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GMP (Good Manufacturing Practice) is an international standard that ensures compliance with the requirements for food substances, biologically active substances used in food and some food products.

The international GMP standard contains all the requirements that a manufacturing company must comply with: from the temperature in the production shop to the clothes of employees.
GMP standards are not only requirements for the production of medicines, but also strict requirements. The consumer can be sure of his health. MT is a completely new approach to technology compliance.
The usual quality control is decided only by some ready-made samples of products and parameters only of their quality or the quality of the delivered batch.
To strengthen GMP, comprehensive laboratory control and regulation of all parameters is carried out, which means that the quality of all products is controlled. GMP rules are used to minimize the risk of manufacturing errors.
Rules in the GMP code:
Clear regulation of all production processes
Production check
Qualified personnel
Development of strict regulations and technological instructions
Registration of all production income and deviations
Self-control in the enterprise
Formulation of the finished product and storage in optimal conditions
In addition to GMP, in the world practice of distribution and other standards corresponding to the practice of research, production, distribution, storage and delivery of medicines:
GEP Good Engineering Practice,
GLP Good Laboratory Practice,
GSP Good Practices for the Storage of Pharmaceutical Products,
GPP Good Pharmaceutical Practice,
GDP Good Distribution Practice.

 

Stainless steel chemical reactors

 

Chemical reactor - equipment for carrying out chemical reactions with a volume of several milliliters to tens of cubic meters. The purpose of the reactor is to develop the final product from the initial components while meeting the requirements of the maximum efficiency of the process.

 

 

 

Reactors are classified according to a number of characteristics:

by the state of the reacting substances:

In homogeneous reactors, one phase takes part: liquid or gas;

In heterogeneous reactors, several phases are involved simultaneously, for example, a liquid and a solid.

 

By the way of organizing the technological process:

♦ In batch reactors, the reagents are loaded into the reactor before or during the operation of the reactor, then the mixture is kept in the reactor and the products are unloaded;

 

♦ In continuous reactors, there is a continuous supply of reagents to the reaction zone and a continuous withdrawal of products;

 

♦ Semi-continuous and semi-batch reactors operate according to the principle of operation of two reagents, one of which is supplied continuously, and the second - periodically, or substances are supplied periodically, while the reaction products are removed continuously.

 

Subdivided into:

 

♦ operating under vacuum;

 

 functioning at high pressure;

 

♦ operating at atmospheric pressure.

 

 

 

In endothermic reactors, the reaction takes place with heat absorption;


In exothermic reactors, the reaction proceeds with the release of heat.


Displacement reactors assume that any element of the flow volume moves at a constant speed and does not mix with other elements, but, on the contrary, displaces them;


In the mixing reactor, the mixture is continuously mixed, in which one element of the starting material, entering the reactor, is immediately mixed with the entire contents of the reactor.


Adiabatic reactors operate without heat exchange with the external environment due to the achievement of thermal insulation on the outer surface of the reactor.


Isothermal reactors operate at a constant temperature, which is kept at the same level at all points of the reaction volume.


In polytropic reactors, the thermal regime is created not only by the intrinsic thermal effect of the process, but also by the constructive and technical factors of the apparatus.


By increasing the pressure in the reaction tank: operating under vacuum at high or atmospheric pressure;


By the thermal effect of chemical processes: endothermic and exothermic equipment;


According to the method of movement of the reaction medium: displacement reactors and mixing reactors.

Displacement reactors assume that any element of the flow volume moves at a constant speed and does not mix with other elements, but, on the contrary, displaces them. This reactor is called a plug flow reactor.


In the mixing reactor, the mixture is continuously mixed, in which one element of the starting material, entering the reactor, is immediately mixed with the entire contents of the reactor;


By thermal regime: adiabatic, isothermal and polytropic.


Adiabatic reactors operate without heat exchange with the external environment due to the achievement of thermal insulation of the outer surface of the reactor.


Isothermal reactors operate at a constant temperature, which is kept at the same level at all points of the reaction volume. In polytropic reactors, the thermal regime is created not only by the own thermal effect of the process, but also by the constructive and technical factors of the apparatus.


