CA1171767A - Reference system for checking a liquid contained in a container transparent to the detection method - Google Patents
Reference system for checking a liquid contained in a container transparent to the detection methodInfo
- Publication number
- CA1171767A CA1171767A CA000380773A CA380773A CA1171767A CA 1171767 A CA1171767 A CA 1171767A CA 000380773 A CA000380773 A CA 000380773A CA 380773 A CA380773 A CA 380773A CA 1171767 A CA1171767 A CA 1171767A
- Authority
- CA
- Canada
- Prior art keywords
- imperfection
- liquid
- checking
- container
- deliberate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/84—Systems specially adapted for particular applications
- G01N21/88—Investigating the presence of flaws or contamination
- G01N21/93—Detection standards; Calibrating baseline adjustment, drift correction
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/84—Systems specially adapted for particular applications
- G01N21/88—Investigating the presence of flaws or contamination
- G01N21/90—Investigating the presence of flaws or contamination in a container or its contents
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/84—Systems specially adapted for particular applications
- G01N21/88—Investigating the presence of flaws or contamination
- G01N21/90—Investigating the presence of flaws or contamination in a container or its contents
- G01N21/9018—Dirt detection in containers
- G01N21/9027—Dirt detection in containers in containers after filling
Landscapes
- General Health & Medical Sciences (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Investigating Materials By The Use Of Optical Means Adapted For Particular Applications (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Investigating Or Analysing Materials By Optical Means (AREA)
Abstract
Reference System for checking a Liquid contained in a Container transparent to the Detection Method Descriptive Abstract The invention relates to a reference system for the non-destructive checking and detection of imperfections in a liquid in a container which is transparent to the selected method of detection.
The system according to the invention is characterised in that it is composed of a set of identical standardized containers all containing the same liquid and each having a single known, deliberate imperfection which is stable and reproducible and capable of producing a signal in the detection system used and which varies in size from one container to another. For pharmaceutical checks the system may comprise in particular a set of pharmaceutical ampoules.
The system according to the invention allows a high degree of accuracy and a saving of time to be achieved for automatic checking and also allows the quality of a visual check to be improved to an appreciable degree.
The system according to the invention is characterised in that it is composed of a set of identical standardized containers all containing the same liquid and each having a single known, deliberate imperfection which is stable and reproducible and capable of producing a signal in the detection system used and which varies in size from one container to another. For pharmaceutical checks the system may comprise in particular a set of pharmaceutical ampoules.
The system according to the invention allows a high degree of accuracy and a saving of time to be achieved for automatic checking and also allows the quality of a visual check to be improved to an appreciable degree.
Description
1~71767 The present invention relates in a general manner to non-destructive checking systems and more particularly to systems of detecting foreign bodies, mainly solids, or imperfections in a liquid contained in a container transparent to the detection method, it being possible to carry out this check even after the said container has been finally sealed for commercial use.
The object of the invention in respect of this checking is a stable and reproducible reference system used to detect such imperfections. It comprises a set of containers which can be similar to the commercial containers.
, All the containers of one set are identical. They all contain the same liquid, but each has one deliberate, clearly defined imperfection which is stable and reproducible, and varies in size from one container to the next.
The set or sets oi standardized containers made in this way may be used to regulate the sensitivi~y of auto~,atic checking de~ices, periodically to check the accuracy oi sensitivity of the said devices and to compare actual imperfections with the standardized imperfections. In these cases of utilization a high degree of accuracy and great saving of time are achieved according to the invention 1~'7~767 for the automatic checking, compared with the statistical methods frequently previously used.
The reference system according to the invention may als~
be used for the information of the personnel carrying out a visual check and as a reference base for the visual check.
~or these two uses, the quality of this visual check is thereby apprecia~ly improved.
The reference system according to the invention may be used more particularly for checking pharmaceutical products, especially ampoules of injectable products.
In this connection pharmacopoeia require that injecta~le liquids in ampoule form be subjected to rigorous checks.
The purpose o~ one such check is to detect, after the ampoules have been sealed, the presence of imperfections of a very varied nature, form and size : textile fibres (from clothing, atmospheric filters, etcetera), granular particles, particles of glass, particles from crystallization, dust, etcetera .....
The aim of this detection is to eliminate all the ampoules containing imperfections visible to the naked eye, for example particles, assuming that these are at least 50 micrometres. This is an empirical method as the detection 7~7 of certain imperfections depends on the checker's keenness of sight, on the type of lighting and its intensity and also on the form and nature of the impe~fection.
