RU2254875C1 - Construction of complex for producing of infusion solution in polymeric containers - Google Patents

Abstract

FIELD: pharmaceutical industry, in particular, equipment used in pharmacies, medical field enterprises, may be part of complex technical medicinal service means.

SUBSTANCE: complex has basic members and units such as reactor, peristaltic pump, filter holder with membrane for solution, connection pipes (set), dosing-pouring device with pinching valve, air filter holder, power unit, compressor unit, compressed gas balloon (for creating excessive pressure in reactor in case of lack of electric energy), compressed air balloon (for supplying air into aseptic dosed pouring unit in case of lack of electric energy).

EFFECT: light-weight construction of complex allowing infusion solutions to be produced and doses of ready solution to be poured into polymeric containers under aseptic conditions.

5 cl, 3 dwg

Description

The invention relates to the field of pharmacy and can be used in pharmacies, including field medical institutions, as well as a separate element in more complex samples of medical equipment.

A device for the production of infusion solutions and blood substitutes, which is part of the vehicle for medical purposes [RF Patent No.2003515, publ. 11/30/93]. The device contains a mixer-radiator, a system of sterilizing filtration and bottling in glass bottles. The technology involves working with glass containers, a possible battle and violation of the tightness of bottles after sterilization, the preparation of “clean” production facilities and does not meet modern requirements.

The main technological stages of the manufacture of injection solutions are their preparation for sterilization, sterilization itself and metered filling.

Most often, sterilization of solutions by filtration in pharmaceutical practice is carried out on the installation of a sterilizing filter USF-293 designed by the Design Bureau of Fine Biological Engineering (Kirishi) and the like. The USF-293 installation was tested in laboratory and pharmacy conditions. However, these installations do not have structural elements to prevent secondary contamination and microbial contamination of sterilized solutions in the filling zone, which does not allow their use for the manufacture of infusion solutions in polymer containers.

Closest to the claimed technical solution is included as an element in an autonomous device for preparing sterile drug solutions containing functional modules. The technological module of the device includes mixers for the preparation of drug solutions, solution delivery compressors, two sterilizing filtration systems for drug solutions, each of which consists of 4 filter holders with connecting hoses and two dispensers. The outputs of the latter are connected to an automatic installation for the formation of polymer bags of low density polyethylene, filling them with a solution and welding. This installation is the largest in overall dimensions and weight of the equipment, the device as a whole becomes too heavy and not always justifiably complex [RF Patent No. 2136316, publ. 09/10/99].

The objective of the invention is the creation of a lightweight construction of the complex, allowing for the manufacture of infusion solutions and aseptic dosed filling of the finished solution in a sterile polymer container.

The problem is solved by the proposed device.

The device of the complex for the manufacture of infusion solutions in polymer containers includes a preparation system and a sterilizing filtration solution, a metered filling system and an energy support module, characterized in that the preparation and sterilizing solution filtration system comprises a reactor with a removable cover, a level gauge and an immersion filter, the outlet of the latter is connected by a peristaltic pump supplying solution with an inlet equipped with connecting hoses of the filter holder assembly and from the outlet the filter holder - to the aseptic dosing system, the aseptic dosing system includes a pinch valve, an aseptic filling microbox that enters the sterilization and air supply unit into the working area and connected to the source of creating excessive air pressure with the second filter holder, as well as a dispenser that makes up a dynamic weighing container with a polymer container measuring system, while the energy support module includes a pneumatic system for creating excess pressure in the reactor, a pneumatic system, providing sterilization by filtering the air entering under pressure, and the formation of a laminar flow of sterile air in the area of aseptic metered filling and optionally - an electric power source.

A device for the manufacture of infusion solutions in polymer containers is also characterized in that the microbox for providing aseptic filling is a pneumohydraulic device that creates a two-layer laminar flow of sterile air.

The filter holder of the device can be mounted on a swivel bracket.

The design feature of the reactor is the ability to supply from it a solution for sterilization by filtration even in the absence of electrical energy. To do this, it is made with a removable cover, hermetically sealed with a screw lock, with a control pressure gauge and two fittings.

Sterilizing filtration and aseptic dosing systems are easily disassembled with the possibility of sterilization.

Moreover, a device for the manufacture of infusion solutions in polymer containers can be made in the form of an independent product or in the form of an element of a stationary or mobile laboratory.

To study the feasibility of manufacturing infusion solutions in polymer containers in the field, a prototype of technological equipment for filter sterilization and aseptic dosed filling of infusion solutions into sterile polyvinyl chloride plastic containers with a filling tube was developed and manufactured.

The complex can be placed both in a specially equipped room (aseptic) of pharmacies of stationary medical institutions, and in an adapted room (tent, engineering structure, etc.) of pharmacies in field medical institutions. In addition, the complex can be installed in a closed universal oversized car body.

The above elements and nodes of the complex are functionally combined into systems: preparation and sterilization of infusion solutions by filtration and aseptic dosed filling of infusion solutions into polymer containers.

