JP2010057597A - Decontamination method of prefilled syringe - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a decontamination method capable of appropriately decontaminating a prefilled syringe to a clearance section using hydrogen peroxide gas. <P>SOLUTION: This decontamination method for decontaminating the surface of a prefilled syringe A sealed in a packaging container D whose at least one part consists of a porous packaging material E, executes; a pre-decontamination process for storing the prefilled syringe A sealed in the packaging container in a decontamination chamber 2 and setting the surface temperature of the prefilled syringe A to 28-32°C; an atmospheric decontamination process, after the pre-decontamination process, introducing air with a temperature of 19-23°C and a relative humidity of 30-50% to the interior of the atmospheric decontamination chamber 2 or introducing hydrogen peroxide solution to the interior of the decontamination chamber 2 to gasfy the same; and a post-decontamination process, after the decontamination process, exhausting the hydrogen peroxide from the interior of the decontamination chamber 2. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a decontamination method for decontaminating the surface of a prefilled syringe enclosed in a packaging container.

  Prefilled syringes are pre-filled plastic syringes (syringes with needles) filled with injections necessary for treatment. For example, compared to administering injections in ampoules or vial containers, the medication operation is safer and more efficient. There is an advantage that can be done.

  The surface of the prefilled syringe is decontaminated in a state of being enclosed in a packaging container after being filled with a medicine. Here, “decontamination” is a concept including chemical T-phase decontamination, sterilization, sterilization, sterilization, and the like. Hydrogen peroxide gas is exclusively used for decontamination of the prefilled syringe. This is because decontamination by heat sterilization or γ-ray sterilization may denature the drug, and decontamination by ethylene oxide gas requires countermeasures against explosion and is disadvantageous in terms of equipment.

  More specifically, when the prefilled syringe is decontaminated, the prefilled syringe enclosed in the packaging container is accommodated in the decontamination chamber, and the decontamination chamber is set to a hydrogen peroxide gas atmosphere. The packaging container of the prefilled syringe is partially composed of a porous packaging material for gas sterilization that does not permeate bacteria but permeates gas (for example, Patent Document 1), and hydrogen peroxide filled in the decontamination chamber The gas permeates the porous packaging material and enters the packaging container to decontaminate the surface of the prefilled syringe.

JP 2007-22640 A

By the way, sterilization strength of E-6 is desired for decontamination of the prefilled syringe. Here, the sterilization strength of E-6 is the exponential sterilization strength when using the bacterial strain most resistant to the decontamination agent. In the case of hydrogen peroxide, 10 ⁶ Geobacillus.Stearothermophilus spores are completely killed. Say strength. However, in the decontamination method using hydrogen peroxide gas, in the case of a prefilled syringe having a narrow gap (hereinafter referred to as a clearance part), the clearance part can be completely decontaminated with sterilization strength of E-6. There wasn't. More specifically, as shown in FIG. 5, the prefilled syringe A sealed in the packaging container D has a clearance portion G formed between the inner wall of the cylinder B and the plunger C. Thus, no suitable decontamination conditions for achieving the sterilization strength of E-6 were found up to the clearance part G. The reason why no suitable decontamination conditions were found was that it was not clear which of the many parameters that define the decontamination conditions directly affects the sterilization strength of the clearance part G. Can be mentioned. In FIG. 5, E is a porous packaging material, F is a transparent film that does not transmit gas, H is a filled medicine, and J is a gasket coupled to the tip of the plunger C.

  This invention is made | formed in view of this present condition, and aims at provision of the decontamination method which can decontaminate appropriately to the clearance part of a prefilled syringe using hydrogen peroxide gas.

