Marya Pharmaceutical Aseptic Liquid Preparation System for Small-Scale Drug Manufacturing

• Customization: Available
• Application: Biotechnology Industry, Chemical industry, Clinical Diagnosis, Food & Beverage Factory, Food Safety, Forensic Science, Pharmaceutical Industry
• Capacity: 20000 L/hr
• Model NO.: MY-FS
• Certification: CE, FDA, GMP, ISO
• Control System: Fully Automatic
• Treatment Process: Filtration, Ultrafiltration
• Warranty of core components: 1 Year
• Tank Material: Stainless Steel 316L
• Temperature Resistance: 150℃
• Working Volume: 2~15000L
• Weighing Control Accuracy: 3%
• Power Supply: 380V 50Hz
• Sealing and Protection Levels: IP65
• Temperature Control Accuracy: Temperature Range-10~150℃ ±0.2℃
• Stirring Speed Control Accuracy: Speed Range 0~450rpm ±3.0%
• Pressure Control Accuracy: Pressure Range-0.01MPa~0.06MPa ±0.01MPa
• Transport Package: Wooden Box
• Specification: 350*180*300
• Trademark: Marya
• Origin: China

Product Description

Marya Pharmaceutical Aseptic Liquid Preparation System for Small-Scale Drug Manufacturing

Introduction

The preparation system is a type of pharmaceutical equipment used to mix and dispense liquids by adding an active pharmaceutical ingredient 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.
 

Classification
 

1.General preparation system: It is used for general small        molecule chemical preparation, such as aqueous injection,      lyophilized powder injection and so on.

2.Complex preparation system: It is used in the production of preparations with complex processes, such as suspensions, emulsions, liposomes, microspheres and other special preparations.

 

3.Biological preparation system: It is used for the preparation of all kinds of products applying biological engineering technology, such as the semi-finished preparation of antibodies, vaccines, blood products, recombinant proteins and so on, and it can also be used for the production of culture medium, purification buffer and other auxiliary liquid preparation.

 

4.CIP station system: It is used to assist in the on-line cleaning of tanks and pipelines of various preparation and bioreactor systems, and can be controlled separately or integrated with other systems.

Features

1.The system can be fully automatic, with modular design, and its follow-up installation and maintenance is convenient.

2.The system follows ASME BPE and GMP design concepts, meets 3D blind corner requirements, and allows for low residue and continuous production.

3.Before manufacturing the equipment in our factory, we will carry out one-to-one three-dimensional design to rationalize the arrangement of pipelines, valves, instruments, etc. in the system to make the operation of the equipment more user-friendly.

4.The automatic control system of CIP and SIP can be turned on by one key, which can automatically detect the end of cleaning and sterilization, with recipe management, electronic signature, electronic records, audit tracking and other computer functions.

5. When the equipment is running, it can realize controllable production of key process parameters of drugs (such as temperature, dissolved oxygen, PH, etc.), and can automatically detect them and give an alarm when there are special conditions outside the set parameters, so as to avoid quality problems of drugs. 

6.The material, process and structure of the equipment meet the requirements of EU PED and FDA certifications. We can provide exquisite pharmaceutical 2L to 15000L tanks made of stainless steel, with internal 316L materials. The tank's Ra is less than 0.4μm, with electrolytic polishing process, no hard-to-clean places.

7.We use a sterilizing-grade liquid filter which is made of polyethersulfone (PES), resistant to solutions of pH 1-14 and temperature up to 150ºC, and has good resistance to organic solvents. It has excellent filtration performance and reliable bacteria rejection ability, fully meeting the filtration requirements of pharmaceutical processes.

 

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