CN102018970B - Sterilization process and equipment of absorbable sutures - Google Patents
Sterilization process and equipment of absorbable sutures Download PDFInfo
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- CN102018970B CN102018970B CN 201010606248 CN201010606248A CN102018970B CN 102018970 B CN102018970 B CN 102018970B CN 201010606248 CN201010606248 CN 201010606248 CN 201010606248 A CN201010606248 A CN 201010606248A CN 102018970 B CN102018970 B CN 102018970B
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Abstract
The invention provides a sterilization process and equipment of absorbable sutures. The invention belongs to the technical field of sterilization and relates to an ethylene oxide sterilizer and process of absorbable sutures. According the invention, the problems that after being sterilized by the previous ethylene oxide sterilizers, the absorbable sutures have relatively high ethylene oxide residues and relative high humidity are solved, thus the requirements for asepsis, low ethylene oxide residues and low humidity of the sterilized sutures are met. The sterilization process is characterized by comprising the following steps: firstly maintaining the temperature and humidity in a container; secondly introducing ethylene oxide into the container; and finally, vacuumizing the container. The equipment for sterilization comprises a control cabinet with a programmable logic controller (PLC), a box body, a heating system, a vacuum system, a feeding system and a humidifying system, and the heating system, the vacuum system, the feeding system and the humidifying system are connected with the box body.
Description
Technical field
The invention belongs to the sterilization technology field, relate to a kind of absorbable suture ethylene oxide sterilizer and technique.
Background technology
Absorbable suture is a kind of small-sized medical supplies that are absorbed by the body by the mode of hydrolysis, its packing need to have high resistance bacterium property and sealing, prevent external environment to its microbial contamination and water, steam to its hydrolysis, aseptic, drying regime after making it remain on sterilization.
Usually the sterilizing methods of absorbable suture adopts chemical method, and biocide selected in sterilization process is generally oxirane.Oxirane is a kind of poisonous, inflammable, explosive gas.Its Bactericidal Mechanism is under certain temperature, pressure, humidity, make by bacterial spore sprouting, the bacterial reproduction on sterilizing article surface, oxirane is absorbed by antibacterial, with bacterioprotein generation alkylating, hinder the normal chemical reaction of bacterioprotein, affect bacterial metabolism, thereby reach the purpose of sterilization.Absorbable suture and packing character thereof and oxirane characteristic and Bactericidal Mechanism thereof have determined that jointly the absorbable suture that absorbable suture is first sterilized after the technological process of rear encapsulation and ethane via epoxyethane sterilization has the characteristic of aseptic, low ethylene oxide residue, dry low humidity.
Ethylene oxide sterilizer in the past and technique thereof are not suitable for the sterilization of absorbable suture, and the absorbable suture after subject matter and shortcoming are to sterilize can not satisfy the requirement of its low ethylene oxide residue, dry low humidity.
Summary of the invention
The sterilization process and the use equipment that the purpose of this invention is to provide a kind of absorbable suture, solution is after ethylene oxide sterilizer sterilization in the past, absorbable suture has high ethylene oxide residual quantity and the problem of high humility relatively relatively, aseptic with the stitching thread after satisfied sterilization, as to hang down ethylene oxide residue, dry low humidity requirement.
For solving the problems of the technologies described above, the invention provides:
A kind of sterilization process of absorbable suture, it mainly is comprised of following steps:
A) absorbable suture subject to sterilization is put into clean sealed container and sealing, and maintained the temperature at 45 ~ 55 ℃, humidity in sealed container 45 ~ 50%, pressure is 0.5torr, and be at least 1 hour standing time;
B) inject ethylene oxide gas in sealed container, make the concentration of the oxirane in sealed container reach 600～1000mg/L, keep more than 6 hours;
C) sealed container is carried out evacuation, oxirane and other gas are extracted out, make the pressure in sealed container reach 0.5tor;
Open at last sealed container, feeding, it is that the clean bench of 100 grades is packed that product is moved to lustration class.
Temperature 45 ~ 50% the time, is conducive to the Growth and reproduction of antibacterial at 45 ~ 55 ℃, humidity; Because the antibacterial that adheres at object surface is the antibacterial that is in brood cell's phase mostly, have stronger resistance, be not easy to kill; When antibacterial grows into adult from the brood cell phase, then fill oxirane in sealed container, the protein generation alkylated reaction of oxirane and antibacterial makes the protein generation degeneration of antibacterial, hinders the normal growth metabolism of antibacterial, thereby reaches the purpose of kill bacteria.
For making absorbable suture after sterilization satisfy the requirement of its low ethylene oxide residue, dry low humidity, sealed container is carried out evacuation, when vacuum reaches high value, as 0.5tor, just can be so that residual degree and the aridity of the oxirane of sealed container interior reach requirement.
As preferably, at c) after step, also carry out following two steps:
D) inject pure nitrogen gas to sealed container pressure and rise to an atmospheric pressure, then sealed container is carried out evacuation, make the pressure in sealed container reach 0.5tor;
E) repetition d) process is 40 ~ 50 times.
When evacuation, by nitrogen, oxirane and steam are wrapped up out, by inflated with nitrogen and evacuation repeatedly, be conducive to reduce sealed container interior oxirane residual degree and the aridity of sealed container is provided.
