Marya Aseptic Stainless Steel Pharmaceutical Liquid Formulation System

• 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: 1year
• 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: 350.00cm * 180.00cm * 300.00cm
• Package Gross Weight: 3500.000kg

Product Description

Marya Aseptic Stainless Steel Pharmaceutical Liquid Formulation System

 

Introduction:

The formulation system is a type of pharmaceutical equipment used to mix and dispense liquids, through which 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. It is widely used in sterile or non-sterile pharmaceutical field.
.
  
Classification of the formulation system:
 

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

 

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

3.Biological formulation 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.

 

Advantages

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.

1. 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.

 

Design details:

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 an electrolytic polishing process, and no hard-to-clean places.
 

All the connectors with the tanks used are clamps or NA, which meets FDA requirements, with sealing parts made of EPDM or PTFE. The jacket nozzle is connected with Union or flange, with PTFE seal gasket.

Each tank is equipped with a set of safety devices including a rupture disc or safety valve and a site pressure indicator to assure the safety of equipment and personnel to the largest extent.

The weighing or liquid level detecting system is used for water refilling and material feeding control of the formulation tank.

Before the water for injection (WFI) is filled into the formulation tank, we can use a sterile double-barreled plate heat exchanger to cool it to the set temperature, which can also be used in the integrity testing of the liquid filter element.

The temperature control and display of the product are realized by the temperature probe installed at the bottom of the tank, and the pressure control and display of the tank is realized by the pressure probe installed at the top.

The tank can fully mix the product and speed up heat transfer by a magnetic stirrer driven by electromagnetic coupling with speed regulation by frequency conversion at the bottom of the tank, or a mechanical stirrer with frequency conversion at the top.

All sterile tanks are equipped with spray balls that can be rotated to spray the inside of the tank for cleaning-in-place (CIP). 

The sterile ventilation and air exhaust filters are installed on the top of every tank, to ensure that all operations in the tank are under sterile conditions.

The tanks are all equipped with sight glasses with illumination to facilitate monitoring and liquid level control.

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