EP2030699B1 - Procédé de nettoyage de petits objets - Google Patents

Procédé de nettoyage de petits objets Download PDF

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Publication number
EP2030699B1
EP2030699B1 EP08014328A EP08014328A EP2030699B1 EP 2030699 B1 EP2030699 B1 EP 2030699B1 EP 08014328 A EP08014328 A EP 08014328A EP 08014328 A EP08014328 A EP 08014328A EP 2030699 B1 EP2030699 B1 EP 2030699B1
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EP
European Patent Office
Prior art keywords
container
pressure
washing liquid
air
objects
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.)
Active
Application number
EP08014328A
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German (de)
English (en)
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EP2030699A1 (fr
Inventor
Hans-Werner Mumm
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Atec Pharmatechnik GmbH
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Atec Pharmatechnik GmbH
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Publication of EP2030699A1 publication Critical patent/EP2030699A1/fr
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    • 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
    • B08B3/10—Cleaning involving contact with liquid with additional treatment of the liquid or of the object being cleaned, e.g. by heat, by electricity or by vibration

Definitions

  • the invention relates to a method for washing smaller objects, in particular closure plugs or other closures for pharmaceutical purposes, according to the preamble of claim 1.
  • the applicant is a method and apparatus for cleaning and sterilization of smaller items, such as plugs of infusion bottles or vials, known where the objects are rinsed in a treatment tank with hot water or a water-air mixture, optionally with the addition of detergents, to remove impurities or foreign bodies, if any, and remove them with the washing liquid from the container.
  • a cleaning and sterilizing machine for smaller items known, such as closure elements of pharmaceutical vessels, with which the objects are treated in a treatment tank first with water, steam, hot air and then possibly for siliconizing with a silicone dispersion.
  • the dispersion is forced out of the container by the supply of compressed air and drained, before the small articles are dried in a hot air stream by introducing sterile filtered and heated compressed air on one side into the container and sucked by applying a vacuum on the other side.
  • the air contained in the interior of the recess escapes, inter alia due to the high surface tension of the aqueous washing liquid or only incomplete from the recess when the objects are flooded in the container with the washing liquid.
  • the remaining in the recesses air bubbles thus prevent wetting of the surfaces with the washing liquid, so there is no depletion of impurities.
  • detergents or other surfactants are often added to the washing liquid in order to counteract the formation of air bubbles in the recesses by reducing the surface tension of the washing liquid and to improve the wetting of their surfaces.
  • surfactants are often added to the washing liquid in order to counteract the formation of air bubbles in the recesses by reducing the surface tension of the washing liquid and to improve the wetting of their surfaces.
  • contamination of the surfaces of the articles with residues of these detergents or surfactants can not be excluded.
  • particulate impurities adhering to the articles may also include, but are not limited to, endotoxins, i.
  • endotoxins can be detected very well even at low concentrations, so that the depletion of endotoxins from sealing plugs for pharmaceutical purposes in the course of a washing process is well suited for assessing the quality of the washing process.
  • the US-A-5,215,593 discloses a method of supplying liquid into a through hole of a substrate having a small diameter.
  • the substrate is first placed in a boiling vapor and / or boiling liquid container, whereby the pressure of the air in the through-hole exceeds the atmospheric pressure.
  • the air is expelled from the through-hole and completely through the boiling vapor and / or the boiling Liquid replaced.
  • the ejection of the air can be accelerated by a vibration deaerator.
  • the present invention seeks to improve a method of the type mentioned in that the air can be completely removed from the recesses without a defined orientation of the objects in order to improve the wetting with the washing liquid.
  • This object is achieved in that the container is moved during the pressure reduction and pressure increase in order to change the orientation of the objects in the container and objects whose recesses point down, turn over.
  • the feature combination according to the invention makes it possible to remove air bubbles adhering to the surface of the objects even from relatively deep and narrow recesses and thus to ensure complete wetting of the surface of the objects with washing liquid, which is responsible for cleaning off impurities, such as particles and endotoxins , Requirement is.
  • the container In order to turn plugs, the recess of which points downwards, so that the air can escape completely from the recess, the container is moved during the repeated lowering and increasing of the pressure, preferably by reversing it one or more times after each pressure change cycle.
  • the success of the method according to the invention is based on the volume change of the air bubbles or on a collapse of the air bubbles due to the change in pressure in the container.