  As a result of intensive studies in order to solve the above problems, the inventors focused attention on the amount of hydrogen peroxide gas condensed in the packaging container. And when the condensation sensor which detects the condensation of hydrogen peroxide gas is enclosed in the packaging container of the prefilled syringe, the condensation sensor and the prefilled syringe are accommodated in the decontamination chamber, and the decontamination method is executed under various conditions. It was discovered that there is a close correlation between the amount of hydrogen peroxide gas condensed in the container (the output value of the condensation sensor) and the sterilization strength of the clearance. Here, the condensation sensor detects and outputs the amount of condensate condensed in the detector, and known products such as the configuration described in PCT / JP / 03/05646 are preferably used. Then, after further trial and error based on this correlation, the inventor can achieve the sterilization strength of E-6 in the clearance portion only when the output of the condensation sensor is a very limited value. I discovered that. As a result of various studies on decontamination conditions for obtaining E-6 sterilization strength at the clearance portion based on the output value of the condensation sensor, the present invention has been achieved.

  The reason why there is a close correlation between the amount of hydrogen peroxide gas condensed in the packaging container and the sterilization strength in the packaging container is considered to be as follows. In general, in the decontamination with hydrogen peroxide gas, it is preferable to condense the hydrogen peroxide gas on the surface of the object to be decontaminated in order to achieve high sterilization strength, but as shown in FIG. In addition, if a large amount of hydrogen peroxide gas is condensed on the surface of the porous packaging material E or at the entrance of the clearance portion G, the diffusion path of the hydrogen peroxide gas is blocked, and excessively deep into the clearance portion G. Hydrogen oxide gas does not spread sufficiently and the required sterilization strength cannot be achieved. On the other hand, if the amount of hydrogen peroxide gas condensed is small, the amount of hydrogen peroxide gas that reaches the clearance G is insufficient, and in this case as well, sufficient sterilization strength cannot be achieved. For this reason, even if the amount of condensation of hydrogen peroxide in the packaging container is too large or small, the clearance part G cannot be appropriately decontaminated. It is considered that an appropriate amount of hydrogen peroxide gas is distributed and the sterilization strength of E-6 is achieved.

  That is, the present invention relates to a decontamination method for decontaminating the surface of a prefilled syringe enclosed in a packaging container at least partially made of a porous packaging material, and a decontamination chamber containing the prefilled syringe enclosed in the packaging container. Before decontamination to bring the temperature to 28-32 ° C., and after the pre-decontamination step, air at 19-23 ° C. and a relative humidity of 30-50% is introduced into the decontamination chamber at normal pressure and gasified Normal pressure decontamination step of introducing the hydrogen peroxide solution into the decontamination chamber or gasification by introducing the hydrogen peroxide solution into the decontamination chamber, and after the normal pressure decontamination step, from the decontamination chamber And a post-decontamination process for discharging hydrogen peroxide. Here, “normal pressure” means that the air is not actively pressurized or depressurized, and does not mean a strict atmospheric pressure. According to this decontamination method, the clearance part of a prefilled syringe can be efficiently decontaminated with appropriate sterilization strength.

  Further, in the decontamination method of the present invention, after the normal pressure decontamination step and before the decontamination step, a depressurization step of depressurizing the decontamination chamber to 2000 Pa or less, and a decontamination chamber depressurized And a vacuum decontamination process in which the gasified hydrogen peroxide solution is introduced into the decontamination chamber or the gas supply step of introducing the hydrogen peroxide solution into the decontamination chamber and gasifying the gas is alternately performed a plurality of times. It is proposed. In such a configuration, by supplying the hydrogen peroxide gas into the decontamination chamber whose pressure has been reduced, the hydrogen peroxide gas can be more reliably and promptly sent to the clearance portion.

  As described above, according to the decontamination method of the present invention, the prefilled syringe enclosed in the packaging container containing the porous packaging material can be decontaminated up to the clearance portion with appropriate sterilization strength. In particular, in the decontamination method of the present invention, it is not necessary to pressurize and depressurize the decontamination chamber. is there.

