RU2264829C2 - Laboratory infusion solutions in polymer containers - Google Patents

Abstract

FIELD: medical engineering.

SUBSTANCE: installation has functional units having maintenance means. It has the laboratory unit proper and storage unit. The proper laboratory unit is divided into two compartments. Frontal compartment serves as auxiliary compartment and the back one serves as assistant aseptic compartment. The proper laboratory unit as a whole comprises functional equipment and maintenance means. An auxiliary compartment of the proper laboratory unit has treated water collector, injection water collector, plant for producing injection water from natural spring water under field conditions, drying box, compressor system, bactericide irradiator, vapor-type sterilizer, arranged along its perimeter. The plant for producing injection water from natural spring water under field conditions comprises precleaning filter, feeding pump, coarse filter, ultrafiltration means, high pressure pump, reverse-osmosis filter, specific electric resistance measurement means, carbon filter, cation-exchange filter, anion-exchange filter, the second specific electric resistance measurement means and cartridge filter for sterilizing by filtering. The reverse-osmosis filter is additionally attached to discharge line. The anion-exchange filter has additional outlet to the treated water collector. The cartridge filter for sterilizing by filtering has additional outlet to the injection water collector. The installation has treated water recirculation option. Complex for producing infusion solutions is mounted in assistant aseptic proper laboratory unit in polymer containers. It comprises system for preparing solution and its sterilizing filtration, aseptic dosing system for filling sterile polymer containers provided with filling needles, and power support unit, unit for controlling infusion solutions quality. The complex for producing infusion solutions in polymer containers has reactor, peristaltic pump, solution filter holder having membrane, connection tube set, dosing and filling device having sphincter valve, air filter holder and micro-box, power supply source, compressor unit. Means for maintaining both units have electrical equipment, illumination, heating and forced ventilation, water supply, internal and external communication systems. Water which quality is not to be higher than that of natural springs is useable in production process raw material.

EFFECT: simplified design.

20 cl, 2 dwg

Description

The invention relates to technical means of field pharmacy and can be used both in military medicine, disaster medicine, and in extreme situations to provide medical assistance to the affected population.

Known mobile sterilization-distillation complex for disaster medicine, comprising a steam boiler with a water heater, characterized in that it further comprises an electric boiler water pump, and including a self-propelled chassis with a first supporting frame, connected to a biaxial trailer having a second supporting frame, characterized in that the first and second load-bearing frames are made in the form of sealed box bodies, inside of which the air purification and ventilation system is rigidly fixed, divided by partitions for steam, boiler, washing, distillation and sterilization-compartment modules installed therein pharmacy equipment, wherein the equipment attachment points are designed as clamps, consisting of a bolted joint with spring dampers [Pat. RF №2074737, publ. 03/10/1997].

A sterilization-distillation device of a pharmacy is known that contains an energy unit, a boiler, washing, distillation and sterilization units, characterized in that it is made in the form of modules and submodules placed respectively in portable containers and microcontainers, while the modules are designed for their functional purpose, are interconnected, easily separable, connected and constructed in the form of inflatable laying-casing [US Pat. RF №2133125, publ. 07/20/1999].

A device is known for a mobile medical complex containing individual medical equipment for military personnel, portable sets of medical equipment, tents, trucks for transporting property and sets of standard medical equipment in the form of stretchers, supports for stretchers, unified racks, machines for accommodating the wounded on stretchers, folding benches , characterized in that it additionally contains a mobile complex of the medical unit of the regiment, consisting of three special installations, - sorted emergency-evacuation, car dressing AP-4, drugstore finished drugs based on GAZ-66 SEA vehicles, a mobile search and recovery complex consisting of armored medical vehicles based on armored personnel carriers, infantry fighting vehicles and landing [Pat. RF №2144812, not valid]. The pharmacy of ready-made medicines for the mobile complex contains a GP-20 dry-fire cabinet for sterilization of medicines with dry heat.

