JPH07101426A - Aseptic packaging method, sterile chamber and sterile packaging device used therefor - Google Patents

Abstract

(57) [Summary] [Structure] The packaged object (A) whose outer surface is to be sterilized is placed in a sterilization chamber (10) in which the packaged article outlet (12) is closed, and the packaged object (A) is packaged. After sterilizing the outer surface of the packaged body, a packaged body having both inner and outer surfaces sterilized is supplied, and has a packaged body introduction port (41) connectable to the packaged body take-out port (12) that is normally closed, An aseptic filling machine (30) having an aseptic interior is provided with an inlet (41) for an object to be packaged, and an outlet (12) for taking out an object to be packaged from the sterilization chamber (10).
Are airtightly connected to each other, and the inlet (41) and the outlet (1) are connected.
2) are opened to communicate the aseptic filling machine (30) with the sterilization chamber (10), and then the packaged object (A) whose outer surface in the chamber (10) is sterilized is aseptically filled (30). ) And filling the packaged body (A) in the packaged body. [Effects] According to the aseptic packaging method of the present invention, the part to be sterilized of the packaged object is separated from the aseptic filling machine. The outer surface can be sterilized easily and without affecting the aseptic filling machine.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an aseptic packaging method for sterilizing the outer surface of an object to be packaged such as a hermetically sealed bag in which medicines and the like are sterilized and a medical instrument whose inside is sterilized, and further sterilizing and packaging it. The present invention relates to a sterilization chamber and an aseptic packaging device used.

[0002]

2. Description of the Related Art Conventionally, disposable medical device packaging is sterilized by autoclave sterilization, gamma ray sterilization, ethylene oxide gas (EOG) sterilization, etc. after final packaging and then sterilized and distributed.

However, along with the development of medical technology and the high demand for safety and hygiene, there have been some medical instruments for which such a sterilization method cannot be directly applied.

For example, in a prefilled syringe, which is a liquid-filled syringe, the medicinal component may decompose when stored in a liquid state. Therefore, a dry powdered drug and purified water for injection which dissolves the drug are set as a set. At the time of use, both are aseptically mixed and administered to a patient.
In such a case, aseptically fill each container with dry powdered medicine and purified water for injection in a clean room, and further package it, and after packaging, autoclave sterilization, radiation sterilization such as gamma ray or electron beam. , EOG sterilization is available.

[0005]

However, the method of sterilizing by the above method after the packaging as described above has the following problems.

That is, in the autoclave sterilization method, the contents are exposed to high-temperature steam, so that not only the medicinal components of the drug are decomposed and absorb moisture, but also the sliding part of the syringe moves in the prefilled syringe. There is a problem that it ends up.

In addition, the sterilization method using radiation has a problem that the medicinal component of the drug may be decomposed, and moreover, it takes a lot of time and cost to collect safety and hygiene data of the drug irradiated with radiation. It is difficult to sterilize only a part.

Further, in the EOG sterilization method, the gas used is toxic, and it takes a lot of time and cost to evaluate safety and hygiene due to the presence of residual EOG and the like. The syringe has a problem that the sliding part of the syringe moves.

For this reason, at present, a method of aseptically filling a powdered dry drug, purified water for injection, etc. with a great deal of labor, and then aseptically enclosing, is implemented. It is desired to develop a sterilization method for improving the method and improving the reliability of sterility.

Further, not limited to pharmaceuticals, the above-mentioned sterilization method is difficult to be applied to medical instruments and the like using materials having no heat resistance, materials having a high gas adsorption property, materials easily deteriorated by radiation, etc. There has been a demand for an aseptic packaging device capable of performing aseptic packaging for these medical instruments.

The present invention has been made in view of the above-mentioned demands, and the outer surface of a packaged object such as a sealed bag in which a medicine or the like which cannot be adopted by the conventional sterilization method is sterilized and a medical instrument in which the inside is sterilized can be easily provided. Moreover, it is an object of the present invention to provide a sterile packaging method that can be sterilized without the above disadvantages and that can more surely sterilize and package a packaged object whose outer surface has been sterilized, a sterilization chamber and a sterile packaging device used therefor.