  • the pressure in the container is lowered, the air bubbles expand, causing some of the air contained therein to escape from the recesses as a result of the increase in volume and to rise in the washing liquid as a result of the increase in volume which breaks the skin of the air bubbles and the air bubbles Collapse and divide into several separate smaller bubbles.
  • the pressure reduction leads to a degassing of the washing liquid.
  • the former In a subsequent increase in the pressure in the container, the former has the consequence that the air remaining in the recesses occupies a significantly lower bubble volume and therefore the contact area between the air bubbles and the surface of the objects is smaller or the surface wetted by the washing liquid becomes larger.
  • the latter causes in a subsequent increase in pressure that air or components thereof diffuse from the air bubbles in the washing liquid and dissolve in the washing liquid, which in particular small air bubbles are completely eliminated. If the pressure increase abruptly, it also leads to a slump of washing liquid in the air bubbles and thus their collapse.
  • remaining air bubbles expand again, collapse again and divide. Often, only part of the bubbles stick to the surface of the objects. The remaining bubbles rise to the surface of the washing liquid, where the air contained in them is sucked by means of a negative pressure generating vacuum pump.
  • the pressure in the container is lowered to a value of less than 600 mbar, preferably to a value less than 300 mbar, and most preferably less than 100 mbar.
  • the bubble volume increases by a multiple, resulting in several times in succession to the collapse of the bubbles and the escape of a portion of the air contained therein.
  • a preferred embodiment of the invention provides to supply warmed in the container heated liquid and to reduce the pressure in the container to below the boiling point of the washing liquid, which in turn is higher, the higher the temperature of the supplied into the container washing liquid.
  • the pressure falls below the boiling point of the washing liquid, it evaporates, whereby vaporous washing liquid penetrates into the bubbles at the phase boundary with the air bubbles.
  • the heat of evaporation is removed from the washing liquid, which cools as a result.
  • the lowering of the pressure in the container preferably takes place in that above a liquid level of the washing liquid in the container air is sucked out of the container, preferably by means of a vacuum pump.
  • the pressure is increased, according to a preferred embodiment of the invention, at least five times, preferably ten times, and more preferably twenty times, that of the pressure Lowering the pressure in the container prevails.
  • the pressure increase is made impact or pulse, because this also leads to a penetration of water through the skin of the air bubbles in the recesses and thus to a collapse of the bubbles and to escape of air from the recesses.
  • the achieved in this way reduction of the bubble volume and thus the contact surface of the air bubbles has a wetting of other surface areas of the objects result.
  • the pressure in the container is increased at least to atmospheric pressure, better up to more than 1500 mbar, and most preferably to a value of about 2000 mbar.
  • the alternate lowering and increasing the pressure in the container is advantageously carried out several times in succession.
  • a negative pressure is applied to the container before the supply of the washing liquid into the container, which is preferably maintained during the supply of the washing liquid.
  • a very low pressure already prevails in the interior of the bubbles which have formed in the recesses of the objects, so that, in the event of a subsequent abrupt increase in pressure, this leads to the breakthrough of washing liquid already described above in the bubbles which leads to a collapse of the same and a division into smaller bubbles.
  • the lowering of the pressure in the container is preferably carried out by means of a vacuum pump connected to the container by air is sucked from the container above the liquid level of the washing liquid, while to increase the pressure sterile sterile compressed air is supplied into the container. Both approaches allow to accurately control the pressure in the container.
  • the container is preferably substantially completely with the Washing liquid filled.
  • the washing liquid is suitably made of pure water to which no detergents or other surface-active substances are added for wetting the surfaces and for removing bubbles.
  • a further preferred embodiment of the invention provides that the objects are supplied to the container before the supply of the washing liquid, and that then applied a negative pressure to the container and steam, preferably saturated steam, is fed into the container.
  • the supplied vapor condenses on the surfaces of the objects and wets them with water in the form of small water droplets. Since these water droplets easily combine with the subsequent supply of the washing liquid into the container with the washing liquid and beyond an adhesion of air bubbles on the surfaces of the Counteracting objects, a complete wetting of the surface is facilitated with the washing liquid.
  • FIGS. 1 to 7 show schematic views of a filled with a washing liquid container with a single, covered by washing liquid stopper during a lowering and an increase in the pressure in the container.
  • the stoppers are filled into a container, such as one in the EP 1 510 227 A1 the applicant described in more detail treatment and transport container in the one mentioned in the above EP 1 449 543 A1 to treat the plugs after closure of the container and the supply of hot water as washing liquid into the container within the same and thereby remove impurities, such as particles or endotoxins, from the surfaces of the plugs and transfer them into the washing liquid ,
