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WO2007071486A1 - Procede et systeme pour l'elimination des impuretes sur des recipients et/ou pour leur sterilisation - Google Patents

Procede et systeme pour l'elimination des impuretes sur des recipients et/ou pour leur sterilisation Download PDF

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Publication number
WO2007071486A1
WO2007071486A1 PCT/EP2006/067940 EP2006067940W WO2007071486A1 WO 2007071486 A1 WO2007071486 A1 WO 2007071486A1 EP 2006067940 W EP2006067940 W EP 2006067940W WO 2007071486 A1 WO2007071486 A1 WO 2007071486A1
Authority
WO
WIPO (PCT)
Prior art keywords
containers
plasma
treatment
steam
plasma process
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.)
Ceased
Application number
PCT/EP2006/067940
Other languages
German (de)
English (en)
Inventor
Kurt Burger
Bernd Wilke
Helmut Weber
Hartmut Knoedler
Johannes Rauschnabel
Jochen Peters
Dunja Weiss
Susanne Lucas
Marc Braeuninger
Jochen Feichtinger
Stefanie Freudenstein
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.)
Robert Bosch GmbH
Original Assignee
Robert Bosch GmbH
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Robert Bosch GmbH filed Critical Robert Bosch GmbH
Priority to EP06819189A priority Critical patent/EP1968654A1/fr
Priority to JP2008546307A priority patent/JP2009519872A/ja
Publication of WO2007071486A1 publication Critical patent/WO2007071486A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04—Heat
    • A61L2/06—Hot gas
    • A61L2/07—Steam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/14—Plasma, i.e. ionised gases

