CN103629895A - Oral liquid bottle fast drying method after high-pressure steam sterilization and oral liquid bottle fast drying equipment - Google Patents
Oral liquid bottle fast drying method after high-pressure steam sterilization and oral liquid bottle fast drying equipment Download PDFInfo
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- CN103629895A CN103629895A CN201310676723.9A CN201310676723A CN103629895A CN 103629895 A CN103629895 A CN 103629895A CN 201310676723 A CN201310676723 A CN 201310676723A CN 103629895 A CN103629895 A CN 103629895A
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Abstract
The invention discloses an oral liquid bottle fast drying method after high-pressure steam sterilization and oral liquid bottle fast drying equipment. The method comprises the following steps that (1) after oral liquid bottles are subjected to high-pressure steam sterilization in a steam sterilization cabinet, the operation enters a drying process, i.e., dry high-temperature compressed air is put into the steam sterilization cabinet until the pressure in the steam sterilization cabinet rises to the set pressure top limit value of the steam sterilization cabinet, and partial moisture in the steam sterilization cabinet is gasified through the self afterheat and the dry high-temperature compressed air; (2) dry high-temperature compressed air is exhausted out of the steam sterilization cabinet until the pressure in the steam sterilization cabinet is reduced to the set lower limit value of the steam sterilization cabinet; (3) the first and the second steps are repeated until the moisture in the steam sterilization cabinet is completely gasified; (4) the oral liquid bottles are taken out from the steam sterilization cabinet after being cooled. The method and the equipment provided by the invention have the advantages that the oral liquid bottles are directly dried in the steam sterilization cabinet after the high-pressure steam sterilization, the operation is convenient, the drying time is greatly reduced, the production efficiency is improved, and in addition, the energy consumption is reduced by more than 90 percent.
Description
Technical field
The present invention relates to the oral liquid bottle furnace drying method after a kind of high pressure steam sterilization, relate in particular to a kind of oral liquid bottle flash baking method after high pressure steam sterilization, also relate to the equipment that uses this flash baking method.
Background technology
Autoclaving (autoclaving) can be killed all microorganisms that comprise brood cell, is best, the most widely used sterilizing methods of current sterilization effect.Conventionally, the sterilizing methods that oral liquid (liquid drugs injection) preparation adopts is autoclaving, and it heats by wet-hot steam, kills the microorganism in oral liquid (liquid drugs injection) under the condition of HTHP.Its process can be divided into intensification, insulation and temperature-fall period, because whole process all touches water or steam, completes product body after sterilization, bottle table all can have water droplet.If not in time product is dried, can affect lamp inspection, the packing of subsequent handling, and product is easily mouldy, has a strong impact on product quality.
Existing drying means is the oral liquid bottle after high pressure steam sterilization to be placed on to drying room dry, and still, the defect of this method is: during (1) due to oven dry, therefore whole drying room heating need to have been heated to unnecessary space, cause a large amount of energy consumptions wastes; Drying time long, often need dry approximately 14 hours, cause production efficiency lower, extended the production cycle of product.
Summary of the invention
First object of the present invention be to provide a kind of easy to operate, can greatly reduce energy consumption, enhance productivity, can significantly shorten the oral liquid bottle flash baking method after the high pressure steam sterilization of production cycle.
Second object of the present invention is to provide a kind of equipment that uses above-mentioned flash baking method.
First object of the present invention realizes by following technical measures: a kind of oral liquid bottle flash baking method after high pressure steam sterilization, is characterized in that comprising the following steps:
(1) the oral liquid bottle that is loaded with oral liquid formulations in wet sterilization cabinet after high pressure steam sterilization, enter dry run, be to be filled with dry high temperature compressed air in wet sterilization cabinet, until wet sterilization cabinet internal pressure rises to wet sterilization cabinet setting pressure higher limit, oral liquid bottle self waste heat and dry high temperature compressed air make the part moisture gasification in wet sterilization cabinet jointly;
(2) will be dried high temperature compressed air exhaust steam bactericidal cabinet, until wet sterilization cabinet internal pressure is down to wet sterilization cabinet setting pressure lower limit;
(3) (1), (2) repeating said steps, until the moisture in wet sterilization cabinet is gasified totally, completes dry run;
(4) after cooling oral liquid bottle, it is taken out from wet sterilization cabinet.
