RU2607148C1 - Device for preparation of dry thermolabile biological materials - Google Patents

Abstract

FIELD: biotechnology.

SUBSTANCE: invention relates to biotechnology, namely to production of biomass for preparation of dry powder forms of immunobiological preparations, in particular drying (dehydration) of liquid thermolabile biologically active materials in multi-component mixture, their grinding and mixing till formation of homogeneous mass, and can be used in pharmaceutical industry for production of powders and tableted drugs for preventing and treating infectious diseases in human and animals. In case of device there is neck with rotary perforated damper, which combines functions of material loading and unloading. On neck of device case there is retainer with wedge-like locks for tight connection to expander-trap, intended for connection to vacuum system, and to catch particles of dried material and return them to working zone of device. Device is installed horizontally on support frame, design of which provides possibility of rotation of device case relative to horizontal axis through 180° and fixing its position with upper and lower orientation of the neck consequently. Cooling water jacket covers 3/4 of working side surface of cylindrical case of device. Device allows to perform in one cycle drying of thermolabile biological material under vacuum conditions at optimum temperature conditions and observing aseptic measures of process and preparation of homogeneous powdered mass by mixing obtained dry material with components of filler.

EFFECT: technical result of invention is creation of tightly closed device design combining functions of drier and mixer-grinder, which makes it possible to intensify process of drying of liquid thermolabile biological materials, reducing their thermal inactivation and probability of contamination of external microbiological flora.

1 cl, 1 dwg

Description

FIELD OF THE INVENTION

The invention relates to the field of biotechnology, specifically to the production of biomass for the preparation of dry powdered forms of immunobiological preparations, in particular drying (dehydration) of liquid thermolabile biologically active materials in a multicomponent mixture, grinding and mixing to obtain a homogeneous mass, and can be used in pharmaceutical production as A device for producing powdered and tableted medicines for the prevention and treatment of infectious diseases man and animals.

State of the art

Known dryer for liquid thermolabile products [and.with. No. 2015473, cl. F26B 11/04, 1994], which contains a sealed housing, inside of which a rotating perforated drum is installed, filled with 20 ... 50% inert bodies. An inductor is arranged inside the layer of inert bodies, having a sectional shape in cross section and mounted rotatably in the lower zone of the drum symmetrically to its vertical axis to form a gap between the inner surface of the drum and the arc of the segment, while the angle of inclination of the flat side of the segment to the horizon is from 0 ° to 28 °.

The disadvantages of the dryer are:

the impossibility of drying the product in a multicomponent mixture, which requires additional operations to unload the dried semi-finished product and mixing with other components in the mixer;

high temperature of heating the material during drying, leading to the inactivation of thermolabile biological materials in the substance.

As the closest analogue (prototype), a dryer for thermolabile materials was selected [USSR patent No. 2056603 C1, F26В 11/14], consisting of a horizontal case with a heated jacket, a chopper mounted for rotation, having a biconical shape with a central cylindrical part formed by blades, placed between the end walls, and the angle of inclination of the generatrix of the conical part is 30-60 °, the end cover, devices for loading and unloading material, a movable sampler, perforation with a shutter, grinding media, odvizhnogo sampler, fortified on the end cap, the housing mounting feet, motor, gearbox, clutch.

The disadvantages of this prototype device include:

drying time;

inconvenience and technical difficulties arising when feeding liquid material into the drying zone, namely, the introduction of liquid material is possible only through the loading neck with the grinder idle, which requires frequent shutdowns of the dryer and opening and closing of the plug on the neck;

limited heat transfer from the heating jacket to the material to be dried due to the small area it covers the working surface of the dryer due to the presence of an unloading device

significant thermal inactivation of the active biological agent in the material to be dried due to its heating upon contact with the surface of the heating jacket;

a high likelihood of contamination of biological material due to being in the form open to the atmosphere during drying;

Leakage in the design of the dryer, leading to the ejection of the dust phase of the material from the loading device as it dries;

the need for disassembling the dryer (disconnecting the end cover from the housing) for the evacuation of grinding media (metal balls);

the difficulty of ensuring tightness of the gate interface and perforation in the device for unloading material.

Disclosure of invention

The purpose of the present invention is the optimization and intensification of the drying process of liquid thermolabile biological materials, reducing losses due to thermal inactivation of the biological agent and increasing its level of protection from extraneous microbiological flora and making it possible to prepare a homogeneous powder mass from the dried material and components of the filler.

The essence of the invention as a technical solution is expressed in the totality of developments aimed at creating a device that allows for drying the thermolabile biological material in a vacuum in one cycle of operation under optimal temperature conditions and observing the asepticity of the process and preparing a homogeneous powder mass by mixing the obtained dried material with filler components.