For sterilization process of the present invention, equipment is used in the sterilization that the invention provides a kind of absorbable suture, comprises switch board, casing and the heating system that is connected with casing, vacuum system, medicine system, humidification system that PLC is housed;
Described casing comprises the stack shell that is cuboid of the both ends open of horizontal positioned, the stack shell sidewall is that double-decker comprises inside and outside two-layer housing, inner layer outer wall is provided with along the open loop water leg of a plurality of annulars of casing length direction layout, described water leg is the sealing water stream channel of fitting with inner layer outer wall, water leg is provided with inlet opening and apopore in open loop place, be communicated with in the inlet opening of adjacent one of them water leg of water leg of open loop place and the apopore of another water leg, water leg forms a continuous water stream channel; Described stack shell inside is provided with several temperature sensors, and stack shell is provided with the hermatic door that is attached thereto cooperation at opening, and the outfan of temperature sensor all is connected with PLC; Casing has several installing holes on its outer wall, and installing hole is through hole 2;
Water leg is wound on stack shell, then when having flow of hot water to cross water leg, water leg can heat stack shell, and the area that contacts with stack shell because of water leg is large and evenly distribute, thereby can carry out homogeneous heating to stack shell and make the temperature difference of stack shell inside less.Casing can also be square, cylinder except above-mentioned cuboid; Water leg also can be fixed in the mode of spiral on casing simultaneously, and for easy to operate, water leg is the channel-section steel that is welded on the stack shell inner layer outer wall, and channel-section steel and internal layer are in conjunction with forming water stream channel, and water leg can be also the pipeline that is welded on the stack shell internal layer.Be communicated with in the inlet opening of adjacent one of them water leg of water leg of open loop place and the apopore of another water leg, can pass through pipeline communication, can also inlet opening and apopore be coupled together by channel-section steel is set, perhaps have connectivity slot in stack shell internal layer relevant position inlet opening and apopore are coupled together.The stack shell both ends open is convenient to deposit or get object, and stack shell can also be the cuboid of end opening one an end sealing.
Mainly the heater in hot water tank, temperature sensor, hot water circulating pump and several pipeline of device in hot water tank form described heating system by the hot water tank that water is housed, device, the outlet of hot water tank is connected by pipeline with the water inlet of hot water circulating pump, the outlet of hot water circulating pump is connected by pipeline with the inlet opening of water leg, the water inlet of hot water tank is connected by pipeline with the apopore of water leg, and the outfan of temperature sensor, the control end of described heater are connected control end and all with PLC are connected with hot water circulating pump;
Heating system is by the effect of pump, and the water that heater via in hot water tank is heated is input in the water leg of casing, and is got back in hot water tank by water return pipeline, thereby consists of the hot water cyclesystem of casing wall heating; Keep or keep the temperature of casing.By the monitoring of heating system and PLC, the temperature of stack shell can be maintained in needed scope.
Described medicine system mainly is comprised of oxirane steel cylinder, drug feeding pipeline, effusion meter and valve that oxirane is housed; Have the medicine feeding hole of oxirane on described stack shell, drug feeding pipeline is connected in turn the medicine feeding hole of oxirane steel cylinder, valve, effusion meter and stack shell;
By being used in combination of effusion meter and valve, control the amount that enters the oxirane in stack shell.
Described vacuum system mainly is comprised of several pipelines, several valves, at least one vacuometer and at least one vacuum pump; Several in through hole 2 on casing are connected with vacuum pump by pipeline, and vacuometer is arranged on box house, and valve is arranged on wherein on several pipelines, and the control end of vacuum pump is connected with PLC;
By vacuum pump, box house gas is taken away, make box house be in middle vacuum or high vacuum state, simultaneously because the vacuum of box house is higher, water vapour content seldom, can keep the aridity of box house like this, can prevent simultaneously bacterial reproduction and effectively lower ethylene oxide residue, also can adopt a plurality of different series connection of pumps evacuation, as better in conjunction with the vacuum effectiveness of taking out in molecular pump and mechanical pump.
Described humidification system is comprised of steam generator, humidification pipeline, valve and humidity sensor, the humidification pipeline is connected in turn the through hole 2 on steam generator, valve, casing, humidity sensor is installed on box house, and the outfan of humidity sensor is connected with PLC.
Steam enters into casing by steam generator, valve, humidification pipeline.Regulate the humidity of box house by humidification system, reach the required humidity of sterilization.
As preferably, described casing also is connected with carburetion system outward, carburetion system mainly is comprised of the hot water tank of carburator, vaporization pump, pipeline, valve, temperature sensor and heating system, hot water tank, vaporization pump, carburator are connected with each other by pipeline, valve installation with pipeline that vaporization pump both sides are connected on, temperature sensor is arranged in carburator, carburator is provided with the through hole 2 that matches with described drug feeding pipeline, and the part of passing through hole 2 and drug feeding pipeline of the drug feeding pipeline in medicine system is built in accommodation space; The outfan of described temperature sensor is connected with PLC.
Carburetion system is by the effect of pump, the water of heater via heating in hot water tank is input in carburator, carburator heats the pipeline of medicine system, makes oxirane be preheated before flowing to casing, during preheating, oxirane liquid in steel cylinder is become gaseous state.Got back in hot water tank by pipeline after water cooling in carburator, thus the hot water cyclesystem of formation carburator.Temperature sensor is the temperature of monitoring carburator, thereby assurance flows to the temperature of the oxirane preheating of casing.