  • the impurities are removed with the washing liquid from the container when it is completely withdrawn from the container after the washing process.
  • the sealing plugs remaining in the container are sterilized by supplying saturated steam into the container before they are optionally dried after a preceding siliconization by supplying hot air.
  • the above-described washing, sterilization and drying of the sealing plugs can also be carried out in containers or plug cleaning systems of a different design, for example in systems with washing-drum-type containers.
  • the closed container 2 serving for washing stopper 6 is therefore only schematic shown.
  • the container 2 has on its upper side a filling opening 4 for filling with sealing plug 6 and an opening into the container interior line 8, which is connected via two controllable shut-off valves 10 and 12 optionally with a vacuum pump 14 or with a compressed air compressed air reservoir 16 containing compressed air.
  • a supply line 18 for supplying washing liquid 20 into the container 2 which is connectable via a controllable shut-off valve 22 with a pump 24 and a container 26 for washing liquid.
  • a pressurized water ring is often present in pharmaceutical plants, from which the required water is removed.
  • Some types of plugs such as the peristaltic plugs 6, enlarged one at a time and in cross-section, for an infusion bottle, have a recess 28 or cavity open on one side only, typically at the bottom of the plug 6.
  • Such a recess 28 complicates a complete wetting of the plug 6 during the washing process, since an air bubble 30 can form during filling of the container 2 with the washing liquid 20 within the recess 28, even if the mouth of the recess 28 faces upward, as in the stopper 6 shown in the drawing.
  • the pressure p in the container 2 filled with the washing liquid 20 is alternately alternately lowered and increased during the washing process, as shown in the figures by a downwardly inclined arrow during the stopper 6 immersed in the washing liquid 20 and is covered by this.
  • the container 2 is after introduction of the sealing plug 6 at atmospheric pressure into the vicinity of the filling opening 4 with the Washing liquid 20 filled so that it completely covers the plug 6.
  • This condition is in Fig. 1 shown and shows that the plug 6 is not wetted by the washing liquid due to the air bubble 30 in the interior of the recess 28, so that there is no further purification of contaminants possible without further action.
  • a negative pressure is first applied in the container 2 by using the vacuum pump 14 via the above the liquid level of the washing liquid 20 into the container 2 opening line 8 air is sucked out of the container 2, such as represented by an arrow A.
  • the pressure within the washing liquid 20 decreases, as a result of which the volume of the air bubble 30 contained in the recess increases and part of the air bubble 30 leaves the recess, as in FIG Fig. 2 shown.
  • the surface of the bladder 20 in contact with the washing liquid 20 increases, until finally the skin of the same breaks in the region of the mouth of the recess 28 and penetrates from outside washing liquid 20 into the collapsing air bladder 30, as in FIG Fig.
  • the vacuum pump 14 When the air pressure above the liquid level of the washing liquid 20 reaches a predetermined value or does not decrease further in spite of continued operation of the vacuum pump 14, which is the case at a pressure of about 50 mbar, the vacuum pump 14 is closed by closing the shut-off valve 10 in the line 8 separated from the container 2 and turned off.
  • the pressure in the container 2 is then increased abruptly by sterilized compressed air is fed into the container 2 by opening the valve 12 above the liquid level until the pressure in the container reaches about 2000 mbar.
  • the rapid increase in pressure in the washing liquid 20 from 50 mbar to about 2000 mbar also causes a collapse of the air bubble 30 contained in the recess 28, wherein the skin of the bladder 30 breaks in the region of the mouth of the recess 28, so that washing liquid 20 into the bladder 30th flows.
  • the air bubble 30 divides into several smaller air bubbles 34, 36, 38, 40, 42, 44, 46, of which those 40, 42, 44, 46, which do not adhere to the surface of the plug 6, to Surface of the washing liquid 20 ascend.
  • the bubble volume decreases approximately by a factor of twenty, as in FIG Fig. 7 represented, whereby only a very small surface in the recess 28 remains unwetted by the washing liquid 20.
  • a portion of the contained in the bubbles 34, 36, 38 dissolves Air in the previously degassed washing liquid 20, with very small bubbles completely dissolve.
  • the container 2 can be rotated in each case between two successive cycles to change the orientation of the plug 6 in the container 2.
  • a complete wetting of the stopper surface with the washing liquid 20 can also be accelerated by subjecting the container 2 first to a vacuum and then to steam, preferably saturated steam, after it has been filled with the stopper 6 and before the washing liquid 20 is supplied.
  • the supplied into the container 2 steam is reflected in its relaxation in the form of smallest water droplets on the surface of the stopper 6 down.
  • These water droplets wet the stopper surface, whereby, in particular, the endotoxins which are readily soluble in water dissolve in the water droplets and, upon melting of the droplets, pass into the aqueous washing liquid 20 which is subsequently introduced into the container.