  On the other hand, when a pressure reduction decontamination process is performed in which the pressure reduction process and the gas supply process are alternately performed a plurality of times after the normal pressure decontamination process and before the decontamination process, it is surely and promptly passed to the clearance section. It becomes possible to send in hydrogen oxide gas.

First, an embodiment of a decontamination apparatus that implements the decontamination method of the present invention will be described with reference to FIGS.
As shown in FIG. 1, the decontamination apparatus 1 includes a decontamination chamber 2. The interior (internal space) of the decontamination chamber 2 is hermetically cut off from the outside and includes a work space 20 for storing the prefilled syringe A that has been packaged. A multi-stage tray 11 formed by stacking trays made of flat nets is disposed in the work space 20, and a packaging container D in which a prefilled syringe A is sealed is placed on the multi-stage tray 11. In the decontamination method, when the inside of the decontamination chamber 2 is depressurized or pressurized, the decontamination chamber 2 must be able to withstand the depressurization condition and the pressurization condition. Also, the capacity of the decontamination chamber 2 according to this embodiment is 30 ^{m 3,} the volume of the working space 20 is 10 ^{m 3.}

  A specific configuration of the decontamination chamber 2 will be described. As shown in FIG. 1, a vertical partition plate 3 that partitions the room is provided in the decontamination chamber 2. A gap formed between the partition plate 3 and the inner wall of the decontamination chamber 2 forms a peripheral circuit 20A through which room air can pass. An opening 3A is provided at the lower end of the partition plate 3 to communicate the work space 20 disposed at the center in the decontamination chamber 2 with the peripheral circuit 20A.

  In addition, a HEPA filter 4 for cleaning the indoor air of the decontamination chamber 2 is disposed horizontally in the upper part of the decontamination chamber 2. Further, a rectifying plate 5 that regulates the airflow of room air is disposed directly below the HEPA filter 4.

  Further, in the decontamination chamber 2, above the HEPA filter 4, three air blowers 15 that blow indoor air in the decontamination chamber 2 in one direction are installed side by side. Each blower 15 is installed in a state where the blower opening 15a is directed downward so as to blow indoor air downward.

  In this configuration, the room air blown by the blower 15 passes through the HEPA filter 4, passes through the current plate 5, and reaches the work space 20. Then, the room air that has reached the working space 20 vertically cuts the multi-stage tray 11 on which the prefilled syringe A is placed from the top to the bottom, enters the peripheral circuit 20A from the opening 3A of the partition plate 3, and The circuit 20A is raised. The room air reaches the installation space of the blower 15, is again blown downward by the blower 15, and circulates in the decontamination chamber 2. That is, the air blower 15 causes the indoor air in the decontamination chamber 2 to flow to form a unidirectional flow in the circulation system. The decontamination chamber 2 has a configuration in which room air flows in the up and down direction in the work space 20, but a configuration in which the rectifying plate 5 is attached to a wall surface and the room air flows in the work space 20 in the horizontal direction may be employed.

  The decontamination chamber 2 is provided with a hydrogen peroxide gas generation and supply device 6. The hydrogen peroxide gas generation and supply device 6 includes a hydrogen peroxide tank 7 containing 30 to 40% (w / w%) hydrogen peroxide, an evaporator 9 for evaporating the hydrogen peroxide, and a peroxidation. A hydrogen peroxide solution supply pump 8 that supplies the hydrogen peroxide solution in the hydrogen water tank 7 to the evaporator 9 is provided. Further, the mixed gas of hydrogen peroxide gas and water vapor generated in the evaporator 9 is supplied to the front of the air blowing port 15 a of the air blowing device 15 in the decontamination chamber 2 by the hydrogen peroxide gas supply pipe 10. A known product is suitably used for the hydrogen peroxide gas generation and supply device 6. The hydrogen peroxide gas generation and supply device 6 introduces hydrogen peroxide water gasified outside the room into the decontamination chamber 2, but instead of such a configuration, the hydrogen peroxide water is supplied to the decontamination chamber 2. The gas may be gasified indoors by being supplied to an evaporator disposed inside.

