Marya Pharmaceutical Equipment Mixes Water Preparation System for Injection Manufacturer & Supplier

Product Description

Marya Pharmaceutical Aseptic Preparation System for Injection Water Treatment Equipment Manufacturer

 

1. Description of the preparation system:

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.
 

Description of the production steps of a general preparation system:

 
2. Classification of the preparation system:
 

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.
 

3. Design details:

The equipment's material, process, and structure 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 a Union or flange, with a 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 are 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 illumination and sight glasses 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.

 

4. 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