CN209247379U - Sterilizing cabinet temperature verifies auxiliary tool - Google Patents
Sterilizing cabinet temperature verifies auxiliary tool Download PDFInfo
- Publication number
- CN209247379U CN209247379U CN201822181315.7U CN201822181315U CN209247379U CN 209247379 U CN209247379 U CN 209247379U CN 201822181315 U CN201822181315 U CN 201822181315U CN 209247379 U CN209247379 U CN 209247379U
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- temp probe
- carrying case
- telescopic rod
- sterilizing cabinet
- box device
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Abstract
The utility model provides a kind of sterilizing cabinet temperature verifying auxiliary tool, box device is loaded including temp probe, biological indicator loads box device, Telescopic rod device, temp probe, which loads, places biological indicator loading box device in box device, Telescopic rod device passes through temp probe and loads box device and fix biological indicator loading box device, temp probe loads and is further fixedly arranged on temp probe in box device, and the temp probe is pierced by temp probe loading box device and is connected with temperature validating instrument.The utility model is suitable for the verifying of pharmaceutical industry sterilizing cabinet and uses, and can match with temperature validating instrument and biological indicator, and to the thermal break-through test in verifying to sterilizing cabinet, the accordance in sterilizing cabinet verification process is effectively ensured.
Description
Technical field
The utility model relates to a kind of sterilizing cabinets used suitable for pharmaceutical industry to carry out temperature validation test tool, especially
It is to be related to a kind of sterilizing cabinet temperature verifying auxiliary tool.
Background technique
In the production of pharmacy corporation aseptic medicine and manufacturing process, sterilizing is very for the production technology of sterile product
Crucial step, is essential.Sterilization process can make cillin bottle used in sterile product production process, rubber plug, filling
Work tool used, the clean garment of employee reach sterile state, and the product of final sterilization also needs to carry out the sterilization treatment of drug
It can be only achieved technique requirement.Sterilization process is the key that guarantee a sterile step in sterile product production process, can reach drug institute
The sterility requirements of the packaging material utensil used etc., to guarantee the quality of drug.
It is required to guarantee that sterilization process can reach expected sterilizing, needs to investigate having for sterilization process by verifying
Effect property.According to the correlation principle of 1 aseptic medicine of Chinese " pharmaceutical production quality management practices " (GMP) annex and requirement, should determine
Phase verifies (every year at least once) validity of sterilization process again.By regularly verifying, so that it is guaranteed that sterilization process
Validity, guarantee to will not influence the aseptic of product.It needs to carry out thermal break-through test to sterilizing cabinet in verification process, pass through
The sterilising temp of sterilizing cabinet and biological indicator challenge test are to investigate sterilization effect.
Sterilizing cabinet thermal break-through test general at present is carried out using temperature validating instrument.Connection is placed inside sterilizing article
The temp probe of temperature validating instrument, and the dedicated biological indicator of sterilizing cabinet is placed in temp probe position, start sterilization process
To be tested.Then investigate sterilization process in temp probe profiling temperatures and sterilized biological indicator growth after
Long bacterium situation.
There is following problem in the test process:
In sterilization process, the temperature verifying probe of arrangement is insecure, often encounters sterilizing article during the test
Inner wall, it is untrue that this will lead to the temperature inaccuracy that the temp probe measures, and actual temperature deviation is too big, influences test knot
Fruit；
In sterilization process, due to the pressure change inside sterilizing cabinet, the biological indicator placed is caused often to sterilize
It floats in the process, deviates from the position placed originally；
In sterilization process, temperature verifying probe and biological indicator cannot remain at the same position, always can
Having temp probe or biological indicator, there is a situation where positions to deviate.
Utility model content
The utility model provides a kind of sterilizing cabinet temperature verifying auxiliary tool, solves asking for sterilizing cabinet thermal break-through test
Topic, it is described that its technical solution is as follows:
A kind of sterilizing cabinet temperature verifying auxiliary tool, including temp probe loading box device, biological indicator loading are box-packed
It sets, Telescopic rod device, temp probe, which loads, places biological indicator loading box device in box device, Telescopic rod device passes through temperature
Probe, which loads box device and fixes biological indicator, loads box device, and temp probe loads to be further fixedly arranged in box device
Temp probe, the temp probe are pierced by temp probe loading box device and are connected with temperature validating instrument.