Automatic devices are known for detecting imperfections in ,~mpoules by photo-electric'means. These, however, do not allow a direct equivalenoe to be established between the detected imperfection and its actual size, except by lengthy, inaccurate~
and arbitrary statistical methods. These methods are not --only costly but too removed from the criteria of accuracy and reproducibility which are to be expec~ed from a method of standardization to be used ~or checking pharmaceutical products.
It w,~s therefore considered necessary to produce a system oi' standardization for devices of the above-mentioned type in order to achieve a high quality check. It also seemed necessary to create reference means for the stafi' carxying out the visual checking.
, The aim of this invention is therefore :
- to overcome the drawbacks of the previous technique, -' to improve the checking of liquids contained in containers transparent to the selected method of detection, ~'7~767 - to reduce the cost of the checks, especially the standardization of the checking devices and their accuracy, - to standardize the strictness of the criteria for rejection in the case of visual checking~as a function of the time and the operators.
These aims are achieved by virtue,of a reference system comprising a set of identical standard containers all containing the same liquid and each containing one known deliberate imperfection which is stable and reproducible and capable of producing a signal in the detection system used, the size o~ the imperfection varying from one container to the next.
.
All the containers of the same.set are identical and, oi course, transparent to the selected method of detection.
They all contain the same liquid, but each has a clearly defined deliberate imperfection which is stable and reproducible ~'nd varies in size from one container to the next.
The liquid in the containers may be identical to the liquid to be checked or~ more simply , may have equivalent properties to those of the liquid to be checked,in respect of the method of detection selected~
.
1'7t~7 The imperfection may consist for example of a bead made oi glass~ metal, plastic or any other material. This imperfection may also consist of a crystal the growth or size of which has been arrested at the required dimensions.
The essential thing is that the said imperfection is defined, reproducible and stable, i.e. of known and unchangeable material, shape, surface state and size.
, The type and size of the standardized imperfections will-be chosen as a function of the imperfections actually encountered and of the detection system which might be, for example, an optical, photo-electrical, electro-magnetic system or a system using X-radiation or gamma radiation.
The size of the imperfections varies from one reference container to another, according,for example, to an arithmetic or geometric progression, so as to cover the entire range of imperfections which are discernible by the eye or detectable by a machine. When calibrated beads are used they are sorted at the beginning by a known method, by sifting for example . In this way sets of reference containers are produced which are suitable for each type of check and for each machine.
For visual checking a set of reference containers may be envisaged having imperfections ranging from the smallest 17~i7 ir,perfection detectable by the practised eye to the imperfection ~hich will always be easily detected. It is obvious that the sizes of thegreatest imperfections are also established as a function of the conditions of use of the visual checking station and as a function of the criteria essential to this checking, for example as a function of the requirements of pharmacopoeia when pharmaceutical products 2re being checked.
The reference containers are chosen at the outset so as to be ~or exa~ple identical or similar to the containers to be checked. They undergo a special treatment so that they are free from any other detrimental imperfections.
Ihese refexence containers will be judged to contain only a standardized imperfection as soon as the other possible i~purities are of an obviously insignificant size in comparison with this standardized imperfec*ion.
.
In the case of pharmaceutical checks the aim of the in~ention is, more particularly, a reference system consisting of a set of ampoules having the characteristics set out abo~e. In this case the standardized ampoules are preferably pharmaceutica a~poules selected at the start to be identical or near~y identical to the ampoules to be checked.
In order to provide a pr'actical example a set of 2 ml standardized ampoules was made according ~o the invention and filled with pharmaceutical-quality water, each ampoule containing a glass bead of a diameter ranging from 30 to 200 micrometres. ThiS set of ampoules has given very satisfactory results on a de'tection device manufactured under the Trade Mark STRUNCK and on another device of the AP~ type which is manufactured under the Trade Mark ROTA.
Of course, various modifications may be made.to the reference systems according to the invention by one ~amiliar with the art~without leaving the scope of the invention. Accordingly. these systems may be adapted to the various fields in which they may be used~ in particular the checking of pharmaceutical products, but also the checking of products of fine chemistry, particularly reactive chemicals.
The object of the invention in respect of this checking is a stable and reproducible reference system used to detect such imperfections. It comprises a set of containers which can be similar to the commercial containers.
