Introduction
Marya Pharmaceutical Formulation System is a modular and intelligent solution designed for high-value pharmaceutical liquid production. Featuring an integrated cleanroom design, it positions major process equipment outside the core clean area, maximizing operational space and flexibility. Production modules can be freely configured and physically segregated according to varying process needs and cleanliness grades, effectively ensuring aseptic operation and product isolation.
Performance Characteristics
1. The formulation system is designed from the ground up in strict compliance with cGMP guidelines, ensuring product quality and regulatory adherence.
2. The highly integrated, modular design consolidates complex piping, valves, and control systems into a unified unit, significantly reducing the equipment footprint. This compact layout offers greater flexibility and space utilization for cleanroom planning.
3. The formulation system automatically and electronically records and assures all parameters and steps for each batch production and cleaning process. Complete with audit trails, it ensures full traceability from raw materials to finished product, meeting all data integrity requirements.
4. The system features a sanitary design that eliminates dead legs in the fluid path. Its modular construction allows for easy disassembly and reassembly, significantly reducing the time and effort required for cleaning and routine maintenance.
5. An integrated, automated CIP system automatically executes cleaning procedures and monitors key parameters (e.g., conductivity) in real-time to verify cleaning efficacy.
Product Parameters
| Name | Parameters |
| Working volume | 2~15000L |
| 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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