WO2015162554A1 - Procédé de post-traitement de produits d'implants stérilisés en zircone - Google Patents

Procédé de post-traitement de produits d'implants stérilisés en zircone Download PDF

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Publication number
WO2015162554A1
WO2015162554A1 PCT/IB2015/052903 IB2015052903W WO2015162554A1 WO 2015162554 A1 WO2015162554 A1 WO 2015162554A1 IB 2015052903 W IB2015052903 W IB 2015052903W WO 2015162554 A1 WO2015162554 A1 WO 2015162554A1
Authority
WO
WIPO (PCT)
Prior art keywords
sterilization
sterilized
temperature
products
packaging
Prior art date
Application number
PCT/IB2015/052903
Other languages
German (de)
English (en)
Inventor
Ulrich Volz
Original Assignee
Ribaxx Ag
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 Ribaxx Ag filed Critical Ribaxx Ag
Publication of WO2015162554A1 publication Critical patent/WO2015162554A1/fr

Links

Classifications

    • 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
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00—Preparations for dentistry
    • A61K6/15—Compositions characterised by their physical properties
    • 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
    • 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
    • A61L2/08—Radiation
    • A61L2/087—Particle radiation, e.g. electron-beam, alpha or beta radiation
    • 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
    • B65B55/12—Sterilising contents prior to, or during, packaging
    • B65B55/16—Sterilising contents prior to, or during, packaging by irradiation
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/01—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics
    • C04B35/48—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on zirconium or hafnium oxides, zirconates, zircon or hafnates
    • C04B35/486—Fine ceramics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0087—Means for sterile storage or manipulation of dental implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00—Preparations for dentistry
    • A61K6/80—Preparations for artificial teeth, for filling teeth or for capping teeth
    • A61K6/802—Preparations for artificial teeth, for filling teeth or for capping teeth comprising ceramics
    • A61K6/818—Preparations for artificial teeth, for filling teeth or for capping teeth comprising ceramics comprising zirconium oxide
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B2235/00—Aspects relating to ceramic starting mixtures or sintered ceramic products
    • C04B2235/70—Aspects relating to sintered or melt-casted ceramic products
    • C04B2235/96—Properties of ceramic products, e.g. mechanical properties such as strength, toughness, wear resistance
    • C04B2235/9646—Optical properties
    • C04B2235/9661—Colour