[0012]

In order to achieve the above-mentioned object, the present invention puts an article to be sterilized on the outer surface in a sterilization chamber in which the outlet for the article to be packaged is closed, and After sterilizing the outer surface, a package is sterilized on both the inner and outer surfaces, and has a packaged body inlet that can be connected to the packaged product outlet that is normally closed, and the inside is kept aseptically. Airtightly connecting the packaged object outlet of the sterilization chamber to the packaged object introduction port of the aseptic filling machine, communicating the aseptic filling machine and the sterilization chamber by opening the introduction port and the extraction port, respectively, Then, an aseptic packaging method is provided, wherein the packaged object having the outer surface in the chamber sterilized is introduced into an aseptic filling machine, and the packaged object is filled in the packaged object.

Further, the present invention has means for sterilizing the outer surface of the packaged article introduced into the interior thereof, and is provided with a cover for an aseptic filling machine to which a package body which is normally closed and whose inner and outer surfaces are sterilized is supplied. There is provided a sterilization chamber comprising a packaged article outlet that is connected to a package inlet.

Further, according to the present invention, a means for filling a package body whose inner and outer surfaces are sterilized with a package body whose outer surface is sterilized, and an opening of the package body filled with this package body are hermetically sealed. An aseptic filling machine, which has a means for sealing, and has a packaged body introduction port that is airtightly connected to the packaged product take-out port of the sterilization chamber, the inside of which is aseptically held, and the sterilization chamber. An aseptic packaging device comprising:

[0015]

According to the aseptic packaging method of the present invention, after sterilizing the outer surface of the object to be packaged in the sterilization chamber separated from the aseptic filling machine, the aseptic filling machine and the sterilization chamber are connected to each other so that they are connected to each other. Since the object to be packaged that has been sterilized is introduced into the aseptic filling machine, the sterilization operation in the sterilization chamber does not affect the aseptic filling machine. Therefore, since a sterilizing agent can be sprayed or steam can be used in the sterilization chamber, the outer surface of the packaged object such as a medical instrument can be effectively sterilized.

Further, the sterilization chamber of the present invention is provided with a means for sterilizing the inside thereof and a packaged product take-out port connected to the packaged product introduction port of the aseptic filling machine, which is effective in the above-mentioned aseptic packaging method. Can be used for

Further, since the aseptic packaging apparatus of the present invention has the above-mentioned configuration, the above aseptic packaging method can be performed.

[0018]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be specifically described below with reference to the drawings. 1 to 3 show an embodiment of an aseptic packaging apparatus used in the aseptic packaging method of the present invention. The aseptic packaging apparatus 1 comprises a sterilization chamber-10 and an aseptic filling machine 30.

The sterilization chamber 10 is for sterilizing the outer surface of an object to be packaged and has a chamber body 11 in the form of a sealed box which can be moved by casters. This chamber body 11
A carry-in port (not shown) for introducing the object A to be packaged is always closed on one side wall, and a side wall facing the carry-in port is provided for taking out the product A to the outside. The outlet 12 is opened, and the outlet 12 is normally closed by an outlet door 13 that is vertically movable. A connection frame 14 is provided on the outer peripheral edge of the outlet 12 so as to project to the outside of the chamber main body 11. The inside of the connection frame 14 is formed as an intermediate chamber 15, and a flange 16 is provided at the tip of the connection frame 14 with a flange 16. It is provided in a shape.

