CA2083541A1 - Process and device for the thorough cleaning and sterilization of pharmaceutical rubber stoppers - Google Patents
Process and device for the thorough cleaning and sterilization of pharmaceutical rubber stoppersInfo
- Publication number
- CA2083541A1 CA2083541A1 CA 2083541 CA2083541A CA2083541A1 CA 2083541 A1 CA2083541 A1 CA 2083541A1 CA 2083541 CA2083541 CA 2083541 CA 2083541 A CA2083541 A CA 2083541A CA 2083541 A1 CA2083541 A1 CA 2083541A1
- Authority
- CA
- Canada
- Prior art keywords
- stoppers
- container
- sterilization
- multipurpose
- rubber stoppers
- 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.)
- Abandoned
Links
- 238000000034 method Methods 0.000 title claims abstract description 19
- 230000001954 sterilising effect Effects 0.000 title claims abstract description 19
- 238000004659 sterilization and disinfection Methods 0.000 title claims abstract description 19
- 238000004140 cleaning Methods 0.000 title claims abstract description 8
- 238000001035 drying Methods 0.000 claims abstract description 4
- 238000004519 manufacturing process Methods 0.000 claims abstract description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 238000005406 washing Methods 0.000 claims description 7
- 230000009993 protective function Effects 0.000 claims description 2
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 2
- 238000003860 storage Methods 0.000 description 3
- 230000003749 cleanliness Effects 0.000 description 2
- 229910021642 ultra pure water Inorganic materials 0.000 description 2
- 239000012498 ultrapure water Substances 0.000 description 2
- 241000518994 Conta Species 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 238000001291 vacuum drying Methods 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B08—CLEANING
- B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
- B08B3/00—Cleaning by methods involving the use or presence of liquid or steam
- B08B3/04—Cleaning involving contact with liquid
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B67—OPENING, CLOSING OR CLEANING BOTTLES, JARS OR SIMILAR CONTAINERS; LIQUID HANDLING
- B67B—APPLYING CLOSURE MEMBERS TO BOTTLES JARS, OR SIMILAR CONTAINERS; OPENING CLOSED CONTAINERS
- B67B1/00—Closing bottles, jars or similar containers by applying stoppers
- B67B1/03—Pretreatment of stoppers, e.g. cleaning, steaming, heating, impregnating or coating; Applying resilient rings to stoppers
Landscapes
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Sealing Of Jars (AREA)
Abstract
Process and device for the thorough cleaning and sterilization of Pharmaceutical rubber stoppers Abstract Rubber stoppers for closing containers (bottles) containing pharmaceutical preparations have to be thoroughly cleaned and sterilized in the production factory. For this purpose, the stoppers are placed in a multipurpose container, in which they are thoroughly cleaned, sterilized and dried. After drying and steri-lization, the stoppers are then stored in the same multipurpose container and held in reserve. This multi-purpose container is also used to feed a machine for inserting rubber stoppers.
(Figure 1) Le A 28 570
(Figure 1) Le A 28 570
Description
Process and device for the thorouqh cleaninq a~d~
sterilization of pharmaceutical rubber stoppers The invention relates to a process for the thorough cleaning and sterilization of rubber stoppers in pharmaceutical factories, in which the stoppers are washed and then introduced into a steam sterilizer for sterilization.
o Before rubber stoppers are used as closing elements for bottles containing pharmaceutical preparations, they have to be cleaned and sterilized. In a known stopper washing-sterilizing machine, the rubber stoppers are charged into a perforated drum, which is placed in a steam sterilizer.
In the steam sterilizer, the stoppers are washed, rinsed, sterilized and then dried. The stoppers are subsequently transferred to a storage container. Apart from the fact that the sterilization is carried out in a relatively expensive, special sterilizer, transfer of the cleaned and sterilized stoppers carries the risk of recontamination.
The object of the invention is to simplify the procedure for the cleaning and sterilization of pharmaceutical rubber stoppers and to reduce the risk of contamination on further handling.
