METHOD FOR PRODUCING MEDICAL GLASS CONTAINER AND BURNER FOR INNER
SURFACE TREATMENT OF MEDICAL GLASS CONTAINER
Technical Field
[0001] The present invention relates to a medical glass
container with little leaching of alkali components or the like
from the inner wall surface of the glass and a method for producing
the same.
The invention also relates to a burner for use in inner surface
treatment of the medical glass container.
Background Art
[0002] Glass containers for use in storage of pharmaceuticals
and the like are generally referred to as "Vial". The vial is
converted from, for example, a borosilicate glass tube. The glass
contains alkali components. The alkali components, such as alkali
borate, are known to adhere or condense to the inner wall of the
vial during conversion. When such alkali components are leached
into pharmaceuticals contained in the vial in the case where the
vial is used as a storage container of pharmaceuticals, i.e., for
medical use, there is a possibility that the pharmaceuticals
deteriorate.
[0003] As a method for suppressing the leaching of alkali
components, a sulfate treatment method to react the alkali
components present on the inner surface of the vial converted from
a glass tube with sulfate or the like to produce sodium sulfate
(Na2SO4) , and removing the sodium sulfate by washing with water or
a chemical vapor deposition method (CVD method) to coat the inner
surface of the vial with a silica (SiO2) thin film is known (Japanese
Examined Patent Application Publication No. 6-76233).
[0004] Medical vials converted from a borosilicate glass tube
are requested to meet the leaching standards of alkali components
defined in ISO4802-1, ISO4802-2, and the like. In a process of
converting a vial from a borosilicate glass tube, the opening of

the vial is first formed, and then the bottom is formed. In a process
of forming the bottom, the glass tube is heated at a higher
temperature, and thus alkali components or the like volatilize from
the glass tube and condense to the inner surface of the vial. Thus,
a deteriorated region where the alkali components or the like are
likely to leach out is formed on the inner surface of the vial.
In order to deal with the problem, so-called low temperature working
in which the heating temperature of the glass tube in converting
the bottom of the vial is adjusted to a lower temperature is carried
out.
[0005] It is also known that the leaching of the alkali
components are reduced by carrying out fire blast of oxygen-gas
flame by a point burner to the deteriorated region on the inner
surface of a vial converted from the glass tube while rotating the
vial (International Publication No. WO2006/123621). The method
has advantages in that other compounds are not required to be
introduced into the vial and the number of processing for converting
a vial with less leaching of alkali components is small.
Summary of Invention
Problems to be Solved by the Invention
[0006] However, with an increase in pharmaceuticals sensitive
to alkali components, vials with much less leaching of alkali
components have been demanded, as compared with the leaching
standards defined in ISO4802 and the like.
[0007] In the case of using a vertical automatic-forming
machine in which a glass tube is held while defining the axial
direction thereof as a vertical direction in the forming of a vial,
even when the glass tube is heated at a lower temperature, alkali
components that volatilize when heated move upward due to a chimney
effect in the glass tube. Then, the alkali components
accumulatively adhere to the inner surface of the glass tube at
the upper portion of the glass tube. Thus, in the vial converted
from the upper portion of the glass tube, the alkali components