It includes temp probe carrying case, temp probe carrying case fixing groove, temp probe dress that temp probe, which loads box device,
Box probe retainer plate is carried, is provided with temp probe carrying case fixing groove on the temp probe carrying case, temp probe passes through temperature
Degree probe carrying case probe retainer plate is fixed in temp probe carrying case, and is filled by the line that top is drawn across temp probe
It carries box fixing groove and is connected to temperature validating instrument.
The temp probe carrying case fixing groove is circle, and temp probe carrying case fixing groove is provided with two groups, by viscous
The mode of patch is fixed on above temp probe carrying case, and the centre of temp probe carrying case fixing groove is provided with for passing through line
Hole slot.
The temp probe carrying case probe retainer plate includes retainer plate ontology, hold-down bars and spring, the retainer plate sheet
Body is ring-type, and hold-down bars passes through retainer plate ontology, and in the annulus sheathed spring passed through.
One end of temp probe carrying case probe retainer plate is pasted and fixed on the inside sidewalls of temp probe carrying case, another
It holds close to telescopic rod.
Telescopic rod device includes telescopic rod and telescopic rod fixing groove, and telescopic rod uses scalable hollow cylinder body rod, is stretched
Bar fixing groove is fixed on scalable hollow cylinder body rod.
The scalable hollow cylinder body rod is that metal or plastics roll, and the telescopic rod fixing groove uses 316L not
Rust steel is made.
The telescopic rod is provided with the body of rod of more piece socket, by stretching or promoting the body of rod to realize the flexible of telescopic rod.
Telescopic rod fixing groove is provided with two groups, and the temp probe carrying case probe retainer plate, which is located at two groups of telescopic rods, to be fixed
Between slot.
For placing biological indicator in the biological indicator carrying case.
Sterilizing cabinet temperature verifying auxiliary tool is suitable for the verifying of pharmaceutical industry sterilizing cabinet and uses, can and temperature validating instrument and
Biological indicator matches, and to the thermal break-through test in verifying to sterilizing cabinet, sterilizing cabinet verification process is effectively ensured
In accordance.
Detailed description of the invention
Fig. 1 is the sterilizing cabinet temperature verifying auxiliary tool；
Fig. 2 is to load effect picture；
Fig. 3 is telescopic rod sectional drawing；
Fig. 4 is the fixing groove sectional view of telescopic rod；
Fig. 5 is the sectional view of temp probe carrying case probe retainer plate；
Fig. 6 is on-the-spot test schematic diagram.
1- temp probe carrying case；2- biological indicator carrying case；3- telescopic rod；4- temp probe carrying case probe is fixed
Circle；5- temp probe carrying case fixing groove；6- telescopic rod fixing groove；7- temp probe；8- biological indicator；9- hold-down bars；10-
Spring；11- temperature validating instrument；12- loading liquid bottle；13- liquid level.
Specific embodiment
The sterilizing cabinet temperature verifies auxiliary tool, whole to be made using 316L stainless steel and silica gel, appearance rule, table
Face is bright and clean, convenient for operation, the liquid disinfections liquid such as alcohol can be used to carry out surface wipes disinfection, convenient for being put into pharmacy corporation sterilizing cabinet
Inside is tested, will not environment to toilet (area) and sterilizing article adversely affect.Sterilizing cabinet temperature verifying
Auxiliary tool can tolerate the challenge of various temperature, convenient for loading and unloading inside sterilizing article, penetrate sterilization type suitable for all kinds of.