Landscapes

  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Mechanical Treatment Of Semiconductor (AREA)
  • Electrical Discharge Machining, Electrochemical Machining, And Combined Machining (AREA)
  • Purification Treatments By Anaerobic Or Anaerobic And Aerobic Bacteria Or Animals (AREA)
  • Cleaning In General (AREA)
  • Cleaning By Liquid Or Steam (AREA)

Claims (14)

  1. Procédé de lavage de petits objets (6), en particulier de bouchons de fermeture (6) à usage pharmaceutique, dans lequel les objets (6) sont mis en contact avec un liquide de lavage (20) dans un récipient (2) fermé pour éliminer des impuretés de la surface des objets (6) et dans lequel la pression qui règne dans le récipient (2) qui contient les objets (6) revêtus par le liquide de lavage (20) est abaissée et relevée en alternance pour éliminer l'air des découpes (28) des objets,
    caractérisé en ce que
    pendant l'abaissement et le relèvement de la pression, le récipient (2) est déplacé pour modifier l'orientation des objets (6) dans le récipient (2) et pour retourner des objets (6) dont les découpes (28) sont orientées vers le bas.
  2. Procédé selon la revendication 1, caractérisé en ce que la pression qui règne au-dessus du niveau de liquide de lavage (20) est abaissée à une valeur inférieure à 100 mbars.
  3. Procédé selon l'une des revendications précédentes, caractérisé en ce que la pression qui règne dans le récipient (2) est abaissée jusqu'en dessous du point d'ébullition du liquide de lavage (20).
  4. Procédé selon l'une des revendications précédentes, caractérisé en ce que la pression qui règne dans le récipient (2) est abaissée en aspirant l'air du récipient (2) au-dessus du niveau du liquide de lavage (20).
  5. Procédé selon l'une des revendications précédentes, caractérisé en ce que la pression qui règne dans le récipient (2) est plusieurs fois abaissée et relevée de manière alternée.
  6. Procédé selon l'une des revendications précédentes, caractérisé en ce que la pression qui règne dans le récipient (2) est relevée dès qu'une dépression prédéterminée a été atteinte dans le récipient (2) ou dès que l'on ne détecte plus de diminution de la pression dans le récipient (2).
  7. Procédé selon l'une des revendications précédentes, caractérisé en ce que la pression qui règne dans le récipient (2) est relevée brusquement.
  8. Procédé selon la revendication 7, caractérisé en ce que la pression est relevée brusquement au moins jusqu'à la pression atmosphérique.
  9. Procédé selon l'une des revendications précédentes, caractérisé en ce que la pression est relevée jusqu'à une valeur supérieure à 1 500 mbars.
  10. Procédé selon l'une des revendications précédentes, caractérisé en ce que pour le relèvement de la pression, on amène de l'air comprimé dans le récipient (2).
