Turnkey Biologics Liquid Preparation System
The Aseptic Liquid Formulation System is a cGMP-compliant pharmaceutical production platform engineered for precision compounding of sterile and non-sterile injectables.
Core Functionality:
• API-Solvent Integration: Blends active ingredients with WFI or organic solvents.
• Dynamic Process Control: Concentration tolerance of ±1%.
• Sterility Assurance: SIP sterilization and 0.22μm membrane filtration.
• Multi-Phase Compatibility: Processes solutions, suspensions, and emulsions up to 8,000 cP.
Fully automatic modular design for convenient installation and maintenance.
Single-key CIP and SIP control with electronic records and audit tracking.
Real-time monitoring of key parameters like temperature, dissolved oxygen, and PH.
ASME BPE and GMP compliant with 3D blind corner requirements.
ANSYS fluid analysis simulation ensuring laboratory process transfer to large-scale production.
Frequently Asked Questions (FAQ)
Q1: Does the system meet international pharmaceutical standards?
Yes, the system is designed to meet cGMP, FDA, and EMA regulatory requirements, including ASME BPE design concepts.
Q2: Can the liquid preparation system be customized?
Absolutely. We provide modular designs and one-to-one three-dimensional design services to meet specific production requirements.
Q3: How is the sterility guaranteed during the process?
The system incorporates automatic CIP (Clean-in-Place) and SIP (Steam-in-Place) cycles, along with 0.22μm membrane filtration.
Q4: What is the maximum viscosity the system can handle?
The system is compatible with multi-phase liquids, supporting viscosities up to 8,000 cP.
Q5: Is data integrity maintained for audits?
Yes, the control system includes 21 CFR Part 11-compliant audit trails, electronic signatures, and batch records.
Q6: What capacities are available for the mixing tanks?
The modular design supports a wide range from 50L pilot batches up to 2,000L commercial-scale production.
SJ medical