As depicted in figs. 1 and 2, the utility model includes 3 component devices: temp probe loads box device, microbial administration
Agent loads box device, Telescopic rod device, and temp probe, which loads, places biological indicator loading box device, telescopic rod dress in box device
It sets to load box device across temp probe and fix biological indicator and loads box device.It is described as follows respectively:
A temp probe load box device: this part include temp probe carrying case 1, temp probe carrying case fixing groove 5,
Temp probe carrying case probe retainer plate 4.The outer surface of the temp probe carrying case 1 is provided with temp probe carrying case and fixes
Slot 5, temp probe 7 is fixed in temp probe carrying case 1 by temp probe carrying case probe retainer plate 4, and passes through top
The line of extraction passes through temp probe carrying case fixing groove 5 and is connected to temperature validating instrument.Temp probe carrying case 1 is stainless using 316L
Steel or silica gel production can load and fixed temperature probe 7.
The box cover of temp probe carrying case 1 is opened, as shown in figure 5, temp probe carrying case probe retainer plate 4 includes fixing
Enclose ontology, hold-down bars 9 and spring 10, the retainer plate ontology is ring-type, hold-down bars 9 passes through retainer plate ontology, and is being passed through
Annulus sheathed spring 10.The outside of hold-down bars 9 is provided with outer limiting device, is stuck in retainer plate outer body, after pulling then
The effect homing of spring 10 can be passed through.Inside is provided with interior limiting device, in the interior limiting device and retainer plate ontology
Spring 10 is placed between outer ring, so that spring 10 is compressed configuration, is popped one's head on retainer plate 4 by adjusting temp probe carrying case
Temp probe 7 is fixed to the inside of temp probe carrying case 1 by spring 10 and hold-down bars 9.
One end of temp probe carrying case probe retainer plate 4 is pasted and fixed on the inside sidewalls of temp probe carrying case, separately
One end is close to telescopic rod.
Then by the line card on 7 top of temp probe to temp probe carrying case fixing groove 5, temp probe carrying case is shut
1 box cover, such temp probe 7 are fixed in the temp probe carrying case 1.Box cover can be in temp probe carrying case 1
Any end, at upper end, then temp probe carrying case fixing groove 5 is mounted on box cover.
The temp probe carrying case fixing groove 5 is circle, and temp probe carrying case fixing groove 5 is provided with two groups, can be with
It is fixed on by way of stickup above temp probe carrying case, the centre of temp probe carrying case fixing groove is provided with for wearing
Cross the hole slot of line.
B biological indicator loads box device: biological indicator carrying case 2 is made of 316L stainless steel, can be loaded and be fixed
Biological indicator 8.The box cover for opening biological indicator carrying case 2, is then put into biological indicator carrying case for biological indicator 8
In 2, the box cover of biological indicator carrying case 2 is shut, such biological indicator 8 is fixed in the biological indicator carrying case 2.
C Telescopic rod device: including telescopic rod 3 and telescopic rod fixing groove 6, the telescopic rod 3 passes through temp probe carrying case
1, and telescopic rod fixing groove 6 is provided in 1 range of temp probe carrying case, telescopic rod 3 is made of metal or plastics, be using
Sheet metal strip or plastic sheet are fixed to the elastic force curly bedding less than external diameter of rod body with memory function in advance, to have certainly
Tight function makes curly bedding always and has to apply stressed elastic potential energy to telescopic rod.
As shown in Figure 3 and Figure 4, the telescopic rod 3 is provided with the body of rod of more piece socket, by stretching or the body of rod being promoted to realize
Telescopic rod stretches.Telescopic rod fixing groove 6 is provided with two groups, and the temp probe carrying case probe retainer plate is located at two groups and stretches
Between bar fixing groove.
When carrying out thermal break-through loading test, the biological indicator carrying case 2 for having loaded biological indicator 8 is installed to flexible
In the telescopic rod fixing groove 6 of bar 3, the temp probe carrying case 1 for having loaded temp probe 7 is then passed through, adjusts the bar of telescopic rod 3
Body can adjust position of the temp probe carrying case 1 in sterilizing article and temp probe carrying case 1 be fixed in sterilizing article
Portion.
By the way that telescopic rod 3 to be fixed on inside sterilizing article, to ensure that the biological indicator 8 and temp probe of loading
7 during the test position will not deviate, also ensure that temp probe 7 and biological indicator 8 always in same position, are protected
The accuracy for having demonstrate,proved the result of test, improves testing efficiency.