leached from the inner surface thereof exceed the standards defined
in ISO4802 and the like in some cases. Therefore, even when low
temperature working is employed, there is a possibility that the
vial converted from the upper portion of the glass tube cannot meet
the standards defined in ISO4802 and the like.
[0008] It is preferable to produce vials with less leaching
of alkali components or the like, irrespective of the direction,
heating temperature, etc., of a glass tube in the converting of
the vials, by suppressing the introduction of other compounds, an
increase in the number of processes, etc., as much as possible.
[0009] Moreover, the glass forming components other than
alkali components are possibly leached from the vials serving as
a primary packaging of pharmaceuticals. In pharmaceuticals, such
as protein preparations, which are expected to increase from now
on, the leaching of a slight amount of the components may cause
problems.
[0010] The present inventors have found that, when a long and
narrow metallic nozzle is used for a gas burner so as to centralize
a gas flame to the deteriorated region on the inner surface of the
vial, the nozzle is remarkably deteriorated by heat and the vial
treatment number per nozzle is small.
[0011] The present invention has been made in view of the
above-described circumstances. It is an object of the invention
to provide a measure for decreasing the leaching values of alkali
components defined in ISO4802 and the like as much as possible in
a glass container for use in storage or the like of pharmaceuticals.
[0012] It is another object of the present invention to sharply
reduce almost components other than the alkali components leached
from the inner surface of the glass container for use in storage
or the like of pharmaceuticals.
(00133 It is still another object of the invention is to provide
a burner for heat treating the inner surface of a medical glass
container, and a measure capable of increasing the glass container
treatment number per nozzle.

[0014] (1) A method for producing a medical glass container
according to the invention includes a fire blast process of scanning
throughout the inner surface of a glass container with a flame of
a burner while emitting the flame of the burner to the internal
space of the glass container and applying the flame to the inner
surface of the glass container.
[0015] The medical glass container refers to glass containers
in which liquid pharmaceuticals are stored and held and from which
the pharmaceuticals can be taken out from the opening for use.
Examples include glass containers generally referred to as vials
or ampules.
[0016] In the fire blast process, when the flame of the burner
is directly applied to the inner surface of the glass container,
residues, such as alkali components or the like condensing and
adhering to the inner surface of the glass container or alkali
components produced when the glass tube is converted, are blown
away to be discharged to the outside of the glass container.
[0017] (2) In the fire blast process, the flame may be applied
to the inner surface while rotating the glass container around the
axis.
[0018] Thus, the flame can be uniformly applied to the inner
surface of the glass container. The inner surface of the glass is
not continuously heated partially with the flame, and thus
deformation of the glass container is prevented.
[0019] (3) In the fire blast process, it is preferable that
the distance from the inner surface of the glass container to the
top end of a nozzle of the burner be uniformly held.
[0020] Thus, the flame can be uniformly applied throughout the
inner surface of the glass container.
[0021] (4) In the fire blast process, it is preferable that
a plasma rich portion of the flame to be emitted from the burner
be applied to the inner surface of the glass container.
[0022] (5) It is preferable to use a burner having a ceramic
nozzle as the burner.

[0023] Examples of the ceramic nozzle include nozzles formed
of heat-resistant ceramics, such as alumina, zirconia, or magnesia.
[0024] (6) The method for producing a medical glass container
according to the invention may also further include a container
converting process of processing a glass tube into a container shape
having the bottom and the opening to form the glass container.
[0025] In the container converting process, the glass tube as
a raw material is processed into a glass container having a container
shape having the bottom and the opening. In this processing, the
glass tube is heated to be transformed into a shape having the bottom
and the opening. When the glass tube is heated, the alkali
components or the like of glass volatilize, and the volatilized
alkali components condense and adhere to the inner surface of the
glass container in a process of cooling the glass container. The
areas to which the alkali components or the like condense and adhere
vary depending on whether the processing is carried out while
directing the axis of the glass tube in a horizontal direction or
the processing is carried out while directing the axis of the glass
tube in a vertical direction. Moreover, when the glass tube is
converted, it is assumed that the alkali component or the like remain
on the inner surface of the glass tube.
[0026] (7) The present invention may be construed as a medical
glass container produced by the method for producing a medical glass
container.
[0027] (8) It is preferable that the amount of sodium to be
leached from the inner surface of the medical glass container meet
the standards defined in ISO4802.
[0028] (9) It is particularly preferable that the amount of
sodium to be leached from the inner surface of the medical glass
container be 1/10 or lower relative to the standards defined in
ISO4802.
[0029] (10) It is preferable that the amount of silicon to
be leached from the inner surface of the medical glass container
be 0.1 ppm or lower.