A vehicle for medical purposes is known, comprising a box body with an air purification and ventilation system, divided by partitions into compartments with medical equipment installed in them. A window is made in the partition near the side wall of the body, which allows maintaining the established air and sanitary-hygienic regime. The complex for the production of sterile drug solutions (RLS) in glass containers is located in a box with a laminar air regime [Pat. RF №2003515, publ. 02.20.1997]. Among the disadvantages of the device, it is worth noting the need for pre-sterilization preparation of containers, sterilizing them before and after filling, and the possible battle of glass bottles with solutions after sterilization.

Closest to the proposed solution, the device contains functional modules - technological, energy, material, administrative. The technological module contains an installation for producing water for injection. It is connected to the intermediate and main collectors of water for injection, the outputs of which are connected to the inputs of two mixers for the preparation of drug solutions. The outputs of the mixers are connected to the inlets of the diaphragm air compressors for supplying the solution from the solution collector. The collection is connected to the outputs of the compressors through the blocks of two systems of sterilizing filtration of drug solutions. Each system consists of 4 filter holders with connecting hoses and is included in two dispensers, the outputs of which are connected to the input of the automatic installation of forming polymer bags, filling them with a solution of medicines and welding, which includes a knot for changing the blow-molded bags. A water quality control unit is connected to the output of the injection water production unit. A solution quality control unit is connected to the output of sterilizing filtration units. The device, implemented on the basis of two trailer body vans and two container bodies, provides continuous radar operating time in the field in an autonomous mode for 3 days.

The disadvantage of this device is the obligatory presence in functionally connected technological equipment of the largest in overall dimensions and weight of the installation of molding polymer bags, filling and welding, working on a strictly defined polymer material [Pat. RF №2136316, publ. 09/10/1999].

The objective of the proposed technical solution is to create a simplified laboratory design for the manufacture and quality control of infusion solutions in polymer containers that meets modern requirements for medical equipment. The raw material for production should be assumed to be water of quality not higher than natural sources.

To achieve this result, we propose a laboratory, compiled in two modules (possibly vans) and allowing to produce sterile infusion solutions, having the source water of the quality of natural sources, aseptically pack them into ready-made sterile plastic containers. A laboratory containing functional modules with support means is distinguished by the fact that it includes the laboratory module itself and the warehouse module made of a base, two side, front and rear panels, as well as roof panels with bevels, equipped with hermetically sealed doors, entrance ramps, windows and hatches, and all windows have double glazing of safety glass; the module of the laboratory itself is divided by a partition with a door equipped with a transfer window into two compartments, the front one is made help, and the back - assistant-aseptic, the front compartment is equipped with its own side door, and the back panel of the assistant-aseptic has a double-leaf door with a window for routine maintenance, installation and dismantling of equipment, the laboratory as a whole is a combination of functionally and structurally connected technological and space-forming equipment and supplies, and the auxiliary laboratory compartment along the perimeter of the wall panels is equipped with a water collector purified, with a collection of water for injection, an installation for receiving water for injection in the field, an oven, a compressor unit, a bactericidal irradiator, along the partition on the adjacent side of the door - with a sink, on the other side of the door - with sterile clothing storage, a steam sterilizer, on the outside of the panel opposite the compressor - heating and ventilation units, in the assistant-aseptic made two laboratory tables of steel profiles with wooden drawers, adjacent to the partition with eraser with a table and hanging shelves, a complex for the manufacture of infusion solutions in polymer containers was mounted, including a solution preparation and sterilizing solution filtration system, aseptic dosing system in sterile polymer containers equipped with a filling needle, and an energy support module, on the opposite, means for controlling the quality of infusion solutions (device for monitoring injection solutions for solids, fluorimeter, refractometer, ionomer, etc.), pharmacy equipment and inventory (scales, weights, measuring utensils, etc.), seats are provided along the tables, air purifiers are mounted symmetrically on the door's rear panel, the warehouse module is also divided into two compartments by a partition with a door, the front one is made with material and the rear one auxiliary, in the recipe-material one of the longitudinal sides is equipped with racks and cabinets for medicines and auxiliary substances, consumables, etc., and on the opposite side a collapsible table for two workplaces is mounted, with the table-top of which is attached to the side panel with piano loops, a safe, a refrigerator are installed, while a hatch is made in the wall with prescription material cabinets, and an exit door is in the rear panel of the warehouse, the auxiliary compartment of the warehouse contains a petro-electric unit, spare parts kit, necessary household equipment and etc., while the means of providing both modules include systems of electrical equipment, lighting, heating and forced ventilation (air purification from radioactive dust, toxic substances, bacterial s means and feeding it into sealed modules), water, internal and external communication.

