Marya Fully Automatic Sterile Pharmaceutical Svp Formulation System for Liquid Preparation

Product Description

Marya Fully Automatic Sterile Pharmaceutical SVP Formulation System for Liquid Preparation
 

Marya Small-volume preparation systems are primarily used for the precise preparation of pharmaceutical solutions which have small volumes (ranging from a few milliliters to several hundred liters) and demand extremely high accuracy, sterility, and consistency. They are essential core equipment in fields such as biopharmaceuticals, sterile formulations, and cell and gene therapy (CGT).

Application Scenarios:

1. Preparation of high-risk drugs: such as anticancer drugs. Requires absolute containment to protect personnel and prevent cross-contamination.

2.Sterile injectable solutions: such as vaccines and eye drops. Requires aseptic production, sterilization-in-place (SIP) capability for all components, and material safety.

3.Biopharmaceuticals and Cell Gene Therapy (CGT): Used for preparation of culture media, buffers, and final drug solutions. Requires high flexibility, often using single-use systems to ensure rapid processing and eliminate cross-contamination risks.

4. Clinical trial drugs: Involves numerous batches with small volumes. Requires modular systems that enable easy recipe changeover, along with comprehensive and compliant data recording.

Performance Features:

1. The liquid mixing vessel incorporates a bottom-mounted magnetically driven agitator, ensuring leak-free operation with enhanced evenly mixing and efficiency.
2. The system adopts 3D modular design, offering a compact and aesthetically pleasing structure with space-saving configuration.
3. The system can achieve fully automated control of production, Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP) operations.
4. Compliant computerized functions including flexible formula management, electronic signatures, electronic records and audit trails, etc.
5. Configurable with online analytical instrumentation (e.g., pH, O3, conductivity) to achieve controllable production of key process parameters.
6. Critical components utilize premium European/American brands, ensuring operational reliability and long-term performance stability.

Technical Parameters:

Vessel Volume	50/300/500 L
Vessel Design Pressure	0.4Mpa
Vessel Design Temperature	150ºC
Temperature Control Accuracy	±1ºC
Stirring Speed	0~400rpm
Weighing Accuracy	3‰

Other Parameters :

Tank Liner Material	316L / 904L / 2507 / Ti
Tank Jacket Material	304
Tank Insulation Layer	Rock wool/Aluminum silicate wool
Tank Surface Treatment	- Internal surface: Electropolished (Ra ≤0.4μm) - External surface: Mechanically Polished (Ra ≤0.8μm)
Regulatory Compliance	NMPA GMP / EMA GMP / FDA GMP /PICs GMP / WHO GMP

 

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