On the other hand, the aseptic filling machine 30 seals the object A to be packaged whose outer surface is sterilized in the sterilization chamber 10 in a hermetically sealed bag, and is provided in the aseptic chamber 40 and the aseptic chamber 40. And an aseptic packaging machine 50 described later. An inlet 41 of the packaged object A is opened on one side wall of the aseptic chamber 40,
The inlet 41 has an inlet door 42 that is vertically movable.
Is attached to the inner wall side of the sterile chamber 40, and the introduction port 41
Is always closed by the door 42. This inlet 4
1. The outlet 12 of the chamber body 11 is provided at the outer peripheral edge of the opening 1
By closely attaching the flange 16 of the connecting frame 14 provided on the outer peripheral edge of the opening of the
1 is configured to be connectable with each other, and by opening both doors 13 and 42, the outlet 12 and the inlet 41 are opened, respectively, and the inside of the sterilization chamber main body 11 and the inside of the aseptic chamber 40 are connected. Communication can be established via the intermediate chamber 15.

A nozzle 20 is provided inside the chamber body 11, and the nozzle 20 is provided in the pipe 2.
While being connected to one end of the pipe 1, the other end of the pipe 21 penetrates the chamber body 11 in an airtight manner and protrudes to the outside, and the other end 21 a of the protrusion is connected to a compressed air supply device via a high-performance filter 22. It is connected to a steam supply device (not shown), and one or both of compressed air and steam are cleaned by a filter 22 by a valve operation and then sent to the nozzle 20.
A sterilizing liquid supply pipe 23, which is located closer to the main body 11 than the filter 22 and is supplied with a sterilizing liquid from a sterilizing liquid supplying device (not shown), is connected to the protruding other end 21 a of the pipe 21. It is configured so that a sterile liquid can be sprayed together with steam. Furthermore, the chamber body 1
An exhaust pipe 24 is connected to 1. It should be noted that clean air that has passed through the filter 22 is blown into the chamber body 11 from the nozzle 20, and the chamber body 11 is always kept at a positive pressure. On the other hand, one end of a pipe 25 having a valve interposed at an appropriate position is connected to the connecting frame 14, and the other end of the pipe 25 is connected to the projecting other end 21 a of the pipe 21 from the pipe 23. When the chamber body 11 is connected to the aseptic chamber 40 by connecting the exhaust pipe 26 to the connecting frame 14, the sterilizing agent is sprayed and dried inside the connecting frame 14 (intermediate chamber 15). The outer surfaces of both doors 22 and 43 of the outlet 12 and the inlet 41 and the inner wall of the connecting frame 14 can be sterilized. In addition, on the front surface of the chamber body 11, operating gloves 17 for operating the inside of the chamber are provided to extend inward from the wall surface of the chamber body 11, and an observation window (not shown) is provided.

As shown in FIG. 3, the aseptic filling machine 30 includes a sterile room 40 and a sterile packing machine 50 disposed in the sterile room 40. This aseptic packaging machine 50 includes a sterilizing device 51, a cutting and opening device 52, a spreading device 53, and a filling device 5.
4. The heat sealing device 55 is provided, and these are arranged in the aseptic chamber 40, and the sealed bag band a is fed into the aseptic chamber 40 from the roll b wound with the sealed bag band a whose inside is sterilized in advance. It is sent to the sterilizer 51, where the sealed bag a is immersed in a pool containing hydrogen peroxide solution and then dried to form a sealed bag a.
Sterilize and dry the outer surface of the bag, and then cut between the sealed bag bands a by the cutting / opening device 52 to separate the individual packing bags, and open one side edge of the separated packing bags to form an opening portion, and expand. The opening part of the packaging bag c is expanded by the device 53, and the packaged object A is put into the packaging bag c from the opening part of the packaging bag c by the filling device 54.
Further, the opened portion of the packaging bag c is heat-sealed by the heat sealing device 55 to obtain the product d.

Next, the object to be packaged A is placed in the chamber 10.
The procedure of sterilizing the surface of the above and supplying the sterilized package A to the aseptic chamber 40 will be described. First, the package A is put into the chamber body 11 from its carry-in port, and the carry-in port is closed. , The door 43 of the outlet 12 is lowered to close the outlet 12. Further, the filter 22 is sterilized in advance with steam (for example, 125 ° C., 30 minutes). Then, in order to improve the sterilization efficiency, steam is introduced from the steam supply device into the chamber main body 11,
The temperature inside 1 is raised to about 60 to 80 ° C. Then, at the same time as supplying the hydrogen peroxide solution from the sterilizing liquid supply pipe 23,
Steam and air are supplied to the pipe 21, and a sterilizing agent in which hydrogen peroxide solution and steam are mixed is sprayed from the nozzle 20 and left for 20 to 30 minutes as it is for a while. As the sterilizing liquid, hydrogen peroxide solution mixed with peracetic acid,
Formalin, sodium hypochlorite, etc. can be used. Then, hot clean air of about 60 to 80 ° C. is supplied to the nozzle 20 and dried for about 30 to 60 minutes.