, All the containers of one set are identical. They all contain the same liquid, but each has one deliberate, clearly defined imperfection which is stable and reproducible, and varies in size from one container to the next.
The set or sets oi standardized containers made in this way may be used to regulate the sensitivi~y of auto~,atic checking de~ices, periodically to check the accuracy oi sensitivity of the said devices and to compare actual imperfections with the standardized imperfections. In these cases of utilization a high degree of accuracy and great saving of time are achieved according to the invention 1~'7~767 for the automatic checking, compared with the statistical methods frequently previously used.
The reference system according to the invention may als~
be used for the information of the personnel carrying out a visual check and as a reference base for the visual check.
~or these two uses, the quality of this visual check is thereby apprecia~ly improved.
The reference system according to the invention may be used more particularly for checking pharmaceutical products, especially ampoules of injectable products.
In this connection pharmacopoeia require that injecta~le liquids in ampoule form be subjected to rigorous checks.
The purpose o~ one such check is to detect, after the ampoules have been sealed, the presence of imperfections of a very varied nature, form and size : textile fibres (from clothing, atmospheric filters, etcetera), granular particles, particles of glass, particles from crystallization, dust, etcetera .....
The aim of this detection is to eliminate all the ampoules containing imperfections visible to the naked eye, for example particles, assuming that these are at least 50 micrometres. This is an empirical method as the detection 7~7 of certain imperfections depends on the checker's keenness of sight, on the type of lighting and its intensity and also on the form and nature of the impe~fection.
Automatic devices are known for detecting imperfections in ,~mpoules by photo-electric'means. These, however, do not allow a direct equivalenoe to be established between the detected imperfection and its actual size, except by lengthy, inaccurate~
and arbitrary statistical methods. These methods are not --only costly but too removed from the criteria of accuracy and reproducibility which are to be expec~ed from a method of standardization to be used ~or checking pharmaceutical products.
It w,~s therefore considered necessary to produce a system oi' standardization for devices of the above-mentioned type in order to achieve a high quality check. It also seemed necessary to create reference means for the stafi' carxying out the visual checking.
, The aim of this invention is therefore :
- to overcome the drawbacks of the previous technique, -' to improve the checking of liquids contained in containers transparent to the selected method of detection, ~'7~767 - to reduce the cost of the checks, especially the standardization of the checking devices and their accuracy, - to standardize the strictness of the criteria for rejection in the case of visual checking~as a function of the time and the operators.
These aims are achieved by virtue,of a reference system comprising a set of identical standard containers all containing the same liquid and each containing one known deliberate imperfection which is stable and reproducible and capable of producing a signal in the detection system used, the size o~ the imperfection varying from one container to the next.
.
All the containers of the same.set are identical and, oi course, transparent to the selected method of detection.
They all contain the same liquid, but each has a clearly defined deliberate imperfection which is stable and reproducible ~'nd varies in size from one container to the next.
The liquid in the containers may be identical to the liquid to be checked or~ more simply , may have equivalent properties to those of the liquid to be checked,in respect of the method of detection selected~
.
1'7t~7 The imperfection may consist for example of a bead made oi glass~ metal, plastic or any other material. This imperfection may also consist of a crystal the growth or size of which has been arrested at the required dimensions.
The essential thing is that the said imperfection is defined, reproducible and stable, i.e. of known and unchangeable material, shape, surface state and size.
, The type and size of the standardized imperfections will-be chosen as a function of the imperfections actually encountered and of the detection system which might be, for example, an optical, photo-electrical, electro-magnetic system or a system using X-radiation or gamma radiation.
The size of the imperfections varies from one reference container to another, according,for example, to an arithmetic or geometric progression, so as to cover the entire range of imperfections which are discernible by the eye or detectable by a machine. When calibrated beads are used they are sorted at the beginning by a known method, by sifting for example . In this way sets of reference containers are produced which are suitable for each type of check and for each machine.
For visual checking a set of reference containers may be envisaged having imperfections ranging from the smallest 17~i7 ir,perfection detectable by the practised eye to the imperfection ~hich will always be easily detected. It is obvious that the sizes of thegreatest imperfections are also established as a function of the conditions of use of the visual checking station and as a function of the criteria essential to this checking, for example as a function of the requirements of pharmacopoeia when pharmaceutical products 2re being checked.
