clean in place) | Vacuuming inside tank |
SIP (Sanitize in Place) | Nitrogen protection |
Hot water circulation | On-line integrity testing |
Multi-level user access rights | PH automatic control |
Recipe management | WFI instant cooling |
Audit trail | Real-time data printing |
Electronic record | Pipeline temperature control |
Other Parameters
Tank Liner Material | 316L / 904L / 2507 / Ti |
Tank Jacket Material | 304 |
Tank Insulation Layer | Rock wool/Aluminum silicate wool |
Tank Surface Treatment | – Internal surface: Electropolished (Ra ≤0.4μm)
– External surface: Mechanically Polished (Ra ≤0.8μm) |
Regulatory Compliance | NMPA GMP / EMA GMP / FDA GMP /PICs GMP / WHO GMP |