After sterilizing the outer surface of the article A to be packaged in the chamber 10 in this manner, or while the sterilization is being performed, the flange 16 of the connecting frame 14 of the chamber body 11 is attached to the outer peripheral wall of the inlet 41 of the aseptic chamber 40. The chamber 10 is connected to the sterile room 40. In this state, a sterilizing liquid is sprayed from the pipe 25 into the intermediate chamber 15 and further dried to sterilize the outer surfaces of both doors 13 and 42 and the inner wall of the connecting frame 14. Thereafter, as shown in FIG. 2, both doors 13 and 42 are pulled up to open the outlet 12 and the inlet 41, and the inside of the chamber body 11 and the sterile chamber 4 are opened.
The inside of 0 is communicated with each other through the intermediate chamber 15. Next, the operation gloves 17 are used to supply the packaged object A from the chamber body 11 into the sterile room 40.

The packaged object A thus supplied into the aseptic chamber 40 is filled in the packaging bag c by mechanically grasping it by the filling device 54, and then the unsealed portion is heat-sealed. The hermetically sealed packaging bag d in which the packaged object A is aseptically packaged is obtained.

FIG. 4 shows another embodiment of the aseptic wrapping apparatus used in the aseptic wrapping method of the present invention. This is a type in which an open box-shaped container is molded, a packaged object is placed in the recess, and the open upper end of the box-shaped container is sealed with a film.

This aseptic packaging apparatus 1'is a sheet sterilizer which immerses and sterilizes in a sterile room 40 a long main sheet g fed into a sterile room 40 from a sheet roll f installed outside the sterile room 40. Liquid pool 60, sheet drying chamber 61 for drying the sheet g to which the sterilizing liquid is attached, sterilized sheet g
A vacuum forming device 62 for forming recesses h at regular intervals to form a box-shaped container in a continuous state is sequentially arranged from the inlet side of the aseptic chamber 40, while the film roll installed outside the aseptic chamber 40. A film sterilizing liquid pool 63 for immersing and sterilizing the seal film j fed out from the i into the aseptic chamber 40 and a film drying chamber 64 for drying the film j to which the sterilizing liquid is attached
Is disposed in the upper portion of the sterile chamber 40, and a sealing device 65 is provided on the outlet side of the sterile chamber 40 to seal the sterilized film j on the open upper end of the box-shaped container continuous body. Thus, the continuous package k in which the box-shaped container continuous body is covered with the sheet g is conveyed to the outside of the aseptic chamber 40.
A cutting device 66 installed outside cuts between the recesses h to separate the individual sealed packages l.

The top plate of the aseptic chamber 40 between the vacuum forming machine 62 and the sealing device 65 has an inlet 41 for the package A.
Is opened, and a door 42 for opening and closing the inlet 41 is provided on the inlet 41 on the inner wall side of the sterile chamber 40.
A connection frame 43 is provided on the outer peripheral edge of the inlet 41 of the aseptic chamber 40, and the inside thereof is formed as an intermediate chamber 44, and the tip of the connection frame 43 is fitted with the outlet 12 of the sterilization chamber body 11. The flange is provided in a brim.