[0030] (11) It is preferable that the amount of boron to be
leached from the inner surface of the medical glass container be
0.05 ppm or lower.
[0031] (12) A burner for inner surface treatment of a medical
glass container according to the invention has a burner body having
a first flow path through which a fuel is circulated and a second
flow path connecting to the first flow path of the burner body,
in which the burner has a long and narrow nozzle that can be inserted
into the internal space of a medical glass container or an
intermediate product thereof as a processing target. The nozzle
is formed of ceramic.
[0032] A fuel is circulated through the first flow path of the
burner body. The fuel is a mixture of gas and oxygen, for example.
The fuel is circulated from the first flow path to the second flow
path, and is burnt at the top end of the nozzle to form a flame.
[0033] The nozzle has a long and narrow shape that can be
inserted into the internal space of the medical glass container
or the intermediate product thereof. For example, when the medical
glass container is converted from a glass tube, the intermediate
product of the medical glass container refers to a product having
the bottom formed at at least one end of the glass tube. Vials or
ampules are mentioned as a typical example thereof. In general,
the medical glass container has a cylindrical shape having the
opening at one portion from which pharmaceuticals are charged or
taken out and having the bottom formed at the side opposite to the
opening. When the bottom is formed at one end of the glass tube,
even the intermediate product of the medical glass container forms
a cylindrical shape in which only the other end at which the opening
is formed opens. The nozzle is inserted into the internal space
of the medical glass container from the opening. The flame emitted
from the top end of the nozzle is intensively applied to the inner
surface of the medical glass container. The flame hits the inner
surface of the medi cal glass container by the flow of the flame,
and then emitted to the outside from the opening. Thus, the nozzle

inserted into the internal space of the medical glass container
is enveloped in the flame. However, since the nozzle is formed of
ceramic, deterioration of the nozzle due to the heat of the flame
is suppressed. Examples of the ceramic include alumina, magnesia,
and zirconia. The nozzle is not required to be entirely formed of
ceramic. At least a portion to be inserted into the internal space
of the medical glass container or the intermediate product thereof
may be formed of ceramic.
[0034] (13) It is preferable that the nozzle be a nozzle that
can be inserted into the internal space of the medical glass
container in which a second diameter of the opening is smaller than
a first diameter of the internal space.
[0035] (14) The present invention may be construed as a
medical glass container whose inner surface is heated using the
burner for inner surface treatment of a medical glass container.
[0036] (15) The present invention may be construed as a method
for producing a medical glass container including removing a
deteriorated region by inserting a burner having a ceramic nozzle
into the internal space of a medical glass container or an
intermediate product thereof, and emitting a flame formed by a fuel
emitted from the nozzle to the medical glass container or the
intermediate product thereof.
Advantages of the Invention
[0037] According to the invention, alkali components or the
like to be leached from the inner surface of a glass container are
sharply reduced by scanning throughout the inner surface of the
glass with a flame of a burner while emitting the flame to the
internal space of the glass container, and applying the flame to
the inner surface.
[0038] According to the invention, a long and narrow nozzle
that can be inserted into the internal space of a medical glass
container or an intermediate product thereof has been made of
ceramic. Thus, even when the nozzle inserted into the internal
space for heat-treating the inner surface of the medical glass

container or the intermediate product thereof is exposed to the
flame, deterioration of the nozzle due to heat of the flame is
suppressed. Thus, the medical glass container treatment number per
nozzle increases, thereby mass-producing medical glass containers
with reduced leacing of alkali components at a low cost.
Brief Description of Drawings
[0039] Fig. 1 is a partial cross sectional view illustrating
the structure of a point burner 10 according to an embodiment of
the invention.
Fig. 2 is a view for describing a container converting
process.
Fig. 3 is a view for describing a container converting
process.
Fig. 4 is a view for describing a fire blast process.
Fig. 5 is a view for describing a fire blast process.
Modes for Carrying Out the Invention
[0040] Hereinafter, preferable embodiments of the invention
will be described. It is a matter of course that this embodiment
is simply one embodiment of the invention, and can be modified
insofar as the gist of the invention is not altered.
[0041]
[Point burner 10]
A point burner 10 illustrated in Fig. 1 is used in a method
for producing a medical glass container according to the invention.
The point burner 10 is used in a fire blast process of the invention
so as to treat an inner surface 54 of a vial 50.
[0042] The point burner 10 is mainly separated roughly into
a burner body 11 and a nozzle 12. The burner body 11 has a tubular
shape having a first flow path 13 through which a mixed gas is
circulated. The mixed gas is a mixture of gas and oxygen, and the
mixed gas generated by a known technique is circulated at a given

