CN114636516A - Positive sample calibration device and method for checking sealing integrity of medicine packaging container - Google Patents
Positive sample calibration device and method for checking sealing integrity of medicine packaging container Download PDFInfo
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- CN114636516A CN114636516A CN202110366374.5A CN202110366374A CN114636516A CN 114636516 A CN114636516 A CN 114636516A CN 202110366374 A CN202110366374 A CN 202110366374A CN 114636516 A CN114636516 A CN 114636516A
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- 238000000034 method Methods 0.000 title claims abstract description 44
- 239000003814 drug Substances 0.000 title claims abstract description 24
- 238000007789 sealing Methods 0.000 title claims abstract description 23
- 238000004806 packaging method and process Methods 0.000 title claims abstract description 18
- 238000012360 testing method Methods 0.000 claims abstract description 52
- 230000007246 mechanism Effects 0.000 claims abstract description 33
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims abstract description 29
- 229910052757 nitrogen Inorganic materials 0.000 claims abstract description 14
- 238000005070 sampling Methods 0.000 claims abstract description 11
- 238000005259 measurement Methods 0.000 claims description 21
- 230000008859 change Effects 0.000 claims description 14
- 239000011148 porous material Substances 0.000 claims description 9
- 239000007789 gas Substances 0.000 claims description 5
- 238000012935 Averaging Methods 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- 230000003068 static effect Effects 0.000 claims description 4
- 238000009512 pharmaceutical packaging Methods 0.000 claims 9
- 238000007689 inspection Methods 0.000 abstract description 4
- 229910001873 dinitrogen Inorganic materials 0.000 abstract 1
- 238000004364 calculation method Methods 0.000 description 6
- 230000007613 environmental effect Effects 0.000 description 3
- 238000001514 detection method Methods 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
- G01M3/00—Investigating fluid-tightness of structures
- G01M3/007—Leak detector calibration, standard leaks
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
- G01M3/00—Investigating fluid-tightness of structures
- G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
- G01M3/26—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors
- G01M3/32—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for containers, e.g. radiators
- G01M3/3236—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for containers, e.g. radiators by monitoring the interior space of the containers
- G01M3/3272—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for containers, e.g. radiators by monitoring the interior space of the containers for verifying the internal pressure of closed containers
Abstract
The invention belongs to the technical field of medicine package integrity inspection, and particularly relates to a positive sample calibration device and method for medicine package container seal integrity inspection. The device comprises a testing cavity, a vacuum pump, a vacuum gauge, a piston mechanism, a distance measuring mechanism, a leak hole, a sampling bottle, a nitrogen bottle, a first valve and a second valve; the vacuum pump is communicated with the test cavity through the first valve; the vacuum gauge is communicated with the test cavity; the piston mechanism is communicated with the test cavity; the distance measuring mechanism and the piston mechanism move synchronously, and the nitrogen gas bottle is communicated with the testing cavity sequentially through the sampling bottle, the leakage hole and the second valve. The device and the method for calibrating the positive sample for checking the sealing integrity of the medicine packaging container provide a solution for calibrating the vacuum attenuation leak detector, provide a solution for calibrating the positive sample, and solve the problem that the high-precision vacuum attenuation leak detector cannot be calibrated and adjusted in the prior art.
Description
Technical Field
The invention belongs to the technical field of medicine package integrity inspection, and particularly relates to a positive sample calibration device and method for medicine package container seal integrity inspection.
Background
The sealing integrity of the medicine packaging container is an important guarantee for the medicine quality, and the quantitative research on the leakage aperture of the medicine packaging container is very important for the testing of the sealing integrity of the medicine packaging container. At present, a vacuum attenuation method is a preferred method for testing the sealing integrity of a medicine packaging container, and the vacuum attenuation method is that a medicine package is placed into a specified testing cavity, the testing cavity is vacuumized, gas in the package leaks out through a leakage hole and enters the testing cavity, or liquid in the package leaks out through the leakage hole and enters the testing cavity and is vaporized, and then the generated pressure change is obtained through a pressure sensor in equipment. The pressure change data is compared with the no-leak package data to determine if the package is leaking and the extent of the leak.