As preferably, also be provided with insulation material between described stack shell internal layer and skin, filled thermal insulation materials is between water leg, and between water leg and casing skin;
Between the stack shell ectonexine, insulation material is set, the heat-insulating properties such as insulation material such as foam, sponge, pottery are good, the light material of quality again, can reduce heat and run off, and improve capacity usage ratio, and then reduce use cost, and quality gently is conducive to move.
As preferably, casing also is connected with compressed air system outward, and the contracting air system mainly is comprised of air compressor, air relief valve, pipeline, pipeline with air compressor, air relief valve, be connected in turn;
As preferably, the upper surface of described stack shell also is provided with the two-way cylinder that is connected with the hermatic door upper end, and the pore at two-way cylinder two ends is connected with described air relief valve by pipeline, electric control valve 27; Casing is respectively equipped with guide rail at the two ends of stack shell, and guide rail is along the upper end edge lengths direction layout of stack shell opening, and the upper end of described hermatic door is connected with several guide wheels, and described guide wheel coordinates with guide rail.
The motion of hermatic door can move to realize by control cylinder, and the problem that the labor intensity of having avoided manpower to open the door is large is saved manpower.Adopt general hydraulic cylinder also passable.
As preferably, described hermatic door is at least double-decker, internal layer is dull and stereotyped, the outer face of described flat board is provided with several seal cavities, seal cavity is covered with dull and stereotyped outer face, and seal cavity is provided with inlet opening and apopore, by pipeline, seal cavity is communicated with successively, the inlet opening of first seal cavity is connected by the apopore of pipeline with the hot water circulating pump of heating system, and the apopore of last seal cavity is connected with the hot water tank of heating system by pipeline; Outer housing for matching with flat board;
By heating system, can heat hermatic door, be conducive to keep inner hygral equilibrium after box sealing.
As preferably, be provided with some reinforcements in hermatic door, be used for reinforcing the structure of sealing.
As preferably, have annular groove on the end face of stack shell two openings, the sealing inflation ring of embedded the anti-oxirane corrosion that flushes with groove or cave in groove, have air inlet and venthole in the inboard that is positioned at inflation ring on groove walls, air inlet is connected with described air relief valve by pipeline, valve, and venthole is connected with vacuum pump by pipeline, valve.
Hermatic door is when closing, air compressor is inflated groove, inflation ring is ejected from groove with hermatic door fully contact, again casing is carried out evacuation, inflation ring is full with the pore filling between stack shell and hermatic door, reaches sealing effectiveness, when unpacking, groove is carried out evacuation, inflation ring cave in groove in and separate with hermatic door, just can open hermatic door.
As preferably, casing also is connected with the dry gas injected system outward, the dry gas injected system is comprised of dry gas steel cylinder, pipeline, valve that dry gas is housed, has the air inlet of dry gas on casing, and pipeline connects dry gas steel cylinder, valve, casing successively.
Dry gas enters into casing by valve, pipeline, dry gas the later stage take out oxirane the time, oxirane is taken out of, guarantee simultaneously the humidity requirement of box house.
As preferably, described valve is electromagnetic valve, and its control end is connected with PLC.
Carry out autocontrol valve by program or manual adjustment, save manpower and increase work efficiency simultaneously.
As preferably, the venthole of the vacuum pump of vacuum system is outer connects a waste gas collection box.
Waste gas reclaims and to be loaded with in casing for the water that absorbs oxirane, pumps into waste gas after vacuum pump is extracted the oxirane in casing out and reclaims in casing, and oxirane easily reacts generating glycol with water, can avoid the oxirane contaminated environment.
The invention has the beneficial effects as follows:
(1) the present invention is full-automatic device, adopts computer programming, under the PLC programme-control, realizes each step action, can adjust in real time, inquire about the parameters in sterilization process;
(2) the sterilization casing is the hexahedron heating, makes more uniform temperature in stack shell, and the difference of maximum temperature and minimum temperature can be controlled in less scope;
(3) steriliser is provided with humidification system and heating system, is conducive to antibacterial and breaks away from the spore phase, thereby play the effect of sterilization;
(4) adopt Sealing Technology and vacuum technique, the absolute pressure in stack shell can be reduced to 0.5torr, thereby remove residual oxirane on the rear product of sterilization, reduce the humidity of product.
(5) oxirane in use, is absorbed by external waste gas collection box, and the ethylene glycol that generates can recycle, and reduces production costs.