flow rate into the first flow path 13 of the burner body 11. The
mixed gas is equivalent to a fuel in the invention.
[0043] The nozzle 12 is provided at the top end of the burner
body 11. The nozzle 12 is roughly separated into a nozzle portion
14 and a connecting portion 15. The connecting portion 15 is a
conical-shaped member having a female screw formed on the inner
surface. Although not illustrated in Fig. 1 in detail, the female
screw disposed on the connecting portion 15 is screwed into a male
screw disposed at the top end of the burner body 11, so that the
nozzle 12 is connected to the top end of the burner body 11. Thus,
the nozzle 12 is exchangeably attached to the burner body 11.
[0044] The nozzle portion 14 is disposed at the top of the
connecting portion 15. The nozzle portion 14 has a straw-like long
and narrow member and is disposed extending from the top of the
connecting portion 15 in the axial direction of the burner body
11. The nozzle portion 14 is made of ceramic. The outer diameter
R1 and the length L1 in the axial direction of the nozzle portion
14 are determined considering the inner diameter R2 of an opening
51 of the vial 50 as a processing target, the depth L2 of the vial
50, or the like. The outer diameter Rl of the nozzle portion 14
is determined so that the top end thereof can be inserted into at
least an internal space 52 from the opening 51 of the vial 50.
Specifically, the outer diameter Rl of the nozzle portion 14 is
enough smaller than the inner diameter R2 of the opening 51. The
length L1 in the axial direction of the nozzle portion 14 is
determined so that a flame 20 emitted from the top end of the nozzle
portion 14 can reach near a bottom 53 of the vial 50. Specifically,
the length L1 of the nozzle portion 14 is longer than the depth
L2 of the vial 50.
[0045] A second flow path 16 as the internal space of the nozzle
portion 14 is connected to the first flow path 13 of the burner
body 11 through the internal space of the connecting portion 15.
Thus, the mixed gas to be circulated into the first flow path 13
at a given flow rate is emitted from the top end of the nozzle portion

14 through the second flow path 16. The mixed gas burns to form
the flame 20.
[0046]
[Vial 50]
The vial 50 is provided with an opening 51 and a bottom 53
by processing a glass tube 60. The inner diameter R3 of the internal
space 52 of the vial 50 is larger than the inner diameter R2 of
the opening 51. More specifically, the vial 50 is a so-called
narrow-mouthed glass container. The vial 50 is an example of the
glass container in the invention. The inner diameter R3 is
equivalent to the first diameter in the invention. The inner
diameter R2 is equivalent to the second diameter in the invention.
[0047]
[Method for producing the vial 50]
Hereinafter, a method for producing the vial 50 will be
described. The production method is mainly separated roughly into
the following two processes:
(1) Container converting process of processing a glass tube
60 into the vial 50 having the opening 51 and the bottom 53, and
(2) Fire blast process of scanning the inner surface 54 by
the nozzle 12 of the point burner 10 while emitting the flame 20
of the point burner 10 to the internal space 52 of the vial 50 and
applying the flame 20 to the inner surface 54.
[0048]
[Container converting process]
As illustrated in Fig. 2(A), the glass tube 60 is fixed so
that the axial direction becomes a horizontal direction (horizontal
direction in Fig. 2) , and a flame of a burner 61 is applied to one
end thereof to pre-heat the glass tube 60. Then, the opening 51
is formed by applying a converting jig 62 to one end of the pre-heated
one end as illustrated in Fig. 2(B) . Specifically, the one end of
the glass tube 60 is narrowed down so that the outer diameter of
the glass tube 60 is reduced by the converting jig 62.

