Classifications

• • C—CHEMISTRY; METALLURGY
  • C03—GLASS; MINERAL OR SLAG WOOL
  • C03B—MANUFACTURE, SHAPING, OR SUPPLEMENTARY PROCESSES
  • C03B23/00—Re-forming shaped glass
  • C03B23/04—Re-forming tubes or rods
  • C03B23/09—Reshaping the ends, e.g. as grooves, threads or mouths
  • C03B23/092—Reshaping the ends, e.g. as grooves, threads or mouths by pressing
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D1/00—Rigid or semi-rigid containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material or by deep-drawing operations performed on sheet material
  • B65D1/09—Ampoules
• • C—CHEMISTRY; METALLURGY
  • C03—GLASS; MINERAL OR SLAG WOOL
  • C03B—MANUFACTURE, SHAPING, OR SUPPLEMENTARY PROCESSES
  • C03B21/00—Severing glass sheets, tubes or rods while still plastic
  • C03B21/06—Severing glass sheets, tubes or rods while still plastic by flashing-off, burning-off or fusing
• • C—CHEMISTRY; METALLURGY
  • C03—GLASS; MINERAL OR SLAG WOOL
  • C03B—MANUFACTURE, SHAPING, OR SUPPLEMENTARY PROCESSES
  • C03B23/00—Re-forming shaped glass
  • C03B23/04—Re-forming tubes or rods
  • C03B23/049—Re-forming tubes or rods by pressing
• • C—CHEMISTRY; METALLURGY
  • C03—GLASS; MINERAL OR SLAG WOOL
  • C03B—MANUFACTURE, SHAPING, OR SUPPLEMENTARY PROCESSES
  • C03B23/00—Re-forming shaped glass
  • C03B23/04—Re-forming tubes or rods
  • C03B23/11—Reshaping by drawing without blowing, in combination with separating, e.g. for making ampoules
• • C—CHEMISTRY; METALLURGY
  • C03—GLASS; MINERAL OR SLAG WOOL
  • C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
  • C03C4/00—Compositions for glass with special properties
  • C03C4/20—Compositions for glass with special properties for chemical resistant glass
• • C—CHEMISTRY; METALLURGY
  • C03—GLASS; MINERAL OR SLAG WOOL
  • C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
  • C03C21/00—Treatment of glass, not in the form of fibres or filaments, by diffusing ions or metals in the surface
  • C03C21/001—Treatment of glass, not in the form of fibres or filaments, by diffusing ions or metals in the surface in liquid phase, e.g. molten salts, solutions
  • C03C21/002—Treatment of glass, not in the form of fibres or filaments, by diffusing ions or metals in the surface in liquid phase, e.g. molten salts, solutions to perform ion-exchange between alkali ions

