EP2138787A2 - Fixation - Google Patents

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Publication number
EP2138787A2
EP2138787A2 EP09007929A EP09007929A EP2138787A2 EP 2138787 A2 EP2138787 A2 EP 2138787A2 EP 09007929 A EP09007929 A EP 09007929A EP 09007929 A EP09007929 A EP 09007929A EP 2138787 A2 EP2138787 A2 EP 2138787A2
Authority
EP
European Patent Office
Prior art keywords
sleeve
carpule
holder according
receptacle
during
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.)
Withdrawn
Application number
EP09007929A
Other languages
German (de)
English (en)
Other versions
EP2138787A3 (fr
Inventor
Gerald Thomas
Jürgen ROTHBAUER
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.)
Optima Group pharma GmbH
Original Assignee
Optima Group pharma 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 Optima Group pharma GmbH filed Critical Optima Group pharma GmbH
Publication of EP2138787A2 publication Critical patent/EP2138787A2/fr
Publication of EP2138787A3 publication Critical patent/EP2138787A3/fr
Withdrawn legal-status Critical Current

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Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B25/00—Details of general application not covered by group F26B21/00 or F26B23/00
    • F26B25/001—Handling, e.g. loading or unloading arrangements
    • F26B25/003—Handling, e.g. loading or unloading arrangements for articles