[0049] As illustrated in Fig. 3 (A) , the glass tube 60 is moved
in the horizontal direction (horizontal direction in Fig. 3)
relative to the burner 60, so that the flame of the burner 61 is
applied to the glass tube 60. The one end of the glass tube 60 on
which the opening 51 has been formed is burnt off by the flame of
the burner 61 and, simultaneously, the bottom 53 is formed at the
burnt-off portion. Thus, as illustrated in Fig. 3 (B), one vial
50 having the opening 51 and the bottom 53 is formed. The container
converting process may be carried out by a so-called vertical
automatic-converting machine for forming the opening 51 and the
bottom 53 at the lower end by fixing the glass tube 60 so that the
axial direction becomes a vertical direction.
[0050]
[Fire blast process]
Subsequently, a fire blast process using the point burner 10
is carried out to the obtained vial 50. In this description, a
process described later is referred to as "Fire blast process".
Here, the fire blast process is a process for removing a deteriorated
region produced on the inner surface 54 by intensively emitting
the flame 20 formed by the mixed gas that is circulated at a
relatively high flow rate to the inner surface 54 of the vial 50.
The fire blast process is equivalent to the heat-treatment in the
invention.
[0051] As illustrated in Fig. 4, the top end of the nozzle
portion 14 of the point burner 10 is inserted into the internal
space 52 from the opening 51 of the vial 50. Then, the position
of the point burner 10 is fixed relative to the vial 50 so that
the flame 20 emitted from the top end of the nozzle portion 14 hits
the inner surface 54 near the bottom 53. The point burner 10 can
be inserted into the vial 50 through the opening 51. And the point
burner 10 can be moved out from the opening 51.
[0052] Specifically, as illustrated in Fig. 4, the vial 50 is
fixed to a support member 21 while the opening 51 and the bottom
53 face each other in the horizontal direction (horizontal direction

in Fig. 4), i.e., a so-called transverse position. The support
member 21 supports the transverse vial 50 while defining the
horizontal direction as the axial direction. The nozzle portion
14 of the point burner 10 is inserted into the opening 51 that is
supported by the support member 21 and opens in the horizontal
direction from the lower portion of the vial 50. The axis of the
nozzle portion 14 extends upwardly relative to the inner surface
54 near the bottom 53 of the vial 50. More specifically, the flame
20 emitted from the nozzle portion 14 hits the upper portion of
the inner surface 54 near the bottom 53 of the vial 50.
[0053] A plasma rich portion is present in the flame 20 to be
emitted from the point burner 10. With respect to the point burner
10, the distance from the top end of the nozzle 12 to the inner
surface 54 is adjusted so that the plasma rich portion in the flame
20 hits the inner surface 54 near the bottom 53 of the vial 50.
[0054] As described above, the vial 50 supported by the support
member 21 is rotated by a rotating machine (not illustrated) while
the plasma rich portion of the flame 20 is applied to the inner
surface 54 of the vial 50, so that the plasma rich portion of flame
20 is uniformly applied to the inner surface 54 near the bottom
53. The alkali components or the like adhering to or remaining on
the inner surface 54 near the bottom 53 are removed by the plasma
rich portion of the flame 20.
[0055] The point burner 10 is moved relative to the vial 50
while changing the state to the state illustrated in Fig. 5 from
the state illustrated in Fig. 4. Specifically, the point burner
10 is moved relative to the vial 50 so that the plasma rich portion
in the flame 20 scans, in the axial direction of the vial 50, a
portion from the inner surface 54 near the bottom 53 of the vial
50 to the inner surface 54 near the opening 51. During the scanning,
the distance from the top end of the nozzle 12 to the inner surface
54 along the axial direction of the nozzle 12 is uniformly held.
[0056] As described above, by moving the point burner 10
relative to the vial 50 in a state where the plasma rich portion