Definitions

• the invention relates to a method for producing glass vials, in particular of pharmaceutical vials and pharmaceutical vials, and a glass vial produced in this way.
• Glass vials which are used for pharmaceutical purposes (also known as “vials") consist of neutral glasses, that is, glasses that can be assigned to the hydrolytic class 1, including the standardized test ISO 719 (DIN 121 1 1) serves.
• the neutral glasses include in particular borosilicate glasses, such as DURAN® or Fiolax® (both registered trademarks of SCHOTT AG, Mainz).
• vials are typically made of borosilicate glass by hot forming from a borosilicate glass tube.
• the mouth of the vial is first formed from the open end of the tube.
• the vial bottom is formed and at the same time the vial is separated from the rest of the glass tube.
• a glass tube is fixed in an upper and a lower chuck and then set in rotation.
• the rotating glass tube is heated in a certain range of one or two separators so far that it becomes deformable.
• the tube is - with continuous rotation and heating by the burner - pulled apart by a linear movement of the lower chuck in the axial direction down.
• the tube expands in the warm-up area with simultaneous tapering of its diameter, so that a constriction area is created.
• the glass tube continues to contract at the constricting area due to the flow pressure of the burner gases, so that the glass wall melts together in the heating area and finally tears off the connection between the upper and lower tube sections.
• EP-A-2 239 237 in order to reduce alkali leaching, it is proposed to treat the inner surface of the glass vial with a burner flame in order to remove alkali components and the like adhered thereto.
• the known preparation processes are relatively complicated or, on the other hand, lead to solutions in which the alkali release is still considered to be too high.
• the invention has for its object to provide a method for producing glass bottles, which is particularly suitable for the production of pharmaceutical liquor and which leads to a reduced alkali release. Furthermore, a correspondingly improved glass bottle is to be created.
• This object is achieved by a method for producing glass bottles, in particular of pharmaceutical bottles, from a glass tube with the following steps:
• step (c) that is, by a reduction in diameter by pressing at least one molding on the softened area, achieved that the softened area is reduced in diameter significantly further before in the subsequent separation step (d) the Separation by means of a burner takes place.
• a further step (b1) is additionally carried out after heating the glass tube in step (b), in which a pulling apart of the rotating glass tube in the axial direction to produce a constricting region (16).
• the steps (a) to (d) and optionally (b1) are carried out with rotating glass tube in the order given.
• the glass tube After separation step (d), in addition to the molded vials, the glass tube remains with a closed end. This is expediently reamed again in a subsequent step by means of a burner (piercing burner), so that subsequently the shaping of the next glass vial can take place.
• the rotating glass tube after step (a) is first heated at one end and shaped to form a neck region of the vial to be formed, before then at a predetermined distance from the end of the local heating by means of a burner he follows.
• the glass tube is preferably driven at a speed of 200 min "1 to 500 min “ 1 , preferably with 250 min “1 to 450 min “ 1 , more preferably with 300 min “1 to 400 min “ 1 .
• a glass tube made of a neutral glass in the form of a borosilicate glass is used for producing the glass vials.
• the shaped body consists of a tungsten alloy, of electrographite or of heat-resistant steel.
• the shaped body is driven in rotation.
• the shaped body is additionally heated.
• the shaped body is tapered in the direction of the glass tube, preferably formed tapered.
• the time is significantly reduced, during which the glass tube is exposed to the flame of the separation burner, so that the Natriumboratabdampfung is significantly reduced.
• the temperature of the separation burner over conventional methods can be reduced.
• the object of the invention is further achieved by a glass vial, in particular a Pharmaflaschchen, with a closed bottom and an open bottle neck, which preferably consists of a neutral glass, in particular of a borosilicate glass, in which the alkali content in the near-surface, hot-deformed region at most is reduced by 30%, preferably at most 20%, more preferably at most 10% compared to the alkali content in the glass interior.
• a glass vial in particular a Pharmaflaschchen
• a closed bottom and an open bottle neck which preferably consists of a neutral glass, in particular of a borosilicate glass, in which the alkali content in the near-surface, hot-deformed region at most is reduced by 30%, preferably at most 20%, more preferably at most 10% compared to the alkali content in the glass interior.
• the object of the invention is achieved by such a glass vial, in particular pharmaceutical vials, in which the sodium release according to ISO 4802-2 is smaller than 0.5 ⁇ g cm 2 , preferably smaller than 0.25 ⁇ g cm 2 ,
• the pharmaceutical vials according to the invention are characterized by a significantly lower alkali delivery than conventional glass vials and have a much lower delamination tendency as well as more uniform alkali distribution than conventional glass vials.
• Figure 1 is a schematic representation of the manufacturing steps for hot forming of pharmaceutical vials according to the prior art.
• Figure 2 is a schematic representation of the manufacturing steps in the formation of pharmaceutical vials according to the invention.
• test results on conventionally produced borosilicate glasses of type 1 with A1 and type 2 with B1 are referred to and the test results are compared to the glass vial according to the invention under otherwise identical conditions and sizes and
• Fig. 4 is an enlarged view of a glass tube in the phase of
• a glass tube 10 which consists for example of a borosilicate glass, such as Fiolax® (registered trademark of SCHOTT AG, Mainz) is between two Clamping chucked and driven to rotate about its longitudinal axis 12, as indicated by an arrow 13.
• Fiolax® registered trademark of SCHOTT AG, Mainz
• the glass tube 10 in Fig. 1 a heated until it is softened and deformable. Once this temperature is reached, the glass tube 10 is pulled apart under continuous rotation and heating by the burner 14 by means of a linear movement of the lower chuck in the axial direction, as indicated by the arrow 17 in Fig. 1 b). As a result, the glass tube expands in the warm-up area with simultaneous tapering of its diameter, and results in a constriction region 16 with a reduced diameter. After the downward movement of the constriction area 16 is further heated. In this case, the glass tube 10 'continues to contract at the point of reduction by the flow pressure of the burner gases, so that the glass wall, as shown in FIG. 1 c), melts together in the heating region and finally the connection between the upper and lower
• the alkali borate evaporation is significantly reduced because the necessary temperature is significantly reduced when separating the glass tube.
• a glass tube 10 which may consist of a borosilicate glass, such as Fiolax® (registered trademark of SCHOTT AG, Mainz), is clamped vertically between an upper chuck 24 and a lower chuck 26 , The glass tube 10 is then driven in rotation about its longitudinal axis 12, for which purpose, for example, a speed of about 300 to 400 rpm can be used. Subsequently, the rotary glass tube 10 is heated by one or two separators 14 with continuous rotation by directing the burner flame directly radially on the glass tube 10, whereby a range of about 2 cm is heated.
• Fiolax® registered trademark of SCHOTT AG, Mainz
• the glass tube 10 As soon as the glass tube 10 has softened to become deformable, it is pulled apart by moving the lower chuck 26 in the axial direction downward, as indicated by the arrow 17. As a result, the glass tube 10 expands in the warming-up area with a simultaneous tapering of its diameter, so that the constriction area 16 is created. Now, the burner 14 is pivoted laterally and upon further rotation of the tube, a molding 28 radially as far as possible pressed into the glass tube 10, so that only the smallest possible glass connection between the upper and lower pipe section remains, as in Fig. 2c) and 2d ) is shown.
• the step of pulling apart in the axial direction to produce a constricting region 16 may also be dispensed with. Instead, a deformation of the at least to the softening temperature E w heated glass tube 10 can be done by pressing the molding 28 directly.
• the molded part 28 used here preferably consists of a tungsten alloy or of electrographite and is rounded or pointed at its surface facing the glass tube 10
• the molded part 28 is pivoted away again and the burner 14 is pivoted back in front of the remaining constricting region 16 of the glass tube 10 "to melt the remaining, narrow glass strand.
• the lower part is the finished glass vial 18 with the bottom 19 and the upper part held in the upper chuck 24 glass tube 10 "'with closed end 21st 2g) and 2h), the closed end of the glass tube 10 "'is again melted by means of the piercing burner 20 in order to obtain an opening 22 at the lower end of the glass tube 10""according to FIG.
• any neck area can be formed by means of a burner flame and possibly a molded part at the lower end of a glass tube, as basically known in the art, before the diameter reduction and the subsequent separation process is started. Since this is not part of the core of the invention, this has not been described in detail here.
• the glass type 2 is the borosilicate glass marketed by Schott AG under the trade name Fiolax®, which has the following main constituents (in the weight percent based on oxide):
• the softening temperature E w is only 785 ° C, while the processing temperature V A is 1 165 ° C.
• the glass tube had to be heated to the processing temperature to be pulled apart to create a constriction.
• test procedure results from the standard ISO 4802-2 and is described in more detail in "Special Glass Containers for Primary Packaging: Alkali Release Measurement", Pharmaceutical Information Letter, 8th Edition, 06/2004, pages 1 to 6.
• FIG. 3 The resulting sodium release in ⁇ " ⁇ / ⁇ " ⁇ 2 is summarized in FIG. 3.
• Bar A1 shows the sodium release on the borosilicate glass type 1 (Fiolax®) and B1 samples on the borosilicate glass type 2 samples, both prepared by the conventional method.
• A2 and B2 show the corresponding sodium release on the glass samples prepared by the process according to the invention.
• FIG. 4 shows a further variant of the method according to the invention.
• the constricting portion 16 of the rotating glass tube 10 ' is applied not only with a single molded body, as described above, but from both sides, each with a shaped body 28a.
• the molded bodies 28a are still driven in rotation. They can, as shown by way of example, be mounted on a movable frame 34 by means of a shaft 36 and driven by a drive 32, which may additionally be coupled to a heating device in order to additionally heat the molded bodies 28a.
• the shaped bodies 28 and 28a are preferably made of a tungsten alloy, pure tungsten or electrographite. This results in a particularly favorable wetting behavior relative to the glass surface. Basically, a production of heat-resistant steel is conceivable, but the wetting behavior is more favorable for tungsten or graphite.
• the shaped body 28 or 28a tapers in the direction of the glass tube, in particular, a tapered shape can be used. In the case of rotationally driven shaped bodies 28a according to FIG. 4, an approximately disc-shaped form thus results, which tapers to a point on the edge sides. It can be assumed that, with such an embodiment according to FIG. 4, a further reduction of the alkali release compared with the test results shown in FIG. 3 can be achieved, in which only a stationary shaped body made of steel was used, which was not heated ,