This object is achieved according to the invention by a process in which the rubber stoppers are thoroughly cleaned with ultrapure water in a multipurpose container equipped with connecting valves for washing water, the multipurpose container with the thoroughly cleaned stoppers is placed in a steam sterilizer, in which the stoppers are sterilized and dried, and, after sterilization and drying, the stoppers are held in reserve in the same multipurpose container without a transfer process.
Le A 28 570 In a preferred embodiment, the multipurpose conta~ 41 filled with the rubber stoppers under laminar flow protection before the washing and sterilization process.
The multipurpose container for carrying out the process according to the invention is characterized in that two connecting valves for water are provided on the container for feeding the container with washing water and emptying it, and in that at least one water-permeable stopper retaining plate is arranged inside the container.
Thus the transport, cleaning and sterilization of the rubber stoppers and the storage of the rubber stoppers at the filling machine take place in one multipurpose container without transfer manipulations. The sterilization can be carried out in a conventional, easily modified steam sterilizer. These sterilizers can then also be used for other sterilization purposes.
Simplification of the procedure markedly reduces the risk of recontamination.~ The multipurpose container fulfils several functions:
- It serves as a transport container with a protective function in respect of the surroundings, for the reception of brand-new rubber stoppers supplied with a relatively high degree of cleanliness.
- The stoppers are thoroughly cleaned, sterilized and dried in the same container.
- The container then serves again as a transport container in the sterile sector of a pharmaceutical production.
Le A 28 570 2 2 ~
- At the bottle filling and stoppering machine, the container serves as a storage container from which the required stoppers can be taken automatically.
The invention is illustrated in greater detail below with the aid of a drawing and an Example. The multipurpose container for pharmaceutical rubber stoppers, shown in the drawing, consists of a stainless steel can l with a cover 2 for closing the charging and discharging orifice 3.
Connectors with shut-off valves 4 and 5, for washing water, are arranged at the top end and at the bottom of the can 1. A stopper retaining plate 6 is fixed just above the bottom of the can 1, directly over the shut-off valve 4. It consists of a perforated plate (sieve) whose holes are substantially smaller than the diameter of the stoppers. A similar but substantially smaller perforated plate 7 is arranged in the cover 2 of the can and prevents stoppers from reaching the upper water connector with the shut-off valve 5-.
" ~) The novel thorough cleaning and sterilization process proceeds for example as follows:
1. Charging of the multipurpose container 1 (can 1) with the rubber stoppers under a laminar flow device (corresponding to clean-room class 3, VDI 2083, in surroundings of cleanliness class VDI 2083);
2. Connection of the can 1 via the shut-off valves 4 and 5 to a cleaning station, also under clean-room class 3, VDI 2083;
3. Opening of the connecting valves 4, 5;
Le A 2B 570 3 83~1 4. Overflow rinsing with ultrapure water having the particle quality of aqua p. io according to DAB, for 10 minutes at 45OC;
sterilization of pharmaceutical rubber stoppers The invention relates to a process for the thorough cleaning and sterilization of rubber stoppers in pharmaceutical factories, in which the stoppers are washed and then introduced into a steam sterilizer for sterilization.
o Before rubber stoppers are used as closing elements for bottles containing pharmaceutical preparations, they have to be cleaned and sterilized. In a known stopper washing-sterilizing machine, the rubber stoppers are charged into a perforated drum, which is placed in a steam sterilizer.
In the steam sterilizer, the stoppers are washed, rinsed, sterilized and then dried. The stoppers are subsequently transferred to a storage container. Apart from the fact that the sterilization is carried out in a relatively expensive, special sterilizer, transfer of the cleaned and sterilized stoppers carries the risk of recontamination.
The object of the invention is to simplify the procedure for the cleaning and sterilization of pharmaceutical rubber stoppers and to reduce the risk of contamination on further handling.
This object is achieved according to the invention by a process in which the rubber stoppers are thoroughly cleaned with ultrapure water in a multipurpose container equipped with connecting valves for washing water, the multipurpose container with the thoroughly cleaned stoppers is placed in a steam sterilizer, in which the stoppers are sterilized and dried, and, after sterilization and drying, the stoppers are held in reserve in the same multipurpose container without a transfer process.