An instrument for detecting the tightness of a medicine packaging container by using a vacuum attenuation method is generally called a vacuum attenuation leak detector, and because of the factors such as the tightness of the instrument, the temperature change in a detection cavity, the change of environmental conditions and the like, the vacuum attenuation leak detector inevitably generates a zero drift phenomenon in the use process, so that a positive medicine of a leakage hole of the known packaging container is required to be used as a zero setting standard of the vacuum attenuation leak detector.
The main problem of the positive sample is that the error value of the size measurement is large, the magnitude of at least +/-1 um is known, the uncertainty of the measurement is large because the pore diameter of the leak is mostly within 10um, the corresponding leak rate value is reflected, the numerical error is quite obvious, meanwhile, for the micropore with a small diameter, the leak path (wall thickness) needs to be considered, the leak rate is not a function relation of the equivalent pore diameter, USP1207.1 is conservative, the assumed length of the nominal diameter of the leak is considered to be ignored, and the related parameter research is carried out on the basis that the pore size is in an approximate range. At present, a method for relatively accurately determining the leak rate value and the equivalent pore diameter of a positive sample is not provided in the field.
Disclosure of Invention
Aiming at the problems, the invention firstly provides a positive sample calibration device for checking the sealing integrity of a medicine packaging container, which comprises a testing cavity, a vacuum pump, a vacuum gauge, a piston mechanism, a distance measuring mechanism, a leak hole, a sampling bottle, a nitrogen bottle, a first valve and a second valve; the vacuum pump is communicated with the test cavity through the first valve; the vacuum gauge is communicated with the test cavity; the piston mechanism is communicated with the test cavity; the distance measuring mechanism and the piston mechanism move synchronously, and the nitrogen cylinder is communicated with the test cavity sequentially through the sampling cylinder, the leak hole and the second valve.
The invention also provides a calibration method of the positive sample calibration device for checking the sealing integrity of the medicine packaging container, which comprises the following steps:
s1: putting a negative sample into the test cavity, opening the first valve and the second valve, and returning a piston in the piston mechanism to a zero position;
s2: starting the vacuum pump to reduce the vacuum degree displayed by the vacuum gauge below a set value 1, closing the first valve, filling pure nitrogen into the test cavity through the leak hole through the second valve to enable the vacuum degree to be increased to a set value 2, and closing the second valve;
s3: the propulsion piston measures the volume coefficient K of the test cavity by adopting a gas expansion method;
s4: recording the pressure rise delta P in the test cavity within a period of time delta t by adopting a static voltage boosting method, and calculating the background leakage rate Q0;
S5: opening a second valve, inflating through the leak hole to enable the test cavity to return to normal pressure, taking out the negative sample, simultaneously putting the positive sample to be detected, and repeating the step 2;
s6: and calculating the leak rate Q of the positive sample to be detected.
As a preferred technical scheme, the negative sample and the positive sample to be calibrated have the same specification and the same batch.
In the formula:
k is the volume coefficient of the mixture,
p0 is the indicated value of the vacuum degree before the piston is pushed, and the unit is Pa;
p' is the indicated value of the vacuum degree after the piston is pushed, and the unit is Pa;
delta L is the indication value change of the piston propulsion distance measuring device, and the unit is m;
d piston diameter in m.
In the formula:
Q0the unit is Pa.m for the background leakage rate3/s;
In the formula:
q is the leakage rate and has the unit of Pa.m3/s;
P0the unit is Pa for the indicating value of the vacuum degree before the piston is pushed;
p' is the indicated value of the vacuum degree after the piston is pushed, and the unit is Pa;
delta L is the indication value change of the piston propulsion distance measuring device, and the unit is m;
d piston diameter in m.
As a preferred technical solution, the method further comprises the following steps:
s7: repeating the measurement n times, averaging n measurementsAnd taking n as an arbitrary integer within 1-20 as the actually measured leakage rate value of the measured sample.
As a preferred technical solution, the method further comprises the following steps:
s8: and calculating the equivalent aperture D.