The present invention is directly dried after high pressure steam sterilization at oral liquid bottle in wet sterilization cabinet, without the oral liquid bottle after sterilization is taken out and puts into drying room oven dry again, therefore, easy to operate; Drying time shortens greatly, has improved production efficiency, can significantly shorten the production cycle; During oven dry, dry high temperature compressed air passes in wet sterilization cabinet, because wet sterilization cabinet space is little, and takes full advantage of the waste heat of oral liquid bottle self after sterilization, compares with existing drying room furnace drying method, saves energy consumption more than 90%.
For fear of oral liquid bottle, under higher temperature, there is bottle explosion, as a modification of the present invention, described step (1)～dry run is (3) divided into the 1st, the 2....N stage, described step (1), (2) as primary drying inflation/deflation process, each stage comprises for several times dry inflation/deflation process, wet sterilization cabinet setting pressure higher limit in N stage is 95～105Kpa, in N stage, wet sterilization cabinet setting pressure lower limit reduces gradually, in the N stage, described wet sterilization cabinet setting pressure lower limit is 0Kpa.
As a further improvement on the present invention, step (1) in, oral liquid bottle is after high pressure steam sterilization, before carrying out dry run, enter the process of rising again, be that the temperature completing in the wet sterilization cabinet of high pressure steam sterilization spray operation is risen to 105～108 ℃, and maintain this temperature 4～6 minutes.Before entering dry run, set up the process of rising again, can improve drying effect, shorten drying time, drying course only needs 80～90 minutes, has further improved production efficiency.
As one embodiment of the present invention, in each dry inflation/deflation process, in wet sterilization cabinet, maximum temperature is 85～100 ℃.
The time of the whole dry run of the present invention is 40～50min.
The present invention step (4) in, water cooling wet sterilization cabinet, in wet sterilization cabinet, be filled with normal temperature compressed air simultaneously, until wet sterilization cabinet internal pressure rises to 95～105Kpa, discharge again normal temperature compressed air, until wet sterilization cabinet internal pressure is down to 0Kpa, as cooling inflation/deflation process once, this cooling inflation/deflation process is several repeatedly, until temperature is 80～85 ℃ in oral liquid bottle.
Of the present inventionly rise again, the overall time dry and cooling procedure is 80～90min.
Second object of the present invention realizes by following technical measures: a kind of equipment that uses above-mentioned flash baking method, comprise wet sterilization cabinet, it is characterized in that: at described wet sterilization, be cashier's office in a shop provided with for being filled with the air inlet of dry high temperature compressed air and for discharging the gas outlet of dry high temperature compressed air.
As a modification of the present invention, described wet sterilization cabinet by cabinet and the chuck being enclosed within outward on cabinet form, described chuck has hollow chamber, in Gai hollow chamber, be provided with heater, by described air inlet, be filled with dried compressed air, heater forms described dry high temperature compressed air by chuck heat drying compressed air simultaneously.
As a further improvement on the present invention, in described wet sterilization cabinet, be provided with pressure sensitive probe, in described air inlet, gas outlet, be respectively equipped with valve, described pressure sensitive probe and valve are connected to respectively the controller being positioned at outside wet sterilization cabinet, described pressure sensitive probe gathers wet sterilization cabinet internal pressure data, and this pressure data is passed to controller, described controller by-pass valve control opens and closes to realize being filled with and discharging of dry high temperature compressed air.
Compared with prior art, the present invention has following significant effect:
(1) the present invention is directly dried after adopting high pressure steam sterilization in wet sterilization cabinet, without the product after sterilization is taken out and puts into drying room oven dry again, easy to operate.
(2) the present invention is dried and is compared with drying room, and drying time shortens greatly, and drying course only needs 80～90min, realizes flash baking effect, has greatly improved production efficiency, can significantly shorten the production cycle.
(3) when the present invention is dried, dry high temperature compressed air passes in wet sterilization cabinet, because wet sterilization cabinet space is little, and takes full advantage of the waste heat of oral liquid bottle self after sterilization, compares with existing drying room furnace drying method, saves energy consumption more than 90%.
(4) present device is to improve and form on the basis of existing wet sterilization cabinet, simple in structure, practical, is suitable for wide popularization and application.
Accompanying drawing explanation
Below in conjunction with the drawings and specific embodiments, the present invention is described in further detail.
Fig. 1 is the overall flow block diagram of the present invention and high pressure steam sterilization operation;
Fig. 2 is the present invention temperature time curve figure in process and high pressure steam sterilization operation that rises again;
Fig. 3 is the temperature/pressure curve map of the present invention and high pressure steam sterilization operation integrated artistic.