Definitions

  • the invention relates to a method and an arrangement for the depletion of contaminants in containers and / or for their sterilization, in particular a method for endotoxin depletion, according to the preamble of claim 1.
  • DE 197 09 067 A1 discloses a process for the sterilization of containers, such as ampoules, vials and similar pharmaceutical packaging, in which the articles to be sterilized are stored in a dry container. be exposed to hot air flow at a temperature of about 350 0 C.
  • Dry heat can be efficiently used for endotoxin depletion and sterilization, but benö- Strengthens a temperature of about 200 0 C, the few materials as can withstand about glass.
  • Aqueous cleaning to dilute existing endotoxin contamination has a low effect on plastic and glass surfaces with a maximum of about 3 log depletion and very variable results.
  • a steam treatment also referred to as a steam injection process, shows only a very slight inactivation of the endotoxin concentration on glass surfaces.
  • Plasma sterilization processes show very different results depending on the material of the surface to be sterilized or the conditions adapted to these materials. On glass, the depletion is satisfactory; under plastic compatible conditions, the inactivation efficiency on plastic surfaces with less than 2 log depletion is very low.
  • the core of the invention is a combination treatment of steam pulse and plasma process for sterilization and depyrogenation of the material surfaces, in which the result is not the added power of the individual process steps, but advantageously an exceeding efficiency.
  • the combination method according to the invention is suitable not only for the filling of pharmaceutical products in plastic and glass containers, but also for the treatment of medical devices, such as infusion sets and the like, as well as implants, such as screws made of polylactide and the like.
  • the process according to the invention enables an endotoxin depletion of more than 4 log on plastics and glass.
  • the temperature of the treated surfaces remains below 120 0 C, so that the inventive method also allows treatment of surfaces made of thermolabile plastics.
  • the inventive method in combination with endotoxin depletion also has an efficient sterilization.
  • the method according to the invention is therefore usable for containers which serve as pharmaceutical packaging means and enables a high yield, i. For example, a throughput of over 300 pieces per minute in a corresponding device.
  • An advantageous embodiment of the invention provides that the steam treatment is carried out with pressure, wherein the steam is expanded in the container, thereby enabling a simple mechanical detachment of the contaminants.
  • the plasma process is preferably carried out in vacuo, as is known from the prior art indicated in the introduction to the description.
  • the surface is preferably dried, as any remaining moisture affects the plasma process. For example, the moisture could freeze out in the plasma process.
  • the steaming may then be followed by an aqueous treatment step to purge detached contamination from the container.
  • Another advantageous embodiment of the invention provides that after the first steam pressure treatment, a drying step takes place and this sequence is repeated at least once.
  • a depletion of particles takes place on the surface during the steam treatment and optionally the aqueous cleaning.
  • a container serving as a pharmaceutical packaging agent may have, for example, surfaces of glass, quartz or plastic.
  • the treatment of such containers is carried out by purification, sterilization and depyrogenation.
  • the surface wetting can be changed by addition of additive gases in the plasma process compared to the initial state.
  • the additive gas for saturation of free binding sites is then preferably added after the plasma process.
  • Additive can here be a hydrophobic coating after the plasma process.
  • the coefficient of friction of the treated surfaces in the plasma process can be adjusted in an advantageous manner. For example, this can be achieved by fluorination or by addition of carbon or hexamethyldisiloxane. In particular, thereby the friction of elastomeric stopper on the container is adjustable.
  • the treated surface is compacted. It is thus formed a barrier for ev. Incoming oxygen, which can affect both the plastic and the contents of the containers. It can thus also a blocking effect for substances that could dissolve into the container from the plastic occur.
  • the plasma sterilization process is followed by a plasma coating process.
  • the treatment preferably results in a surface which reduces adhesion and cell growth.
  • the treatment may preferably be adjusted so as to result in a surface in which the adhesion and growth of cells is promoted.
  • a particularly advantageous embodiment of the invention relates to a device for carrying out a method described above, which comprises means for treating a surface with steam, as well as means for subsequent treatment of the surface with a plasma.
  • Fig. 1 is a schematic representation of a device for carrying out an inventive
  • FIG. 2 is a diagram showing the effect of a method according to the invention applied to a plastic vial over a conventional method in which only steam is used.
  • FIG is compared to a conventional method in which only plasma is used, as well as
  • Fig. 2 II is a diagram showing the effect of a invention applied to a glass vial according to the invention
  • An apparatus shown in FIG. 1 for carrying out endotoxin depletion on surfaces by means of a combination of steam treatment and plasma process essentially comprises a steam treatment station 30, a plasma treatment station 40 and conveyor belts 20, 21 for feeding and forwarding them as vials 10, 11, 12, 13, 14 exported containers to, between and from the treatment stations 30, 40th
  • the illustrated device according to the invention thus represents an alternative to a conventional cleaning machine and an adjoining heat sterilization and de-pyrogenization tunnel.
  • Vi- located in the plasma treatment station 40 as 13 are then subjected to a plasma process, as described in the prior art DE 199 03 935 Al.
  • the vials are transferred in a passage through the device shown in Fig. 1 of an initial non-sterile state I first by the Dampfrich adaptation- and then by the plasma treatment in a final sterile state II.
  • the filling and sealing of the sterile vial 14 takes place by means of schematically indicated device elements 50, 60 and 70, which are not essential to the operation of the invention.
  • FIGS. 2 I and 2 II the effect of the method according to the invention is shown compared to a conventional method in which only steam is used and to a conventional method in which only plasma is used, once for the de-crystallization and the sterilization of an art - Material vials (Fig. 2 I) and once for Entpryogenmaschine and the sterilization of a glass vial (Fig. 2 II).
  • thermolabile plastics such as polylactide
  • the method is in principle also suitable for depleting BSE-causing prion contamination on temperature-sensitive surfaces.