The reference containers are chosen at the outset so as to be ~or exa~ple identical or similar to the containers to be checked. They undergo a special treatment so that they are free from any other detrimental imperfections.
Ihese refexence containers will be judged to contain only a standardized imperfection as soon as the other possible i~purities are of an obviously insignificant size in comparison with this standardized imperfec*ion.
.
In the case of pharmaceutical checks the aim of the in~ention is, more particularly, a reference system consisting of a set of ampoules having the characteristics set out abo~e. In this case the standardized ampoules are preferably pharmaceutica a~poules selected at the start to be identical or near~y identical to the ampoules to be checked.
In order to provide a pr'actical example a set of 2 ml standardized ampoules was made according ~o the invention and filled with pharmaceutical-quality water, each ampoule containing a glass bead of a diameter ranging from 30 to 200 micrometres. ThiS set of ampoules has given very satisfactory results on a de'tection device manufactured under the Trade Mark STRUNCK and on another device of the AP~ type which is manufactured under the Trade Mark ROTA.
Of course, various modifications may be made.to the reference systems according to the invention by one ~amiliar with the art~without leaving the scope of the invention. Accordingly. these systems may be adapted to the various fields in which they may be used~ in particular the checking of pharmaceutical products, but also the checking of products of fine chemistry, particularly reactive chemicals.
Claims (9)
1. A reference system for the non-destructive checking and detecting of imperfections which may be present in a liquid to be checked in a container which is transparent to the method of detecting comprising a plurality of identical reference containers, each container containing a quantity of a reference liquid; and a plurality of discrete, known, deliberate, reference imperfections, one said reference imperfection being contained in each said reference container, each reference imperfection being selected from the group con-sisting of imperfections which are reproducible, stable in the reference liquid and capable of producing a sound when detected, each reference imperfection being of a different size.
2. The system of Claim 1 wherein the reference liquid is identical to the liquid to be checked.
3. The system of Claim 1 wherein, with respect to the chosen method of detecting, the reference liquid has properties corresponding to those of the liquid to be checked.
4. The system of claim 1 or claim 2 or claim 3 wherein the deliberate imperfection is composed of a crystal, the growth or size of which has been arrested at the required dimensions.
5. The system of claim 1 or claim 2 or claim 3 wherein the deliberate imperfection is composed of a small bead.
6. The system of claim 1 or claim 2 or claim 3 wherein the deliberate imperfection is composed of a small glass bead.
7. The system of claim 1 or claim 2 or claim 3 wherein the deliberate imperfection is composed of a small metal bead.
8. The system of claim 1 or claim 2 or claim 3 wherein the deliberate imperfection is composed of a small plastic bead.
9. The system of claim 1 wherein the reference containers and the container to be checked are composed of closed pharmaceutical ampoules.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR8014621 | 1980-07-01 | ||
| FR8014621A FR2486241A1 (en) | 1980-07-01 | 1980-07-01 | REFERENCE SYSTEM FOR CONTROLLING A LIQUID CONTAINED IN A TRANSPARENT CONTAINER IN THE DETECTION MODE |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1171767A true CA1171767A (en) | 1984-07-31 |
Family
ID=9243713
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000380773A Expired CA1171767A (en) | 1980-07-01 | 1981-06-26 | Reference system for checking a liquid contained in a container transparent to the detection method |
Country Status (19)
| Country | Link |
|---|---|
