Marya Pharmaceutical Oral Liquid Sterile Preparation System for Large-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-PS
• 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: 150ºC
• Working Volume: 2~15000L
• Weighing Control Accuracy: 3%
• Power Supply: 380V 50Hz
• Sealing and Protection Levels: IP65
• Temperature Control Accuracy: Temperature Range-10~150ºC ±0.2ºC
• 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
• Package Size: 2100.00cm * 1200.00cm * 2400.00cm
• Package Gross Weight: 1200.000kg

Product Description

Marya Pharmaceutical Oral Liquid Sterile Preparation System for Large-Scale Drug Manufacturing

Introduction

Oral Liquid Sterile Preparation System is a highly automated production equipment, which is specially used for producing oral liquid preparations in compliance with the requirements of Good Manufacturing Practice (GMP). The system integrates advanced sterilization technology, aseptic filling technology and intelligent control system to ensure that the product remains aseptic throughout the production process, effectively preventing microbial contamination and safeguarding the safety and stability of the drug.
 

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.Modular design, cost-saving and worry-free. The pre-tested modular equipment provides significant savings on installation, faster delivery, and a high level of flexibility and convenience.

2.Fully automatic running system, intelligent and efficient. The one-button automatic control system of CIP and SIP can automatically detect the end of cleaning and sterilization, with recipe management, electronic signature, electronic records, audit tracking and other computer functions, realizing production automation.

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

4.3D simulation design and rational layout. Before manufacturing the equipment in our factory, we will carry out the same size ratio 3D design to rationalize the arrangement of pipelines, valves, instruments, etc. in the system to make the operation of the equipment more user-friendly. 


 

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

Product Design Details:

1. The material, process and structure of the equipment meet the requirements of EU PED and FDA certification. We can provide exquisite pharmaceutical grade stainless steel tanks ranging from 2L to 15000L, with an internal material of 316L and an electrolytic polishing process Ra<0.4μm, no dead space for cleaning and sterilization. 

2. Each tank is equipped with a safety device consisting of a rupture disc or safety valve and an on-site pressure indicator to assure the safety of equipment and personnel in largest extend.

3.The water filling and feeding control of the formulation tank uses a weighing system or a liquid level detection system.

4.All aseptic tanks are equipped with cleaning balls that rotates to spray the inside of the tank to achieve cleaning-in-place (CIP) function.