| Customization: | Available |
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| Application: | Biotechnology Industry, Chemical industry, Clinical Diagnosis, Food & Beverage Factory, Food Safety, Forensic Science, Pharmaceutical Industry |
| Capacity: | 20000 L/hr |
| Shipping Cost: | Contact the supplier about freight and estimated delivery time. |
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| Refund policy: | Claim a refund if your order doesn't ship, is missing, or arrives with product issues. |
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Introduction
Marya's fully automated WFI preparation system represents a cutting-edge solution for pharmaceutical liquid formulation. This advanced system precisely combines APIs with Water for Injection (WFI) through an integrated process of controlled mixing, heating, sterilization and filtration to achieve exact therapeutic concentrations.
Designed for both sterile and non-sterile pharmaceutical applications, the system features complete automation from raw material input to final dosage form output. Its intelligent process control ensures batch-to-batch consistency while maintaining strict compliance with pharmaceutical manufacturing standards.
Classification
General Formulation System
For small-molecule chemical prep (e.g., aqueous injections, lyophilized powder injections).
Complex Formulation System
Handles advanced processes: suspensions, emulsions, liposomes, microspheres.
Biological Formulation System
For biotech products (antibodies/vaccines/blood products/recombinant proteins) & auxiliary liquids (media/buffers).
Pre-tested modular equipment reduces installation costs, accelerates delivery, and ensures flexibility.
1-click CIP/SIP with auto-detection for cleaning/sterilization completion.
Computerized features: Recipe management, e-signature, e-records, and audit trail for full automation.
Critical parameter control (temp, DO, pH) with auto-alerts for deviations to ensure drug quality.
Pre-production 3D modeling optimizes piping, valve, and instrument placement for user-friendly operation.
Premium Material & Compliance
316L stainless steel tanks (2L-12,000L) with electrolytic polishing (Ra<0.4µm), ensuring cleanability and compliance with EU PED & FDA standards.
FDA-compliant connections (clamps/NA) and seals (EPDM/PTFE), with PTFE gaskets for jacket nozzles.
Sterility Assurance
Sterile ventilation/exhaust filters and CIP spray balls for aseptic operations.
Optional sterile double-tube plate heat exchanger for WFI cooling and filter integrity testing.
Safety & Control Systems
Integrated safety devices (burst disc/safety valve + pressure gauge) for equipment/personnel protection.
Precision temperature (bottom probe) and pressure (top probe) monitoring with automated controls.
Efficient Mixing & Heat Transfer
Magnetic stirrer (bottom, electromagnetic-driven) or mechanical stirrer (top), both with variable frequency speed regulation.
Accurate Material Handling
Weighing/liquid-level detection for controlled water addition and material feeding.
High-Performance Filtration
Sterilization-grade PES filters (pH 1-14, 150°C resistant) with organic solvent compatibility and reliable bacterial retention.
Operational Visibility
Illuminated sight glasses for real-time level monitoring.
| Name | Parameters |
| Working volume | 2~15000L |
| Material | 304, 316L, 904L, TA2 |
| Stirring type | Upper mechanical, lower magnetic stirring |
| Stirring speed control accuracy | Speed range 0~450rpm ±3.0% |
| Temperature control accuracy | Temperature range-10~150ºC ±0.2ºC |
| Pressure control accuracy | Pressure range-0.01Mpa~0.06Mpa ±0.01MPa |
| Weighing control accuracy | 3‰ |
| Power supply | 380V 50Hz (Note: Other voltages require a transformer) |
| Sealing and protection levels | IP65 |
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