The proposed solution is accordingly illustrated.

Figure 1 shows the design of the system for the preparation and sterilization of infusion solutions by filtration.

Figure 2 presents the design of the aseptic dosed filling system.

Figure 3 presents the design of the sterilization unit and the air supply to the working area.

A system for preparing and sterilizing infusion solutions in polymer containers (FIG. 1) comprises a stainless steel reactor 1 of 3 mm thickness. A float with measured divisions (level gauge 2) and a silicone tube with a submersible filter 3, which is a funnel equipped with a filter screen, are placed in the reactor. The funnel and mesh are made of stainless steel. The reactor is equipped with a stirrer 4 for faster dissolution and mixing of medicinal substances in the water for injection coming from the collection 5.

The reactor is made with a removable cover 6, hermetically sealed with a screw lock, with two fittings 7, 7 ^a - for draining the liquid and supplying gas from the cylinder under pressure, respectively, and with a control gauge 8.

To release air from the filter holder into the reactor, a tube 9 is provided, equipped with a clamp 11. The reactor is mounted on a pallet 10. Pinch valve 12, the filter holder 13 (d = 293 mm) on the swivel bracket, allowing easy assembly and disassembly, and the peristaltic pump 14 is connected system of silicone tubes with a manometer 8 ^b . An electric cable 15 for controlling the system of aseptic dosed filling of infusion solutions is connected to the system through a pinch valve 12.

The electrical circuit for controlling the filling system (FIG. 2) includes the indicators “READY” 16, “BULK” 17, “DOSE” 18 and the START button 19 mounted on the dispenser 20. This also includes the power supply 21, (mounted on a shelf 22) and socket 23 of the power supply.

Functionally, the aseptic dosed filling system for infusion solutions consists of two units: supplying a sterile solution and filling containers and supplying sterile air to the working area.

As part of the unit for supplying sterile air to the working area from the compressor, a pressure gauge 8 ^{a is made} , connected to a filter holder 25 for sterilizing the air by means of silicone tubes 26 (inlet, connecting, transitional). A bracket 24 is mounted on the upper plane of the shelf 22, fixing the filter holder 25. The compressed air line is led to microbox 27 made with a cover 28. A line b for supplying a sterile solution from its preparation and sterilization system is connected to microbox 27 through a tube system and pinch valve 12. The microbox is equipped with a folding clamp 29 and the output is connected to the filling needle 30 and the filling tube 31 of the container 32 of injection solutions. The container is attached with a clothespin 33 to the lever of the dispenser 20. The dispenser is designed as a weighing device with electronic control, activated through the power supply 21 from the socket 23. The lever is equipped with a control weight 34 to compensate for the mass of empty containers. On the upper plane of the shelf 22, a bracket 35 is made for attaching scissors.

The sterilizing filtering system of the complex operates as follows.

The infusion solution to be sterilized by filtration under a pressure of about 0.2 MPa is fed through the inlet pipe into the inner space of the filter holder 13, is pressed through the pores of 0.15-0.2 microns of the sterilizing membrane. The sterile filtrate through the outlet pipe through a silicone tube enters through the pinch valve 12 to the inlet fitting of the microbox 27. Depending on the state of the pinch valve, the operating mode of the system changes. When the valve 12 is pressed, that is, turned off, the filtering stops and the liquid at the outlet of the filter and in the tube is under pressure. When voltage is applied to the valve 12 from the electronic device 21 of the weighing batcher 20, the valve opens and the sterile filtrate enters the microbox 27 at a speed of about 15 ml / s for subsequent filling into the polymer container 32.

The design of the sterilization unit and the air supply to the working area is presented in figure 3.

The block has a filter holder 25 (d = 90 mm), a microbox 27, a microbox cover 28, an air supply pipe to the filter 26, air supply pipes to the micro box and a transition 26 ^a , fittings for sterile air 36, a filter holder cover 37, a filter holder body 38, rubber ring 39, sterilizing membrane 40, sterilizing membrane 40 ^a , support mesh 41, filter holder bracket 42 (d = 90 mm), filter holder bracket 43 (d = 293 mm), filter holder 25 (d = 90 mm) assembly, microbox 27 assembled; and - air.

Block sterilization and air supply to the working area is as follows. From the compressor, a purified, but not sterile air is supplied through a silicone inlet tube 26 at a pressure of 0.02-0.05 MPa. The pressure value is controlled by a built-in pressure gauge 8 ^a . For normal operation of the pneumatic system, an air supply of 20-40 l / min should be provided. Sterilization of air is carried out as it passes through the membrane 40 with a pore size of 0.15-0.20 μm, a diameter of 90 mm (Teflon, nuclear or other) located in the filter holder 25.