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Packages (AREA)

Abstract

L'invention concerne un procédé d'élimination en particulier d'endotoxines sur des surfaces, lequel procédé est constitué d'une combinaison d'un traitement à la vapeur et d'un traitement au plasma. La surface est d'abord traitée à la vapeur et l'élimination des endotoxines est ensuite complétée par un traitement au plasma qui assure un effet de stérilisation. L'invention décrit en outre un dispositif en vue de la mise en œuvre du procédé.
PCT/EP2006/067940 2005-12-19 2006-10-30 Procede et systeme pour l'elimination des impuretes sur des recipients et/ou pour leur sterilisation Ceased WO2007071486A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP06819189A EP1968654A1 (fr) 2005-12-19 2006-10-30 Procede et systeme pour l'elimination des impuretes sur des recipients et/ou pour leur sterilisation
JP2008546307A JP2009519872A (ja) 2005-12-19 2006-10-30 容器における不純物の減少及び／又は容器の滅菌を行う方法並びに装置

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE102005061024 2005-12-19
DE102005061024.2 2005-12-19
DE102006035979A DE102006035979A1 (de) 2005-12-19 2006-08-02 Verfahren und Anordnung zur Abreicherung von Verunreinigungen an Behältnissen und/oder zu deren Sterilisation
DE102006035979.8 2006-08-02

Publications (1)

Publication Number Publication Date
WO2007071486A1 true WO2007071486A1 (fr) 2007-06-28

Family

ID=37654747

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2006/067940 Ceased WO2007071486A1 (fr) 2005-12-19 2006-10-30 Procede et systeme pour l'elimination des impuretes sur des recipients et/ou pour leur sterilisation

Country Status (4)

Country Link
EP (1) EP1968654A1 (fr)
JP (1) JP2009519872A (fr)
DE (1) DE102006035979A1 (fr)
WO (1) WO2007071486A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5697997A (en) * 1992-12-07 1997-12-16 Nobel Biocare Ab Method and device for preparing implant surfaces
DE19715583A1 (de) * 1997-04-15 1998-10-22 Pierre Dr Flecher Sterilisator für den Medizinbereich
DE19748098A1 (de) * 1997-10-17 1999-07-15 Inst Niedertemperatur Plasmaph Verfahren zur Sterilisation von empfindlichen Gütern
DE19937008A1 (de) * 1999-08-05 2001-02-15 Bosch Gmbh Robert Verfahren und Vorrichtung zur sterilen Verapckung von Stoffen in Kunststoffbehältnisse
WO2002022447A1 (fr) * 2000-09-15 2002-03-21 Rüdiger Haaga GmbH Procede pour realiser la sterilisation et la depyrogenation de contenants laves
WO2003014415A1 (fr) * 2001-08-07 2003-02-20 Schott Glas Materiau composite constitue d'un substrat et d'une couche barriere
US20050113535A1 (en) * 2003-11-21 2005-05-26 Katherine Glasgow Ionizing radiation stable polyarylestercarbonate compositions

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5697997A (en) * 1992-12-07 1997-12-16 Nobel Biocare Ab Method and device for preparing implant surfaces
DE19715583A1 (de) * 1997-04-15 1998-10-22 Pierre Dr Flecher Sterilisator für den Medizinbereich
DE19748098A1 (de) * 1997-10-17 1999-07-15 Inst Niedertemperatur Plasmaph Verfahren zur Sterilisation von empfindlichen Gütern
DE19937008A1 (de) * 1999-08-05 2001-02-15 Bosch Gmbh Robert Verfahren und Vorrichtung zur sterilen Verapckung von Stoffen in Kunststoffbehältnisse
WO2002022447A1 (fr) * 2000-09-15 2002-03-21 Rüdiger Haaga GmbH Procede pour realiser la sterilisation et la depyrogenation de contenants laves
WO2003014415A1 (fr) * 2001-08-07 2003-02-20 Schott Glas Materiau composite constitue d'un substrat et d'une couche barriere
US20050113535A1 (en) * 2003-11-21 2005-05-26 Katherine Glasgow Ionizing radiation stable polyarylestercarbonate compositions

Also Published As

Publication number Publication date
JP2009519872A (ja) 2009-05-21
DE102006035979A1 (de) 2007-06-28
EP1968654A1 (fr) 2008-09-17

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