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• Chemical & Material Sciences (AREA)
• Engineering & Computer Science (AREA)
• Materials Engineering (AREA)
• Organic Chemistry (AREA)
• General Chemical & Material Sciences (AREA)
• Mechanical Engineering (AREA)
• Ceramic Engineering (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Geochemistry & Mineralogy (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Re-Forming, After-Treatment, Cutting And Transporting Of Glass Products (AREA)
• Containers Having Bodies Formed In One Piece (AREA)

Priority Applications (6)

Applications Claiming Priority (2)

Related Child Applications (1)

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ID=51022831

Family Applications (1)

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Citations (6)

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• 2013
  • 2013-07-17 DE DE102013107607.6A patent/DE102013107607B4/de not_active Revoked
• 2014
  • 2014-06-16 JP JP2016526478A patent/JP6567516B2/ja active Active
  • 2014-06-16 EP EP14733575.6A patent/EP3022160B1/de active Active
  • 2014-06-16 EP EP19212455.0A patent/EP3632859A1/de not_active Withdrawn
  • 2014-06-16 WO PCT/EP2014/062550 patent/WO2015007445A1/de not_active Ceased
  • 2014-06-16 CN CN201480040577.3A patent/CN105377779B/zh active Active
• 2016
  • 2016-01-19 US US15/000,072 patent/US10442718B2/en active Active
• 2019
  • 2019-07-31 JP JP2019141216A patent/JP2019214508A/ja active Pending
  • 2019-09-09 US US16/564,089 patent/US20200002212A1/en not_active Abandoned

Patent Citations (6)

Non-Patent Citations (2)

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