of the flame 20 is applied to the inner surface 54 of the vial 50,
the plasma rich portion of the flame 20 scans a portion from the
inner surface 54 near the bottom 53 to the inner surface 54 near
the opening 51. During the scanning, the vial 50 supported by the
support member 21 is rotated by a rotating machine (not shown).
Thus, the alkali components or the like adhering to or remaining
on the inner surface 54 of the vial 50 are uniformly removed. Thus,
the leaching of the alkali components or the like from the inner
surface 54 of the vial 50 is suppressed.
[0057] There is no limitation on the direction in which the
point burner 10 is moved relative to the vial 50. For example, the
direction may be a direction from the inner surface 54 near the
bottom 53 to the inner surface 54 near the opening 51 or an opposite
direction thereto or a direction from the vicinity of the center
of the bottom 53 and the opening 51 to the opening 51 or the bottom
53, respectively.
[0058]
[Working effects of this embodiment]
According to this embodiment, by scanning throughout the
inner surface 54 of the vial 50 with the flame 20 while emitting
the flame 20 of the point burner 10 to the internal space 52 of
the vial 50, and applying the plasma rich portion of the flame 20
to the inner surface 54, the alkali components or the like leached
from the inner surface 54 of the vial 50 are sharply reduced.
[0059] In the point burner 10 described above, the nozzle
portion 14 that can be inserted into the internal space 52 of the
vial 50 is made of ceramic. Therefore, even when the inner surface
54 of the vial 50 is fire blasted so that the nozzle portion 14
is exposed to the flame 20, deterioration of the nozzle portion
14 due to heat of the flame 20 is suppressed. Thus, the treatment
number of the vial 50 per nozzle 12 increases, and thus the vial
50 in which the leaching of the alkali components is suppressed
is mass-produced at a low cost.

[0060] Moreover, the point burner 10 according to this
embodiment is particularly useful for the case where the long and
narrow nozzle portion 14 is inserted into the internal space 52
of the vial 50 whose inner diameter R2 of the opening 51 is smaller
than the inner diameter R3 of the internal space 52 and fire blasted,
and thus the nozzle portion 14 is always exposed to the flame 20
discharged to the outside of the vial 50 from the opening 51.
[0061]
[Modification]
In the embodiment described above, the method for producing
the vial 50 including the container converting process and the fire
blast process is described. However, in the method for producing
a medical glass container according to the invention, the container
converting process is not essential. More specifically, the fire
blast process may be carried out to a glass container produced by
a known process other than the container converting process
described above.
[0062] This embodiment describes an aspect in which the vial
50 is converted from a glass tube, and then the point burner 10
is used for carrying out fire blast. However, the process of forming
the opening 51 and the bottom 53 on a glass tube to form the vial
50 may also be carried out by the point burner 10.
[0063] Moreover, this embodiment describes an aspect in which
the point burner 10 is used for the vial 50 for carrying out the
fire blast. However, the point burner 10 may be used to an
intermediate product of the vial 50 for carrying out fire blast.
For example, even in an aspect in which an intermediate product
in which the bottom 53 is formed at one end of a glass tube as a
raw material of the vial 50 and the opening 51 is not yet formed
at the other end thereof may be fire blasted by inserting the nozzle
12 of the point burner 10 into the internal space 52 from the opening
at the other end, the same working effects as described above are
demonstrated.
[Examples]