  11. Procédé selon l'une des revendications précédentes, caractérisé en ce que le liquide de lavage est de l'eau qui ne contient ni détergent ni substances tensioactives.
  12. Procédé selon l'une des revendications précédentes, caractérisé en ce que de la vapeur d'eau est amenée dans le récipient (2) avant l'amenée de liquide de lavage dans le récipient (2).
  13. Procédé selon l'une des revendications précédentes, caractérisé en ce qu'avant l'apport de vapeur d'eau, une dépression est appliquée dans le récipient (2).
  14. Procédé selon l'une des revendications précédentes, caractérisé en ce qu'avant et/ou pendant l'apport de liquide de lavage (20) dans le récipient (2), une dépression est appliquée dans le récipient (2).
EP08014328A 2007-08-28 2008-08-12 Procédé de nettoyage de petits objets Active EP2030699B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102007040522A DE102007040522A1 (de) 2007-08-28 2007-08-28 Verfahren zum Waschen von kleineren Gegenständen

Publications (2)

Publication Number Publication Date
EP2030699A1 EP2030699A1 (fr) 2009-03-04
EP2030699B1 true EP2030699B1 (fr) 2010-10-13

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ID=40032645

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EP08014328A Active EP2030699B1 (fr) 2007-08-28 2008-08-12 Procédé de nettoyage de petits objets

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EP (1) EP2030699B1 (fr)
AT (1) ATE484345T1 (fr)
DE (2) DE102007040522A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102017126329A1 (de) * 2017-11-09 2019-05-09 Lpw Reinigungssysteme Gmbh Verfahren zur Reinigung eines Werkstücks
CN114778872B (zh) * 2022-06-13 2022-11-29 深圳市帝迈生物技术有限公司 样本分析仪及样本分析仪的控制方法

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04250874A (ja) * 1991-01-09 1992-09-07 Canon Inc 液体導入装置
DE4409659C2 (de) 1994-03-21 1997-05-07 Apparate Und Behaeltertechnik Reinigungs- und Sterilisieranlage
DE19714603C1 (de) * 1997-04-09 1998-10-29 Schwarz Ernst Mafac Gmbh Verfahren und Vorrichtung zur Reinigung von Werkstücken
ATE231007T1 (de) * 1999-02-03 2003-02-15 Meditecnic Inc Vorrichtung zum sterilisieren eines hohlraums
DE29923723U1 (de) 1999-04-13 2001-02-22 Smeja Gmbh & Co Kg Reinigungs- und Sterilisiermaschine
JP2004241754A (ja) * 2002-07-16 2004-08-26 Chem Art Technol:Kk 基板処理方法及び基板処理装置
DE102004007263A1 (de) 2003-02-20 2004-09-02 Atec Pharmatechnik Gmbh Vorrichtung und Verfahren zur Behandlung von kleineren Gegenständen
EP1510227B1 (fr) 2003-09-01 2011-10-05 Atec Pharmatechnik Gmbh Conteneur de traitement et de transport

Also Published As

Publication number Publication date
EP2030699A1 (fr) 2009-03-04
DE102007040522A1 (de) 2009-03-05
ATE484345T1 (de) 2010-10-15
DE502008001503D1 (de) 2010-11-25

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