Marya Pharmaceutical Injectable Sample Dispensing System Automatic Sampling Preparation System

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

Product Description

Basic Specifications

Model NO.MY-FS
CertificationCE, FDA, GMP, ISO
Control SystemFully Automatic
Treatment ProcessFiltration, Ultrafiltration
Tank MaterialStainless Steel 316L
Working Volume2~15000L
Temperature Resistance150℃
Power Supply380V 50Hz
Protection LevelIP65

Introduction

The preparation system is a type of pharmaceutical equipment used to mix and dispense liquids by adding an API to a solvent such as water for injection, and then formulating it into a pharmaceutical agent that meets the desired concentration after stirring, heating, sterilization and filtration.

Preparation System View 1
Preparation System View 2

System Classification

1. General preparation system: Used for general small molecule chemical preparation, such as aqueous injection and lyophilized powder injection.

General System

2. Complex preparation system: Used for preparations with complex processes, such as suspensions, emulsions, liposomes, and microspheres.

Complex System

3. Biological preparation system: Used for biological engineering products like antibodies, vaccines, blood products, and recombinant proteins.

Biological System

4. CIP station system: Used for on-line cleaning of tanks and pipelines, controlled separately or integrated with other systems.

CIP System

Key Features

Fully automatic modular design for convenient installation and maintenance.
Follows ASME BPE and GMP design concepts with 3D blind corner requirements.
One-key CIP and SIP control with recipe management and audit tracking.
Real-time monitoring of temperature, dissolved oxygen, and PH with alarm systems.
Stainless steel 316L tanks (2L to 15000L) with electrolytic polishing (Ra < 0.4μm).
Sterilizing-grade PES liquid filters resistant to pH 1-14 and up to 150ºC.

Product Parameters

Name Parameters
Working volume2~15000L
Stirring speed control accuracyRange 0~450rpm ±3.0%
Temperature control accuracyRange -10~150ºC ±0.2ºC
Pressure control accuracyRange -0.01Mpa~0.06Mpa ±0.01MPa
Weighing control accuracy3‰
Power supply380V 50Hz
Sealing and protection levelsIP65

Product Gallery

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Frequently Asked Questions

Q: What is the working volume range of the system? A: The system supports a wide working volume range from 2L up to 15,000L to accommodate various production scales.
Q: What materials are used for the pharmaceutical tanks? A: The tanks are made of high-quality Stainless Steel 316L with an internal surface roughness (Ra) of less than 0.4μm, achieved through electrolytic polishing.
Q: Does the system comply with international pharmaceutical standards? A: Yes, the system follows ASME BPE and GMP design concepts and meets the requirements for EU PED and FDA certifications.
Q: How is the cleaning and sterilization process managed? A: The system features a fully automatic CIP (Clean-in-Place) and SIP (Sterilize-in-Place) control system that can be activated with a single key.
Q: What are the temperature and pH limits for the filtration system? A: The sterilizing-grade PES liquid filters are resistant to solutions with pH values from 1 to 14 and temperatures up to 150ºC.
Q: Can the system monitor key process parameters in real-time? A: Yes, it provides controllable production and automatic detection for parameters such as temperature, dissolved oxygen, and PH, with built-in alarm functions.

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