Le A 28 570 In a preferred embodiment, the multipurpose conta~ 41 filled with the rubber stoppers under laminar flow protection before the washing and sterilization process.
The multipurpose container for carrying out the process according to the invention is characterized in that two connecting valves for water are provided on the container for feeding the container with washing water and emptying it, and in that at least one water-permeable stopper retaining plate is arranged inside the container.
Thus the transport, cleaning and sterilization of the rubber stoppers and the storage of the rubber stoppers at the filling machine take place in one multipurpose container without transfer manipulations. The sterilization can be carried out in a conventional, easily modified steam sterilizer. These sterilizers can then also be used for other sterilization purposes.
Simplification of the procedure markedly reduces the risk of recontamination.~ The multipurpose container fulfils several functions:
- It serves as a transport container with a protective function in respect of the surroundings, for the reception of brand-new rubber stoppers supplied with a relatively high degree of cleanliness.
- The stoppers are thoroughly cleaned, sterilized and dried in the same container.
- The container then serves again as a transport container in the sterile sector of a pharmaceutical production.
Le A 28 570 2 2 ~
- At the bottle filling and stoppering machine, the container serves as a storage container from which the required stoppers can be taken automatically.
The invention is illustrated in greater detail below with the aid of a drawing and an Example. The multipurpose container for pharmaceutical rubber stoppers, shown in the drawing, consists of a stainless steel can l with a cover 2 for closing the charging and discharging orifice 3.
Connectors with shut-off valves 4 and 5, for washing water, are arranged at the top end and at the bottom of the can 1. A stopper retaining plate 6 is fixed just above the bottom of the can 1, directly over the shut-off valve 4. It consists of a perforated plate (sieve) whose holes are substantially smaller than the diameter of the stoppers. A similar but substantially smaller perforated plate 7 is arranged in the cover 2 of the can and prevents stoppers from reaching the upper water connector with the shut-off valve 5-.
" ~) The novel thorough cleaning and sterilization process proceeds for example as follows:
1. Charging of the multipurpose container 1 (can 1) with the rubber stoppers under a laminar flow device (corresponding to clean-room class 3, VDI 2083, in surroundings of cleanliness class VDI 2083);
2. Connection of the can 1 via the shut-off valves 4 and 5 to a cleaning station, also under clean-room class 3, VDI 2083;
3. Opening of the connecting valves 4, 5;
Le A 2B 570 3 83~1 4. Overflow rinsing with ultrapure water having the particle quality of aqua p. io according to DAB, for 10 minutes at 45OC;
5. Draining of the water out of the can 1;
6. Closing of the connecting valves 4, 5;
7. Transporting of the can 1 into the steam sterilizer;
8. Connection of the can to a rotary device in the steam sterilizer;
9. Opening of the connecting valves 4, 5;
10. Sterilization of the stoppers by a conventional fractional backing pressure process with constant or alternating rotation of the can for a period of 15 minutes at temperatures 2121C;
11. Drying of the stoppers by a conventional vacuum drying process with constant or alternating rotation of the can;
12. Closing of the connecting valves 4, 5;
13. Withdrawal of the can 1 from the sterile side of the sterilizer.
Le A 28 570 4 . .
Le A 28 570 4 . .
Claims (5)
1. A process for the cleaning and sterilization of rubber stoppers in pharmaceutical factories, in which the stoppers are thoroughly cleaned and then placed in a steam sterilizer, characterized in that the stoppers are thoroughly cleaned in a multipurpose container (1) equipped with connecting valves (4, 5) for washing water, in that the multipurpose container (1) with the washed stoppers is placed in a steam sterilizer, in which the stoppers are sterilized and dried, and in that, after sterilization and drying, the stoppers are held in reserve in the same multipurpose container (1).
2. A process according to Claim 1, characterized in that the multipurpose container (1) is also used as a transport container with a protective function in respect of the surroundings, for feeding a production unit with rubber stoppers.
3. A process according to Claims 1 and 2, characterized in that the multipurpose container (1) undergoes a rotational or reciprocal movement during the sterilization.
4. A process according to Claim 1, characterized in that the multipurpose container is filled with the rubber stopper under laminar flow protection before the washing and sterilization process.
