JP5163882B2 - Sterilization method - Google Patents

Description

  The present invention relates to a sterilization method, and more particularly to a sterilization method for sterilizing an object to be sterilized by supplying a sterilization gas to a decompressed chamber.

Conventionally, as a sterilization method for sterilizing an object to be sterilized such as a syringe packaged in a packaging container or a medical device having a complicated internal structure, a sterilized gas such as hydrogen peroxide vapor is supplied to a depressurized chamber. A method for sterilizing is known (Patent Documents 1 to 6).
Among these, in Patent Documents 2, 3, 4, and 6, in particular, a depressurization step for depressurizing a chamber containing an object to be sterilized, a sterilization gas supply step for supplying sterilization gas into the chamber, and a sterilization gas are supplied. A sterilization gas supply cycle including a decompression step of restoring the pressure of the decompressed chamber is repeated a plurality of times.
Here, in the decompression step, the inside of the chamber is in a high vacuum state of several kPa or less, and when the gas suddenly flows into the chamber in the decompression step, the inside of the packaging container and the medical device are complicated. It is possible to reach a proper internal structure and sterilize efficiently.
Japanese Patent No. 2780982 Japanese translation of PCT publication No. 6-510932 Japanese Patent No. 2928640 Japanese Patent No. 378337 Special table 2004-508104 gazette Japanese Patent No. 3845110

However, when the object to be sterilized is a syringe prefilled with a medicine, if the inside of the chamber is in a high vacuum state, bubbles may be generated from the medicine, and thus there may be a case where the high vacuum state cannot be achieved.
In a repeated sterilization gas supply cycle, the chamber is in a high vacuum state every time the pressure is reduced, and the sterilization gas is purged. Therefore, a large amount of sterilization gas must be supplied each time the sterilization gas supply process is performed. did not become.
On the other hand, if the sterilization gas supply cycle is executed with the interior of the chamber in a low vacuum state during the decompression process, the sterilization gas will not reach the internal structure of the article to be sterilized at a stretch, so the number of cycles must be increased. This will increase the amount of sterilization gas used.
In addition, since the amount of sterilization gas discharged from the packaging container and internal structure part is small during the sterilization process, the amount of sterilization gas remaining increases, sterilization efficiency decreases, and the aeration time for removing the sterilization gas increases. There was a problem.
In view of such problems, the present invention provides a sterilization method capable of efficiently performing sterilization.

That is, the sterilization method according to the present invention includes a depressurization step for depressurizing a chamber containing an object to be sterilized, a sterilization gas supply step for supplying a sterilization gas into the chamber, and a decompressed chamber supplied with the sterilization gas. In a sterilization method for sterilizing an object to be sterilized in the chamber by repeating a sterilization gas supply cycle consisting of a re-pressure step to compress multiple times,
The article to be sterilized has a packaging container or a storage bag, and uses a material that allows hydrogen peroxide vapor to penetrate into at least a part of the packaging container or the storage bag.
While the sterilization gas is hydrogen peroxide vapor, the pressure in the sterilization gas supply cycle is reduced in the range of 10 kPa to 80 kPa in the chamber,
Between the sterilization gas supply cycle and the sterilization gas supply cycle, the pressure was reduced without supplying the hydrogen peroxide vapor to the chamber, and a depressurization step of depressurizing the decompressed chamber in the range of 10 kPa to 80 kPa. It is characterized in that the inside of the packaging container or the storage bag is sterilized with hydrogen peroxide vapor that has penetrated the material by performing at least one decompression pressure cycle comprising a decompression step of decompressing the chamber.

  As described above, since the depressurization pressure cycle in which the sterilization gas is not supplied is performed at least once during the sterilization gas supply cycle in which the sterilization gas is supplied, sterilization can be performed with a smaller amount of sterilization gas than in the past. Even in a low vacuum state, a sufficient sterilization effect can be obtained.