As a preferred technical scheme, the calculation method for calculating the equivalent aperture D is
In the formula:
d is the equivalent pore diameter, and the unit is mum;
q is the leakage rate value measured by a vacuum attenuation method sample, and the unit is std3/s。
Has the beneficial effects that:
(1) the positive sample calibration device and method for checking the sealing integrity of the medicine packaging container provided by the invention provide a solution for calibrating the vacuum attenuation leak detector, provide a solution for calibrating positive samples, and solve the problem that the high-precision vacuum attenuation leak detector cannot be calibrated and adjusted in the past;
(2) the calibration method provided by the invention fully considers the change of environmental factors, introduces the pressure rise rate value of the calibration chamber, avoids the influence of slight change of the environmental pressure on the experimental result, and improves the detection precision as much as possible;
(3) the calibration method provided by the invention discloses a calculation method of the equivalent aperture of the leak hole, avoids the error brought by the leak path (wall thickness) to the measurement, avoids the influence of the large size measurement error value to the settlement of the leak rate value, and further improves the measurement precision.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
FIG. 1 is a schematic structural diagram of a positive sample calibration device for checking the sealing integrity of a medicine packaging container provided by the present invention;
wherein, the device comprises a test cavity 1, a vacuum pump 2, a vacuum gauge 3, a piston mechanism 4, a distance measuring mechanism 5, a leak hole 6, a sampling bottle 7, a nitrogen cylinder 8, a first valve 9 and a second valve 10.
Detailed Description
The invention will be further understood by reference to the following detailed description of preferred embodiments of the invention and the examples included therein.
When describing embodiments of the present application, the use of "preferred," "preferably," "more preferred," and the like, is meant to refer to embodiments of the invention that may provide certain benefits, under certain circumstances. However, other embodiments may be preferred, under the same or other circumstances. In addition, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, nor is it intended to exclude other embodiments from the scope of the invention.
In this document, relational terms such as first, second, and the like may be used solely to distinguish one entity from another entity without necessarily requiring or implying any actual such relationship or order between such entities. Furthermore, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a component, apparatus, or device that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such component, apparatus, or device.
When a component, element, or layer is referred to as being "on," "bonded to," "connected to," or "coupled to" another element or layer, it may be directly on, bonded to, connected to, or coupled to the other element, or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being "directly on," "directly coupled to," "directly connected to" or "directly coupled to" another element or layer, there may be no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a similar manner (e.g., "between … …" versus "directly between … …," "adjacent" versus "directly adjacent," etc.). As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
The invention firstly provides a positive sample calibration device for checking the sealing integrity of a medicine packaging container, which comprises a testing cavity, a vacuum pump, a vacuum gauge, a piston mechanism, a distance measuring mechanism, a leak hole, a sampling bottle, a nitrogen bottle, a first valve and a second valve; the vacuum pump is communicated with the test cavity through the first valve; the vacuum gauge is communicated with the test cavity; the piston mechanism is communicated with the test cavity; the distance measuring mechanism and the piston mechanism move synchronously, and the nitrogen cylinder is communicated with the test cavity sequentially through the sampling cylinder, the leak hole and the second valve.
Preferably, the distance measuring mechanism is one of a micrometer, a displacement sensor and a laser distance measuring instrument.
The invention also provides a calibration method of the positive sample calibration device for checking the sealing integrity of the medicine packaging container, which comprises the following steps:
s1: putting a negative sample into the test cavity, opening the first valve and the second valve, and returning a piston in the piston mechanism to a zero position;
s2: starting the vacuum pump to reduce the vacuum degree displayed by the vacuum gauge to be below a set value 1, then closing the first valve, filling pure nitrogen into the test cavity through the leak hole through the second valve to enable the vacuum degree to be increased to a set value 2, and closing the second valve;
s3: the propulsion piston measures the volume coefficient K of the test cavity by adopting a gas expansion method;
s4: recording the pressure rise delta P in the test cavity within a period of time delta t by adopting a static voltage boosting method, and calculating the background leakage rate Q0;
S5: opening a second valve, inflating through the leak hole to enable the test cavity to return to normal pressure, taking out the negative sample, simultaneously putting the positive sample to be detected, and repeating the step 2;
s6: and calculating the leak rate Q of the positive sample to be detected.
Preferably, the set value 1 is 10to 50Pa, and the set value 2 is 0.1 to 10 torr.
In some preferred embodiments, the negative sample is of the same format, batch, as the positive sample to be calibrated.
In the formula:
k is a volume coefficient of the mixture,
P0the unit is Pa for the indicating value of the vacuum degree before the piston is pushed;
p' is the indicated value of the vacuum degree after the piston is pushed, and the unit is Pa;
delta L is the indication value change of the piston propulsion distance measuring device, and the unit is m;
d piston diameter in m.