Le A 28 570 5
Le A 28 570 5
5. A multipurpose container for carrying out the process according to Claims 1 to 4, characterized in that two connecting valves (4, 5) for water are provided on the container (1) for charging the container (1) with washing water and emptying it, and in that at least one water-permeable stopper retaining plate (6) is arranged inside the container (1).
Le A 28 570 6
Le A 28 570 6
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19914138751 DE4138751A1 (en) | 1991-11-26 | 1991-11-26 | METHOD AND DEVICE FOR CLEANING AND STERILIZING PHARMACEUTICAL RUBBER PLUGS |
| DEP4138751.1 | 1991-11-26 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2083541A1 true CA2083541A1 (en) | 1993-05-27 |
Family
ID=6445553
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2083541 Abandoned CA2083541A1 (en) | 1991-11-26 | 1992-11-23 | Process and device for the thorough cleaning and sterilization of pharmaceutical rubber stoppers |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP0544161A1 (en) |
| CA (1) | CA2083541A1 (en) |
| DE (1) | DE4138751A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6659115B1 (en) | 1999-04-13 | 2003-12-09 | Smeja Gmbh & Co. Kg | Cleaning and sterilizing machine |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR9302851A (en) * | 1993-07-14 | 1995-04-25 | Pereira Antonio Martins | Integrated unit for bottle caps / stoppers treatment |
| DE4409659C2 (en) * | 1994-03-21 | 1997-05-07 | Apparate Und Behaeltertechnik | Cleaning and sterilizing system |
| DE19714093A1 (en) * | 1997-04-07 | 1998-10-08 | Alge High Future Gmbh | Instrument sterilisation tray having sealed cover with connection for e.g. steam, to clean inside only |
| CN102397864B (en) * | 2011-12-05 | 2014-02-26 | 楚天科技股份有限公司 | Material receiving device for rubber plug cleaning machine |
| CN103477986A (en) * | 2013-09-16 | 2014-01-01 | 上海市农业科学院 | Water plant tissue-culture explant cleaning and sterilizing device |
| CN117566663B (en) * | 2024-01-03 | 2024-05-28 | 福建明一生态营养品有限公司 | Full-automatic sealing device for milk powder production |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE694228C (en) * | 1938-09-07 | 1940-07-27 | Seitz Werke Gmbh | |
| DE1126072B (en) * | 1959-11-20 | 1962-03-22 | Grashey & Poujarniscle | Device for the sterilization of bottle corks |
| DE1156670B (en) * | 1960-02-20 | 1963-10-31 | Seitz Werke Gmbh | Sterilizing device for vessel closures |
| DE1818622U (en) * | 1960-07-26 | 1960-09-22 | Grashey & Poujarniscle | CORK BAG. |
| SU728862A1 (en) * | 1977-08-17 | 1980-04-25 | Kozlenko Don Sh | Method of sterilization of rubber articles |
| CH637041A5 (en) * | 1979-03-13 | 1983-07-15 | Ciba Geigy Ag | Plug cleaning device |
| US4934392A (en) * | 1987-11-20 | 1990-06-19 | Shubert Systems Limited | Cleaning apparatus |
| DE3931368A1 (en) * | 1989-09-20 | 1991-03-28 | Smeja Gmbh & Co Kg | CLEANING AND STERILIZING MACHINE FOR SMALL OBJECTS, LIKE LOCKING ELEMENTS OF PHARMACEUTICAL VESSELS |
-
1991
- 1991-11-26 DE DE19914138751 patent/DE4138751A1/en not_active Withdrawn
-
1992
- 1992-11-13 EP EP92119435A patent/EP0544161A1/en not_active Withdrawn
- 1992-11-23 CA CA 2083541 patent/CA2083541A1/en not_active Abandoned
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6659115B1 (en) | 1999-04-13 | 2003-12-09 | Smeja Gmbh & Co. Kg | Cleaning and sterilizing machine |
Also Published As
| Publication number | Publication date |
|---|---|
| EP0544161A1 (en) | 1993-06-02 |
| DE4138751A1 (en) | 1993-05-27 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Dead |