The sterilization chamber 10 comprises a cylindrical chamber body 11, one end surface of which is closed and
An inlet (not shown) for inserting the article to be packaged into the chamber is provided on the one end surface so as to be openable and closable, and the other end portion has an outlet 1 for carrying the article A to be packaged out of the sterilization chamber body 11.
2 is open, and a door 13 for opening and closing the outlet 12 is attached inside the outlet 12. Also, the chamber body 1
Although not shown in the figure, as in the embodiment of FIG. 1, clean air, sterilizing agent, and steam can be supplied to the chamber 1 from the outside of the chamber main body 11,
The inner wall of the chamber body 11 and the outer surface of the packaged object A carried into the chamber body 11 are sterilized, and clean air is constantly sent into the chamber body 11 to keep the chamber body 11 at a positive pressure. .

A flange (not shown) that engages with the flange 43 of the inlet 41 of the sterile chamber 40 is provided on the outer peripheral edge of the chamber body 11 on the outlet 12 side. The main body 10 is the sterile room 4
It can be attached to 0. In addition,
In the connecting frame 43, as in the embodiment of FIG.
4, a sterilizing liquid is sprayed, a clean air supply nozzle (not shown) is provided, and an exhaust pipe (not shown) is provided to sterilize the inside of the intermediate chamber 44. As a result, the outer surfaces of both doors 13 and 42 and the inner wall of the connecting frame 43 can be sterilized. Further, a receiving plate 45 is provided below the introduction port 41 of the aseptic chamber 40 so that the package A can be received by receiving the package A dropped from the introduction port 41 by its own weight.

Next, the procedure of sterilizing the outer surface of the packaged object A in the sterilization chamber body 11 and then supplying it to the sterilization chamber 40 will be described. First, the chamber body 11 separated from the sterilization chamber 40 and laid sideways. The object A to be packaged is put inside, and the outlet 12 is closed by the door 13 to sterilize the surface of the object A to be packaged as in the case of FIG. After that, when the chamber body 11 is attached to the sterile room 40, the chamber body 11 is placed upright from the top plate of the sterile room 40 with the outlet 12 facing downward, and the packaged object A in the chamber body 11 has its own weight. Overlap. Then, the inside of the intermediate chamber 44 is sterilized, and the chamber body 11
The package A inside is ready to be put into the sterile room 40.

In order to hermetically and aseptically package the object A to be packaged by using such an aseptic packaging apparatus 1 ', the main sheet g is fed out from the roll f around the main sheet g into the aseptic chamber 40, and the space between the rolls is set. Sheet sterilization liquid pool 60 while running
To sterilize both sides of the main body sheet g, and to dry the main body sheet g to which the sterilizing liquid adheres while traveling between the rolls in the drying chamber 61, and to dry the main body sheet g on the hot plate of the vacuum forming machine 62. The main sheet g by passing between 62a and 62b
Is softened, and then the recess h is formed by the vacuum forming dies 62c and 62d. On the other hand, the flange of the outlet 12 of the chamber body 11 containing the sterilized package A is placed in the sterile chamber 40.
After connecting with the flange of the connecting frame 43 of the introduction port 41, the inside of the intermediate chamber 44 is sterilized. Then, the doors 13 and 42 are opened and closed to drop the package A on the receiving plate 45 in the sterile room 40 by its own weight to place the package A on the receiving plate 45, and to move the main sheet g concave portion h. And is dropped into the recess h of the main sheet g. On the other hand, the seal film j fed out from the roll i wound with the seal film j into the aseptic chamber 40 is immersed in the film sterilization pool 63 while traveling between the rollers, and then in the drying chamber 64, the seal film j to which the sterilizing liquid is adhered. And a seal film j sterilized on both sides is laminated on the main body sheet g containing the packaged object A so as to cover the concave portion h, and then the sealing surface of the seal film j and the main body sheet g is heated by the sealing device 65. Adhesion is performed to seal the concave portion h with a seal film j, and a long connected packaging bag k is formed in which the objects to be packaged A are sealed at regular intervals. The connected packaging bag k is sent to the outside of the aseptic chamber 40, then cut by the cutter 66 into individual sealed packaging bags 1 and transferred by the conveyor 68.