Definitions

  • the invention relates to a method for the aftertreatment of zirconia implant products, which has been exposed to the sterilization of a beta, gamma or other high-energy radiation.
  • Sterility is an absolute must. According to the EN 556 standard, they are considered sterile if the
  • a sterilization process is the so-called steam sterilization. Sterilization with moist heat at which the heat of condensation of the water vapor, on which precipitates colder sterilized. Condensing steam heats up sterilized material very quickly with even temperature distribution. Also
  • thermostable instruments in the surgical field (metal instruments, tubing, cables, cautery, compresses, swabs, and other textiles) as well as textiles and rubber
  • thermostable instruments metal instruments, tubing, cables, cautery, compresses, swabs, and other textiles
  • textiles and rubber To complete a sterilization process and store the sterilized materials or products, these products are placed in containers.
  • Containers may be, for example, special bags, boxes or the like. In order to carry out a proper sterilization process, one needs one
  • thermolabile items since they are exposed to a temperature range of 37 ° C - 60 ° C.
  • EO gas ethylene oxide
  • the highly toxic u. explosive ethylene oxide (EO) is defined under
  • Plasma sterilization known. In addition to chemical and thermal processes, high-energy electron beams (beta-sterilization) or electromagnetic waves (gamma sterilization, X-ray sterilization) can reliably destroy the DNA of microorganisms and inactivate microbial contamination. Radiation sterilization is also economically attractive, since it is the only process that allows the sterilization of products, including their packaging, without any appreciable value
  • the advantage of this type of high energy radiation sterilization is that sterilization of the product occurs in the shipping package. There is no significant increase in the temperature of the product, so that temperature-sensitive or frozen products could be sterilized. The product is immediately available after sterilization. There is no
  • Titanium implants are usually sterilized with gamma
  • Zirconia is the common name for Zirconia ZrO 2. This zirconia is made of zircon (the silicate of
  • Packaging of medical and pharmaceutical products is subject to complex requirements. Primarily, the packaging serves as a sterile barrier system. The sterilization of the products is thereby made possible and the durability can be guaranteed over a defined period of time.
  • the manufacture of packaging and packaging processes takes place under Class A / B (ISO 5) class C (ISO 7) and class D (ISO 8) clean room conditions and complies with the requirements of the MPG, AMG and EN ISO 9001: 2008 ,
  • the labeling of the packaging is based on customer wishes and the legal requirements. The traceability is guaranteed without interruption. All sterile barrier systems are validated. Mechanical stress tests supplement the requirements for the safety and sterility of the products.
  • Zirconia changes its color from white to black, gray or purple / pink during beta, gamma or other high-energy sterilization.
  • the white color changes in such a way that the product can not be used after such irradiation for aesthetic reasons, at least in the visible range.
  • gamma ray sterilization can only be used on zirconia products when these products are not optically apparent (e.g., hip joint implants).
  • Zirconia dental implants are therefore excluded from the gamma sterilization process and must be sterilized with water vapor, ethylene oxide or plasma consuming.
  • the work steps are complex, with many intermediate steps are provided. On the one hand, this increases the costs, but on the other hand, the error rate, namely, insufficient sterilization or that the product is again contaminated, if it will be in another packaging.
  • the object is to provide a method that allows sterilization of zirconium oxide products, in particular implants in the use of the per se comfortable packaging and the per se by beta, gamma or other high-energy radiation (hard radiation) occurring Discoloration at least reduced.
  • hard radiation has the advantage that a simple but very efficient and sufficient sterilization of the product is achieved, such that the product can remain completely in the packaging and such that several such packaged products can be sterilized by an exposure process.
  • the basic idea of the invention is to further treat zirconia, which is once discolored by beta, gamma or other high-energy sterilization, without, however, accepting it from already sterilized packaging already exposed to beta, gamma or other high-energy radiation to restore the discoloration to white or even better to return to natural colors.
  • the complete package i. the implant product (with the implant placed in the package) is heated in a chamber or oven, in particular a tempering oven, after the product has been exposed to beta, gamma or other high energy radiation.
  • a chamber or oven in particular a tempering oven
  • Sterilization by beta, gamma or other high-energy radiation allows product-friendly workflows, namely a sterilization of the product in its final packaging. This is a contamination by subsequent
  • the product already sterilized and contained in the package is only treated by a single further processing process, without changing the previous status, namely that the product is sterilized.
  • it is intended to heat or temper the sterilized product in its packaging or even a whole batch consisting of several such products.
  • the entire already sterilized batch is preferably passed after the irradiation with the high-energy radiation, in particular gamma rays, subsequently into a tempering furnace.
  • temperatures between 60 and 1 50 degrees Celsius This has temperatures between 60 and 1 50 degrees Celsius.
  • the products are then exposed to the appropriate temperature. It can with increasing the temperature increase or increase. For example, it is intended to expose the products initially at 60 degrees Celsius temperature for 3 hours. For the remaining 3 hours, a temperature of about 1 30 degrees Celsius is to be selected. Alternatively, it is also intended to expose the products at 1 50 degrees Celsius temperature for 1 0 minutes.
  • the appropriate temperature it is intended to expose the products initially at 60 degrees Celsius temperature for 3 hours. For the remaining 3 hours, a temperature of about 1 30 degrees Celsius is to be selected. Alternatively, it is also intended to expose the products at 1 50 degrees Celsius temperature for 1 0 minutes.
  • the implant is already fully inserted in a package before this implant is exposed to high-energy radiation.
  • This packaging consists for example of polycarbonate. The radiation penetrates the
  • Packaging and thus several packaging sorted as a batch with one exposure. This can be sterilized very efficiently and purposefully.
  • the packaging is also temperature stable at least up to a temperature of at least 1 50 degrees Celsius, so that an introduction into a chamber or oven with a temperature of about 1 50 degrees Celsius, the packaging unchanged leaves. Only the color of the product, ie the zirconia implant, changes.
  • transfer and placement aids can be screwed or clicked on the implant and thus provide the user with a comfortable and safe
  • the package forms a closed unit with the transfer and insertion aid. This closed unit is then preferably supplied in one batch (several such packages) to high energy sterilization sterilization.
  • the packaging is made of polycarbonate, it can at least be designed in such a way that there is a viewing window on the product. This allows the consumer to get an idea of the product before removing it from the sterilized packaging.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Ceramic Engineering (AREA)
  • Composite Materials (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials Engineering (AREA)
  • Structural Engineering (AREA)
  • Organic Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Toxicology (AREA)
  • Mechanical Engineering (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