The illustrated embodiment will be described below. FIG. 1 shows a sterilization apparatus 2 for sterilizing a packaging container 1 as an object to be sterilized with hydrogen peroxide vapor as a sterilization gas.
First, the packaging container 1 will be described. As shown in FIG. 2, the packaging container 1 is packaged with a syringe 3, and this syringe 3 is provided so as to be capable of moving forward and backward with respect to the syringe 3a and the syringe 3a. And a cap 3c fitted to the tip of the syringe 3a.
The packaging container 1 is composed of a transparent container body 1a and a lid 1b that covers the opening of the container body 1a. After the syringe 3 is accommodated in the container body 1a, the container body 1a is covered by the lid 1b. The syringe 3 is packaged by closing the opening.
The container body 1a is made of a material that cannot transmit bacteria such as polyethylene terephthalate, and since it is transparent, the stored syringe 3 can be visually observed.
The lid 1b is made of a material that allows gas such as hydrogen peroxide vapor to pass through while preventing the passage of bacteria and the like, and a high-density polyethylene sheet can be used as the material having such properties. Specifically, “Tyvek” (registered trademark) manufactured by DuPont is known.
When such a packaging container 1 is sterilized by the sterilization apparatus 2, hydrogen peroxide vapor can be permeated into the packaging container 1 through the lid 1b to sterilize the surface of the syringe 3. .
And even if it moves the packaging container 1 to the environment which is not sterilized after that, since the approach of bacteria etc. from the said cover body 1b is prevented, the aseptic condition inside the packaging container 1 can be maintained.
Note that such a packaging container 1 is disclosed in Patent Document 6 and is conventionally known, and thus further detailed description is omitted.
In addition to the packaging container 1, according to the sterilization device 2, a bag for storing many syringes of a syringe as disclosed in FIG. 2 of Patent Document 5, a medical handpiece having a complicated internal structure, etc. Sterilization is possible.

The sterilizer 2 includes a chamber 11 that can accommodate a plurality of the packaging containers 1, a transformer 12 that changes the pressure inside the chamber 11, and a sterilization gas supply unit 13 that supplies hydrogen peroxide vapor into the chamber 11. And aeration means 14 for removing hydrogen peroxide vapor in the chamber 11 after completion of sterilization, and these are controlled by control means (not shown).
The chamber 11 is installed in a sterilized clean room (not shown), a door 11a having an interlock (not shown) for carrying in and out the packaging container 1, a heater 15 for maintaining the inside of the chamber 11 at a predetermined temperature, and the chamber 11 And a pressure sensor 16 for measuring the internal pressure.
Since the inside of the chamber 11 is depressurized by the transformer 12, the chamber 11 has a structure that can withstand this depressurization. When the door 11 a is closed, the inside of the chamber 11 is kept airtight. .
The heater 15 maintains the interior of the chamber 11 at a temperature suitable for effective sterilization with the hydrogen peroxide vapor, and specifically maintains the interior of the chamber 11 at about 37 ° C. .
The pressure sensor 16 measures the pressure inside the chamber 11 and transmits the measurement result to the control means.

The transformer 12 includes an exhaust passage 17 for exhausting gas inside the chamber 11, an intake passage 18 for supplying air outside the chamber 11 to the inside of the chamber 11, and a vacuum pump 19 provided in the exhaust passage 17. And a catalyst 20 provided in the exhaust passage 17.
In order to decompress the inside of the chamber 11 by the transformer 12, the valve 18a of the intake passage 18 is closed and the valve 17a of the exhaust passage 17 is opened, and the vacuum pump 19 is operated in this state.
Then, the gas inside the chamber 11 is exhausted from the exhaust passage 17, and the control means operates the vacuum pump 19 until the pressure is reduced to a required pressure while monitoring the pressure inside the chamber 11 by the pressure sensor 16.
At this time, if hydrogen peroxide vapor is present inside the chamber 11, the hydrogen peroxide vapor sucked into the intake passage 18 is decomposed into water and oxygen by the catalyst 20 and then is discharged to the outside of the sterilizer 2. Discharged.
On the other hand, in order to restore the pressure inside the chamber 11 decompressed by the transformer 12, the valve 18a of the intake passage 18 may be opened and the valve 17a of the exhaust passage 17 may be closed.
Then, the sterilized air in the clean room flows into the chamber 11, and the control means monitors the pressure inside the chamber 11 by the pressure sensor 16, and when the pressure is restored to approximately atmospheric pressure, the valve of the intake passage 18 is turned on. Close.