  An air supply circuit 21 including an air supply circuit HEPA filter 22 and an air supply device 23 is connected to the decontamination chamber 2. When the air supply device 23 is driven, outside air is supplied to the air supply circuit. The air is supplied into the decontamination chamber 2 through the circuit HEPA filter 22. More specifically, the air supply circuit 21 has one end opened to the outside and the other end communicated with the decontamination chamber 2, and the heater 24, humidifier 25, cooling coil 26, air supply device in that order from the outdoor side. 23, a heater 27, an adjustment valve 28, and an air supply circuit HEPA filter 22 are disposed. The air supply circuit 21 can adjust the temperature and humidity of the air introduced into the decontamination chamber 2 by appropriately operating these devices. The adjustment valve 28 is used to adjust the air supply amount.

  The decontamination chamber 2 is connected to an exhaust circuit 30 including a catalyst 31, an adjustment valve 32, an exhaust circuit HEPA filter 33, and an exhaust device 34. More specifically, the exhaust circuit 30 includes a catalyst 31, an adjustment valve 32, an exhaust circuit HEPA filter 33, and an exhaust device 34 in order from the decontamination chamber 2 side, and one end communicates with the decontamination chamber 2. The other end is open to the outside of the room. When the exhaust device 34 is driven, the indoor air in the decontamination chamber 2 is decomposed by the catalyst 31, further cleaned by the exhaust circuit HEPA filter 33, and exhausted to the outside. The adjustment valve 32 is used to adjust the exhaust amount.

  The decontamination chamber 2 includes a temperature sensor 12 that measures the room temperature of the work space 20, a concentration sensor 13 that measures the concentration of hydrogen peroxide gas in the work space 20, and a pressure sensor 14 that measures the atmospheric pressure of the work space 20. And. A known product is preferably used for each of the sensors 12, 13, and 14.

  Further, the decontamination chamber 2 is provided with a heater 16 made of heating wire, and the temperature of the decontamination chamber 2 can be appropriately increased by the operation of the heater 16.

  In addition, the decontamination apparatus 1 includes a humidity sensor 17 and a temperature sensor 18 that detect the humidity and temperature of outdoor air introduced into the decontamination chamber 2. A known product is preferably used for each of the sensors 17 and 18.

  As shown in FIG. 2, the decontamination device 1 includes a decontamination control device 37. The decontamination control device 37 includes a central processing unit CPU 40, a read-only storage device ROM 41 connected to the central processing unit CPU 40, and a readable storage device RAM 42. Here, the central processing unit CPU 40 executes a predetermined program. The storage device ROM 41 stores an operation program and data used for arithmetic processing. The storage device RAM 42 stores calculation data, measurement data, and the like.

  The decontamination control device 37 includes a hydrogen peroxide solution supply pump 8, temperature sensors 12 and 18, concentration sensor 13, pressure sensor 14, humidity sensor 17, heaters 16, 24 and 27, humidifier 25, cooling coil 26, The adjusting valves 28 and 32, the blower 15, the air supply device 23, and the exhaust device 34 are connected to each other.

  The decontamination control device 37 outputs a control command signal to the hydrogen peroxide solution supply pump 8 according to a predetermined program, and drives it so that a predetermined amount of hydrogen peroxide solution can be supplied to the evaporator 9. Supply of a predetermined amount of hydrogen peroxide gas into the decontamination chamber 2 is started.