L'invention concerne un procédé de post-traitement de produits d'implants stérilisés en zircone qui ont été soumis à une stérilisation par un rayon à haute énergie bêta, gamma ou autre, ledit procédé consistant à soumettre à un revenu le produit d'implant disposé dans son emballage à une température comprise entre 60 et 150 degrés Celsius pendant un temps de séjour défini, après l'exposition au rayon à haute énergie.
PCT/IB2015/052903 2014-04-22 2015-04-21 Procédé de post-traitement de produits d'implants stérilisés en zircone WO2015162554A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102014105608.6A DE102014105608B4 (de) 2014-04-22 2014-04-22 Verfahren zur Sterilisation von Zirkonoxid-Implantaten mit Gamma-Strahlung
DE102014105608.6 2014-04-22

Publications (1)

Publication Number Publication Date
WO2015162554A1 true WO2015162554A1 (fr) 2015-10-29

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ID=53189860

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2015/052903 WO2015162554A1 (fr) 2014-04-22 2015-04-21 Procédé de post-traitement de produits d'implants stérilisés en zircone

Country Status (2)

Country Link
DE (1) DE102014105608B4 (fr)
WO (1) WO2015162554A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017109112A1 (fr) * 2015-12-24 2017-06-29 Straumann Holding Ag Procédé de préparation d'un corps céramique stérilisé comprenant ou essentiellement constitué de zircone stabilisée d'une couleur définie

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107708603A (zh) * 2015-07-01 2018-02-16 株式会社南陶 补缀物包装盒、补缀物、带有包装盒的补缀物

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06293579A (ja) * 1993-04-07 1994-10-21 Ngk Spark Plug Co Ltd 着色セラミックスの製造方法
US20100217331A1 (en) * 2009-02-25 2010-08-26 Warsaw Orthopedic, Inc. System and methods of maintaining space for augmentation of the alveolar ridge
US20110270407A1 (en) * 2002-12-24 2011-11-03 Cadorel, Catherine Medical or veterinary material, method for the production and use thereof
EP2698171A1 (fr) * 2012-08-14 2014-02-19 Straumann Holding AG Procédé de stérilisation de composants dentaires comprenant du polyméthacrylate de méthyle
WO2015025656A1 (fr) * 2013-08-20 2015-02-26 株式会社ナントー Prothèse

Family Cites Families (6)

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Publication number Priority date Publication date Assignee Title
DE4440337A1 (de) 1994-11-11 1996-05-15 Dds Drug Delivery Services Ges Pharmazeutische Nanosuspensionen zur Arzneistoffapplikation als Systeme mit erhöhter Sättigungslöslichkeit und Lösungsgeschwindigkeit
SE9801901L (sv) 1998-05-29 1999-08-02 Bone Support Ab Förfarande för framställning av pulverkomponent till cement för medicinskt bruk, användning av sådan pulverkomponent samt sådan pulverkomponent
DE19957788A1 (de) 1999-12-01 2001-07-05 Schott Glas Tropfflasche
EP1434607A1 (fr) 2001-10-11 2004-07-07 Straumann Holding AG Implants osteophiles
DE102009005534B3 (de) 2008-12-18 2010-04-01 Heraeus Medical Gmbh Sporozide Zusammensetzungen und deren Verwendung
DE102009024616A1 (de) 2009-06-08 2010-12-23 Telos Gmbh Sterilisierbare Implantatbeschichtung und Verfahren zu deren Herstellung

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06293579A (ja) * 1993-04-07 1994-10-21 Ngk Spark Plug Co Ltd 着色セラミックスの製造方法
US20110270407A1 (en) * 2002-12-24 2011-11-03 Cadorel, Catherine Medical or veterinary material, method for the production and use thereof
US20100217331A1 (en) * 2009-02-25 2010-08-26 Warsaw Orthopedic, Inc. System and methods of maintaining space for augmentation of the alveolar ridge
EP2698171A1 (fr) * 2012-08-14 2014-02-19 Straumann Holding AG Procédé de stérilisation de composants dentaires comprenant du polyméthacrylate de méthyle
WO2015025656A1 (fr) * 2013-08-20 2015-02-26 株式会社ナントー Prothèse

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017109112A1 (fr) * 2015-12-24 2017-06-29 Straumann Holding Ag Procédé de préparation d'un corps céramique stérilisé comprenant ou essentiellement constitué de zircone stabilisée d'une couleur définie
US20190001011A1 (en) * 2015-12-24 2019-01-03 Straumann Holding Ag Process for the preparation of a sterilized ceramic body comprising or essentially consisting of stabilized zirconia of a defined colour
US11135331B2 (en) 2015-12-24 2021-10-05 Straumann Holding Ag Process for the preparation of a sterilized ceramic body comprising or essentially consisting of stabilized zirconia of a defined colour

Also Published As

Publication number Publication date
DE102014105608A1 (de) 2015-10-22
DE102014105608B4 (de) 2024-09-26

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