| EP (1) | EP0043330B1 (en) |
| JP (1) | JPS5740637A (en) |
| KR (2) | KR830006689A (en) |
| AT (1) | AT389768B (en) |
| BE (1) | BE889447A (en) |
| BR (1) | BR8104248A (en) |
| CA (1) | CA1171767A (en) |
| CH (1) | CH643952A5 (en) |
| DE (1) | DE3166169D1 (en) |
| DK (1) | DK274381A (en) |
| ES (1) | ES8301537A1 (en) |
| FR (1) | FR2486241A1 (en) |
| GB (1) | GB2078950B (en) |
| GR (1) | GR74564B (en) |
| IE (1) | IE51360B1 (en) |
| IL (1) | IL63092A (en) |
| IT (1) | IT1145169B (en) |
| LU (1) | LU83462A1 (en) |
| PT (1) | PT73290B (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2520875A1 (en) * | 1982-02-01 | 1983-08-05 | Aerospatiale | METHOD AND DEVICE FOR DETECTING FOREIGN BODIES IN A LIQUID |
| AU606217B2 (en) * | 1987-10-07 | 1991-01-31 | De Beers Industrial Diamond Division (Proprietary) Limited | Separation of diamond particles from gangue |
| EP0409898A4 (en) * | 1988-04-13 | 1992-03-18 | International Integrated Systems, Inc. | System of fluid inspection and/or identification |
| GR1001292B (en) * | 1989-06-08 | 1993-07-30 | Int Integrated Systems Inc | System for the detection or and determination of a fluid |
| DE102013103992A1 (en) | 2013-04-19 | 2014-10-23 | Krones Ag | Test container for testing inspection equipment |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2045580A1 (en) * | 1969-06-02 | 1971-03-05 | Sereb Ste | Visual estimation of suspended particles - in liquid |
| US3901588A (en) * | 1973-06-19 | 1975-08-26 | Pfizer | Calibrating device for light scatter photometering instrument |
| DE2620046C3 (en) * | 1976-05-06 | 1979-03-29 | Fa. Hermann Heye, 3063 Obernkirchen | Adjustment method and device for error detection in a hollow body made of transparent material |
-
1980
- 1980-07-01 FR FR8014621A patent/FR2486241A1/en active Granted
-
1981
- 1981-06-02 GR GR65132A patent/GR74564B/el unknown
- 1981-06-14 IL IL63092A patent/IL63092A/en unknown
- 1981-06-22 DK DK274381A patent/DK274381A/en not_active Application Discontinuation
- 1981-06-23 AT AT0278281A patent/AT389768B/en not_active IP Right Cessation
- 1981-06-26 CA CA000380773A patent/CA1171767A/en not_active Expired
- 1981-06-26 KR KR1019810002317A patent/KR830006689A/en unknown
- 1981-06-29 ES ES503893A patent/ES8301537A1/en not_active Expired
- 1981-06-29 IT IT67894/81A patent/IT1145169B/en active
- 1981-06-29 JP JP56099780A patent/JPS5740637A/en active Pending
- 1981-06-29 CH CH427881A patent/CH643952A5/en not_active IP Right Cessation
- 1981-06-30 IE IE1459/81A patent/IE51360B1/en unknown
- 1981-06-30 BE BE0/205264A patent/BE889447A/en not_active IP Right Cessation
- 1981-06-30 GB GB8120205A patent/GB2078950B/en not_active Expired
- 1981-06-30 EP EP81401049A patent/EP0043330B1/en not_active Expired
- 1981-06-30 LU LU83462A patent/LU83462A1/en unknown
- 1981-06-30 DE DE8181401049T patent/DE3166169D1/en not_active Expired
- 1981-06-30 PT PT73290A patent/PT73290B/en unknown
- 1981-07-01 BR BR8104248A patent/BR8104248A/en unknown
-
1985
- 1985-11-08 KR KR2019850014773U patent/KR870002748Y1/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| KR830006689A (en) | 1983-10-06 |
| GR74564B (en) | 1984-06-29 |
| AT389768B (en) | 1990-01-25 |
| PT73290B (en) | 1982-07-01 |
| FR2486241B1 (en) | 1983-12-16 |
| EP0043330A1 (en) | 1982-01-06 |
| IE811459L (en) | 1982-01-01 |
| KR870002748Y1 (en) | 1987-08-17 |
| CH643952A5 (en) | 1984-06-29 |
| BE889447A (en) | 1981-10-16 |
| ES503893A0 (en) | 1982-12-01 |
| GB2078950B (en) | 1984-02-08 |
| IL63092A0 (en) | 1981-09-13 |
| DE3166169D1 (en) | 1984-10-25 |
| GB2078950A (en) | 1982-01-13 |
| IE51360B1 (en) | 1986-12-10 |
| LU83462A1 (en) | 1983-04-06 |
| BR8104248A (en) | 1982-03-23 |
| ATA278281A (en) | 1989-06-15 |
| EP0043330B1 (en) | 1984-09-19 |
| DK274381A (en) | 1982-01-02 |
| IL63092A (en) | 1985-12-31 |
| IT1145169B (en) | 1986-11-05 |
| JPS5740637A (en) | 1982-03-06 |
| IT8167894A0 (en) | 1981-06-29 |
| PT73290A (en) | 1981-07-01 |
| FR2486241A1 (en) | 1982-01-08 |
| ES8301537A1 (en) | 1982-12-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry |