CN103629895B - A kind of oral liquid bottle flash baking method after high pressure steam sterilization and equipment thereof - Google Patents
A kind of oral liquid bottle flash baking method after high pressure steam sterilization and equipment thereof Download PDFInfo
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- CN103629895B CN103629895B CN201310676723.9A CN201310676723A CN103629895B CN 103629895 B CN103629895 B CN 103629895B CN 201310676723 A CN201310676723 A CN 201310676723A CN 103629895 B CN103629895 B CN 103629895B
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Abstract
The invention discloses a kind of oral liquid bottle flash baking method after high pressure steam sterilization and equipment thereof, method comprises the following steps: (1) oral liquid bottle in wet sterilization cabinet after high pressure steam sterilization, enter dry run, namely be filled with dry high temperature compressed air in wet sterilization cabinet, until pressure rises to wet sterilization cabinet setting pressure higher limit in wet sterilization cabinet, oral liquid bottle self waste heat and dry high temperature compressed air make the portion of water in wet sterilization cabinet gasify jointly; (2) by dry high temperature compressed air exhaust steam bactericidal cabinet, until in wet sterilization cabinet Pressure Drop to wet sterilization cabinet setting pressure lower limit; (3) repeat step (1), (2), until the moisture in wet sterilization cabinet is gasified totally; (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, easy to operate; Drying time shortens greatly, improves production efficiency; And, energy consumption more than 90% can be saved.
Description
Technical field
The present invention relates to the oral liquid bottle furnace drying method after a kind of high pressure steam sterilization, particularly relate to a kind of oral liquid bottle flash baking method after high pressure steam sterilization, also relate to the equipment using this flash baking method.
Background technology
Autoclaving (autoclaving) can kill all microorganisms comprising brood cell, is best, the most widely used sterilizing methods of current sterilization effect.Usually, namely the sterilizing methods that oral liquid (liquid drugs injection) preparation adopts is autoclaving, and it is heated 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, and because whole process all touches water or steam, after completing sterilization, product body, bottle table all can have water droplet.If carry out drying to product not in time, the lamp inspection of subsequent handling, packaging can be affected, and product is easily mouldy, has a strong impact on product quality.
Existing drying means be by high pressure steam sterilization after oral liquid bottle be placed on drying room and dry, but the defect of this method is: (1) owing to when drying needing whole drying room to heat, therefore heated unnecessary space, cause a large amount of energy consumption to waste; (2) drying time is long, often needs drying about 14 hours, causes production efficiency lower, extend 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, significantly can shorten the high pressure steam sterilization of production cycle after oral liquid bottle flash baking method.
Second object of the present invention is to provide a kind of equipment using above-mentioned flash baking method.
First object of the present invention is realized 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 being loaded with oral liquid formulations in wet sterilization cabinet after high pressure steam sterilization, enter dry run, namely be filled with dry high temperature compressed air in wet sterilization cabinet, until pressure rises to wet sterilization cabinet setting pressure higher limit in wet sterilization cabinet, oral liquid bottle self waste heat and dry high temperature compressed air make the portion of water in wet sterilization cabinet gasify jointly;
(2) by dry high temperature compressed air exhaust steam bactericidal cabinet, until in wet sterilization cabinet Pressure Drop to wet sterilization cabinet setting pressure lower limit;
(3) repeating said steps (1), (2), 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, puts into drying room oven dry again without the need to being taken out by the oral liquid bottle after sterilization, therefore, easy to operate; Drying time shortens greatly, improves production efficiency, significantly can 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, compared with existing drying room furnace drying method, saves energy consumption more than 90%.
In order to avoid oral liquid bottle at relatively high temperatures bottle explosion occurs, 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 dry inflation/deflation process for several times, wet sterilization cabinet setting pressure higher limit in N number of stage is 95 ~ 105Kpa, in N number of 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 namely that the temperature completed in the wet sterilization cabinet of high pressure steam sterilization spray operation is risen to 105 ~ 108 DEG C, 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, further increases production efficiency.
As one embodiment of the present invention, in each dry inflation/deflation process, in wet sterilization cabinet, maximum temperature is 85 ~ 100 DEG C.
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 pressure rises to 95 ~ 105Kpa in wet sterilization cabinet, discharge normal temperature compressed air again, until in wet sterilization cabinet Pressure Drop to 0Kpa, as once cooling inflation/deflation process, this cooling inflation/deflation process is several repeatedly, until temperature is 80 ~ 85 DEG C in oral liquid bottle.
Of the present inventionly to rise again, overall time that is dry and cooling procedure is 80 ~ 90min.
Second object of the present invention is realized by following technical measures: a kind of equipment using above-mentioned flash baking method, comprising wet sterilization cabinet, it is characterized in that: being provided with the air inlet for being filled with dry high temperature compressed air and the gas outlet for discharging dry high temperature compressed air cashier's office in a shop at described wet sterilization.
As a modification of the present invention, described wet sterilization cabinet is made up of cabinet and the chuck be enclosed within outward on cabinet, described chuck has hollow chamber, heater is provided with in this hollow chamber, be filled with dried compressed air by described air inlet, heater forms described dry high temperature compressed air by chuck heat drying compressed air simultaneously.
As a further improvement on the present invention, pressure sensitive probe is provided with in described wet sterilization cabinet, valve is respectively equipped with in described air inlet, gas outlet, described pressure sensitive probe and valve are connected to the controller be positioned at outside wet sterilization cabinet respectively, pressure data in described pressure sensitive probe acquires wet sterilization cabinet, 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) directly drying in wet sterilization cabinet after the present invention adopts high pressure steam sterilization, putting into drying room oven dry again without the need to being taken out by the product after sterilization, easy to operate.
(2), compared with the present invention is dried with drying room, drying time shortens greatly, and drying course only needs 80 ~ 90min, realizes flash baking effect, substantially increases production efficiency, significantly can 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, compared with existing drying room furnace drying method, saves energy consumption more than 90%.
(4) present device improves to form on the basis of existing wet sterilization cabinet, and structure is simple, 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 that the present invention rises again temperature time curve figure in process and high pressure steam sterilization operation;
Fig. 3 is the temperature/pressure curve map of the present invention and high pressure steam sterilization operation integrated artistic.
Detailed description of the invention
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 being loaded with oral liquid formulations after high pressure steam sterilization, enters the process of rising again in wet sterilization cabinet.See Fig. 1, high pressure steam sterilization process comprises: be evacuated to-30Kpa, maintains 2min; Heat up, temperature-rise period is 16min again; Sterilization process temperature is 119 ± 1 DEG C, and pressure is 98 ± 2Kpa, maintains 26min, normal sterilization value F0 ﹥ 8; Spray operation maintains 26min, and after spray, temperature is down to 65 DEG C; The process of rising again is that the temperature completed in the wet sterilization cabinet of high pressure steam sterilization spray operation is risen to 108 DEG C from 65 DEG C, and maintains this temperature 5 minutes, and the whole process of rising again is 15min.
Then dry run is entered, namely be filled with dry high temperature compressed air in wet sterilization cabinet, until pressure rises to wet sterilization cabinet setting pressure higher limit in wet sterilization cabinet, oral liquid bottle self waste heat and dry high temperature compressed air make the portion of water in wet sterilization cabinet gasify jointly;
(2) by dry high temperature compressed air exhaust steam bactericidal cabinet, until in wet sterilization cabinet Pressure Drop to wet sterilization cabinet setting pressure lower limit;
(3) repeating said steps (1), (2), 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, comprise 4 dry inflation/deflation processes in the 1st stage, comprises 2 dry inflation/deflation processes in the 2nd stage, wet sterilization cabinet setting pressure higher limit in each dry inflation/deflation process of each stage is 100Kpa, in wet sterilization cabinet, maximum temperature is 100 DEG C, and whole dry run maintains 50min, the F that follow-up phase is accumulative as calculated
0value is only 0.743, whole sterilization drying course F
0value is 17.1, F
0value recruitment is only equivalent to original 4.5%, therefore significantly can not increase F
0value, sterility assurance level is not less than existing process for sterilizing.Sterilizing program is given the normal sterilization value F0 of product and is the area that L-t Curves encloses, see Fig. 2, t
1for liquid temperature-rise period reaches the time of 100 DEG C, t
2for dropping to the time of 100 DEG C in liquid cooling procedure, t
3for temperature in the process of rising again is higher than the time of 100 DEG C, t
4for temperature in the process of rising again drops to the time of 100 DEG C.100 DEG C time, L value (L is sterilization rate) is 0.008, when temperature is lower than 100 DEG C, can ignore, therefore F
0only accumulative t
1to t
2, t
3to t
4sterilizing value in process.