The sterilizing gas supply means 13 includes a tank 21 for storing a hydrogen peroxide aqueous solution having a predetermined concentration, a measuring device 22 for measuring the weight of the tank 21, and a feed for supplying a required amount of the hydrogen peroxide aqueous solution from the tank 21. The liquid pump 23, an evaporator 24 that evaporates the aqueous hydrogen peroxide solution inside the chamber 11, and a fan 25 provided inside the chamber 11.
A 35 wt% aqueous hydrogen peroxide solution is stored in the tank 21, and the measuring device 22 measures the amount of the hydrogen peroxide aqueous solution and transmits it to the control means.
The liquid feed pump 23 feeds the aqueous hydrogen peroxide solution in the tank 21 to the evaporator 24 in the chamber 11. At this time, the control means determines that the amount of the aqueous hydrogen peroxide solution is reduced. Since the liquid is fed while being measured by the vessel 22, it is possible to accurately feed the aqueous hydrogen peroxide solution.
The evaporator 24 is provided so that its evaporation surface is exposed inside the chamber 11, and an aqueous hydrogen peroxide solution is dropped from the liquid feed pump 23 onto the evaporation surface.
When the aqueous hydrogen peroxide solution is dropped on the evaporation surface, the aqueous hydrogen peroxide solution instantly evaporates to become hydrogen peroxide vapor, and this hydrogen peroxide vapor is diffused throughout the chamber 11 by the fan 25. .

The aeration means 14 is connected to the chamber 11 to constitute a closed circuit, forms a closed circuit, a catalyst 27 provided in the circulation path 26, a blower 28 for circulating gas, and dehumidification of the gas flowing through the circulation path 26 The dehumidifier 29 that performs the above operation, the heater 30 that raises the gas to a predetermined temperature, and the concentration sensor 31 that measures the concentration of the gas flowing through the circulation passage 26 are configured.
Both ends of the circulation passage 26 are connected to the chamber 11, and when the gas inside the chamber 11 is sucked from the inlet side of the circulation passage 26 by the blower 28, the gas passes through the catalyst 27 and the like from the outlet side. It circulates inside the chamber 11.
The catalyst 27 decomposes the hydrogen peroxide vapor contained in the gas sucked from the chamber 11 into oxygen and water, the dehumidifier 29 dehumidifies the gas containing the decomposed oxygen and water, and the heater 15. Heats this gas to a predetermined temperature.
For this reason, since the hydrogen peroxide vapor sucked by the aeration means 14 is circulated again in the chamber 11 in a decomposed state, the concentration of the hydrogen peroxide component in the chamber 11 gradually decreases. .
The concentration sensor 31 is provided on the upstream side of the catalyst 27. The concentration sensor 31 measures the concentration of hydrogen peroxide contained in the gas sucked by the blower 28 and confirms that the concentration has decreased to a predetermined concentration. Yes.
The aeration means 14 is not limited to the circulation type described above, and the gas inside the chamber 11 sucked by the blower via the catalyst is discharged outside without being circulated, and the outside gas is sucked by the blower, A 1-through system may be used in which the inside of the chamber 11 is supplied via a dehumidifier and a heater.