By above installation, the utility model is had the following characteristics that
1,1 loading temperature of the temp probe carrying case probe 7 can prevent from being rebuffed during temperature validation test, make
At the false situation of temperature test.
2, the biological indicator loads box device and loads biological indicator 8, is capable of fixing biological indicator 8, prevents from verifying
Biological indicator 8 floats in sterilizing cabinet sterilization process when test.
3, the temp probe carrying case and Telescopic rod device are capable of fixing temp probe 7 and biological indicator 8, it is ensured that temperature
Probe 7 and biological indicator 8 remain at same position, do not change.
In addition, the temp probe loads box device and Telescopic rod device is to dismantle, Telescopic rod device energy basis is wanted
It asks the position adjusted loading temperature probe 7 and biological indicator 8 inside sterilizing article and is fixed, be applicable to all kinds of wear
Saturating sterilization type.
The sterilizing cabinet temperature verifies auxiliary tool at the scene in use, can be operated in accordance with the following steps:
1, it is checked before test
Check the situation of the loading and unloading of temp probe carrying case 1 and telescopic rod 3, it is ensured that temp probe carrying case 1 is installed to flexible
The phenomenon that loosens and can move is not had after bar 3, such as not enough should securely be pre-processed.
2, prepare before test
A carries out disinfection processing to sterilizing cabinet temperature verifying auxiliary tool and necessary instrument, utensil and other items；
B gets out biological indicator, will place by the temperature validating instrument and temp probe calibrated and mating test computer
Near sterilizing cabinet, data line and power supply line are connected；
The preceding calibration test of c progress temp probe.
3, it is loaded before test
A is loaded the loading of box first: carrying case being removed from telescopic rod, the temp probe for the number of finishing is loaded into
In temp probe carrying case, then the biological indicator for the number of finishing is loaded into biological indicator carrying case.
B carrying case loading finishes the carrying case that will have been loaded and is installed on telescopic rod, is allowed to be fixed on telescopic rod.
C is as shown in fig. 6, be placed into sterilizing article for biological indicator carrying case and temp probe carrying case and telescopic rod
It is internal, it is noted that if it is the cillin bottle 12 that liquid is housed, to need to be entirely located in holder part under liquid level 13, and be placed into
The position of laws and regulations requirement, it is ensured that temp probe and biological indicator will not touch bottle inner wall.
The temp probe and biological indicator that d numbers other all load according to the method described above to be finished, and is placed on verifying
In sterilizing cabinet position as defined in scheme.
4, start thermal break-through test
The intra-record slack byte time of temperature validating instrument 11 is arranged in a, counts at interval of data of the defined time to record
Analysis (minimum, maximum, fluctuation and average).
The F0 value that temperature validating instrument calculates temperature verifying probe is arranged in b.
The clock of c pulling temperature validating instrument and sterilizing cabinet, it is ensured that when temperature validating instrument and equipment clock difference are no more than regulation
Between.
Sterilization cycle parameter is arranged according to sterilizing cabinet standard practice instructions in d.
E starts validating instrument data record, starts simultaneously at sterilization cycle.
F temperature validating instrument monitoring circulation, since reading circulation on validating instrument, sterilizing starts, and sterilizing terminates and circulation knot
The beam time.
G stops temperature validating instrument after circulation is completed to stop.
5, test is completed
After the completion of a test, thermal break-through verifying temperature test is generated using temperature validating instrument and is reported, is checked in sterilization phase,
Within the specified temperature range whether all temp probes, if has sufficient sterilization time, whether F0 value reaches defined
Range.
B cuts off temperature validating instrument external power supply, and the sterilizing article of loading is drawn off, and takes out biological indicator and is put into regulation
Under conditions of cultivate, observe the long bacterium situation of biological indicator.
Then it reloads biological indicator and temp probe according to above-mentioned steps, repeats 2 tests.Continuous 3 times
It must be successful for testing, otherwise once unsuccessful all to be investigated.After the completion of 3 tests, after being carried out to temp probe
Calibration.
