Media Preparation System

Based on state-of-the-art pharmaceutical process paradigms and profound accumulated expertise in automated bioprocessing and sterile manufacturing, we have engineered a dedicated modular skid system for sterile liquid formulation and preparation. Built upon a compact footprint, high-level automation integration and functionally modular architecture, this platform is inherently designed to satisfy rigorous GMP requirements across global jurisdictions. It serves a broad spectrum of application scenarios, encompassing culture medium and buffer preparation, sterile drug substance and drug product manufacturing, as well as the complex formulation of high-value liquid biopharmaceutical intermediates and finished dosage forms.

The system incorporates a series of sanitary and sterile design features to safeguard process integrity. Magnetic stirring is implemented as the preferred agitation solution to eliminate the risk of shaft leakage. All branch valves adhere to 3D sanitary design principles, and the entire fluid contact circuit is constructed for minimal product retention, with dead-leg-free block valves deployed at critical junctions. The unit is pre-configured for fully automated CIP and SIP sequences, coupled with automatic tank pressure regulation to stabilize sterilization and cleaning cycles. The full workflow, including representative sampling, can be executed automatically, which effectively curbs manual intervention, mitigates human-induced error, strengthens end-to-end batch traceability and supports robust audit trail management.

Its control architecture is deeply customized on Siemens PLC platforms, integrated with premium-brand HMI touch panels for intuitive local operation. Both standalone PLC and plant-wide DCS control modes are offered to accommodate line-level or site-level orchestration. All programming and configuration follow ISA-88 standards for structured batch manufacturing control, and the platform supports seamless interfacing with MES and other intelligent manufacturing management systems. Remote monitoring capability is enabled via web publishing; authorized users can view real-time equipment status and process parameters from computers, tablets or smartphones either within the local area network or through VPN-secured public network access, balancing operational convenience with cybersecurity and data confidentiality. The control layer is fully aligned with FDA 21 CFR Part 11 governing electronic records, electronic signatures and audit trails, fulfilling prevailing global data integrity expectations.

We deliver a complete validation package including CSV documentation to underpin continuous compliance throughout the equipment lifecycle, spanning design, fabrication, site execution and routine commercial operation. Available working volumes range from 15 L up to 5000 L. Core wetted components such as formulation vessels, magnetic mixers, sanitary tubing, process valves and instrumentation are sourced from qualified domestic and international suppliers. The 3D modular layout achieves space efficiency and orderly arrangement with ergonomic access for routine operation and maintenance. Additional design highlights include adaptable adapter plates, and all contact and enclosure materials are compatible with cleanroom environments and resilient against routine gaseous and thermal sterilization exposure.

Control System

Validation Documentation