In the present embodiment, in the 1st stage, in each dry inflation/deflation process, wet sterilization cabinet setting pressure lower limit is 30Kpa, and the time adds up to 25min; In the 2nd stage, in each dry inflation/deflation process, wet sterilization cabinet setting pressure lower limit is 0Kpa, and the time adds up to 25min.Visible, the 1st stage and the 2nd stage steam bactericidal cabinet setting pressure lower limit reduce gradually, can prevent oral liquid bottle from relatively high temperatures bottle explosion occurring like this.See Fig. 3, in whole dry run, temperature remains 100 DEG C, is in stable state, the pressure in wet sterilization cabinet then along with dried compressed air be filled with and discharge presents periodic change.
(4) after cooling oral liquid bottle, it is taken out from wet sterilization cabinet, specifically water cooling wet sterilization cabinet, in wet sterilization cabinet, be filled with normal temperature compressed air simultaneously, until pressure rises to 100Kpa in wet sterilization cabinet, discharge normal temperature compressed air again, until in wet sterilization cabinet Pressure Drop to 0Kpa, as once cooling inflation/deflation process, twice repeatedly, until temperature is 80 ~ 85 DEG C in oral liquid bottle, whole cooling procedure is 15min, now, wet sterilization in-cabinet temperature is 65 DEG C, takes out oral liquid bottle.
More than rise again, overall time that is dry and cooling procedure is 80min.
Using an equipment for above-mentioned flash baking method, comprise wet sterilization cabinet, being provided with the air inlet for being filled with dry high temperature compressed air and the gas outlet for discharging dry high temperature compressed air cashier's office in a shop at wet sterilization.Wet sterilization cabinet is made up of cabinet and the chuck be enclosed within outward on cabinet, chuck has hollow chamber, in this hollow chamber, be provided with heater, be filled with dried compressed air by air inlet, heater forms dry high temperature compressed air by chuck heat drying compressed air simultaneously.Pressure sensitive probe is provided with in wet sterilization cabinet, valve is respectively equipped with in air inlet, gas outlet, pressure sensitive probe and valve are connected to the controller be positioned at outside wet sterilization cabinet respectively, pressure data in pressure sensitive probe acquires wet sterilization cabinet, 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 carried out 4 tests, and Children Oral Liquid kind has carried out 8 tests, and result of the test is all qualified.
1, quick sterilization dries 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(mainly arranges water mitigation by after steam pressure, spray);
(2) measure bottle inner liquid medicine immediately after offeing for sale, the temperature of bottle inner liquid medicine is 80-85 DEG C;
(3) offeing for sale, there is the fragmentary globule on aluminium-plastic cap surface, rear section, also there is droplet (occurring this type of probability 2-3%) lid inner side, but places 30min at normal temperatures after offeing for sale, and in lid table/lid, the globule can all evaporate dry under the waste heat of body;
To in quick sterilization drying course bottle explosion situation check, bottle explosion relative to improper sterilization technique without significant difference; Body remains without oral liquid, and lamp inspection process does not find that caking, body are by liquid medicine contamination situation yet;
(5) test effect reaches designing requirement.
2, quick sterilization is used to dry sample light signal inspection situation
(table 2)
Draw from table 2 statistics, quick sterilization drying procedure of the present invention can not increase oral liquid bottle bottle explosion, breakage risk.
3, quick sterilization dries synchronous verification sample detection case
(1) sensory evaluation: synchronous checking 12 batches of quick sterilization post-drying oral liquid products, contrast with a batch improper sterilization oral liquid product, bikini organoleptic examination is without significant difference;
(2) microorganism detection: 12 batches of quick sterilizations dry sample total plate count, mould yeast and Escherichia coli inspection, and microorganism detection is all qualified;
(3) physical and chemical inspection: the oral liquid of two kinds of different sterilization drying mode productions detects polyoses content respectively, to adopting that 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 synchronous checking mean microbicidal drying time; Sterilization drying course can not increase bottle explosion, breakage risk; Sensory evaluation, polysaccharide testing result and improper sterilization dry sample without significant difference.
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 number of stage is 95 ~ 105Kpa, in N number of 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, process of rising again, is namely that the temperature completed in the wet sterilization cabinet of high pressure steam sterilization spray operation is risen to 105 ~ 108 DEG C, and maintains this temperature 4 ~ 6 minutes; In each dry inflation/deflation process, in wet sterilization cabinet, maximum temperature is 85 ~ 100 DEG C; The time of whole dry run is 40 ~ 50min; Step (4) in, in wet sterilization cabinet, be filled with normal temperature compressed air until pressure rises to 95 ~ 105Kpa in wet sterilization cabinet, cooling inflation/deflation process repeatedly for several times, until temperature is 80 ~ 85 DEG C in oral liquid bottle; Rise again, overall time that is dry and cooling procedure is 80 ~ 90min.