Hereinafter, a method for sterilizing the packaging container 1 using the sterilization apparatus 2 having the above configuration will be described.
First, a plurality of packaging containers 1 are accommodated in the chamber 11, and the chamber 11 is closed by the door 11a. At this time, the packaging body 1 is placed so that the lid 1 b of the packaging container 1 is exposed inside the chamber 11.
Next, the transformer 12 and the sterilizing gas supply unit 13 are operated to sterilize the interior of the chamber 11 according to the steps shown in FIG.
First, a decompression step A1 is performed in which the pressure inside the chamber 11 is decompressed by the transformer 12. Thereby, the inside of the chamber 11 is depressurized to 10 kPa to 80 kPa (hereinafter, absolute pressure), and more preferably, depressurized to 70 kPa.
Subsequently, a sterilization gas supply step A2 for supplying hydrogen peroxide vapor to the chamber 11 by the sterilization gas supply means 13 is performed. Specifically, a predetermined amount of aqueous hydrogen peroxide solution is evaporated inside the chamber 11 by the evaporator 24 by the sterilizing gas supply means 13.
As a result, hydrogen peroxide vapor is generated inside the chamber 11, and this hydrogen peroxide vapor diffuses throughout the chamber 11 by the fan 25. Further, the pressure inside the chamber 11 gradually increases with the generation of hydrogen peroxide vapor.
The sterilizing gas supply means 13 stops when a predetermined amount of aqueous hydrogen peroxide solution is supplied into the chamber 11, and then operates the fan 25 for a predetermined time to sufficiently diffuse hydrogen peroxide vapor into the chamber 11. .
When the sterilizing gas supply step A2 is completed, a pressure-reducing step A3 is performed in which the inside of the chamber 11 is decompressed by the transformer 12. As a result, clean air from the clean room flows into the chamber 11 and the pressure inside the chamber 11 is restored to atmospheric pressure.
In the following description, the steps including the pressure reducing step A1, the sterilizing gas supply step A2, and the decompression step A3 are collectively referred to as a sterilizing gas supply cycle A.

When the sterilization gas supply cycle A ends, the internal pressure of the chamber 11 becomes atmospheric pressure by the return pressure step A3 in the sterilization gas supply cycle A.
From this state, in the present embodiment, the pressure reducing step B1 for reducing the pressure inside the chamber 11 by the transformer 12 is performed again. Thereby, the inside of the chamber 11 is again decompressed to 10 kPa to 80 kPa, preferably 70 kPa.
At this time, the hydrogen peroxide vapor contained in the gas inside the chamber 11 is discharged to the outside of the chamber 11 through the exhaust passage 17, but is decomposed into oxygen and water by the catalyst 20 on the way, Hydrogen oxide vapor is not discharged from the sterilizer 2 to the outside.
Subsequently, a pressure-reducing step B <b> 2 in which the inside of the chamber 11 is decompressed by the transformer 12 is performed. Here, unlike the sterilization gas supply cycle A, the sterilization gas supply process is not performed and hydrogen peroxide vapor is not supplied to the chamber 11.
By this decompression step B2, clean air in the clean room flows into the chamber 11 again, whereby the interior of the chamber 11 is decompressed to atmospheric pressure.
In the following description, the process including the pressure reducing process B1 and the pressure reducing process B2 is collectively referred to as a pressure reducing pressure cycle B.
The depressurization pressure cycle B may be performed at least once between the sterilization gas supply cycle A and the sterilization gas supply cycle A. In this embodiment, the depressurization pressure cycle B is performed once during the sterilization gas supply cycle A. Is supposed to do.
In the sterilization gas supply cycle A and the depressurization pressure cycle B, it is not always necessary to restore the pressure to the atmospheric pressure in the decompression steps A3 and B2, and the pressure is restored to the substantially atmospheric pressure that is slightly negative with respect to the atmospheric pressure. Also good.

When the sterilization gas supply cycle A and the depressurization pressure cycle B are repeated a predetermined number of times, the aeration means 14 is operated to perform aeration, and the hydrogen peroxide vapor inside the chamber 11 is removed.
Specifically, the blower 28 of the aeration means 14 is operated to suck the gas inside the chamber 11 into the circulation passage 26, and the hydrogen peroxide vapor contained in the gas is decomposed into oxygen and hydrogen by the catalyst 27. By repeating this, the hydrogen peroxide concentration inside the chamber 11 is gradually reduced.
Then, aeration is performed for a predetermined time set in advance, and when the concentration sensor 31 confirms that the hydrogen peroxide concentration in the chamber 11 is equal to or lower than the predetermined concentration, the control means stops the aeration means 14. The operator can take out the packaging container 1 inside the chamber 11.