  The decontamination control device 37 outputs a blow control command signal to the blower 15, the air supply device 23, and the exhaust device 34 according to a predetermined program, and the devices 15, 23, The number of rotations of the fan in the interior 28 (for example, [rpm] per minute is changed) as appropriate. Further, the decontamination control device 37 outputs a control signal to the regulating valves 28 and 32 according to a predetermined program, and controls the open / closed state of the valves 28 and 32. Measurement data is transmitted from the temperature sensors 12, 18, the concentration sensor 13, the pressure sensor 14, and the humidity sensor 17 to the decontamination control device 37, and sequentially stored in the storage device RAM 42. Further, the decontamination control device 37 outputs a control command signal to the heater 16 according to a predetermined program and heats the inside of the decontamination chamber 2 to raise the inside of the decontamination chamber 2 to an appropriate temperature.

Next, a first decontamination method of the prefilled syringe by the decontamination apparatus 1 will be described.
As shown in FIG. 3, the first decontamination method is a pre-contamination step for conditioning the decontamination chamber 2 before decontamination, and the surface of the prefilled syringe A with the decontamination chamber 2 as a hydrogen peroxide gas atmosphere. And a post-decontamination process for discharging hydrogen peroxide from the decontamination chamber 2.

  First, in the pre-contamination process, as shown in FIG. 1, the prefilled syringe A is enclosed in a packaging container D partially made of a porous packaging material, and placed on the multistage tray 11 in the work space 20. The decontamination chamber 2 is sealed. And as conditioning before a normal pressure decontamination process, the temperature in the decontamination chamber 2 is maintained at 28-32 degreeC for the predetermined time, and the surface temperature of the prefilled syringe A is warmed to 28-32 degreeC. Specifically, the decontamination control device 37 drives the air supply device 23 to introduce outdoor air into the decontamination chamber 2, and drives the exhaust device 34 to supply substantially the same amount of gas as the introduced air. Exhaust from the decontamination chamber 2. At the same time, the decontamination control device 37 drives the air blower 15 to cause the indoor air to flow, thereby forming a one-way flow in the decontamination chamber 2 and appropriately operating the heater 16 in the decontamination chamber 2. Then, the temperature in the decontamination chamber 2 is controlled to be maintained at 28 to 32 ° C. In the pre-decontamination process, the temperature in the decontamination chamber 2 is maintained for 20 to 60 minutes. This is because if the time is shorter than this, the prefilled syringe A is not sufficiently heated by the ambient atmosphere, and the conditioning may be insufficient.

  When the pre-decontamination process is completed, the decontamination control device 37 executes an atmospheric pressure decontamination process. Specifically, the decontamination control device 37 drives the hydrogen peroxide solution supply pump 8 to continuously introduce hydrogen peroxide gas into the decontamination chamber 2 and drives the blower device 15. Hydrogen peroxide gas is circulated in the room, and the inside of the decontamination chamber 2 is made a hydrogen peroxide gas atmosphere. The decontamination control device 37 executes such a normal pressure decontamination process for 60 to 180 minutes. Here, in this atmospheric pressure decontamination process, the amount of hydrogen peroxide gas introduced into the decontamination chamber 2 is converted to 35% (w / w%) hydrogen peroxide water, and the capacity of the decontamination chamber 2 is 1 200 to 400 g per m3. In addition, the circulating air volume of the air in the decontamination chamber 2, that is, the air flowing into the work space 20 is 100 ventilation / hour or more with respect to the capacity of the decontamination chamber 2. The decontamination control device 37 drives the air supply device 23 to introduce outdoor air into the decontamination chamber 2, and drives the exhaust device 34 to decontaminate substantially the same amount of gas as the introduced air. Drain from chamber 2. At this time, the decontamination control device 37 appropriately drives the heaters 24 and 27, the humidifier 25 and the cooling coil 26 based on the outputs of the external humidity sensor 17 and the temperature sensor 18, and introduces air into the decontamination chamber 2. Is adjusted to 19 to 23 ° C. and a relative humidity of 30 to 50%. Here, the amount of air introduced into the decontamination chamber 2 is 20 ventilation / hour or more with respect to the capacity of the decontamination chamber 2.

