Cream/Ointment Production

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Emulsifier

图片1 .jpgProduct Details



Pharmaceutical cream or  ointment is used as a means of delivering an active ingredient directly to the  required area of the skin. Products can be either a water-in-oil (w/o) or  oil-in-water (o/w) emulsion, consisting of waxes, emollients and lubricants  dispersed in an oil phase, and a water phase containing emulsifying, stabilizing  and thickening agents, preservatives and in some cases, colorant. Active  ingredients are dispersed in either phase or added when the emulsion has been  formed and allowed to cool.

 

Manufacture of pharmaceutical  creams and ointments presents a number of challenges; A GMPMax emulsifying mixer  can rapidly disperse solids into liquids, hydrate thickening and stabilizing  agents, break down agglomerates and finely reduce particle and globule size to  form stable emulsions and suspensions. Mixing times are dramatically reduced,  while product uniformity and consistency are greatly improved.  

The key to creating a stable  emulsion is obtaining the finest possible droplet size. The more shear energy  introduced into the mix, the smaller the suspended droplets will become,  creating a fine stable emulsion.

The high shear rotor/stator  design of the GMPMax mixer is ideally suited to this application and can easily  achieve emulsions with a droplet size of 2 to 5 microns. Finer emulsions down to  0.5 microns can be obtained, depending on the formulation. In many cases, this  can eliminate the need for high pressure homogenizers.

GMPMax offers a range of  in-tank and In-Line mixers widely used for preparation of emulsions, from  laboratory scale up to bulk production units.

 

When used in the cosmetic  industry, homogenization provides more stable, uniform emulsions with higher  performance characteristics. In the pharmaceutical industry, the primarily  mechanical nature of the homogenization process provides direct access to  enzymes, proteins, liposome and intracellular active substances without having  to utilize chemical lysis of the membrane. Other effects are seen in the  preparation of stable solutions of products with different physical  characteristics (proteins, creams, solutions of active principles, oils,  vitamins). The increase in the surface area of the micronized particles is also  of interest to the chemical and petrochemical industries because of the  resulting enhancement of transformation reactions. This also creates further  advantages, such as: noticeable reduction of catalyzing substances,  intensification of pigment color, enhanced use and reduced quantity of  additives, viscosity control of finished products. Crushing of active principle  particles generates an increase in surface area, thus enhancing preparation  assimilation.

 

 

GMPMax turbine emulsifying machine is a coaxial and triple type  mixer, suitable to stable homogenizing and emulsifying, the finished granular is  very small. The quality of emulsifying depends on the disperse of the granular  on the preparation stage. The smaller the granular is, the weaker the trend of  accumulation to the surface becomes, thus the smaller the opportunity for the  emulsifying to be broken becomes. Relying on mixing of reversed impeller, under  the condition of homogenizing turbine and vacuum status, you can get the  high-quality effect of emulsifying and mixing.

 

Structure

This unit applies upper  coaxial triple type mixer and hydraulic lifting mode to open the cover. The  speed of rapid homogenizing mixer is 0-3500 rpm (frequency control); the speed  of slow-speed scraping mixer is 0-70rpm (frequency control); the homogenizing  head applies high cutting eddy current type emulsifying mixer. The slow-speed  scraping mixer automatically abuts closely to the bottom and wall of boiler. By  applying vacuum sucking, this unit can suck in powder material by using vacuum  to avoid powder flying upward. The whole process is performed under the vacuum  condition in order to keep from the production of air bubble after the material  is mixed at high speed and up to hygienic asepsis requirement. This system is  equipped with CIP cleaning equipment. The parts of container, which contact the  material, are made of SUS316L stainless steel and inner surface mirror polish is  up to 300MESH (sanitary level). In order to ensure stability of control part,  the electric control parts apply the products from German Siemens. The unit is  made completely in conformity with GMP and is the most advanced, ideal ointment  and cream production equipment currently in China.

 

Low-Speed Mixing  System

Two reversed low-speed mixing  systems, composed of a hanging bracket full of scrapers as well as  impeller.

The full automatic movable  scraper’s surface is made of PTFE, only working under the condition with  material. It’s easy for disassembly and cleaning.

Dynamic balancing coaxial  shaft

Outer hanging brackets and  inner impellers are made of stainless steel SUS316L.

The timing is controlled by  PLC to facilitate the setting of working time.