As described above, in the sterilization method in the present embodiment, the depressurization pressure cycle B is performed at least once between the sterilization gas supply cycle A and the sterilization gas supply cycle A. It is assumed that sterilization is performed in this process.
First, in the sterilization gas supply cycle A, if hydrogen peroxide vapor is supplied to the chamber 11 by the sterilization gas supply step A2 in a state where the chamber 11 is depressurized by the pressure reduction step A1, the inside of the chamber 11 is depressurized, so that the peroxide Hydrogen vapor will diffuse throughout the interior of the chamber 11.
From this state, the hydrogen peroxide vapor floating inside the chamber 11 is introduced into the chamber 11 by rapidly returning the pressure inside the chamber 11 from the reduced pressure state to the atmospheric pressure by the pressure-reducing step A3. The flow forcibly penetrates into the packaging container 1 through the lid 1b.
For this reason, the hydrogen peroxide vapor also contacts the surface of the syringe 3 housed in the packaging container 1 so that the surface of the syringe 3 is sterilized.

Here, when the depressurization step B1 in the depressurization pressure cycle B is performed subsequent to the sterilization gas supply cycle A, the hydrogen peroxide vapor is also discharged at a certain rate together with the gas inside the chamber 11.
However, the hydrogen peroxide vapor discharged here is hydrogen peroxide vapor floating outside the packaging container 1, and the hydrogen peroxide vapor permeating into the packaging container 1 is blocked by the lid 1b and discharged. In addition, since the pressure is reduced to a low vacuum state of 10 kPa to 80 kPa, preferably 70 kPa, the decrease in the hydrogen peroxide vapor concentration inside the packaging container 1 is considered to be very small.
In this state, when the pressure-reducing step B2 in the pressure-reducing pressure cycle B is performed, the hydrogen peroxide vapor remaining inside the packaging container 1 wraps deeper inside the packaging container 1 due to the inflowing gas. Can be pushed into the part.
Then, by repeating the sterilization gas supply cycle A and the depressurization pressure cycle B, the concentration of hydrogen peroxide inside the packaging container 1 can be gradually increased, and the syringe 3 accommodated in the packaging container 1 The entire surface can be sterilized.
As described above, even if the depressurization pressure cycle B in which hydrogen peroxide vapor is not supplied during the sterilization gas supply cycle A is performed, a sterilization effect equivalent to the sterilization method in which only the sterilization gas supply cycle A is repeated can be obtained. .
Further, since no hydrogen peroxide vapor is supplied into the chamber 11 during the decompression pressure cycle B, the amount of hydrogen peroxide required for sterilization can be reduced to the minimum necessary, and the time required for aeration is also shortened. Therefore, sterilization can be performed efficiently.