Description of drawings
Fig. 1 is barrel body structure schematic diagram of the present invention;
Fig. 2 is a kind of schematic diagram of box sealing door endothecium structure of the present invention;
Fig. 3 is that box sealing door of the present invention coordinates enlarged diagram with the stack shell end face;
Fig. 4 is box sealing door of the present invention and stack shell end face fit structure top view;
Fig. 5 is the another kind of schematic diagram of box sealing door endothecium structure of the present invention;
Fig. 6 is a kind of schematic diagram of apparatus of the present invention;
Fig. 7 is the second schematic diagram of apparatus of the present invention;
Fig. 8 is the third schematic diagram of apparatus of the present invention;
in figure: 1, stack shell, 2, through hole, 3, water leg, 4, the inlet opening, 5, apopore, 6, hermatic door, 7, the sealing inflation ring, 8, guide rail, 9, casing, 10, cylinder, 11, pulley, 12, pipeline, 13, seal cavity, 14, air inlet, 15, venthole, 16, the oxirane steel cylinder, 17, the vaporization pump, 18, hot water tank, 19, hot water circulating pump, 20, steam generator, 21, carburator, 22, the dry nitrogen gas cylinder, 23, vacuum pump, 24, air compressor, 25, air relief valve, 26, electromagnetic valve, 27, automatically controlled, 28, contiguous block, 29, connecting rod, 30, the waste gas collection box.
The specific embodiment
The present invention is further illustrated below in conjunction with description of drawings and the specific embodiment.
Embodiment 1: equipment (referring to accompanying drawing 6,7,8) is used in a kind of sterilization of absorbable suture, comprise that switch board (not shown in FIG.), casing 9 and the heating system that is connected with casing 9, vacuum system, medicine system, humidification system, compressed air system, carburetion system, dry gas injected system, vacuum system that PLC is housed connect a waste gas collection box 30 outward;
Wherein casing 9 comprises that the stack shell 1(that is cuboid of both ends open of horizontal positioned is referring to accompanying drawing 1), stack shell 1 sidewall is that double-decker comprises inside and outside two-layer housing, internal layer is the cuboid of both ends open, inner layer outer wall is provided with along the open loop water leg 3 of a plurality of annulars of casing 9 length directions layouts, water leg 3 is provided with inlet opening 4 and apopore 5 in open loop place, the inlet opening 4 of a water leg 3 in adjacent water leg 3 and the apopore of another water leg 35 are communicated with to get up, and whole water leg 3 forms a passage; Described water leg 3 is the sealing water stream channel of fitting with inner layer outer wall, and the sealing water stream channel combines (referring to accompanying drawing 1) by the channel-section steel that is welded on stack shell 1 inner layer outer wall and stack shell 1 internal layer, and adjacent water leg 3 is communicated with by channel-section steel; The outer housing for matching with internal layer of stack shell 1 is filled with insulation material between stack shell 1 internal layer and skin, insulation material is foam, and filled thermal insulation materials is between water leg 3 and between water leg 3 and casing 9 skins.All have a plurality of through holes that match on the skin of stack shell 1 and internal layer, through hole is in communication with the outside stack shell 1 inside.Casing 9 is equipped with at two openings of stack shell 1 hermatic door 6 that matches with stack shell 1, for strengthening the seal degree between hermatic door 6 and stack shell 1 open end, the viton seal ring (not shown in FIG.) of the annular that cooperatively interacts is installed all on hermatic door 6 and stack shell 1 end face;
heating system is mainly by the hot water tank 18 that water is housed, the heater (not shown in FIG.) of device in hot water tank 18, device is in the hot water tank 18, hot water circulating pump 19 and pipeline 12 form, the outlet of hot water tank 18 is connected by pipeline 12 with the water inlet of hot water circulating pump 19, the outlet of hot water circulating pump 19 is connected by pipeline 12 with the inlet opening 4 of the passage that is formed by water leg 3, the water inlet of hot water tank 18 is connected by pipeline 12 with the apopore 5 of the passage that is formed by water leg 3, the outfan of temperature sensor, the control end that the control end of heater is connected with hot water circulating pump all be connected (not shown in FIG.) with PLC.
Medicine system mainly is comprised of the oxirane steel cylinder 16 that oxirane is housed, drug feeding pipeline, effusion meter and electromagnetic valve 26; Have the medicine feeding hole of oxirane on described stack shell 1, drug feeding pipeline is connected in turn the medicine feeding hole of oxirane steel cylinder 16, electromagnetic valve 26, effusion meter and stack shell 1, and wherein the control end of electromagnetic valve 26 is connected with PLC.
Vacuum system mainly is comprised of pipeline 12, electromagnetic valve 26, vacuometer and vacuum pump 23; The through hole 2 that is positioned at 9 four jiaos of ends of casing is connected with electromagnetic valve 26, vacuum pump 23 successively by pipeline 12, and vacuometer is arranged on casing 9 inside, and the control end that the control end of electromagnetic valve 26, the outfan of vacuometer are connected with vacuum pump is connected with PLC respectively.
Humidification system is comprised of steam generator 20, pipeline 12, electromagnetic valve 26 and humidity sensor, pipeline 12 is connected in turn steam generator 20, electromagnetic valve 26, casing 9, humidity sensor is installed on casing 9 inside, and the control end that the outfan of humidity sensor is connected with electromagnetic valve is connected with PLC respectively.
Carburetion system mainly is comprised of the hot water tank 18 of carburator 21, vaporization pump 17, pipeline 12, electromagnetic valve 26, temperature sensor and heating system, hot water tank 18, vaporization pump 17, carburator 21 are connected with each other by pipeline 12, electromagnetic valve 26 is arranged on the pipeline 12 that is connected with pump 17 both sides of vaporizing, temperature sensor is arranged in carburator 21, carburator 21 is provided with the through hole 2 that matches with described drug feeding pipeline, and the part of passing through hole 2 and drug feeding pipeline of the drug feeding pipeline in medicine system is built in accommodation space; The control end that the outfan of described temperature sensor is connected with electromagnetic valve is connected with PLC respectively.