Chemical reactors made of stainless steel with a capacity of 50 l to 50 m3 are used for operation under pressure and vacuum in the widest range of temperatures (from -80 to + 350 ° C). They are used for hydrolysis, neutralization, crystallization, evaporation and other processes, so it is important that almost all process connections and threaded adapters can be easily disassembled and replaced. A wide range of accessories allows the reaction vessel to be used for any process.

 

In the chemical industry, a variety of materials are used to make equipment.

 

This is due to the fact that various and specific requirements are imposed on structural materials for chemical equipment.

 

The materials used for such purposes must:


 have sufficient mechanical strength and resistance to corrosion and processed substances;


 have appropriate physical properties (for example, good thermal conductivity);


 easy to be machined;


 do not have an inhibitory effect in the processes carried out in this equipment;


 do not affect the purity of the reaction products;


 be cheap and affordable.

 

The main requirement for materials of chemical devices in most cases is their corrosion resistance, since it determines the durability of chemical equipment. Therefore, the most common material for the manufacture of chemical reactors is now stainless steel.

The chemical reactor is made of acid-resistant stainless steel AISI 316. Equipped with an anchor stirrer with continuously variable speed control. Also has a steam heating jacket, temperature sensors, thermostat. The cover is lifted by two pneumatic cylinders along linear guides:

 


 

Stainless steel is an alloy steel resistant to corrosion in the atmosphere and corrosive environments. Stainless steel chemical reactors are ideal for the pharmaceutical industry, as their design features ensure maximum surface cleanliness and provide the necessary heat and material flux to meet the stringent GMP requirements. Also, these reactors are used in food, perfumery and cosmetic, chemical and paint and varnish industries.


Working with reactors made of stainless steel is safe, because it excludes the possibility of mechanical damage to the vessel, in contrast to glass reactors, which is an important factor when working with aggressive and explosive media. The mechanical strength will ensure a long service life of the equipment.


Chemical reactors made of stainless steel with a capacity of 50 l to 50 m3 are used for operation under pressure and vacuum in the widest range of temperatures (from -80 to + 350 ° C). They are used for hydrolysis, neutralization, crystallization, evaporation and other processes, so it is important that almost all process connections and threaded adapters can be easily disassembled and replaced.


A wide range of accessories allows the reaction vessel to be used for any process.


The main grades of stainless steel from which the reactors are made are AISI 316 (08X17H13M2), AISI 321 (08X18H10T) and AISI 304 (08X18H10).

 

 

C

Mn

P

S

Si

Cr

Ni

Mo

Ti

AISI 304

0,08 max

2,0 max

0,045 max

0,03 max

1,0 max

18-20

8-10,5

-

 

AISI 316

0,08 max

2,0 max

0,045 max

1,0 max

1,0 max

16-18

10-14

2-3

 

AISI 321

0,08 max

2,0 max

0,045 max

0,3 max

1,0 max

17-19

9-12

-

5*C% 0,5 max

 

Chemical composition (AISI 304, AISI 316, AISI 321).


AISI 304 is the most versatile and widely used of all stainless steel grades. Its chemical composition, mechanical properties, weldability and corrosion / oxidation resistance provide the best choice in most cases at a relatively low cost.


AISI 316 grade is a modification of AISI 304 steel with the addition of molybdenum and a higher nickel content. The presence of these elements in such a mass fraction significantly increases the corrosion resistance in most environments. Molybdenum makes steel more resistant to corrosion in chloride environments, seawater and acetic acid vapors. AISI 316 steel also has excellent mechanical and corrosive properties at low temperatures.


AISI 321 grade is a corrosion-resistant, heat-resistant, heat-resistant steel, unstable in sulfur-containing environments. This steel grade does not undergo intergranular corrosion even when welding in mild corrosive environments due to the addition of titanium to form a hard alloy.


In addition, it is possible to use special grades of steel, taking into account the requirements specified in the customer's specifications.


When ordering the manufacture of the TM "Roza Vetrov" reactor, you get an impeccable quality of the materials used (only certified European steels) and work performed, full warranty and post-warranty service of the manufactured equipment.


The customer has the ability to control the quality of the manufactured equipment at all stages of its production.


The price for chemical reactors depends on the volume of the reactor and the functions performed, depending on the technical specifications of the customer. The Roza Vetrov Group of Companies will manufacture a chemical reactor in full compliance with the applicable equipment quality standards and customer requirements from high-quality materials from European manufacturers in the shortest possible time at the most reasonable prices.