# US 9,758,420 B2 · Method for manufacturing glass containers for pharmaceutical use

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- Number: US 9,758,420 B2
- Document ID: US9758420B2
- Status: Granted
- Kind: B2
- Application number: 14/893,783
- Filed: 2014-05-27
- Published: 2016-04-21
- Granted: 2017-09-12
- Earliest claimed: 2013-05-30
- Assignees: Dalwick Continental Corp
- Applicants: Dalwick Continental Corp
- Inventors: José de Jesús Delgado Carranza
- Web page: https://patentgrep.com/patent/US9758420B2

## CPC

- C03B 23/04: Re-forming tubes or rods
- B65B 23/22: Packaging glass ampoules, lamp bulbs, radio valves or tubes, or the like
- B65B 55/06: by heat
- B65B 55/14: by heat
- C03B 21/02: by cutting (C03B9/46 takes precedence)
- C03B 23/09: Reshaping the ends, e.g. as grooves, threads or mouths
- C03B 23/097: {by blowing}
- C03B 23/11: Reshaping by drawing without blowing, in combination with separating, e.g. for making ampoules
- C03B 32/00: Thermal after-treatment of glass products not provided for in groups {C03B19/00} , C03B25/00 - C03B31/00 {or C03B37/00}, e.g. crystallisation, eliminating gas inclusions or other impurities; {Hot-pressing vitrified, non-porous, shaped glass products}
- A61J 1/065: {Rigid ampoules, e.g. glass ampoules}
- A61J 1/1468: {Containers characterised by specific material properties}
- C03B: MANUFACTURE, SHAPING, OR SUPPLEMENTARY PROCESSES
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE

## Abstract

The present invention relates to a method for manufacturing glass containers for pharmaceutical use. This method allows obtaining containers with a low degree of alkalinity. In some preferred embodiments the process allows the manufacture of sterile containers and substantially free of particles ready to be used by the pharmaceutical industry.

## Claims

### Claim 1

Method for manufacturing tubular glass containers for pharmaceutical use, comprising:
1) a step of providing a glass tube with a closed lower end and a closed upper end;
2) a step of opening the lower end of the glass tube;
3) a step of cutting a first length of tube by heating so as to seal a portion of the glass tube above a position where cutting is performed, such that the glass tube is closed at its lower end;
4) a step of discarding the first length of tube;
5) a step in which an explosion is caused inside a glass tube closed at both ends by heating the tube, wherein a magnitude of the explosion is enough to open the lower end of the tube;
6) a step of forming a mouth of the glass container;
7) a step of separating the glass container from the glass tube by heating such that the lower end of the tube is closed, and
8) a step in which air is injected into the mouth of a glass container while the container is heated at its base to form the bottom of the container and to obtain a produced container, wherein the mouth of the glass container is the opened lower end of the tube;
9) a step of transporting the produced containers to an electric furnace through a path that includes protective air curtains that protect the container from possible particles, the furnace is in a class “C” area, according to Mexican standard NOM-059-SSA1-2006, and, before introducing the containers in this class “C” area, an internal sweep is performed to the container with clean filtered air and with clean steam;
10) a step of sterilizing the containers in the electric furnace;
11) a step of sterilizing a packaging for the containers in a class “C” area;
12) a step of transporting the containers out of the furnace to a class “A” area, according to Mexican standard NOM-059-SSA1-2006, that is protected with a class “B” area, according to Mexican standard NOM-059-SSA1-2006; and
13) a step of packing the containers in the packaging in the class “A” area.

### Claim 2 (depends on 1)

Method according to claim 1, wherein after step b), steps a), 5), 6) and b) are repeated until the length of the glass tube after the separating the glass container from the glass tube is less than the length of a container.

### Claim 3 (depends on 1)

Method according to claim 1, wherein the air injection of step b) is performed by a mechanical injector, which injects air under pressure whose trajectory forms an angle between 20° and 80° with a wall of the container.

### Claim 4 (depends on 3)

Method according to claim 3, wherein the angle is between 30° and 60°.

### Claim 5 (depends on 4)

Method according to claim 4, wherein the angle is 45°.

### Claim 6 (depends on 1)

Method according to claim 1, wherein the sterilization of the containers is performed at a temperature higher than 5000 C.

### Claim 7 (depends on 1)

Method according to claim 1, wherein the containers are packed with double sterile bag.

### Claim 8 (depends on 1)

The method of claim 1, wherein the internal sweep is performed to an untreated container with clean filtered air and with clean steam.

### Claim 9

Method for manufacturing tubular glass containers for pharmaceutical use, comprising:
i) providing a glass tube with a closed lower end and a closed upper end;
ii) opening the lower end of the tube;
iii) cutting a first length of tube by heating so as to seal a portion of the glass tube above a position where cutting is performed, such that the glass tube remains closed at its lower end;
iv) discarding the first length of tube;
v) causing an explosion inside the glass tube by heating the tube, wherein a magnitude of the explosion is enough to open the lower end of the tube;
vi) forming a mouth of a glass container;
vii) separating the glass container from the glass tube by heating such that the lower end of the tube remains closed, and
viii) injecting air into the mouth of the glass container while the container is heated at its base to form the bottom of the container and to obtain a produced container, wherein the mouth of the glass container is the opened lower end of the tube,
ix) transporting the produced containers to an electric furnace through a path that includes protective air curtains that protect the container from possible particles, wherein the furnace is in a class “C” area, according to Mexican standard NOM-059-SSA1-2006, and before introducing the containers in this class “C” area, an internal sweep is performed to the container with clean filtered air, and a blast with clean steam,
x) sterilizing the containers in the electric furnace;
xi) sterilizing a packaging for the containers in the class “C” area;
xii) transporting the containers out of the furnace to a class “A” area, according to Mexican standard NOM-059-SSA1-2006, that is protected with a class “B” area, according to Mexican standard NOM-059-SSA1-2006;
xiii) packing the containers in the packaging in the class “A” area.

### Claim 10

A method of manufacturing tubular glass containers for pharmaceutical use, comprising:
a) removing an end portion of a glass tube in such a manner as to seal a lower end of the glass tube, comprising:
opening the lower end of the tube, and
cutting off the end portion of the tube by heating in such a manner that a portion of the glass tube above the end portion of the tube is sealed;
b) heating the tube, such that an explosion is caused within the tube that opens the lower end of the tube;
c) forming a mouth of a glass container at the lower end of the tube;
d) heating an upper part of the tube so as to remove the glass container from the tube and seal a new lower end of the tube;
e) injecting air into the mouth of the glass container while the container is heated at its base in such a manner that a bottom of the container is formed and in such a manner as to yield a produced container, the mouth of the glass container being the mouth previously formed at the opened lower end of the tube;
f) transporting the produced containers to an electric furnace through a path that includes protective air curtains that protect the container from possible particles, wherein the furnace is in a class “C” area, according to Mexican standard NOM-059-SSA1-2006;
g) performing an internal sweep of the container with clean filtered air and blasting the internal portion of the container with clean steam;
h) introducing the containers into the class “C” area and sterilizing the containers in the electric furnace;
i) sterilizing a packaging for the containers in the class “C” area;
j) transporting the containers out of the furnace to a class “A” area, according to Mexican standard NOM-059-SSA1-2006, that is protected with a class “B” area, according to Mexican standard NOM-059-SSA1-2006;
k) packing the containers in the packaging in the class “A” area.