The dry gas injected system is comprised of the dry nitrogen gas cylinder 22 that dry gas is housed, pipeline 12, electromagnetic valve 26, by pipeline 12, dry nitrogen gas cylinder 22, electromagnetic valve 26, casing 9 is connected successively, and the control end of electromagnetic valve 26 is connected with PLC.
Embodiment 2: equipment (referring to accompanying drawing 7) is used in a kind of sterilization of absorbable suture, and its structure is basic identical with embodiment 1, and difference is the design that hermatic door 6 and stack shell 1 coordinate:
The upper surface of stack shell 1 is fixed with the two-way cylinder 10(that is connected with hermatic door 6 upper ends referring to accompanying drawing 3,4), the contiguous block 28 of a rectangle is fixed in the upper end of hermatic door 6, a connecting rod 29 is extended to two-way cylinder 10 directions in the middle part of contiguous block 28, the two ends of connecting rod 29 respectively with contiguous block 28 be connected the piston of cylinder 10 and be connected, drive the motion of hermatic door 6 by the piston movement of two-way cylinder 10, the pore at two-way cylinder 10 two ends is connected with air compressor 24 by pipeline 12, electric control valve 27, air relief valve 25; Casing 9 is respectively equipped with guide rail 8 at the two ends of stack shell 1, guide rail 8 is arranged along the upper end edge lengths direction of stack shell 1 opening, two hook-shaped contiguous blocks 28 are extended in the top of the two ends direction guiding rail 8 of described contiguous block 28, be fixed with respectively pulley 11 on described two hook-shaped contiguous blocks 28, pulley 11 coordinates with guide rail 8.
Have annular groove (referring to accompanying drawing 2) on the end face of two openings of stack shell 1, the sealing inflation ring 7 of embedded the anti-oxirane corrosion that flushes with groove or cave in groove, have air inlet 14 and venthole 15 on groove walls in the inboard of inflation ring, air inlet 14 is connected with air compressor 24 by pipeline 12, electromagnetic valve 26, venthole 15 is connected with vacuum pump 23 by pipeline 12, electromagnetic valve 26, and the control end that the control end of electromagnetic valve 26 is connected with vacuum pump is connected with PLC respectively.
Hermatic door 6 is double-decker, internal layer is dull and stereotyped, the outer face of described flat board is provided with 6 seal cavities 13, seal cavity 13 is rectangular, seal cavity 13 is covered with dull and stereotyped outer face (referring to accompanying drawing 5), seal cavity 13 is provided with inlet opening 4 and apopore 5, by pipeline 12, seal cavity 13 is communicated with successively, the inlet opening 4 of first seal cavity 13 is connected with the apopore 5 of the hot water circulating pump 19 of heating system by pipeline 12, and the apopore 5 of last seal cavity 13 is connected with the hot water tank 18 of heating system by pipeline 12; Outer housing for matching with the internal layer flat board.
Embodiment 3: equipment (referring to accompanying drawing 6) is used in a kind of sterilization of absorbable suture, and its structure is basic identical with embodiment 1, its distinguish with the design of hermatic door 6:
Hermatic door 6 is double-decker, internal layer is dull and stereotyped, the outer face of described flat board is provided with 8 seal cavities 13, seal cavity 13 is triangular in shape, seal cavity 13 is covered with dull and stereotyped outer face (referring to accompanying drawing 2), seal cavity 13 is provided with inlet opening 4 and apopore 5, by pipeline 12, seal cavity 13 is communicated with successively, the inlet opening 4 of first seal cavity 13 is connected with the apopore 5 of the hot water circulating pump 19 of heating system by pipeline 12, and the apopore 5 of last seal cavity 13 is connected with the hot water tank 18 of heating system by pipeline 12; Outer housing for matching with the internal layer flat board.Be the intensity of enhanced leaktightness door 6, be welded with the reinforcement (not shown) of M shape in the space of hermatic door 6.
Embodiment 4: equipment (referring to accompanying drawing 8) is used in a kind of sterilization of absorbable suture, and its structure is basic identical with embodiment 2, its distinguish with the connected mode of the venthole 15 of the design of hermatic door 6 and stack shell 1 end face groove:
Hermatic door 6 is double-decker, internal layer is dull and stereotyped, the outer face of described flat board is provided with 8 seal cavities 13, seal cavity 13 is triangular in shape, seal cavity 13 is covered with dull and stereotyped outer face (referring to accompanying drawing 2), seal cavity 13 is provided with inlet opening 4 and apopore 5, by pipeline 12, seal cavity 13 is communicated with successively, the inlet opening 4 of first seal cavity 13 is connected with the apopore 5 of the hot water circulating pump 19 of heating system by pipeline 12, and the apopore 5 of last seal cavity 13 is connected with the hot water tank 18 of heating system by pipeline 12; Outer housing for matching with flat board.Be the intensity of enhanced leaktightness door 6, be welded with the reinforcement (not shown) of M shape in the space of hermatic door 6.