The design features of microbox 27 are determined by the specifics of its purpose. It is a pneumohydraulic device that provides sterile conditions in the area of connection of the filling needle 30 of the container 32 with a drain tip. The basis for ensuring sterile conditions in the working area is the creation of a two-layer laminar flow of sterile air moving at a speed of 0.3-0.5 m / s. A pneumatic system consisting of a compressor unit of the UK-40-2M type, a sterilizing air filter 25, a control pressure gauge 8 ^a and silicone connecting tubes 26 for air supply is intended for its production. The tubes are connected to fittings 36 for sterile air (3 pcs.), Located on the upper plane of the microbox. Inside the micro-box, due to specially calculated air elements, a two-layer laminar flow of sterile air is formed, which forms a sterile air curtain under the micro-box with a diameter of 10-15 cm.

The system of aseptic dosed filling of infusion solutions in polymer containers works as follows.

After the preparatory operations for its disassembly, sterilization and assembly are completed, the compressor is turned on, the cover 28 of the microbox 27 is removed and the presence of an air curtain is checked. The power of the dispenser is turned on, while the indicator 16 "READY" on its console lights up. Preparing to fill the container. Then the button 19 "START" dispenser is pressed. This action opens the pinch solenoid valve 12 and the sterilized solution begins to flow into the microbox 27 (line b), the 17 BULK indicator lights up. After a certain time (depending on the value of the set dose), the container 32 is filled to a predetermined volume, the balance beam lowers and a special electronic sensor 21 is triggered - dosing is completed. The pinch valve 12 is de-energized and the infusion solution stops flowing into the microbox, and indicator 18 “DOSE” lights up on the dispenser 20. After that, the operator seals the filling tube 31, carefully removes the needle 30 from the drain tip and the container 32 from the clothespin 33.

The test results showed that the deviations from the set dosing volumes of infusion solutions were not more than 1%, which fully corresponds to the norms of permissible deviations in the total volume of liquid dosage forms made by the mass-volume method.

The quality of infusion solutions is ensured by the proposed complex, which carries out preparation, sterilization by filtration and aseptic filling of sterilized solutions and the use of polyvinyl chloride containers with a filling needle for packaging ready-made solutions.

Currently existing technical means do not allow to fully implement the proposed technology for the manufacture of infusion solutions in polymer containers in the field.

For the first time, a prototype was developed and manufactured - a set of technological equipment for the preparation, sterilization by filtration, and aseptic dosed filling of infusion solutions into polymer containers. A fundamentally new structural element of the complex, which ensures the prevention of microbial contamination of sterilized infusion solutions in the filling zone, is the microbox. Its use allows filling sterile polymer containers in rooms belonging to different classes of air purity.

The operator’s productivity when working at the complex is from 70 to 80 containers with a volume of 450 ml per hour, from 105 to 120 containers with a volume of 200 ml per hour.

There is a standby mode of the complex in the absence of electrical energy. When operating in the indicated mode, a cylinder with compressed gas (N ₂ or CO ₂ ) is used to supply solutions, and a cylinder with compressed air is used to supply air.

When working in standby mode with the help of the complex, at least 170 containers with 450 ml infusion solutions can be made.

Dimensions of the complex (placed on a special table) - 2500 × 600 × 1700 mm; occupied area - 1.5 m ² , power consumption (at 220 V, 50 Hz) - not more than 0.5 kW, which allows you to mount the complex in the back of a van on a heavy truck chassis (for example, ZIL-131).

Claims (5)

1. The device complex for the manufacture of infusion solutions in polymer containers, including a system for preparing and sterilizing filtering a solution, a system for its aseptic dosing and an energy support module, characterized in that the system for preparing and sterilizing filtering a solution contains a reactor with a removable lid, a level gauge and an immersion filter, the outlet of the latter is connected by means of a peristaltic pump supplying solution to the inlet of the filter holder provided with connecting hoses from the outlet of the filter holder to the aseptic dosed filling system, which includes a pinch valve, an aseptic filling microbox that enters with the second filter holder in the sterilization and air supply unit in the working area and is connected to the source of creating excess air pressure, as well as a dispenser that is made with polymer dynamic weighing measuring system with the container, while the energy support module includes a pneumatic system for creating excess pressure in the reactor, a pneumatic system, Continuous sterilization by filtering the air entering under pressure, and the formation of a laminar flow of sterile air in the aseptic dosed filling zone, and optionally an electric power source. 2. The device complex for the manufacture of infusion solutions in polymer containers according to claim 1, characterized in that the aseptic filling microbox is a pneumohydraulic device that creates a two-layer laminar flow of sterile air. 3. The device complex for the manufacture of infusion solutions in polymer containers according to claim 1, characterized in that the filter holder is mounted on a swivel bracket. 4. The device complex for the manufacture of infusion solutions in polymer containers according to claim 1, characterized in that the sterilizing filtration and aseptic dosing systems are easily disassembled with the possibility of sterilization. 5. The device complex for the manufacture of infusion solutions in polymer containers according to any one of claims 1 to 4, characterized in that it is made as a stand-alone device or as an element of a stationary or mobile laboratory.

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