Definitions

  • the invention relates to the treatment of pharmaceutical products in freeze-drying.
  • Freeze-drying is one way to preserve pharmaceutical products. But first the pharmaceutical products have to be bottled.
  • the containers to be filled are first cleaned in washing machines. They are treated in rotary machines or tunnel washing machines with various media usual in pharmacy. In the subsequent sterilization tunnel, a safe sterilization and depyrogenation of the containers takes place during heating to a defined temperature. Thereafter, the containers are fed to the filling machine. With suitable for the different forms of containers mounts these are transported through the machine. There are a variety of methods for filling the containers available. Subsequently, suitable rubber stoppers are placed on the containers, especially for the freeze-drying, and then the feed to the freeze-drying process takes place.
  • the containers containing the pharmaceutical product contained therein are placed in a cooling chamber where they are cooled to a temperature below the triple point of water. Thereafter, the cooling chamber is brought into communication with a vacuum chamber, that is evacuated the cooling chamber itself. Therefore, the cooling chamber must be mechanically designed so that it can withstand the low pressures.
  • cooling plates are more or less densely packed many product containers, of which the product container arranged at the edge are closer to the walls of the cooling chamber. Due to an uncontrolled, lateral heat radiation, in particular through the walls of the cooling chamber of the drying process runs at the edge of the product containers faster than in the center of the cooling plate.
  • the invention is based on the object to provide a way to achieve a uniform drying and thus shorter drying times in pharmaceutical products in total.
  • the invention proposes a holder for the product container used in pharmacy, for the sake of simplifying the term cartridges is used in the following, which should just include the other product containers used to accommodate pharmaceutical products such as syringes, vials or the like.
  • the invention also proposes the use of such a fixture during freeze-drying and during other processes. Further developments of the invention are the subject of dependent claims.
  • cartridges or other containers used for the pharmaceutical products such a preferably made of metal sleeve can be produced with a very well-defined footprint, which then stands on the cooling plate. Due to the large-area contact between the sleeve and the cooling plate, the entire sleeve assumes the temperature of the cooling plate during heating through the cooling plate. The heat transfer by heat radiation then no longer takes place only on the small footprint of the pharmaceutical product container, but in addition over the entire inwardly directed wall surface of the recording. So there is a better and thus faster heat transfer to the interior of the carpules instead. Due to the high proportion of radiant heat for the heat transfer from the sleeve to the product container, the manufacturing tolerances of the product container have only a small influence on the heat transfer.
  • the sleeves are preferably made of metal. As a result, they already have a not inconsiderable weight, which causes the center of gravity of the unit of sleeve and container to shift downwards. This improves transport safety.
  • the bottom of the sleeve has holes or openings, which favor the heat transfer through a hot air flow.
  • the sleeve consists of a pharmaceutical-appropriate material, ie a material that can be sterilized.
  • a pharmaceutical-appropriate material ie a material that can be sterilized.
  • 316 L stainless steel in question.
  • the sleeve with a pharmaceutical-appropriate coating, for example with an HC coating. Then, a non-pharmaceutic material can be used for the sleeve.
  • the sleeve is integrally formed, so that no interruptions of the heat transfer can occur.
  • the bottom of the receptacle is formed only by a circumferential shoulder on which the container rests, while the rest of the bottom has an opening.
  • the sleeve should improve the heat transfer and, if necessary, the stability of the product container. It makes sense and is within the scope of the invention that the sleeve in its lower region, in which it rests on the cooling plate, has a greater wall thickness than in its upper region. As wall thickness, a range of approximately 0.5 mm to 2 mm is provided as a minimum.
  • the invention proposes in a further development to arrange the container in the sleeves before the actual freeze-drying process, namely during sterilization, in which then simultaneously a sterilization of the sleeve, during filling of the carpules and during transport into the cooling chamber.
  • the containers can remain in the sleeves even after freeze-drying, namely during unloading and closing.
  • the sleeves serve primarily to secure and accommodate the container during transport and during downtime the. When actually filling it may also be useful to remove the carpule from the sleeve and after the Fill again into the sleeve. The same is true when setting a plug.
  • FIG. 1 shows a side view of a carpule, which has the shape of a slim long bottle.
  • the cross section of this container is circular. Due to the large length in relation to the small base 2 of this container is not very stable. At the top surface opposite the base 2 there is an opening 4 through a neck 3 reduced in diameter, onto which a plug is loosely placed or laid during freeze-drying.
  • a sleeve 5 is proposed by the invention, which in FIG. 2 in the Longitudinal section is shown.
  • the sleeve 5 is integrally formed and made of metal, for example stainless steel. It has a cylindrical surface 6, which is smooth. At the bottom of the sleeve 5, a base 7 is formed, which lies in a plane and has only low manufacturing tolerances.
  • a cylindrical receptacle 8 is formed in the sleeve 5, which extends smoothly from the upper side 9 of the sleeve 5 to a bottom, which is formed by a shoulder 10.
  • the shoulder 10 lies in a plane perpendicular to the longitudinal axis of the sleeve 5 and parallel to the base surface 7. In the middle, the bottom 10 has a passage opening 11.
  • the inner diameter of the receptacle 8 is on the outer diameter of the carpule 1 of FIG. 1 Voted. It is slightly larger than the outer diameter of the carpule 1.
  • the sleeve 5 has a wall thickness, which is about 20% of the total diameter of the sleeve 5 in the example shown.
  • the carpule 1 of the FIG. 1 is inserted from above into the receptacle 8 of the sleeve 5 and then rests on the shoulder 10. The result is in FIG. 3 shown.
  • the combination of metallic sleeve 5 and carpule 1 is placed on a base, such as a conveyor belt, with which the unit can be pushed from both parts into the cooling chamber.
  • a base such as a conveyor belt
  • the stability improves, and the lower manufacturing tolerances of the sleeve 5 improves the heat transfer between the cooling plate and the sleeve 5.
  • FIG. 4 shows one of the FIG. 2 corresponding section through a sleeve of another embodiment.
  • the sleeve 15 is constructed in the lower area practically the same as the sleeve 5 of FIG. 2 , So she has a footprint 7 with the same characteristics as in the embodiment of FIG. 2 , In this area, the outer surface 6 of the lower sleeve portion is also located on a cylindrical surface. Above the lower part results over an inclined shoulder 12 a reduction in diameter on the outside, but not on the inside. Therefore, the wall thickness is reduced in the upper area.
  • a receptacle 18 is formed, which is also cylindrical in the lower region, and then passes over a shoulder portion 13 in a second slightly larger diameter in diameter. Overall, the sleeve 15 is thus significantly longer. It is for the same carpule 1 as the sleeve 5 of FIG. 2 , Inserting the carpule 1 in the receptacle 18, so the area along which a heat transfer from the sleeve can take place on the interior of the carpule 1, again significantly increased.
  • the increased wall thickness in the lower area contributes to improving the stability.
  • a smaller wall thickness for example in the range of 1 to 2 mm, is sufficient.
  • the sleeve requires a sufficient wall thickness to supply the radiated energy via heat conduction again.
  • the increased wall thickness in the base area serves to improve the stability and to increase the area over which the heat is introduced from the cooling plate.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP09007929A 2008-06-27 2009-06-17 Fixation Withdrawn EP2138787A3 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102008031809A DE102008031809A1 (de) 2008-06-27 2008-06-27 Halterung