[0064] Hereinafter, Examples of the invention will be
described.
[0065]
[Production of the vial 50]
By the container converting process in the embodiment
described above, a 2 mL vial having on outer diameter of 15 mm,
a total length of 33 mm, and a diameter in the opening of 7.0 mm
was produced. A temperature for heating a glass tube when producing
the vial was adjusted to a relatively low temperature or high
temperature. In this Example, a process in which the heating
temperature of a glass tube is a low temperature is referred to
as low temperature working and a process in which the heating
temperature of a glass tube is a high temperature is referred to
as high temperature working. The processing of the glass tube was
carried using a so-called vertical automatic-converting machine.
[0066]
[Examples 1 and 2]
Each of the vials produced by the low temperature working and
the high temperature working was subjected to the fire blast process
in the embodiment described above. As a nozzle portion of a point
burner, an alumina nozzle having an inner diameter of 1.0 mm was
used. To the inner surface of the vial subjected to the low
temperature working, the fire blast process for 45 seconds was
carried out and to the inner surface of the vial subjected to the
high temperature working, the fire blast process for 55 seconds
was carried out. The vial subjected to the low temperature working
to which the fire blast process for 45 seconds was carried out was
defined as Example 1 and the vial subjected to the high temperature
working to which the fire blast process for 55 seconds was carried
out was defined as Example 2.
[0067]
[Comparative Examples 1 and 2]
To each of the vials obtained by the low temperature working
and the high temperature working, the vial subjected to the low

temperature working and not subjected to the fire blast process
was defined as Comparative Example 1 and the vial subjected to the
high temperature working and not subjected to the fire blast process
was defined as Comparative Example 2.
[0068]
[Leaching amount of alkali components]
The leaching amount of alkali components was measured for each
of the vials of Examples 1 and 2 and Comparative Examples 1 and
2 described above. The measurement was carried out by charging each
vial with 2 mL of distilled water and heating the same at 121°C for
60 minutes. After cooling, the sodium contained in the distilled
water charged in each vial was measured. The measurement of sodium
was carried out by the atomic absorption method defined in ISO4802-2.
The sodium amounts (µg/mL) obtained in each vial of Examples 1 and
2 and Comparative Examples 1 and 2 are shown in Table 1.
[0069]


[0070] As shown in Table 1, the leaching of sodium of 0.36 µg/mL
was confirmed in the vial of Example 1 and the leaching of sodium
of 0.39 µg/mL was confirmed in the vial of Example 2. The leaching
amounts of sodium were lower than about 1/10 of the maximum value
of 4 . 5 µg/mL specified in ISO4802-2, and far below the maximum value.
In contrast, the leaching of sodium of 1.63 µg/mL was confirmed
in the vial of Comparative Example 1 and the leaching of sodium
of 8.10 µg/mL was confirmed in the vial of Comparative Example 2.
The leaching amount of sodium from the vial of Comparative Example
1 was lower than the maximum value of 4.5 µg/mL specified in
ISO4802-2 but was 4 or more times that of the vial of Example 1.
The leaching amount of sodium from the vial of Comparative Example
2 further exceeded the maximum value of 4.5 µg/mL specified in
ISO4802-2.
[0071]
[Leaching amount of other components except than alkali]
The leaching amount of other components except alkali was
measured for each of the vials of Examples 1 and 2 and Comparative
Examples 1 and 2 described above. The measurement was carried out
by charging each vial with 2 mL of distilled water for injection,
and heating each vial at 121°C for 60 minutes. After cooling, other
components (Si, Al, B, Ca, Ba) contained in the distilled water
charged in each vial were measured. The' measurement of other
components was carried out by ICP (inductively coupled plasma)
spectrometry. The amounts (ppm) of other components obtained in
each vial of Examples 1 and 2 and Comparative Examples 1 and 2 are
shown in Table 2.
[0072]


[0073] As shown in Table 2, the leaching of Si of 0.03 ppm was
confirmed in the vial of Example 1 and the leaching amounts of Al,
B, Ca, and Ba were all 0.00 ppm. In the vial of Example 2, the
leaching of 0.06 ppm of Si, 0.01 ppm of Al, and 0.01 ppm of B were
confirmed, and the leaching amounts of Ca and Ba were all 0.00 ppm.
[0074] In contrast, in the vial of Comparative Example 1, the
leaching of each of 1.34 ppm of Si, 0.01 ppm of Al, 0.79 ppm of
B, and 0.01 ppm of Ba was confirmed, the leaching amount of Ca was
0.00 ppm. In the vial of Comparative Example 2, the leaching of