Embodiment 5: a kind of sterilization process of absorbable suture, adopt the device in embodiment 4, and it is comprised of following steps:
A) close all electromagnetic valves 26, the hermatic door 6 of casing 9 is opened, but the stitching thread of the needs sterilization of packing into, and hermatic door 6 closes;
B) vacuum system is moved, and opens the electromagnetic valve 26 of vacuum system, opens vacuum pump 23, and observes the vacuum demonstration on switch board, when casing 9 internal vacuums reach 0.5tor, and shut electromagnetic valve door 26 and vacuum pump 23;
C) keep vacuum 30 minutes, observe the vacuum situation of change of casing 9 inside, judge the sealing property of casing 9, if the vacuum seal performance is good, there is no gas leak phenomenon, continue following process; If gas leakage is arranged, check casing 9;
D) heating system operation, the electromagnetic valve 26 of heating system is all opened, heater begins heating to the water of hot water tank 18 inside, and when water temperature reached 55 ℃, hot water circulating pump 19 began to start, the calandria stopped heating, flow of hot water outside casing 9 water leg 3 and casing 9 is begun heating, until the temperature of casing 9 inside reaches 53 ℃, when hot water tank 18 water temperatures during lower than 53 ℃, calandria begins heating, and maintenance heat water container 18 water temperatures are at 53 ℃ ~ 55 ℃;
E) humidification system operation, open the electromagnetic valve 26 of humidification system, produce dampness after steam generator 20 heating, dampness enters casing 9 inside through valve, pipeline 12, the humidity sensor of casing 9 inside is monitored its humidity, observe the humidity display on switch board, when the humidity of casing 9 inside reaches 50%, valve-off and steam generator 20;
F) carburetion system and medicine system are moved simultaneously, corresponding electromagnetic valve 26 is opened, vaporization pump 17 pumps into the water in hot water tank 18 in carburator 21, and the pipeline 12 that oxirane is flowed through that has that passes carburator 21 is heated, after hot water is cooling, pass back into again hot water tank 18 inside through piping 12; During the medicine system operation, oxirane flows into casing 9 inside through electromagnetic valve 26, pipeline 12, effusion meter, due to oxirane with liquid storage, be gaseous state after through carburator 21 heating, and by effusion meter, oxirane is added up, when the concentration of the oxirane of casing 9 inside reaches 1000mg/L, close the electromagnetic valve 26 of medicine system, carburetion system is out of service simultaneously; Oxirane rests in casing 9, keeps 6 hours;
G) heating system is closed, vacuum system moves again, opens the electromagnetic valve 26 of vacuum system, and oxirane and other gases of casing 9 inside are extracted out, until casing 9 internal pressures are down to 0.5torr, closes vacuum valve;
H) dry gas injected system operation, corresponding electromagnetic valve 26 is opened, nitrogen injects, when casing 9 internal pressures rise to an atmospheric pressure, close the electromagnetic valve 26 of dry gas injected system, the electromagnetic valve 26 of opening vacuum system continues to be evacuated to pressure drop to 0.5torr;
I) the repetitive operation last action is 45 times; Logical drying nitrogen returns to an atmospheric pressure with casing 9 internal pressures again;
Detecting the interior humidity of casing 9 is 1%RH, reaches the requirement standard.
Unpack at last, it is that the clean bench of 100 grades is packed that product is moved to lustration class.
Embodiment 6: a kind of sterilization process of absorbable suture, adopt the device in embodiment 4, and it is comprised of following steps:
J) close all valves, the hermatic door 6 of casing 9 is opened, but the stitching thread of the needs sterilization of packing into, and hermatic door 6 closes;
K) vacuum system is moved, and opens the valve of vacuum system, opens vacuum pump 23, and observes the vacuum demonstration on switch board, when casing 9 internal vacuums reach 0.5torr, and valve-off and vacuum pump 23.
L) keep vacuum 30 minutes, observe the vacuum situation of change of casing 9 inside, judge the sealing property of casing 9, if the vacuum seal performance is good, there is no gas leak phenomenon, continue following process; If gas leakage is arranged, check casing 9.
M) heating system operation, the valve of heating system is all opened, heater begins heating to the water of hot water tank 18 inside, and when water temperature reached 55 ℃, hot water circulating pump 19 began to start, the calandria stopped heating, flow of hot water outside casing 9 water leg 3 and casing 9 is begun heating, until the temperature of casing 9 inside reaches 48 ℃, when hot water tank 18 water temperatures during lower than 48 ℃, calandria begins heating, and maintenance heat water container 18 water temperatures are at 48 ℃ ~ 55 ℃;
N) humidification system operation, open the humidification system valve, produce dampness after steam generator 20 heating, dampness enters casing 9 inside through valve, pipeline 12, the humidity sensor of casing 9 inside is monitored its humidity, observe the humidity display on switch board, when the humidity of casing 9 inside reaches 45%, valve-off and steam generator 20;
O) carburetion system and medicine system are moved simultaneously, respective valves is opened, and vaporization pump 17 pumps into the water in hot water tank 18 in carburator 21, and to there being the pipeline 12 that oxirane is flowed through to heat, after hot water is cooling, through reflux again people's hot water tank 18 inside of piping 12; During the medicine system operation, oxirane flows into casing 9 inside through valve, pipeline 12, effusion meter, and heating is gaseous state through carburator 21 time, when the concentration of the oxirane of casing 9 inside reaches 600mg/L, close the medicine system valve, carburetion system is out of service simultaneously; Oxirane rests in casing 9, keeps 8 hours;
P) heating system is closed, vacuum system moves again, opens the vacuum system valve, and oxirane and other gases of casing 9 inside are extracted out, until casing 9 internal pressures are down to 0.5tor, closes vacuum valve;
Q) dry gas injected system operation, respective valves is opened, and nitrogen injects, and when casing 9 internal pressures rose to an atmospheric pressure, valve-off was opened vacuum valve and is continued to be evacuated to pressure drop to 0.5torr;
R) the repetitive operation last action is 45 times; Logical drying nitrogen returns to an atmospheric pressure with casing 9 internal pressures again;
Detecting the interior humidity of casing 9 is 1%RH, reaches the requirement standard.
