Basic Info.
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
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
Packaging & Delivery
Package Size
350.00cm * 180.00cm * 300.00cm
Package Gross Weight
3500.000kg
Product Description
Marya Pharmacy's Aseptic Small-Capacity Liquid Preparation System for Vial Use
Introduction
The Marya Pharmacy's Aseptic Small-Capacity Liquid Preparation System is designed for vial application. This formulation system, as a key piece of pharmaceutical equipment, operates by adding the active pharmaceutical ingredient to a solvent like water for injection. It then undertakes processes such as agitation, heating, sterilization, and filtration to blend and dispense the liquid, ultimately formulating it into a pharmaceutical agent with the precise concentration required, ensuring sterility and quality for small-volume liquid production in the pharmaceutical field.
Classification
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.
Introduction
The Marya Pharmacy's Aseptic Small-Capacity Liquid Preparation System is designed for vial application. This formulation system, as a key piece of pharmaceutical equipment, operates by adding the active pharmaceutical ingredient to a solvent like water for injection. It then undertakes processes such as agitation, heating, sterilization, and filtration to blend and dispense the liquid, ultimately formulating it into a pharmaceutical agent with the precise concentration required, ensuring sterility and quality for small-volume liquid production in the pharmaceutical field.
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 |