each of 23.3 ppm of Si, 2.39 ppm of Al, 6.99 ppm of B, 0.50 ppr
of Ca, and 0.86 ppm of Ba was confirmed.
[0075] Thus, in each vial of Examples 1 and 2, other components
of Si, Al, B, Ca, and Ba were detected slightly or not at all. It
contrast, in each vial of Comparative Examples 1 and 2, other
components were all detected, except Ca in Comparative Example 1,
and in particular the evaluation values of Si, Al, and B were
remarkably different from those of Examples 1 and 2.

CLAIMS
1. A method for producing a medical glass container, comprising
a fire blast process of scanning throughout an inner surface of
a glass container with a flame of a burner while emitting the flame
of the burner to the internal space of the glass container and
applying the flame to the inner surface of the glass container.
2. The method for producing a medical glass container according
to claim 1, wherein, in the fire blast process, the flame is applied
to the inner surface while rotating the glass container around the
axis.
3. The method for producing a medical glass container according
to claim 1 or 2, wherein, in the fire blast process, a distance
from the inner surface of the glass container to the top end of
a nozzle of the burner is uniformly held.
4. The method for producing a medical glass container according
to any one of claims 1 to 3, wherein, in the fire blast process,
a plasma rich portion of the flame to be emitted from the burner
is applied to the inner surface of the glass container.
5. The method for producing a medical glass container according
to any one of claims 1 to 4, wherein a burner having a ceramic nozzle
is used as the burner.
6. The method for producing a medical glass container according
to any one of claims 1 to 5, further comprising a container
converting process of processing a glass tube into a container shape
having a bottom and an opening to form the glass container.
7. A medical glass container, which is produced by the method
for producing a medical glass container according to any one of
claims 1 to 6.
8 . The medical glass container according to claim 7, wherein the
amount of sodium to be leached from the inner surface of the medical
glass container meets the standards defined in ISO4802.
9. The medical glass container according to claim 7, wherein
the amount of sodium to be leached from the inner surface of the

medical glass container is 1/10 or lower relative to the standards
defined in IS04802.
10. The medical glass container according to claim 7, wherein the
amount of silicon to be leached from the inner surface of the medical
glass container is 0.1 ppm or lower.
11. The medical glass container according to claim 7, wherein the
amount of boron to be leached from the inner surface of the medical
glass container is 0.05 ppm or lower.
12. A burner for inner surface treatment of a medical glass
container, comprising:
a burner body having a first flow path through which a fuel
is circulated; and
a second flow path to be connected to the first flow path of
the burner body,
the burner having a long and narrow nozzle that can be inserted
into the internal space of a medical glass container or an
intermediate product thereof as a processing target, and
the nozzle being formed of ceramic.
13. The burner for inner surface treatment of a medical glass
container according to claim 12, wherein the nozzle is a nozzle
that can be inserted into the internal space of the medical glass
container in which a second diameter of the opening is smaller than a
first diameter of the internal space.
14. A medical glass container, whose inner surface is heated using tine
burner for inner surface treatment of a medical glass container
according to claim 12 or 13.
15. A method for producing a medical glass container, comprising
removing a deteriorated region by inserting a burner having a
ceramic nozzle into the internal space of a medical glass container
or an intermediate product thereof, and emitting a flame formed
by a fuel emitted from the nozzle to the medical glass container
or the intermediate product thereof.

To provide a measure for reducing the leaching values of
alkali components defined in ISO4802 and the like as much as possible
in a glass container for use in storage or the like of
pharmaceuticals or the like.
The measure includes a container converting process of
processing a glass tube 60 into a container shape having a bottom
53 and an opening 51 to form a vial 50 and a fire blast process
of scanning an inner surface 54 of the vial 50 with a flame 20 of
a point burner 10 while emitting the flame 20 to an internal space
52 of the vial 50 and applying the flame 20 to the inner surface
54.