Unpack at last, it is that the clean bench of 100 grades is packed that product is moved to lustration class.
Claims (10)
1. the sterilization process of an absorbable suture is characterized in that it mainly is comprised of following steps:
A) absorbable suture subject to sterilization is put into clean sealed container and sealing, and maintained the temperature at 45～55 ℃, humidity in sealed container 45～50%, pressure is 0.5torr, and be at least 1 hour standing time;
B) inject ethylene oxide gas in sealed container, make the concentration of the oxirane in sealed container reach 600～1000mg/L, keep more than 6 hours;
C) sealed container is carried out evacuation, oxirane and other gas are extracted out, make the pressure in sealed container reach 0.5torr;
Open at last sealed container, feeding, it is that the clean bench of 100 grades is packed that product is moved to lustration class.
2. the sterilization process of absorbable suture according to claim 1, is characterized in that: at c) after step, also carry out following two steps:
D) inject pure nitrogen gas to sealed container pressure and rise to an atmospheric pressure, then sealed container is carried out evacuation, make the pressure in sealed container reach 0.5torr;
E) repetition d) process is 40～50 times.
3. equipment is used in the sterilization of an absorbable suture, it is characterized in that: comprise switch board, casing and the heating system that is connected with casing, vacuum system, medicine system, humidification system that PLC is housed;
Described casing comprises the stack shell that is cuboid of the both ends open of horizontal positioned, the stack shell sidewall is that double-decker comprises inside and outside two-layer housing, inner layer outer wall is provided with along the open loop water leg of a plurality of annulars of casing length direction layout, described water leg is the sealing water stream channel of fitting with inner layer outer wall, water leg is provided with inlet opening and apopore in open loop place, be communicated with in the inlet opening of adjacent one of them water leg of water leg of open loop place and the apopore of another water leg, water leg forms a continuous water stream channel; Described stack shell inside is provided with several temperature sensors, and stack shell is provided with the hermatic door that is attached thereto cooperation at opening, and the outfan of temperature sensor all is connected with PLC; Casing has several installing holes on its outer wall, and installing hole is through hole;
Mainly the heater in hot water tank, temperature sensor, hot water circulating pump and several pipeline of device in hot water tank form described heating system by the hot water tank that water is housed, device, the outlet of hot water tank is connected by pipeline with the water inlet of hot water circulating pump, the outlet of hot water circulating pump is connected by pipeline with the inlet opening of water leg, the water inlet of hot water tank is connected by pipeline with the apopore of water leg, and the outfan of temperature sensor, the control end of described heater are connected control end and all are connected with PLC with hot water circulating pump;
Described medicine system mainly is comprised of oxirane steel cylinder, drug feeding pipeline, effusion meter and valve that oxirane is housed; Have the medicine feeding hole of oxirane on described stack shell, drug feeding pipeline is connected in turn the medicine feeding hole of oxirane steel cylinder, valve, effusion meter and stack shell;
Described vacuum system mainly is comprised of several pipelines, several valves, at least one vacuometer and at least one vacuum pump; Several in through hole on casing are connected with vacuum pump by pipeline, and vacuometer is arranged on box house, and valve is arranged on wherein on several pipelines, and the control end of vacuum pump is connected with PLC;
Described humidification system is comprised of steam generator, humidification pipeline, valve and humidity sensor, the humidification pipeline is connected in turn the through hole on steam generator, valve, casing, humidity sensor is installed on box house, and the outfan of humidity sensor is connected with PLC.
4. equipment is used in the sterilization of absorbable suture according to claim 3, it is characterized in that: described casing also is connected with carburetion system outward, carburetion system is mainly by carburator, the vaporization pump, pipeline, valve, the hot water tank of temperature sensor and heating system forms, hot water tank, the vaporization pump, carburator is connected with each other by pipeline, valve installation with pipeline that vaporization pump both sides are connected on, temperature sensor is arranged in carburator, carburator is provided with the through hole that matches with described drug feeding pipeline, the part of passing through hole and drug feeding pipeline of the drug feeding pipeline in medicine system is built in accommodation space, the outfan of described temperature sensor is connected with PLC.
5. equipment is used in the sterilization of absorbable suture according to claim 3, it is characterized in that: also be provided with insulation material between described stack shell internal layer and skin, filled thermal insulation materials is between water leg, and between water leg and casing skin.