  In such a normal pressure decontamination process, the hydrogen peroxide gas introduced into the chamber enters the packaging container D while circulating in the decontamination chamber 2, and the surface of the prefilled syringe A is appropriately decontaminated by the invaded hydrogen peroxide gas. It will be dyed.

  When the normal pressure decontamination process is finished, the decontamination control device 37 executes a post-decontamination process in order to remove hydrogen peroxide in the decontamination chamber 2. More specifically, first, the decontamination control device 37 stops driving the hydrogen peroxide solution supply pump 8 to stop the supply of hydrogen peroxide gas. Subsequently, the decontamination control device 37 drives the air supply device 23 and the blower device 15 to introduce air into the decontamination chamber 2 from the outside, and drives the exhaust device 34 to generate hydrogen peroxide gas. The air in the decontamination chamber 2 is cleaned and exhausted to the outside. And if the decontamination control apparatus 37 performs this post-decontamination process for predetermined time, it will stop the air blower 15, the exhaust apparatus 34, and the air supply apparatus 23, and will complete | finish a series of decontamination methods. In addition, this post-decontamination process is performed for 90 minutes or more. If the post-decontamination step is performed for 90 minutes or more, the hydrogen peroxide supplied to the surface of the prefilled syringe A can be removed to a harmless level.

  Next, a second decontamination method using the decontamination apparatus 1 different from the first decontamination method will be described. As shown in FIG. 4, this decontamination method is characterized in that a vacuum decontamination step is performed after the normal pressure decontamination step and before the decontamination step. In this decontamination method, the pre-decontamination process and the post-decontamination process are the same as the first decontamination method. The normal pressure decontamination process is the same as the first decontamination method except that the execution time is shortened from 120 minutes to 30 minutes.

  The vacuum decontamination process efficiently peroxidizes by alternately repeating a pressure reduction process for depressurizing the interior of the decontamination chamber 2 and a gas supply process for introducing hydrogen peroxide gas into the decontamination chamber 2 that has been decompressed. Hydrogen is fed into the packaging container D to decontaminate the prefilled syringe surface.

  In such a decontamination method, when the execution time (30 minutes) of the normal pressure decontamination process ends, the decontamination control device 37 proceeds to the vacuum decontamination process. In the vacuum decontamination process, as shown in FIG. 4, first, the depressurization process is performed to depressurize the decontamination chamber 2, and then the gas supply process and the depressurization process are alternately performed. And if a gas supply process is performed a predetermined number of times (here 5 times), a pressure reduction process will be finally performed, a pressure reduction decontamination process will be complete | finished, and it transfers to the post-decontamination process.

  More specifically, in the depressurization step, the decontamination control device 37 first closes the adjustment valve 28 of the air supply circuit 21 to stop the supply of outdoor air, and drives the exhaust device 34 for a predetermined time (about 1 minute). Thereby, the atmospheric pressure in the decontamination chamber 2 is reduced to 2000 Pa or less.

  In the gas supply process, the decontamination control device 37 closes the adjustment valves 28 and 32 of the air supply circuit 21 and the exhaust circuit 30, drives the blower device 15 to flow room air, and moves the inside of the decontamination chamber 2. The hydrogen peroxide solution supply pump 8 is continuously driven to supply the hydrogen peroxide gas into the decontamination chamber 2. In such a gas supply process, the introduced hydrogen peroxide gas diffuses more quickly than the normal pressure as much as the decontamination chamber 2 is depressurized, and the packaging container D is smoother than the normal pressure. It will invade inside. The gas supply process is performed for 5 to 10 minutes.

  In this way, in the vacuum decontamination process, hydrogen peroxide gas is repeatedly introduced into the decontamination chamber 2 that has been depressurized by alternately repeating the pressure reduction process and the gas supply process a plurality of times, and the surface of the prefilled syringe A is removed. Decontaminate. Such a vacuum decontamination process has an advantage that the decontamination time can be relatively shortened because the hydrogen peroxide gas can be diffused in a shorter time than the normal pressure decontamination process.