In the formula:
Q0the unit is Pa.m for the background leakage rate3/s;
In the formula:
q is the leakage rate and has the unit of Pa.m3/s
P0the unit is Pa for the indicating value of the vacuum degree before the piston is pushed;
p' is the indicated value of the vacuum degree after the piston is pushed, and the unit is Pa;
delta L is the indication value change of the piston propulsion distance measuring device, and the unit is m;
d piston diameter in m.
In some preferred embodiments, the method further comprises the steps of:
s7: repeating the measurement n times, averaging n measurementsAnd taking n as an arbitrary integer within 1-20 as the actually measured leakage rate value of the measured sample.
In some preferred embodiments, the method further comprises the steps of:
s8: and calculating the equivalent aperture D.
In some preferred embodiments, the calculation method for calculating the equivalent aperture diameter D is
In the formula:
d is the equivalent pore diameter, and the unit is mum;
q is the leakage rate value measured by a vacuum attenuation method sample, and the unit is std3/s。
Examples
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.
Without conflict, embodiments of the present disclosure and features of the embodiments may be combined with each other to arrive at new embodiments.
Example 1
The positive sample calibration device for checking the sealing integrity of the medicine packaging container shown in fig. 1 comprises a testing cavity 1, a vacuum pump 2, a vacuum gauge 3, a piston mechanism 4, a distance measuring mechanism 5, a leak hole 6, a sampling bottle 7, a nitrogen bottle 8, a first valve 9 and a second valve 10; the vacuum pump 2 is communicated with the test cavity 1 through the first valve 9; the vacuum gauge 3 is communicated with the test cavity 1; the piston mechanism 4 is communicated with the test cavity 1; the distance measuring mechanism 5 is connected with the piston mechanism 4, and the nitrogen cylinder 8 is communicated with the testing cavity 1 sequentially through the sampling cylinder 7, the leak hole 6 and the second valve 10.
The distance measuring mechanism is a micrometer.
Example 2
The invention also provides a calibration method of the positive sample calibration device for checking the sealing integrity of the medicine packaging container, which comprises the following steps:
s1: placing a negative sample into the testing cavity 1, opening the first valve 9 and the second valve 10, and returning the piston in the piston mechanism 4 to a zero position;
s2: starting the vacuum pump 2 to reduce the vacuum degree displayed by the vacuum gauge 3 to be below a set value 1, then closing the first valve 9, filling pure nitrogen into the test cavity 1 through the leak 6 through the second valve 10to enable the vacuum degree to be increased to be a set value 2, and closing the second valve 10;
s3: the propulsion piston measures the volume coefficient K of the test cavity 1 by adopting a gas expansion method;
s4: recording the pressure rise delta P in the test cavity 1 within a period of time delta t by adopting a static boosting method, and calculating the background leakage rate Q0;
S5: opening a second valve 10, inflating through the leak hole 6 to restore the test cavity 1to normal pressure, taking out the negative sample, simultaneously putting the positive sample to be detected, and repeating the step 2;
s6: and calculating the leak rate Q of the positive sample to be detected.
Preferably, the set value 1 is 30Pa and the set value 2 is 1 torr.
In some preferred embodiments, the negative sample is of the same format, same batch, as the positive sample to be calibrated.
In some of the preferred embodiments of the present invention,the volume coefficient K is calculated by
In the formula:
k is a volume coefficient of the mixture,
P0the unit is Pa for the indicating value of the vacuum degree before the piston is pushed;
p' is the indicated value of the vacuum degree after the piston is pushed, and the unit is Pa;
delta L is the indication value change of the piston propulsion distance measuring device, and the unit is m;
d piston diameter in m.
In the formula:
Q0the unit is Pa.m for the background leakage rate3/s;
In the formula:
q is the leakage rate and has the unit of Pa.m3/s
P0the unit is Pa for the indicating value of the vacuum degree before the piston is pushed;
p' is the indicated value of the vacuum degree after the piston is pushed, and the unit is Pa;
delta L is the indication value change of the piston propulsion distance measuring device, and the unit is m;
d piston diameter in m.