According to the two types of aseptic packaging apparatus shown in FIGS. 1 to 3 and FIG. 4, a relatively small sterilization chamber is used, which is detachable from the sterilization chamber in which the aseptic packaging machine is installed. Since it is separated, even if a pressure such as steam is applied in the sterilization chamber, it does not affect the sterilization chamber, and therefore it is suitable for sterilization of solid substances in various forms.

In the above example, one sterilization chamber is used. However, a plurality of sterilization chambers may be provided so that a plurality of sterilization chambers can be connected to each other. If the sterilization operation of the other sterilization chamber is carried out while the finished packaged object is being carried into the sterile room, the sterilized packaged object can be continuously supplied to the sterile room.

The aseptic packaging apparatus of the present invention is not limited to the above-mentioned embodiment, and other sterilization methods may be adopted for the sterilization method of the object to be packaged, the form of the sterilization chamber and the aseptic packaging machine. The type, the connecting means between the sterilization chamber and the sterilization chamber, and the like can be variously changed without departing from the scope of the present invention.

[0036]

According to the aseptic packaging method of the present invention, the part to be sterilized of the object to be packaged is separated from the aseptic filling machine, so that a sealed bag in which a drug or the like is sterilized is packaged or a medical instrument in which the inside is sterilized is packaged. The outer surface of the body can be sterilized easily and without affecting the aseptic filling machine.

Further, according to the sterilization chamber and the aseptic packaging apparatus of the present invention, the above aseptic packaging method can be effectively performed.

[Brief description of drawings]

FIG. 1 is an abbreviated cross-sectional view showing an embodiment of the aseptic packaging device of the present invention, showing a state in which a sterile chamber and a sterile chamber are separated.

FIG. 2 is an abbreviated cross-sectional view showing a state in which a sterile room and a sterilization room are connected in the above example.

FIG. 3 is an abbreviated perspective view showing an example of the aseptic packaging device of the present invention.

FIG. 4 is an abbreviated sectional view showing another example of the aseptic packaging device of the present invention.

[Explanation of symbols]

 1, 1 ′ Aseptic packaging device 10 Sterilization chamber 11 Sterilization chamber body 12 Outlet port 13 Outlet door 20 Nozzle 23 Sterilizer supply pipe 30 Aseptic filling machine 40 Aseptic chamber 41 Inlet port 42 Inlet door 50 Aseptic packaging machine 51 Sterilization Device 52 Cutting / opening device 53 Expanding device 54 Filling device 55 Sealing device 60 Sheet sterilization liquid pool 61 Drying chamber 62 Vacuum forming machine 63 Film sterilization pool 64 Drying chamber 65 Sealing device 66 Cutter A Packaged object a Sealing bag d Product g Main sheet h Recessed j Seal film l Sealed package

Claims (3)

[Claims] 1. A package in which the outer surface of the package is to be sterilized, the outer surface of the package is sterilized, and then both the inner and outer surfaces are sterilized. Is supplied, has a packaged body introduction port that can be connected to the packaged body take-out port that is normally closed, and the sterilization chamber at the packaged body introduction port of an aseptic filling machine in which the inside is aseptically retained. The air-tightly connecting the object to be packaged, opening the inlet and the outlet respectively to communicate the aseptic filling machine and the sterilization chamber, and then aseptically sterilizing the object to be packaged whose outer surface is sterilized. A method for aseptic packaging, which comprises introducing the material to be packaged into a filling machine and filling the packaged body. 2. An object to be packaged introduction of an aseptic filling machine, which has means for sterilizing the outer surface of the object to be packaged introduced therein, and is supplied with a package which is normally closed and whose inner and outer surfaces are sterilized. A sterilization chamber comprising an outlet for an object to be packaged connected to the sterilization chamber. 3. A means for filling a package body sterilized on both the inner and outer surfaces thereof with a packaged article whose outer surface is sterilized, and a means for hermetically sealing an opening of the package body filled with the packaged article. An aseptic filling machine, comprising: a packaged body introduction port that is airtightly connected to the packaged body take-out port of the sterilization chamber according to claim 2; An aseptic packaging device comprising the described sterilization chamber.