The specific embodiment
As shown in Figures 1 to 3, the oral liquid bottle flash baking method after a kind of high pressure steam sterilization of the present invention, comprises the following steps:
(1) the oral liquid bottle that is loaded with oral liquid formulations after high pressure steam sterilization, enters the process of rising again in wet sterilization cabinet.Referring to Fig. 1, high pressure steam sterilization process comprises: be evacuated to-30Kpa, maintain 2min; Heat up, temperature-rise period is 16min again; Sterilization process temperature is 119 ± 1 ℃, and pressure is 98 ± 2Kpa, maintains 26min, standard sterilizing value F0 ﹥ 8; Spray operation maintains 26min, and after spray, temperature is down to 65 ℃; The process of rising again is to rise to 108 ℃ by completing temperature in the wet sterilization cabinet of high pressure steam sterilization spray operation from 65 ℃, and maintains this temperature 5 minutes, and the whole process of rising again is 15min.
Then enter dry run, be to be filled with dry high temperature compressed air in wet sterilization cabinet, until wet sterilization cabinet internal pressure rises to wet sterilization cabinet setting pressure higher limit, oral liquid bottle self waste heat and dry high temperature compressed air make the part moisture gasification in wet sterilization cabinet jointly;
(2) will be dried high temperature compressed air exhaust steam bactericidal cabinet, until wet sterilization cabinet internal pressure is down to wet sterilization cabinet setting pressure lower limit;
(3) (1), (2) repeating said steps, until the moisture in wet sterilization cabinet is gasified totally, completes dry run;
Step (1)～dry run is (3) divided into the 1st, the 2....N stage, in the present embodiment, be divided into 2 stages, step (1), (2) as primary drying inflation/deflation process, in the 1st stage, comprise dry inflation/deflation process 4 times, in the 2nd stage, comprise dry inflation/deflation process 2 times, wet sterilization cabinet setting pressure higher limit at every turn dry inflation/deflation process of each stage is 100Kpa, in wet sterilization cabinet, maximum temperature is 100 ℃, and whole dry run maintains 50min, as calculated the F of follow-up phase accumulative total
0value is only 0.743, whole sterilization drying course F
0value is 17.1, F
0it is original 4.5% that value recruitment is only equivalent to, and therefore can significantly not increase F
0value, sterility assurance level is not less than existing process for sterilizing.The standard sterilizing value F0 that sterilizing program is given product is the area that L-t Curves encloses, referring to Fig. 2, and t
1for liquid temperature-rise period reaches the time of 100 ℃, t
2for dropping to the time of 100 ℃, t in liquid cooling procedure
3for the time of temperature in the process of rising again higher than 100 ℃, t
4for temperature in the process of rising again drops to the time of 100 ℃.L value in the time of 100 ℃ (L is sterilization rate) is 0.008, when temperature is during lower than 100 ℃, can ignore, so F
0only add up t
1to t
2, t
3to t
4sterilizing value in process.
In the present embodiment, in the 1st stage, in dry inflation/deflation process, wet sterilization cabinet setting pressure lower limit is 30Kpa at every turn, and the time adds up to 25min; In the 2nd stage, in dry inflation/deflation process, wet sterilization cabinet setting pressure lower limit is 0Kpa at every turn, and the time adds up to 25min.Visible, the 1st stage and the 2nd stage wet sterilization cabinet setting pressure lower limit reduce gradually, can prevent that like this oral liquid bottle under higher temperature, bottle explosion occurring.Referring to Fig. 3, in whole dry run, temperature remains 100 ℃, in state stably, the pressure in wet sterilization cabinet along with dried compressed air be filled with and discharge presents periodic variation.
(4) after cooling oral liquid bottle, it is taken out from wet sterilization cabinet, specifically water cooling wet sterilization cabinet, is filled with normal temperature compressed air simultaneously in wet sterilization cabinet, until wet sterilization cabinet internal pressure rises to 100Kpa, discharge again normal temperature compressed air, until wet sterilization cabinet internal pressure is down to 0Kpa, as cooling inflation/deflation process once, twice repeatedly, until temperature is 80～85 ℃ in oral liquid bottle, whole cooling procedure is 15min, now, wet sterilization in-cabinet temperature is 65 ℃, takes out oral liquid bottle.
More than rise again, the overall time dry and cooling procedure is 80min.