In some preferred embodiments, the method further comprises the steps of:
s7: repeating the measurement n times, averaging n measurementsAnd taking n as an arbitrary integer within 1-20 as the actually measured leakage rate value of the measured sample.
In some preferred embodiments, the method further comprises the steps of:
s8: and calculating the equivalent aperture D.
In some preferred embodiments, the calculation method for calculating the equivalent aperture diameter D is
In the formula:
d is the equivalent pore diameter, and the unit is mum;
q is the leakage rate value measured by a vacuum attenuation method sample, and the unit is std3/s。
Finally, it should be noted that the above-mentioned contents are only used for illustrating the technical solutions of the present invention, and not for limiting the protection scope of the present invention, and that the simple modifications or equivalent substitutions of the technical solutions of the present invention by those of ordinary skill in the art can be made without departing from the spirit and scope of the technical solutions of the present invention.
Claims (10)
1. A positive sample calibration device for checking the sealing integrity of a medicine packaging container is characterized by comprising a testing cavity, a vacuum pump, a vacuum gauge, a piston mechanism, a distance measuring mechanism, a leak hole, a sampling bottle, a nitrogen bottle, a first valve and a second valve; the vacuum pump is communicated with the test cavity through the first valve; the vacuum gauge is communicated with the test cavity; the piston mechanism is communicated with the test cavity; the distance measuring mechanism and the piston mechanism move synchronously, and the nitrogen cylinder is communicated with the test cavity sequentially through the sampling cylinder, the leak hole and the second valve.
2. A method for calibrating a positive sample calibration device for checking the seal integrity of a pharmaceutical packaging container according to claim 1, comprising the steps of:
s1: putting a negative sample into the test cavity, opening the first valve and the second valve, and returning a piston in the piston mechanism to a zero position;
s2: starting the vacuum pump to reduce the vacuum degree displayed by the vacuum gauge below a set value 1, closing the first valve, filling pure nitrogen into the test cavity through the leak hole through the second valve to enable the vacuum degree to be increased to a set value 2, and closing the second valve;
s3: the propulsion piston measures the volume coefficient K of the test cavity by adopting a gas expansion method;
s4: recording the pressure rise delta P in the test cavity within a period of time delta t by adopting a static voltage boosting method, and calculating the background leakage rate Q0;
S5: opening a second valve, inflating through the leak hole to enable the test cavity to return to normal pressure, taking out the negative sample, simultaneously putting the positive sample to be detected, and repeating the step 2;
s6: and calculating the leak rate Q of the positive sample to be detected.
3. The method for calibrating a positive sample for checking the sealing integrity of a pharmaceutical packaging container according to claim 2, wherein the negative sample is of the same specification and the same batch as the positive sample to be calibrated.
4. The method for calibrating a positive sample for checking the sealing integrity of a pharmaceutical packaging container according to claim 2, wherein the volume coefficient K is calculated by
In the formula:
k is the volume coefficient of the mixture,
P0the unit is Pa for the indicating value of the vacuum degree before the piston is pushed;
p' is the indicated value of the vacuum degree after the piston is pushed, and the unit is Pa;
delta L is the indication value change of the piston propulsion distance measuring device, and the unit is m;
d piston diameter in m.
6. The method for calibrating a positive sample for checking the sealing integrity of a pharmaceutical packaging container according to claim 2, wherein the leak rate Q is calculated by
In the formula:
q is the leakage rate and has the unit of Pa.m3/s;
P0the unit is Pa for the indicating value of the vacuum degree before the piston is pushed;
p' is the indicated value of the vacuum degree after the piston is pushed, and the unit is Pa;
delta L is the indication value change of the piston propulsion distance measuring device, and the unit is m;
d piston diameter in m.
7. The method for calibrating a positive sample for checking the sealing integrity of a pharmaceutical packaging container according to claim 2, further comprising the steps of:
9. The method for calibrating a positive sample for checking the sealing integrity of a pharmaceutical packaging container according to claim 2, further comprising the steps of:
s8: and calculating the equivalent aperture D.
10. The method for calibrating a positive sample for checking the sealing integrity of a pharmaceutical packaging container according to claim 9, wherein the equivalent pore diameter D is calculated by
In the formula:
d is the equivalent pore diameter, and the unit is mum;
q is the leakage rate value measured by a vacuum attenuation method sample, and the unit is std3/s。
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2021
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