Moreover, according to the sterilization method of the present embodiment, the pressure inside the chamber 11 is set to 10 kPa to 80 kPa, more preferably 70 kPa, in the decompression steps A1 and B1 by the sterilization gas supply cycle A and the depressurization pressure cycle B.
On the other hand, in Patent Document 1, the pressure inside the chamber is 1 to 20 Torr (0.01 kPa to 2.66 kPa), and in Patent Document 3 is 0.1 to 40 Torr (0.001 kPa to 5.33 kPa) in a high vacuum state. The pressure is reduced to.
Such a conventional way of thinking is that hydrogen peroxide vapor is pushed into a complicated internal structure portion or the inside of a tubular body at a time by setting the inside of the chamber to a high vacuum state.
However, each time the sterilization gas supply process is repeated, if the inside of the chamber is brought into a high vacuum state by the decompression process, the vaporized hydrogen peroxide is discharged from the chamber and the condensed hydrogen peroxide is also vaporized and discharged. Therefore, in order to obtain a sufficient sterilization effect, a large amount of hydrogen peroxide vapor has to be supplied to the chamber each time.
On the other hand, in the sterilization method of this embodiment, the inside of the chamber 11 only needs to be in a low vacuum state, and since the pressure reduction range from the atmospheric pressure is small, the discharge amount of hydrogen peroxide in the pressure reduction process A1 is reduced. The amount of hydrogen peroxide vapor used can be minimized.
Further, by providing the pressure-reducing step B2, the hydrogen peroxide vapor can be penetrated deep into the packaging container 1, and the concentration of the hydrogen peroxide vapor in the chamber 11 can be lowered, so that the aeration time can be shortened. Also become.
Further, since it is not necessary to increase the degree of vacuum inside the chamber 11 so much, the chamber 11 does not need to be structured to withstand high vacuum, and the vacuum pump 19 of the transformer 12 needs to have high performance. Therefore, the manufacturing cost of the sterilizer 2 can be reduced.
And it can prevent that the to-be-sterilized object will receive some influence by decompressing the inside of the chamber 11 to a high vacuum state.
Specifically, in the case of sterilizing the syringe 3 filled with the drug as in the present embodiment, when the pressure of the chamber 11 is reduced to a vacuum state, the air contained in the drug expands and the volume of the drug is increased. Bubbles may be generated inside.
At this time, the plunger 3b of the syringe 3 may move forward and backward due to the volume expansion of air, and hydrogen peroxide adhering to the inner wall of the syringe 3a may be mixed into the medicine.
Although such a phenomenon varies depending on the type of the syringe 3 and the type of the drug, it has been confirmed by experiments that the phenomenon occurs when the pressure inside the chamber 11 is set to 15 kPa or less.

Hereinafter, an experiment was conducted on the sterilization method according to the present invention (invention methods 1 and 2), and an experiment was conducted on the sterilization method in which only the sterilization gas supply cycle A was repeated without performing the depressurization pressure cycle B from the sterilization method. (Comparison methods 1 and 2).
The comparison methods 1 and 2 are conventionally known sterilization methods, that is, sterilization methods in which the inside of the chamber is in a high vacuum state. It is an experiment on whether it can be obtained.
Experimental conditions common in the inventive method and the comparative method Volume of chamber 11: 1 m ³
Number of packaging containers 1: 480
Sterilization target: Bacteria applied on the surface of the syringe 3 (10 ⁶ CFU of B. stearothermophilus ATCC # 12980)
Concentration of aqueous hydrogen peroxide solution: 35% by weight Concentration of the pressure inside the chamber 11 by the decompression steps A1 and B1: 70 kPa (absolute pressure)

In the experiment according to Invention Method 1, the amount of the aqueous solution of hydrogen peroxide in the sterilization gas supply step A2 was 5 g at a time, and the sterilization gas supply cycle A and the depressurization pressure cycle B were repeated 20 times. In other words, in Invention Method 1, a total of 5 g × 20 times = 100 g of hydrogen peroxide aqueous solution was used.
Further, in the experiment according to the invention method 2, the amount of the aqueous hydrogen peroxide solution supplied in the sterilization gas supply step A2 was 4 g at a time, and the sterilization gas supply cycle A and the depressurization pressure cycle B were repeated 25 times. . That is, in Invention Method 1, a total of 4 g × 25 times = 100 g of hydrogen peroxide aqueous solution was used.
On the other hand, in the experiment according to the comparative method 1, the amount of the aqueous solution of hydrogen peroxide in the sterilization gas supply step A2 was 5 g at a time, and the sterilization gas supply cycle A was repeated 20 times. That is, in Comparative Method 1, a total of 5 g × 20 times = 100 g of hydrogen peroxide aqueous solution was used.
Further, in the experiment according to the comparative method 2, the amount of the aqueous solution of hydrogen peroxide in the sterilization gas supply step A2 was 1.5 g per time, and the sterilization gas supply cycle A was repeated 40 times. That is, in the comparative method 1, a total of 1.5 g × 40 times = 60 g of hydrogen peroxide aqueous solution was used.

