Marya Pharmaceutical Oncology Drugs Formulation System with Digital Twin Integration

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Marya Pharmaceutical Oncology Drugs Formulation System with Digital Twin Integration

Customization:	Available
Application:	Biotechnology Industry, Chemical industry, Clinical Diagnosis, Food & Beverage Factory, Food Safety, Forensic Science, Pharmaceutical Industry
Capacity:	20000 L/hr

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Product Description

Pharmaceutical Oncology Drugs Formulation System

The Formulation System is a specialized pharmaceutical apparatus designed for liquid mixing and dispensing operations. This equipment enables the preparation of pharmaceutical solutions by combining active pharmaceutical ingredients (APIs) with solvents such as water for injection. Through integrated processes including controlled stirring, heating, sterilization, and filtration, the system produces medicinal solutions at precise target concentrations.

Basic Information

Model NO.

MY-FS

Certification

CE, FDA, GMP, ISO

Control System

Fully Automatic

Treatment Process

Filtration, Ultrafiltration

Tank Material

Stainless Steel 316L

Power Supply

380V 50Hz

Temp Accuracy

±0.2ºC

Protection Level

IP65

System Classification

General Formulation System: For small-molecule chemical prep (e.g., aqueous injections, lyophilized powder injections).
Complex Formulation System: Handles advanced processes: suspensions, emulsions, liposomes, microspheres.
Biological Formulation System: For biotech products (antibodies/vaccines/recombinant proteins) & auxiliary liquids.

Core Advantages

Modular Design & Automation

Pre-tested modular equipment reduces installation costs and ensures flexibility. The system features 1-click CIP/SIP with auto-detection and computerized recipe management with audit trails.

Real-Time Monitoring & 3D Modeling

Critical parameter control for temperature, DO, and pH with auto-alerts. Pre-production 3D modeling optimizes piping and valve placement for ergonomic operation.

Design Features

Premium Compliance: 316L stainless steel tanks (2L-12,000L) with electrolytic polishing (Ra<0.4µm).
Sterility Assurance: Sterile ventilation filters, CIP spray balls, and optional double-tube plate heat exchangers.
Safety Systems: Integrated burst discs, safety valves, and precision pressure monitoring.
Efficient Mixing: Choice of magnetic stirrer (bottom) or mechanical stirrer (top) with variable frequency.
Precision Filtration: Sterilization-grade PES filters resistant up to 150°C.

Product Parameters

Name	Parameters
Working volume	2~15000L
Material	304, 316L, 904L, TA2
Stirring type	Upper mechanical, lower magnetic stirring
Speed Accuracy	Range 0~450rpm ±3.0%
Temp Control	Range -10~150ºC ±0.2ºC
Pressure Range	-0.01Mpa~0.06Mpa ±0.01MPa
Weighing Accuracy	3‰
Protection Level	IP65

Facility & Production Capability

Certificates & Global Presence

Packaging & Shipping

Frequently Asked Questions

1. What materials are used in the construction of the formulation tanks?

The system utilizes high-grade 316L stainless steel for all product-contact surfaces, ensuring maximum corrosion resistance and compliance with FDA and GMP standards.

2. Does the system support automated cleaning and sterilization?

Yes, the system is equipped with a fully automated 1-click CIP (Clean-in-Place) and SIP (Sterilize-in-Place) function, including automatic detection for cycle completion.

3. What is the range of working volumes available?

The system is highly scalable, with working volumes ranging from 2 Liters for R&D purposes up to 15,000 Liters for large-scale industrial production.

4. How precise is the temperature and stirring control?

The system provides high-precision control with a temperature accuracy of ±0.2ºC and stirring speed accuracy of ±3.0% within a range of 0~450rpm.

5. Is the control system compliant with digital record requirements?

Yes, the computerized system includes recipe management, electronic signatures, electronic records, and a full audit trail to meet modern pharmaceutical regulatory requirements.

6. Can the system handle biological products like vaccines?

Absolutely. We offer a specialized Biological Formulation System specifically designed for antibodies, vaccines, blood products, and recombinant proteins.