Water injection plant for injection is implemented by combining a pre-filter, feed pump, coarse filter, ultrafilter, high pressure pump, reverse osmosis filter, resistivity meter, carbon filter, cation filter, anion exchange filter, second resistivity meter and filter cartridge for sterilization by filtration, and the reverse osmosis filter is additionally connected to the discharge line, the anion exchange filter has additionally output to the collection of the purified water and the filter cartridge for filtration sterilization - for the collection of water for injection, and the arrangement is adapted to recycle the treated water.

The complex for the manufacture of infusion solutions in polymer containers contains a reactor, a peristaltic pump, a filter holder with a solution membrane, a set of connecting tubes, a metering and dispensing device with a pinch valve, an air filter holder and a microbox, a power supply unit, and a compressor unit.

All compartments of the laboratory and warehouse modules are additionally equipped with carbon dioxide OU-2 fire extinguishers and first-aid kits.

The living and working conditions of staff comply with established hygiene standards.

A team of two people - a pharmacist and a pharmacist in 16 hours of work can produce from 500 to 600 l of infusion solutions and perform all the procedures for quality control.

The laboratory can be designed as a quick-moving mobile field pharmaceutical equipment, while the laboratory itself is mounted on the chassis of a heavy truck (for example, ZIL-131), and the warehouse can be mounted on the chassis of a two-axle trailer with ladders and bolts to the chassis frame side members, and in the transport position under ladder is fixed to the van body, removable design - at the rear doors and a retractable fixed - at the side.

The time required to deploy a field laboratory is no more than 45 minutes, and the time for complete readiness for the manufacture of infusion solutions is from 2.5 to 3.5 hours.

The drawing shows the layout of the laboratory itself.

The laboratory module itself is divided by a partition with a door equipped with a transfer window into two compartments, the front one is made as an auxiliary and the back one as an aseptic assistant, the front compartment is equipped with its own side door, and a double door with a window for routine maintenance is provided in the rear panel of the aseptic assistant , installation and dismantling of equipment, all windows are double glazed from shatterproof tempered glass.

The auxiliary compartment of the laboratory along the perimeter of the walls is equipped with an installation for receiving water for injection in the field, a collection of purified water 2, a collection of water for injection 3, an installation for receiving water for injection in the field 4, an oven 5, a compressor unit 7, a sink 9, and a sterile storage clothes 17, on the outside of the panel with the compressor installation, a heater 6 and a filter-ventilation unit 8 are mounted, in the assistant-aseptic along the longitudinal sides two laboratory tables made of steel ofilia with wooden boxes, on the right table there are tools for monitoring the quality of infusion solutions (a device for monitoring injection solutions for mechanical impurities 10, a fluorimeter 11, a refractometer 12, an ionomer, etc.), pharmacy equipment and inventory 13 (scales, weights, measuring dishes, etc.), on the left and hinged shelves mounted complex 16 for filter sterilization and aseptic dosing filling of infusion solutions into plastic containers, a cylinder 15 with a reducer is mounted nearby, on the rear panel there is a symmetrical door with air purifiers 14 are mounted; seats 18 are provided along the tables.

The warehouse module is also divided into two compartments by a partition with a door, the front one is made with prescription material and the back one is auxiliary, in the prescription material one of the longitudinal sides is equipped with racks and cabinets for medicinal and auxiliary substances, consumables, etc., and on the opposite side, a collapsible table for two workplaces is mounted, the tabletop of which is attached to the side panel with the help of piano loops, a chair, a safe, a refrigerator are installed, while in the wall with prescription materials In the warehouse, a hatch is made, and in the rear panel of the warehouse there is an exit door, the auxiliary compartment contains a petro-electric unit, a spare part kit, necessary household equipment (washing, etc.), while the support tools include electrical equipment, lighting, heating and forced ventilation ( air purification from radioactive dust, toxic substances, bacterial agents and its supply to sealed modules), water supply, internal and external communications.