Use an equipment for above-mentioned flash baking method, comprise wet sterilization cabinet, at wet sterilization, be cashier's office in a shop provided with for being filled with the air inlet of dry high temperature compressed air and for discharging the gas outlet of dry high temperature compressed air.Wet sterilization cabinet by cabinet and the chuck being enclosed within outward on cabinet form, chuck has hollow chamber, in Gai hollow chamber, be provided with heater, by air inlet, be filled with dried compressed air, heater forms dry high temperature compressed air by chuck heat drying compressed air simultaneously.In wet sterilization cabinet, be provided with pressure sensitive probe, in air inlet, gas outlet, be respectively equipped with valve, pressure sensitive probe and valve are connected to respectively the controller being positioned at outside wet sterilization cabinet, pressure sensitive probe gathers wet sterilization cabinet internal pressure data, and this pressure data is passed to controller, controller by-pass valve control opens and closes to realize being filled with and discharging of dry high temperature compressed air.
The present embodiment has carried out two kind simultaneous tests, and Ms's oral liquid kind has been carried out 4 tests, and Children Oral Liquid kind has been carried out 8 tests, and result of the test is all qualified.
1, quick sterilization is dried on-the-spot follow-up situation
(table 1)
As known from Table 1:
(1) after sterilization, the time dimension of flash baking is held in 138-173min, and average 149min(is mainly subject to the impact of steam pressure, the rear draining of spray);
(2) after offeing for sale, immediately bottle inner liquid medicine is measured, the temperature of bottle inner liquid medicine is 80-85 ℃;
(3) the aluminium-plastic cap surface, rear section of offeing for sale has the fragmentary globule, lid inner side also to have droplet (the probability 2-3% that occurs this type of), but after offeing for sale, places at normal temperatures 30min, and the interior globule of lid table/lid can all evaporate dry under the waste heat of body;
(4) bottle explosion situation in quick sterilization drying course is checked, bottle explosion with respect to normal process for sterilizing without significant difference; Body is residual without oral liquid, and lamp inspection process does not find that caking, body are subject to liquid medicine contamination situation yet;
(5) test effect reaches designing requirement.
2, use quick sterilization to dry sample light signal inspection situation
(table 2)
From table 2 statistics, draw, quick sterilization drying procedure of the present invention can not increase oral liquid bottle bottle explosion, damaged risk.
3, quick sterilization is dried synchronous verification sample detection case
(1) sensory evaluation: synchronously verify 12 batches of quick sterilization post-drying oral liquid products, contrast with a same batch normal sterilization oral liquid product, bikini organoleptic examination is without significant difference;
(2) microorganism detection: 12 batches of quick sterilizations are dried sample total plate count, mould yeast and Escherichia coli check, and microorganism detection is all qualified;
(3) physical and chemical inspection: the oral liquid of two kinds of different sterilization drying modes productions detects respectively polyoses content, to adopting, quick sterilization is dried, existing sterilization stoving process children, Ms's oral liquid polysaccharide detected value carry out non-parametric test, result there are no significant difference.
To sum up, quick sterilization drying cabinet is 149 minutes through the average sterilization drying time of synchronous checking; Sterilization drying course can not increase bottle explosion, damaged risk; Sensory evaluation, polysaccharide testing result are dried sample without significant difference with normal sterilization.
In other embodiments, step (1)～dry run is (3) divided into the 1st, the 2....N stage, wet sterilization cabinet setting pressure higher limit in N stage is 95～105Kpa, in N stage, wet sterilization cabinet setting pressure lower limit reduces gradually, in the N stage, wet sterilization cabinet setting pressure lower limit is 0Kpa; Step (1) in, the process of rising again, is that the temperature completing in the wet sterilization cabinet of high pressure steam sterilization spray operation is risen to 105～108 ℃, and maintains this temperature 4～6 minutes; In each dry inflation/deflation process, in wet sterilization cabinet, maximum temperature is 85～100 ℃; The time of whole dry run is 40～50min; Step (4) in, in wet sterilization cabinet, be filled with normal temperature compressed air until wet sterilization cabinet internal pressure rises to 95～105Kpa, cooling inflation/deflation process repeatedly for several times, until temperature is 80～85 ℃ in oral liquid bottle; Rise again, the overall time dry and cooling procedure is 80～90min.
Embodiments of the present invention are not limited to this; according to foregoing of the present invention; according to ordinary skill knowledge and the customary means of this area; do not departing under the above-mentioned basic fundamental thought of the present invention prerequisite; the present invention can also make modification, replacement or the change of other various ways, within all dropping on rights protection scope of the present invention.