The problem is solved due to the fact that in the device for the preparation of dry thermolabile biological materials (hereinafter referred to as the device), the following distinctive features are provided:

in the case of the device there is a neck with a rotating perforated damper that combines the functions of loading (upper neck position) and unloading (lower neck position) of the material;

on the neck of the device case there is a latch with wedge-shaped locks for hermetically connecting the expansion tank to it, designed to connect the device to a vacuum system (the expansion tank has a fitting for connecting the device to the vacuum system), and to capture particles of dried material and return them to the working device zone.

The device is installed horizontally on the supports of the bed, the design of which provides the ability to rotate the housing of the device relative to the horizontal axis by 180 ° and fixation of its position, respectively, with the upper and lower orientation of the neck;

a cooling water jacket covers 3/4 of the lateral working surface of the cylindrical part of the device body;

there is a nozzle for the dosed supply of liquid thermolabile biological material into the internal cavity of the drying device, mounted in the end cover of the housing along the axis of rotation of the paddle mixer.

When developing the shape and size of the device, we proceeded from the requirements of generally accepted physical, kinematic and geometric factors for mixing devices [1-5].

The technical result of the invention

The technical result of the invention is: creating a design of a hermetically sealed device combining the functions of a dryer and a mixer-grinder, which makes it possible to intensify the drying process of liquid heat-sensitive biological materials, reduce their thermal inactivation and the likelihood of contamination by extraneous microbiological flora. At the same time, an optimal combination of the main indicators of the technological process was achieved: energy supply, duration and laboriousness of carrying out both individual operations, and the process as a whole, the specific activity of biological material, its microbiological purity and device performance (yield of powdery mass) according to the specific activity of the material.

The way to achieve a technical result

The specified result is achieved:

a change in the design of the bed, which consists in installing the device on two supports with lodges located along the axis of the casing, which made it possible to expand the technical capabilities of the device, namely, to ensure that its casing rotates 180 ° relative to the horizontal axis. This made it possible to combine the functions of loading and unloading materials in one node - the neck with a perforated damper. Due to this, the technical capabilities for creating vacuum conditions in the device have increased, which, in turn, has led to a reduction in the drying time of the material and a decrease in the losses of the specific activity of the material;

removing from the design of the prototype dryer a device for unloading material with perforation and a shutter, which allowed to increase the volume of the cooling water jacket and its area until it reaches full coverage of the working surface of the proposed device and, accordingly, the exposure zone on the material to be dried, which ensured the creation of optimal temperature conditions as for the processes of moisture exchange in the drying process, and to reduce the thermal inactivation of the bioagent in the composition of the dried material;

hermetically sealed design of the device, allowing its connection to the vacuum system, which in combination with the rotation of the rotor-mixer allowed to intensify the drying process of liquid thermolabile biological material;

by installing a fitting in the central part of the end cap of the device, which allows metered supply of liquid thermolabile biological material to the drying zone under conditions of creating a vacuum and a predetermined temperature, mixing the components and dehydrating the biomass at the same time, which reduces the time to obtain the finished product and reduces the inactivation of the bioagent in the resulting substances.

Justification of compliance with the eligibility criterion of "novelty."

The proposed technical solution is new, since data on such a device is not known from publicly available information.

Justification of compliance with the eligibility criterion "inventive step"

The proposed technical solution has an inventive step, because of the published scientific data and the known technical solutions there is no precedent for the practical use of such a device that allows drying of biological thermolabile materials in one cycle of work and, on the basis of these materials, with the addition of filler ingredients, powdered forms of drugs used for prevention and treatment of infectious diseases of humans and animals. The pilot industrial model of the device is made in a single copy.

Justification of compliance with the eligibility criterion "industrial applicability"

The proposed technical solution is industrially applicable, since standard metal processing equipment and control devices can be used for its implementation. The device in accordance with our technical specifications can be mass-produced at the appropriate enterprise.

The created device allows for the implementation of appropriate technological operations for drying liquid biologically active pharmaceutical substances with a minimum decrease in the quality of the obtained semi-finished product and can be used to obtain granular mass for the preparation of powdered and tablet medicines used for the prevention and treatment of infectious diseases of humans and animals.

The technical essence and principle of operation of the proposed device are illustrated in figure 1, which schematically shows a General view of a device for the preparation of dry thermolabile biological materials. The device consists of a horizontal cylindrical body 1 with a conical end, a cooling water jacket, a fitting 2 for introducing coolant into the cooling water jacket, and a fitting 10 for draining coolant from the cooling water jacket, paddle rotor-mixer 3, perforated damper 4, expander-trap 5 with a fitting 6 and wedge-shaped constipation, the neck 7 of the body with wedge-shaped constipation, the rotary handle 8 of the perforated damper 4, the end cover 9 of the housing; the fitting 10 for feeding into the internal cavity of the device dried liquid thermolabile biological material, the latch 12 position of the housing of the device; grinding media 13 (metal balls) and beds with supports 14.