The speed of the equipped  reduction motor can be controlled directly by inverter to 0-70  rpm

The low-speed mixing system  produces two independent countercurrent flows inside the  material.

One vertical fluid along the  center can force material to fluid to the bottom of container. Its function is  to convey the material to the bottom of homogenizing-turbine  rapidly.

Another circle flow forces the  material encircle the inner wall of the mixing container to facilitate the  material to make heat-exchange during heating or cooling stage, which can  prevent the material from being damaged due to overheat or  overcooling.

 

High Speed Homogenizing  Mixing System

High-speed homogenizing-mixing  activity is accomplished by one turbine installed on the center bottom of  tank.

Turbine is composed of dentate  stator and rotor with impeller

Turbine is made of stainless  steel SUS316L, rotating parts pass the dynamic balancing coaxial  shaft.

The timing is controlled on  the control panel to facilitate the setting of working  time.

Adjust speed by inverter  control: 0-3500 rpm

This kind of structure i.e.  executing on the turbine not from the bottom can assure high cleanness of the  process project. The reasons are as follows:

a) The material will not be  polluted without the influence of motor flange connection.  

b) Turbine is made easy for  cleaning, maintenance, assembly and disassembly.

c) The bottom of tank is  completely smooth without connection and is easy to clean.

d) Assemble a valve on the  center bottom of the tank for discharge.

e) The mixing and homogenizing  motors are installed on the top of the tank, which is far from the processing  area.

f) Strictly ensure the safety  of the operators.

 

Heating/Cooling  System

Heated by the steam in the  double jackets

The temperature of material in  the container may be controlled through temperature sensor signal from the  control panel

Temperature control is  composed of temperature module and temperature sensor installed at the bottom of  the tank. Actual temperature of material may be read  correctly.

Cooling is directly  accomplished by the external cold water through the  jacket.

 

Vacuum  System

Liquid ring vacuum pump is  equipped with solenoid control valve at the water inlet.

Vacuum gauge indicates the  vacuum in the container. Max value is -0.95Mpa, and the vacuum can kept for more  than 10 hours

Vacuum safety switch is  designed to keep the upper cover from opening at the state of  vacuum.

Air tightness of upper cover  is ensured by the silicon filling material on the flange.

Theoretically, max. vacuity is  730 mm/Hg at 20. In order to get optimal emulsifying result,  air mustn’t enter into the material. For the process under vacuum condition,  you’re allowed to add liquid or powder to the container  directly

 

Upper Cover Lifting  System

The lifting of upper cover is  fulfilled by a series of hydraulic devices. The device is fitted with a safe  limit system, which can keep the upper cover stopping at any expected  position.

 

Tilting System of  Container

Tilting system of container  used for discharge is accomplished by a series of mechanical devices and stops  at any angle.

 

Feeding  System

Directly add the material to  the tank after opening the cover

Under the vacuum condition,  the material will be absorbed into the tank by the suction valve through the  strainer. Under the vacuum condition, the additive (powder) will directly enter  the turbine through the hoper for excipient and additive mounted on the upper  cover or the valve at the center bottom of tank so as to shorten the dispersing  time

 

Discharging  System

Discharge the material from  the inclined container

Positive-pressure discharging  through compressed air is available

 

Process  Control

Observation window is equipped  with wind board and lamp with good inner visibility.

 

Safety  System

When the upper cover is open,  stop using the mixing and homogenizing motors and vacuum  pump

Limit micro switch  automatically executes the ON/OFF of the upper cover.

Control device will prevent  the water in the empty chamber from reaching the boiling  point.

The double-key system for  sealing the upper cover accords with current EC safety  standard.

Note: different parameters can  be customized to the request of users to reach optimal  performance.

 

 

Key words

Homogenizer, emulsifier,  cream/ointment manufacturing machine, vacuum emulsifier

Tube filling machine,  laminated tube filling machine, metal tube filling machine

cosmetic, chemical,  pharmaceutical and petrochemical industries

Adhesives - Starches -  Antibiotics - Cellulose and derivatives - Waxes - Colorants - Cosmetics - Beauty  creams - Toothpaste - Detergents - Emulsifying disinfectants - Emulsions -  Greases - Latex - Liposome suspensions - Lotions - Emulsifiable oils -  Lubricating oils - Pigments - Perfumes - Proteins - Resins - Syrups - Paints -  Vitamins

 

Clients