To study the possibility of mass production of infusion solutions in the field, a prototype of the mobile technical equipment of the medical service, the field laboratory of injection solutions, was developed and manufactured. The laboratory is a fast-moving mobile field pharmaceutical equipment and is intended for the manufacture of the most widely used in extreme situations infusion solutions in polymer containers.

A brief technical description of the box body in which the laboratory and warehouse are located is presented in Table 1.

Table 1
Technical characteristics of laboratory vans No. p / p Name of indicator Characteristic for a box body laboratories warehouse 1 Overall dimensions, mm: length 7450 6045 (with drawbar) width 2400 2400 height 3310 3199 2 Internal dimensions, mm: length 4000 4000 width 2250 2250 height (axis) 1800 1800 3 Internal dimensions of rooms divided by a partition into compartments, mm: front 1434 × 2250 3076 × 2250 rear 2542 × 2250 900 × 2250 4 Outdoor air temperature during operation, ° С from -40 to +50 5 Splash-proof during operation or during heavy sprinkling for 30 minutes Full (water must not penetrate inside the wagon) 6 Weight with equipment, kg 7950 (with car) 4162 (with trailer)

The walls of the modules on the inside are covered with light blue plastic, and the floors are covered with brown relin. These materials are waterproof, have low thermal conductivity, are resistant to chemicals and fully comply with the requirements for finishing materials used for interior decoration of pharmacies.

The work of the laboratory is as follows.

Deployment of the laboratory is carried out on flat areas with dense soil (grass) with a size of at least 12 × 8 m. In this case, the properties of the terrain, the presence of access roads, wind direction, etc. If there are water sources in the area where the laboratory is deployed, then the site, if possible, is chosen in the immediate vicinity to provide water. The laboratory and warehouse on the site are located in such a way that through the supply ventilation and open doors air does not get contaminated by the exhaust gases of the car’s engines, gas unit and heater. After the laboratory is installed on the site under the modules, drainage channels with a slope and pits for receiving wastewater come off at the drainage water outlet. On the leeward side at a distance of at least 10 m from the laboratory, a pit breaks out to drain the waste water and connects to the laboratory and the warehouse by weirs.

As the studies showed, the time required to install the laboratory and equipment of the deployment site is from 30 to 45 minutes.

Coagulation of the laboratory is carried out in the reverse order. When rolling up the laboratory, it is necessary to drain the water from all tanks and the water supply system, and place and fix the dishes, technological and laboratory equipment, and other accessories in places that correspond to the laying patterns.

Preparation of the laboratory for work begins with bringing habitability and livelihood systems, as well as technological equipment into working condition. After installing the laboratory, the electrical system is connected to a power source and grounded, the fuel tanks of the gas-electric unit and heaters are filled with fuel. At a site 2-3 meters from the port side of the laboratory, the rubber-fabric tank is laid out and filled with water.

After bring the equipment into working condition.

Studies have shown that the time required for direct preparation of the laboratory for work is from 1.5 to 2.5 hours, the time the laboratory is completely ready for the production of infusion solutions is from 2.5 to 3.5 hours.

Next, water for injection is obtained at the water treatment plant, and the corresponding nodes of the sterilization and bottling complex, other necessary items and auxiliary material are prepared for sterilization and sterilized for a specified time.

The complex of preparation and sterilization of solutions is activated and metered filling is carried out.

The work of technological equipment is carried out in accordance with the instructions.

During the tests to study the production capabilities of the laboratory, 500 l of infusion solutions in polymer containers were made, including 100 l of solutions: sodium chloride 0.9%; glucose 5.0%; novocaine 0.5%; Ringer-Locke; Popov antishock.

All of the above solutions meet the relevant requirements.

