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Pharmaceutical Formulation System


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Pharmaceutical Formulation System

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 the sterile or non-sterile pharmaceutical field.
  • Formulation system121
  • Formulation system331
  • Formulation system551
  • injection water equipment system10-1
Formulation system121

Formulation system121

Formulation system331

Formulation system331

Formulation system551

Formulation system551

injection water equipment system10-1

injection water equipment system10-1

Product description
Parameters

1. Classification:

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 various products of 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 preparation of culture medium production, purified buffer solution and other auxiliary liquid.

 

2. 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. 

 

 

 

3.Design details:
1) We can provide exquisite pharmaceutical grade stainless steel tanks ranging from 2L to 12000L, with internal material of 316L and an electrolytic polishing process Ra<0.4 μ m, which makes it have no hard-to-clean places and can meet the requirements of PED of EU and FDA certification.


2) All the connections to the tanks adopt clamps and NA, and the sealing material is EPDM or PTFE, which is in compliance with FDA. Jacket nozzle connection adopts Union or flange, and the sealing gasket is made of PTFE.


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


4) The weighing or liquid level detecting system is used for water addition and material feeding control.

 

5) Before the WFI (water for injection) enters the preparation tank, we can use a clean grade sterile double tube plate heat ex-changer to cool it to the set temperature, which can also be used in integrity testing of the liquid filter element.


6) The temperature control and display of the product is 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 of the tank.


7) To fully mix the product and speed heat transmitting, we install a magnetic stirrer driven by electromagnetic coupling with frequency conversion speed regulation at the bottom of the tank, or install a mechanical stirrer with frequency conversion at the top of the tank.


8) All the sterile tanks are equipped with spray ball to complete CIP. 


9) Sterile ventilation and air exhaust filters are installed on the top of every tank, to assure that all operations are under the sterile conditions.


10) The tanks are all equipped with sight glasses with illumination to monitor and control the level. 


11) We use a sterilization grade liquid filter which is made of polyethersulfone (PES), can withstand solutions of pH 1-14 and temperatures up to 150℃, and has good resistance to organic solvents. It has excellent filtration performance and reliable bacterial retention ability, fully meeting the filtration requirements of pharmaceutical processes.

 

 4.Design parameters:

Name

Parameters

Volume

2~15000L

Material

304、316L、904L、TA2

Stirring type

Upper mechanical stirring, lower magnetic stirring

Stirring speed control accuracy

Speed range 0~450rpm

 ±3.0%

Temperature control accuracy

Temperature range-10~150℃

±0.2℃

Pressure control accuracy

Pressure range-0.01Mpa~0.06Mpa

±0.01MPa

Weighing control accuracy

3‰

Power supply

380V 50Hz

(Note:Other voltages require transformer)

IP grade

IP65

Keyword:
Formulation system
Preparation system
Pharmaceutical Liquid Preparation system
Formulation Mixing Tank system
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