Publications (2)

Publication Number Publication Date
EP2138787A2 true EP2138787A2 (fr) 2009-12-30
EP2138787A3 EP2138787A3 (fr) 2012-02-29

Family

ID=41114847

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09007929A Withdrawn EP2138787A3 (fr) 2008-06-27 2009-06-17 Fixation

Country Status (3)

Country Link
US (1) US20100251560A1 (fr)
EP (1) EP2138787A3 (fr)
DE (1) DE102008031809A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101970964B (zh) * 2008-03-19 2012-05-23 株式会社盛本医药 冷冻干燥方法及冷冻干燥装置
WO2018204484A1 (fr) * 2017-05-02 2018-11-08 Massachusetts Institute Of Technology Procédés de lyophilisation et produits associés
JP2019184152A (ja) * 2018-04-09 2019-10-24 株式会社アルバック ホルダ及び凍結乾燥システム

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3571940A (en) * 1969-04-21 1971-03-23 Cenco Medical Health Supply Co Thermal cassette
US6440101B1 (en) * 2000-05-31 2002-08-27 Abbott Laboratories Syringe systems for lyophilized drugs and methods for making the same
US20050171813A1 (en) * 2004-02-04 2005-08-04 Jordan Mchael L. System for identifying and sorting orders
WO2006013360A1 (fr) * 2004-08-03 2006-02-09 Micropharm Limited Appareil de séchage par lyiophilisation

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1778456A1 (de) * 1968-04-30 1971-08-26 Martin Christ Kg Verfahren und Vorrichtung zum Gefriertrocknen
US4001944A (en) * 1975-08-25 1977-01-11 Parke, Davis & Company Freeze-drying process
US4351158A (en) * 1980-01-22 1982-09-28 American Home Products Corporation Method of producing multicomponent lyophilized product
US4491082A (en) * 1982-04-01 1985-01-01 Ppg Industries, Inc. Cylindrical sleeve applicator for use in manufacturing chemically treated filaments
US5860360A (en) * 1996-12-04 1999-01-19 Day International, Inc. Replaceable printing sleeve
AU7291398A (en) * 1997-05-06 1998-11-27 Thermoceramix, L.L.C. Deposited resistive coatings
US20080034998A1 (en) * 2006-08-08 2008-02-14 Byers Joseph L Method of making a printing blanket or sleeve including cast polyurethane layers
WO2009030342A1 (fr) * 2007-08-28 2009-03-12 Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg Dispositif récepteur
US20090166357A1 (en) * 2007-12-28 2009-07-02 Petersen Chris C Wast receptacle

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3571940A (en) * 1969-04-21 1971-03-23 Cenco Medical Health Supply Co Thermal cassette
US6440101B1 (en) * 2000-05-31 2002-08-27 Abbott Laboratories Syringe systems for lyophilized drugs and methods for making the same
US20050171813A1 (en) * 2004-02-04 2005-08-04 Jordan Mchael L. System for identifying and sorting orders
WO2006013360A1 (fr) * 2004-08-03 2006-02-09 Micropharm Limited Appareil de séchage par lyiophilisation

Also Published As

Publication number Publication date
DE102008031809A1 (de) 2009-12-31
EP2138787A3 (fr) 2012-02-29
US20100251560A1 (en) 2010-10-07

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