In the event of extreme situations or in case of sudden mass admission of victims to medical facilities, the laboratory can be given as a means of amplification to existing autonomous hospitals of various profiles.

The living and working conditions in the laboratory correspond to the established hygiene standards and are given in Table 2.

table 2
Basic medical-tactical and medical-technical characteristics of the laboratory No. p / p Name of indicator Characteristic indicator 1 Maximum speed, km / h 80 2 Cruising range, km up to 650 3 Ready time for the production of infusion solutions, h, no more 3,5 4 Production capabilities for the manufacture and quality control of infusion solutions in polymer containers, l / day. 500-600 5 Number of personnel 6 including pharmaceutical staff 4 6 Stock of medicines and auxiliary means, expendable medical property, providing autonomous work, days, no less than fifteen 7 Combined artificial illumination of workplaces with incandescent lamps, Lx, not less than: aseptic assistant 250 prescription material 250 subsidiary 200 8 Sound level during equipment operation, dBA, no more 95

Thus, a prototype of the field laboratory of injection solutions was developed and manufactured. The technical capabilities of the laboratory ensure that all technological operations for the manufacture of infusion solutions in polymer containers are carried out directly in the laboratory and warehouse modules, regardless of the time of year, meteorological or other conditions. The living and working conditions of laboratory personnel correspond to established hygienic standards and are incomparably better than in pharmacies in field medical institutions.

The laboratory staff provides for the following positions: chief, pharmacist, two pharmacists, an orderly, and an orderly driver (a total of 6 people).

A team of two people - a pharmacist and a pharmacist for 16 hours of work can produce from 500 to 600 l of infusion solutions and perform all the studies required to control their quality.

The laboratory is a highly mobile and autonomous technical means of field pharmacy that meets modern requirements for mobile technical means of medical service. The laboratory is fully prepared for the production of infusion solutions from 2.5 to 3.5 hours.

In the event of extreme situations or sudden mass admission of victims to field medical facilities, it is advisable to give the laboratory to military field hospitals of various profiles.

Claims (3)

1. The laboratory of infusion solutions in polymer containers, containing functional modules with support facilities, characterized in that it includes the laboratory module itself and the storage module, while the laboratory module itself is divided into two compartments, the front compartment is auxiliary, and the rear compartment is aseptic, actually the laboratory as a whole contains functional equipment and means of support, and the auxiliary compartment of the laboratory itself is equipped with a collection of purified water around the perimeter, sat a water heater for injection, a unit for receiving water for injection in the field from natural spring water, an oven, a compressor unit, a bactericidal irradiator, a steam sterilizer, while the installation for producing water for injection in the field from natural spring water is implemented by connecting a pre-filter, feed pump, coarse filter, ultrafilter, high pressure pump, reverse osmosis filter, electrical resistivity meter, angle filter a filter, a cation exchange filter, an anion exchange filter, a second resistivity meter and a filter cartridge for filter sterilization, the reverse osmosis filter is additionally connected to the discharge line, the anion exchange filter has an additional outlet to the purified water collector, and the filter sterilization filter cartridge to the collection water for injection, and the installation is made with the possibility of recirculation of the purified water; in the assistant aseptic laboratory itself, a production complex is mounted TWA of infusion solutions in polymer containers, including a system for preparing and sterilizing filtration of a solution, a system for its aseptic dosing into sterile polymer containers equipped with a filling needle, as well as an energy support module, means for monitoring the quality of infusion solutions, while the complex for the production of infusion solutions in polymer containers contains reactor, peristaltic pump, filter holder with a solution membrane, set of connecting tubes, metering device full-casting with pinch valve, air filter holder and microbox, power supply unit, compressor installation, means of providing both modules include systems of electrical equipment, lighting, heating and forced ventilation, water supply, internal and external communications. 2. The laboratory according to claim 1, characterized in that each of the functional modules is equipped with hermetically sealed doors. 3. The laboratory according to claim 1, characterized in that the laboratory itself is mounted on the chassis of a heavy truck, and the warehouse is mounted on the chassis of an automobile two-axle trailer.