Claims (10)
1. the oral liquid bottle flash baking method after high pressure steam sterilization, is characterized in that comprising the following steps:
(1) the oral liquid bottle that is loaded with oral liquid formulations in wet sterilization cabinet after high pressure steam sterilization, enter dry run, be to be filled with dry high temperature compressed air in wet sterilization cabinet, until wet sterilization cabinet internal pressure rises to wet sterilization cabinet setting pressure higher limit, oral liquid bottle self waste heat and dry high temperature compressed air make the part moisture gasification in wet sterilization cabinet jointly;
(2) will be dried high temperature compressed air exhaust steam bactericidal cabinet, until wet sterilization cabinet internal pressure is down to wet sterilization cabinet setting pressure lower limit;
(3) (1), (2) repeating said steps, until the moisture in wet sterilization cabinet is gasified totally, completes dry run;
(4) after cooling oral liquid bottle, it is taken out from wet sterilization cabinet.
2. the oral liquid bottle flash baking method after high pressure steam sterilization according to claim 1, it is characterized in that: described step (1)～dry run is (3) divided into the 1st, the 2....N stage, described step (1), (2) as primary drying inflation/deflation process, each stage comprises for several times dry inflation/deflation process, wet sterilization cabinet setting pressure higher limit in N stage is 95～105Kpa, in N stage, wet sterilization cabinet setting pressure lower limit reduces gradually, in the N stage, described wet sterilization cabinet setting pressure lower limit is 0Kpa.
3. the oral liquid bottle flash baking method after high pressure steam sterilization according to claim 2, it is characterized in that: step (1) in, oral liquid bottle is after high pressure steam sterilization, before carrying out dry run, enter the process of rising again, be that the temperature completing in the wet sterilization cabinet of high pressure steam sterilization spray operation is risen to 105～108 ℃, and maintain this temperature 4～6 minutes.
4. the oral liquid bottle flash baking method after high pressure steam sterilization according to claim 3, is characterized in that: in each dry inflation/deflation process, in wet sterilization cabinet, maximum temperature is 85～100 ℃.
5. according to the oral liquid bottle flash baking method after the high pressure steam sterilization described in claim 1～4 any one, it is characterized in that: the time of whole dry run is 40～50min.
6. the oral liquid bottle flash baking method after high pressure steam sterilization according to claim 5, it is characterized in that: step (4) in, water cooling wet sterilization cabinet, in wet sterilization cabinet, be filled with normal temperature compressed air, until wet sterilization cabinet internal pressure rises to 95～105Kpa, then discharge normal temperature compressed air simultaneously, until wet sterilization cabinet internal pressure is down to 0Kpa, as cooling inflation/deflation process once, this cooling inflation/deflation process repeatedly for several times, until temperature is 80～85 ℃ in oral liquid bottle.
7. the oral liquid bottle flash baking method after high pressure steam sterilization according to claim 6, is characterized in that: described in rise again, the overall time dry and cooling procedure is 80～90min.
8. a right to use requires the equipment of the oral liquid bottle flash baking method after the high pressure steam sterilization described in 1, comprise wet sterilization cabinet, it is characterized in that: at described wet sterilization, be cashier's office in a shop provided with for being filled with the air inlet of dry high temperature compressed air and for discharging the gas outlet of dry high temperature compressed air.
9. equipment according to claim 8, it is characterized in that: described wet sterilization cabinet by cabinet and the chuck being enclosed within outward on cabinet form, described chuck has hollow chamber, in Gai hollow chamber, be provided with heater, by described air inlet, be filled with dried compressed air, heater forms described dry high temperature compressed air by chuck heat drying compressed air simultaneously.
10. equipment according to claim 8 or claim 9, it is characterized in that: in described wet sterilization cabinet, be provided with pressure sensitive probe, in described air inlet, gas outlet, be respectively equipped with valve, described pressure sensitive probe and valve are connected to respectively the controller being positioned at outside wet sterilization cabinet, described pressure sensitive probe gathers wet sterilization cabinet internal pressure data, and this pressure data is passed to controller, described controller by-pass valve control opens and closes to realize being filled with and discharging of dry high temperature compressed air.
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| CN114588285A (en) * | 2022-03-22 | 2022-06-07 | 山东新华医疗器械股份有限公司 | Sterilization method |
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| PB01 | Publication | ||
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