The device described above for preparing dry thermolabile biological materials is used as follows.

The device is mounted on the supports 14 of the bed and fixed in position with the neck and fixed in position with the neck 7 up. An adsorbent, which is one of the components of the finished powder mass, is poured into the device through the neck 7 and grinding media (metal balls) 13. On the neck 7 of the device, an expander-trap 5 is mounted by means of wedge-shaped locks. The device is connected through the nozzle 6 to the vacuum line. To the nozzle 11 of the device by means of silicone tubes connect the supply system of liquid thermolabile biological material. Through the nozzles 2 and 10, a cooling water jacket of the device is connected to the refrigerant supply system. The refrigerant is introduced into the cooling water jacket, the rotation of the paddle rotor-mixer 3 is turned on, and the device body, the adsorbent loaded into it and the grinding media 13 are cooled to a predetermined temperature.

After the adsorbent reaches a predetermined temperature, the vacuum system is turned on and a vacuum is created in the working area of the device with a predetermined residual pressure. After this, liquid thermolabile biological material is fed into the working zone of the device through the nozzle 11 at a given volumetric speed. Liquid material falling into the working area of the device is mixed with adsorbent. The resulting mixture by rotation of the paddle rotor-mixer 3 is mixed, as a result of which desorption of moisture from the mixture occurs from it under the action of vacuum at a given temperature. After the introduction of all the liquid material, the device is disconnected from the liquid material supply system. In the working area of the device, temperature conditions are created that are most optimal for preserving the biological properties of the dried material and for desorption of moisture (depends on the type of dried biological material and adsorbent). After the drying is completed, the device is evacuated, the expander-trap 5 is disconnected, and the calculated quantities of the ingredients — components for preparing the finished powder mass — are added to it. A collection tank is attached to the neck of the device (similar to a trap expander 5, but without a fitting in the bottom) and a paddle mixer 3 is turned on for 4-5 minutes to mix and grind the components. After the specified time, the rotation of the rotor-mixer is stopped, the constipation on the bed of the bed 12 is released and the device is turned down with its neck. The device is fixed by constipation 12 on the lodgement and the paddle rotor-mixer 3 is turned on. The finished powdery homogeneous multicomponent mass, passing the perforated damper 4 in the neck 7 of the body, is poured into the receiving container. Metal balls 13, lingering on the perforated shutter 4, remain in the cavity of the device. After collecting the obtained powdery mass in a container, it is separated from the device, hermetically sealed with a lid and transferred for further use. By turning the handle 8 of the perforated damper 4, the neck opening is opened and metal balls 13 are removed from the device cavity. After the indicated operation is completed, the device can be used for the next operation cycle.

Information sources

1. Goncharovich I.F., Uryev NB, Talysnik M.A. Vibration technology in the food industry. - The food industry. - M .: 1977. - S. 32-34.

2. Domashnev A.D. Design and calculation of chemical apparatus. Mashgiz. - M .: 1961.

3. Makarov Yu.I. Devices for mixing bulk materials. Engineering. - M .: 1973.

4. Bogdanov V.V., Borner R.V. et al. Polymer blending. Chemistry. - L .: 1979.

5. Ryabinin D. D., Lukach Yu.E. Mixing machines for plastics and rubber compounds. Engineering. - M., 1972.

Claims (1)

A device for preparing dry thermolabile biological materials, comprising a horizontal cylindrical body with a cooling water jacket and an end cap, an expander-trap, hermetically connected by means of wedge-shaped locks to the neck of the case for loading the initial and unloading of finished materials, freely placed grinding bodies, a fitting for supplying liquid thermolabile biological material, perforated damper for separating grinding media from the finished material during unloading, blade a rotor-mixer installed between the end wall and the cover of the housing with the possibility of rotation along the axis of the housing, characterized in that the device housing has a neck with a rotating perforated damper that combines the functions of loading and unloading material, on the neck of the device body there is a latch with wedge-shaped locks for hermetically attaching to it an expander-trap, designed both to connect the device to a vacuum system, and to capture particles of dried material and return expanding them into the working area of the device, the device is installed horizontally on the supports of the bed, the design of which allows the device to rotate about 180 ° relative to the horizontal axis and fix its position, respectively, with the upper and lower throat orientations; a cooling water jacket covers 3/4 of the lateral working surface of the cylindrical part of the device body; there is a nozzle for the dosed supply of liquid thermolabile biological material into the internal cavity of the drying device, mounted in the end cap along the axis of rotation of the paddle mixer.

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