Embodiments of the present invention are not limited thereto; according to foregoing of the present invention; according to ordinary technical knowledge and the customary means of this area; do not departing under the present invention's above-mentioned basic fundamental thought prerequisite; the present invention can also make the amendment of other various ways, replacement or change, all drops within rights protection scope of the present invention.
Claims (8)
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 being loaded with oral liquid formulations in wet sterilization cabinet after high pressure steam sterilization, enter dry run, namely be filled with dry high temperature compressed air in wet sterilization cabinet, until pressure rises to wet sterilization cabinet setting pressure higher limit in wet sterilization cabinet, oral liquid bottle self waste heat and dry high temperature compressed air make the portion of water in wet sterilization cabinet gasify jointly;
(2) by dry high temperature compressed air exhaust steam bactericidal cabinet, until in wet sterilization cabinet Pressure Drop to wet sterilization cabinet setting pressure lower limit;
(3) repeating said steps (1), (2), 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;
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 dry inflation/deflation process for several times, wet sterilization cabinet setting pressure higher limit in N number of stage is 95 ~ 105Kpa, in N number of stage, wet sterilization cabinet setting pressure lower limit reduces gradually, and in the N stage, described wet sterilization cabinet setting pressure lower limit is 0Kpa.
2. the oral liquid bottle flash baking method after high pressure steam sterilization according to claim 1, 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, namely be that the temperature completed in the wet sterilization cabinet of high pressure steam sterilization spray operation is risen to 105 ~ 108 DEG C, and maintain this temperature 4 ~ 6 minutes.
3. the oral liquid bottle flash baking method after high pressure steam sterilization according to claim 2, is characterized in that: in each dry inflation/deflation process, in wet sterilization cabinet, maximum temperature is 85 ~ 100 DEG C.
4. the oral liquid bottle flash baking method after high pressure steam sterilization according to claim 3, is characterized in that: the time of whole dry run is 40 ~ 50min.
5. the oral liquid bottle flash baking method after high pressure steam sterilization according to claim 4, it is characterized in that: step (4) in, water cooling wet sterilization cabinet, in wet sterilization cabinet, be filled with normal temperature compressed air simultaneously, until pressure rises to 95 ~ 105Kpa in wet sterilization cabinet, then discharge normal temperature compressed air, until in wet sterilization cabinet Pressure Drop to 0Kpa, as once cooling inflation/deflation process, this cooling inflation/deflation process is several repeatedly, until temperature is 80 ~ 85 DEG C in oral liquid bottle.
6. the oral liquid bottle flash baking method after high pressure steam sterilization according to claim 5, is characterized in that: described in rise again, overall time that is dry and cooling procedure is 80 ~ 90min.
7. the equipment of the oral liquid bottle flash baking method after the high pressure steam sterilization using described in claim 1, comprising wet sterilization cabinet, it is characterized in that: being provided with the air inlet for being filled with dry high temperature compressed air and the gas outlet for discharging dry high temperature compressed air cashier's office in a shop at described wet sterilization; Described wet sterilization cabinet is made up of cabinet and the chuck be enclosed within outward on cabinet, described chuck has hollow chamber, heater is provided with in this hollow chamber, be filled with dried compressed air by described air inlet, heater forms described dry high temperature compressed air by chuck heat drying compressed air simultaneously.
8. equipment according to claim 7, it is characterized in that: in described wet sterilization cabinet, be provided with pressure sensitive probe, valve is respectively equipped with in described air inlet, gas outlet, described pressure sensitive probe and valve are connected to the controller be positioned at outside wet sterilization cabinet respectively, pressure data in described pressure sensitive probe acquires wet sterilization cabinet, 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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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107007851A (en) * | 2017-01-19 | 2017-08-04 | 张家港欧思瑞医疗科技有限公司 | A kind of lotion concentration sterilizing cabinet |
| CN108088173B (en) * | 2018-01-09 | 2023-06-02 | 连云港千樱医疗设备有限公司 | Drying method and drying machine for oral liquid bottles |
| CN114588285B (en) * | 2022-03-22 | 2023-12-01 | 山东新华医疗器械股份有限公司 | Sterilization method |
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