6. equipment is used in the sterilization of absorbable suture according to claim 3, it is characterized in that: casing also is connected with compressed air system outward, compressed air system mainly is comprised of air compressor, air relief valve, pipeline, pipeline with air compressor, air relief valve, be connected in turn.
7. equipment is used in the sterilization of absorbable suture according to claim 3, it is characterized in that: the upper surface of described stack shell also is provided with the two-way cylinder that is connected with the hermatic door upper end, and the pore at two-way cylinder two ends is connected with air relief valve by pipeline, electric control valve; Casing is respectively equipped with guide rail at the two ends of stack shell, and guide rail is along the upper end edge lengths direction layout of stack shell opening, and the upper end of described hermatic door is connected with several guide wheels, and described guide wheel coordinates with guide rail.
8. equipment is used in the sterilization of absorbable suture according to claim 3, it is characterized in that: described hermatic door is at least double-decker, internal layer is dull and stereotyped, the outer face of described flat board is provided with several seal cavities, seal cavity is covered with dull and stereotyped outer face, seal cavity is provided with inlet opening and apopore, by pipeline, seal cavity is communicated with successively, the inlet opening of first seal cavity is connected by the apopore of pipeline with the hot water circulating pump of heating system, and the apopore of last seal cavity is connected with the hot water tank of heating system by pipeline; Outer housing for matching with flat board; Be provided with some reinforcements in hermatic door, be used for reinforcing the structure of sealing.
9. equipment is used in the sterilization of absorbable suture according to claim 3, it is characterized in that: have annular groove on the end face of stack shell two openings, the sealing inflation ring of embedded the anti-oxirane corrosion that flushes with groove or cave in groove, have air inlet and venthole in the inboard that is positioned at inflation ring on groove walls, air inlet is connected with air relief valve by pipeline, valve, and venthole is connected with vacuum pump by pipeline, valve.
10. equipment is used in the sterilization of absorbable suture according to claim 3, it is characterized in that: casing also is connected with the dry gas injected system outward, the dry gas injected system is comprised of dry gas steel cylinder, pipeline, valve that dry gas is housed, have the air inlet of dry gas on casing, pipeline connects dry gas steel cylinder, valve, casing successively.
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| CN 201010606248 CN102018970B (en) | 2010-12-27 | 2010-12-27 | Sterilization process and equipment of absorbable sutures |
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| CN 201010606248 CN102018970B (en) | 2010-12-27 | 2010-12-27 | Sterilization process and equipment of absorbable sutures |
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| CN102018970B true CN102018970B (en) | 2013-06-19 |
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Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102565289A (en) * | 2012-02-02 | 2012-07-11 | 山东新华医疗器械股份有限公司 | Detector used for detecting comprehensive resistance of oxirane sterilization indicator |
| CN103673574B (en) * | 2013-12-18 | 2015-08-05 | 山东新华医疗器械股份有限公司 | A kind of pharmaceutical sterilization equipment cleaning-drying servicing unit and disinfecting and drying method |
| CN104258435B (en) * | 2014-10-11 | 2017-04-05 | 四川省科学城海天实业有限公司 | Vacuum nitrogen fumigation device and method thereof |
| CN107096055B (en) * | 2016-02-23 | 2023-07-14 | 大连正旦海洋生物技术有限公司 | Cultural relic disinfection system and cultural relic disinfection method |
| CN107235189B (en) * | 2017-05-15 | 2019-01-29 | 珠海稻田医疗科技有限公司 | The sterilizing sealing technique of absorbability suture |
| CN107192131A (en) * | 2017-07-04 | 2017-09-22 | 武健 | One kind energy-conservation water jacketing |
| CN108371426B (en) * | 2018-03-21 | 2020-12-04 | 青岛大学心血管病研究所（青岛大学附属心血管病医院） | Intelligent pharmacy innovation management service device |
| CN110361321A (en) * | 2019-07-29 | 2019-10-22 | 杭州意能电力技术有限公司 | A kind of heat power equipment stoppage in transit corrosion simulation test device |
| CN111068086A (en) * | 2019-12-11 | 2020-04-28 | 吉林华碳科技发展有限公司 | Method for disinfecting environment-friendly medical material |
| CN111789982A (en) * | 2020-07-23 | 2020-10-20 | 滑县红太阳医疗器械有限公司 | Ethylene oxide sterilization process |
| CN115337428B (en) * | 2022-08-17 | 2023-06-27 | 浙江博控智能设备有限公司 | Sterilization equipment structure and sterilization process |
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| CN1365834A (en) * | 2002-01-18 | 2002-08-28 | 周波 | Absorptive polyacrylic collagen suture as synthetic high-molecular material and its preparing process |
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| AU473919B2 (en) * | 1972-05-31 | 1976-07-08 | Ethicon Inc. | Control release suture |
| JP3653644B2 (en) * | 1995-08-25 | 2005-06-02 | 株式会社岡村製作所 | Shelf equipment |
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| CN1365834A (en) * | 2002-01-18 | 2002-08-28 | 周波 | Absorptive polyacrylic collagen suture as synthetic high-molecular material and its preparing process |
| CN101623507A (en) * | 2008-07-08 | 2010-01-13 | 梁金平 | Method used for germicidal treatment of catgut suture |
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