Sterilizing cabinet temperature verifying auxiliary tool is suitable for the verifying of pharmaceutical industry sterilizing cabinet and uses, can and temperature validating instrument and
Biological indicator matches, and to the thermal break-through test in verifying to sterilizing cabinet, sterilizing cabinet verification process is effectively ensured
In accordance.
Claims (10)
1. a kind of sterilizing cabinet temperature verifies auxiliary tool, it is characterised in that: load box device, biological indicator including temp probe
Box device, Telescopic rod device are loaded, temp probe, which loads, places biological indicator loading box device, Telescopic rod device in box device
Box device is loaded across temp probe and fixes biological indicator and loads box device, and temp probe loads also solid in box device
Surely it is provided with temp probe, the temp probe is pierced by temp probe loading box device and is connected with temperature validating instrument.
2. sterilizing cabinet temperature according to claim 1 verifies auxiliary tool, it is characterised in that: temp probe loads box device
Including temp probe carrying case, temp probe carrying case fixing groove, temp probe carrying case probe retainer plate, the temp probe
Temp probe carrying case fixing groove is provided on carrying case, temp probe is fixed on by temp probe carrying case probe retainer plate
In temp probe carrying case, and the line drawn by top passes through temp probe carrying case fixing groove and is connected to temperature validating instrument.
3. sterilizing cabinet temperature according to claim 2 verifies auxiliary tool, it is characterised in that: the temp probe carrying case
Fixing groove is circle, and temp probe carrying case fixing groove is provided with two groups, and temp probe loading is fixed on by way of stickup
Above box, the centre of temp probe carrying case fixing groove is provided with the hole slot for passing through line.
4. sterilizing cabinet temperature according to claim 2 verifies auxiliary tool, it is characterised in that: the temp probe carrying case
Probe retainer plate includes retainer plate ontology, hold-down bars and spring, and the retainer plate ontology is ring-type, and hold-down bars passes through retainer plate sheet
Body, and in the annulus sheathed spring passed through.
5. sterilizing cabinet temperature according to claim 4 verifies auxiliary tool, it is characterised in that: temp probe carrying case probe
One end of retainer plate is pasted and fixed on the inside sidewalls of temp probe carrying case, and the other end is close to telescopic rod.
6. sterilizing cabinet temperature according to claim 1 verifies auxiliary tool, it is characterised in that: Telescopic rod device includes flexible
Bar and telescopic rod fixing groove, telescopic rod use scalable hollow cylinder body rod, and telescopic rod fixing groove is fixed on scalable open circles
On cylinder bar.
7. sterilizing cabinet temperature according to claim 6 verifies auxiliary tool, it is characterised in that: the scalable hollow cylinder
Body rod is that metal or plastics roll, and the telescopic rod fixing groove is made of 316L stainless steel.
8. sterilizing cabinet temperature according to claim 7 verifies auxiliary tool, it is characterised in that: the telescopic rod is provided with more
The body of rod for saving socket, by stretching or promoting the body of rod to realize the flexible of telescopic rod.
9. sterilizing cabinet temperature according to claim 6 verifies auxiliary tool, it is characterised in that: telescopic rod fixing groove is provided with
Two groups, the temp probe carrying case probe retainer plate is located between two groups of telescopic rod fixing grooves.
10. sterilizing cabinet temperature according to claim 1 verifies auxiliary tool, it is characterised in that: the biological indicator dress
It carries in box for placing biological indicator.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201822181315.7U CN209247379U (en) | 2018-12-25 | 2018-12-25 | Sterilizing cabinet temperature verifies auxiliary tool |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201822181315.7U CN209247379U (en) | 2018-12-25 | 2018-12-25 | Sterilizing cabinet temperature verifies auxiliary tool |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN209247379U true CN209247379U (en) | 2019-08-13 |
Family
ID=67534405
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201822181315.7U Active CN209247379U (en) | 2018-12-25 | 2018-12-25 | Sterilizing cabinet temperature verifies auxiliary tool |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN209247379U (en) |
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2018
- 2018-12-25 CN CN201822181315.7U patent/CN209247379U/en active Active
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