The experimental results are as shown in FIG. 4, and according to the inventive methods 1 and 2, it was possible to confirm the total death of the bacteria attached to the surface of the syringe 3. The time required from the start of sterilization to the end of sterilization when the hydrogen peroxide concentration inside the chamber 11 was 1 ppm or less by aeration was about 4 hours.
On the other hand, according to the comparison methods 1 and 2, hydrogen peroxide is condensed inside the chamber 11 to form droplets, and the survival of bacteria is confirmed on the surface of the syringe 3, so that it does not die completely. It was. The time required from the start of sterilization to the end of sterilization was about 8 hours.

About the experimental result concerning the said comparison methods 1 and 2 having been obtained, it is guessed as follows.
First, since the pressure inside the chamber 11 in the decompression step A1 is set to 70 kPa, the amount of air exhausted inside the chamber 11 at the time of decompression is small, and hydrogen peroxide is contained inside the chamber 11 every time the sterilization gas supply cycle A is repeated. It is thought that it was accumulated in the droplets.
When hydrogen peroxide is condensed into droplets, it is known that a sufficient sterilization effect cannot be obtained, and it is presumed that the bacteria were not completely killed.
Further, it is presumed that the time required for aeration is increased due to the accumulation of a large amount of hydrogen peroxide in the chamber 11, and the time required from the start of sterilization to the end of sterilization is increased.
On the other hand, in the experimental results according to the inventive methods 1 and 2, since the hydrogen peroxide vapor inside the chamber 11 can be sufficiently discharged by the depressurization pressure cycle B, the hydrogen peroxide does not condense and aeration It is speculated that this could be done in a short time.

The block diagram of the sterilizer which concerns on a present Example. The side view of the packaging container as a to-be-sterilized thing. The figure which showed the process of the sterilization method concerning a present Example. The table | surface which shows the experimental result by invention method 1 and 2 and comparative method 1 and 2. FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Packaging container 2 Sterilizer 11 Chamber 12 Transformer means 13 Sterilization gas supply means 14 Aeration means A A sterilization gas supply cycle A1 Depressurization process A2 Sterilization gas supply process A3 Pressure reduction process B Decompression pressure cycle B1 Pressure reduction process B2 Pressure reduction process

Claims (4)

A sterilization gas supply comprising a depressurization step for depressurizing a chamber containing an object to be sterilized, a sterilization gas supply step for supplying a sterilization gas into the chamber, and a decompression step for depressurizing the decompressed chamber supplied with the sterilization gas In a sterilization method for sterilizing an object to be sterilized in the chamber by repeating a cycle a plurality of times,
The article to be sterilized has a packaging container or a storage bag, and uses a material that allows hydrogen peroxide vapor to penetrate into at least a part of the packaging container or the storage bag.
While the sterilization gas is hydrogen peroxide vapor, the pressure in the sterilization gas supply cycle is reduced in the range of 10 kPa to 80 kPa in the chamber,
Between the sterilization gas supply cycle and the sterilization gas supply cycle, the pressure was reduced without supplying the hydrogen peroxide vapor to the chamber, and a depressurization step of depressurizing the decompressed chamber in the range of 10 kPa to 80 kPa. A sterilization method characterized by sterilizing the inside of the packaging container or the storage bag with hydrogen peroxide vapor that has permeated the material by performing at least one depressurization cycle comprising a decompression step of decompressing the chamber. .   2. The sterilization method according to claim 1, wherein the pressure in the chamber in the depressurization step in the sterilization gas supply cycle and the depressurization pressure cycle is 70 kPa.   3. The sterilization method according to claim 1, wherein the pressure in the chamber is returned to substantially atmospheric pressure in the return pressure step in the sterilization gas supply cycle and the pressure reduction cycle. The object to be sterilized is a syringe containing a liquid therein, it consists with the packaging container or packaging bag accommodating the syringe therein, and the surface of the syringe inside the packaging container or packaging bag penetrates the material The sterilization method according to any one of claims 1 to 3, wherein the sterilization is performed with hydrogen peroxide vapor.

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