Fully Automated WFI Preparation System
This fully automated WFI preparation system represents a cutting-edge solution for pharmaceutical liquid formulation. It 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. Intelligent process control ensures batch-to-batch consistency while maintaining strict compliance with pharmaceutical manufacturing standards.
System Classification
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General Formulation System: For small-molecule chemical preparations such as aqueous injections and lyophilized powder injections.
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Complex Formulation System: Handles advanced processes including suspensions, emulsions, liposomes, and microspheres.
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Biological Formulation System: For biotech products (antibodies, vaccines, blood products, recombinant proteins) and auxiliary liquids like media and buffers.
Core Advantages
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Modular Design: Pre-tested modular equipment reduces installation costs, accelerates delivery, and ensures operational flexibility.
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Fully Automated Operation: Features 1-click CIP/SIP with auto-detection. Includes recipe management, e-signatures, e-records, and audit trails for full digital compliance.
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Process Control & Monitoring: Real-time monitoring of critical parameters (temperature, DO, pH) with automated alerts to ensure drug quality.
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3D Simulation: Pre-production 3D modeling optimizes piping, valve, and instrument placement for an ergonomic and user-friendly layout.
Frequently Asked Questions
1. What materials are used for the preparation tanks?
The system utilizes high-grade 316L stainless steel for tanks, featuring electrolytic polishing (Ra<0.4µm) to ensure the highest standards of cleanability and pharmaceutical compliance.
2. Does the system support automatic sterilization?
Yes, the system is designed with a "1-click" CIP (Clean-in-Place) and SIP (Sterilization-in-Place) functionality, complete with automatic detection to verify completion.
3. What is the working volume range for these systems?
We offer a wide range of working volumes, from small-scale 2L units to large-scale 15,000L industrial systems, tailored to specific production needs.
4. How is the temperature and stirring accuracy maintained?
The system features precision controls providing temperature accuracy of ±0.2ºC and stirring speed control accuracy of ±3.0%, ensuring consistent batch quality.
5. Is the system compliant with international data standards?
Absolutely. The computerized control system includes recipe management, electronic signatures, electronic records, and audit trails to meet strict regulatory requirements.
6. Can the system handle biological products like vaccines?
Yes, our Biological Formulation System is specifically designed to handle sensitive biotech products including antibodies, vaccines, and recombinant proteins.
CarniTe Machinery