  The embodiments of the present invention described so far can be variously modified without departing from the scope of the present invention. For example, the configuration in which the decontamination device 1 is controlled by the decontamination control device 37 may be configured to be controlled by an operator. In the decontamination apparatus 1, the gasified hydrogen peroxide solution and the outdoor air are separately introduced into the decontamination chamber 2. In the atmospheric pressure decontamination step according to the present invention, the gasified hydrogen peroxide solution is introduced. And the outdoor air may be mixed outside the decontamination chamber 2, and the mixed gas may be introduced into the decontamination chamber 2.

<Test 1>
Biological indicator (Apex Laboratories, Inc. Biological Indicator (# HMV-091) Geobacillus.Stearothermophilus ACC # 12980) is installed in the clearance part of a commercially available prefilled syringe, and the prefilled syringe is partially porous packaging (Tyvek (Registered trademark)) was enclosed in a plastic pillow package, and this was used as a sample for evaluation.

A plurality of the samples for evaluation were accommodated in the decontamination chamber 2 of the decontamination apparatus 1, and decontamination was performed under conditions according to the first decontamination method (Examples 1 and 2). Moreover, the following three conditions were changed from the said 1st decontamination method, and each decontamination was performed (comparative examples 1-5).
・ Temperature in the decontamination chamber at the end of the precontamination process (temperature before decontamination)
・ Air temperature to be introduced into the decontamination chamber 2 in the normal pressure decontamination process (introduction air temperature)
-The temperature of the air introduced into the decontamination chamber 2 in the normal pressure decontamination process (introduction air temperature),
Table 1 shows the decontamination conditions and results in Examples 1 and 2 and Comparative Examples 1 to 5. In Examples 1 and 2 and Comparative Examples 1 to 5, conditions (gas introduction amount, introduction time, etc.) other than those shown in Table 1 were made common with the conditions in the first decontamination method.

  As shown in Table 1, the evaluation samples (Example 1 and Example 2) that performed the first decontamination method were all negative in BI determination. On the other hand, in the samples for evaluation in which the decontamination methods of Comparative Examples 1 to 5 were executed, the BI determination was positive in some of the samples for evaluation in any of the comparative examples. This result suggests that according to the first decontamination method, the clearance of the prefilled syringe can be appropriately decontaminated with the sterilization strength of E-6.

<Test 2>
A plurality of the same samples for evaluation as in Test 1 were accommodated in the decontamination chamber 2 of the decontamination apparatus 1, and the second decontamination method was executed. As a result, all the BI determinations of the evaluation samples were negative. This result suggests that according to the second decontamination method, the sterilization strength of E-6 can be reliably achieved up to the clearance part of the prefilled syringe.

It is a schematic longitudinal cross-sectional view of the decontamination apparatus. It is a block circuit diagram which controls a decontamination method. It is a flowchart which shows the procedure of a 1st decontamination method. It is a flowchart which shows the procedure of a 2nd decontamination method. It is explanatory drawing which shows the cross section of the packaging container D which enclosed the prefilled syringe A.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Decontamination apparatus 2 Decontamination chamber 6 Hydrogen peroxide gas generation supply apparatus 12 Temperature sensor 15 Air blower 21 Air supply circuit 23 Air supply apparatus 30 Exhaust circuit 34 Exhaust apparatus A Prefilled syringe B Cylinder C Plunger D Packaging container E Porous package Material G Clearance section

Claims (2)

In a decontamination method for decontaminating the surface of a prefilled syringe enclosed in a packaging container at least partially made of a porous packaging material,
A pre-contamination step for setting the temperature in the decontamination chamber containing the prefilled syringe enclosed in the packaging container to 28 to 32 ° C .;
After the decontamination step, air of 19 to 23 ° C. and a relative humidity of 30 to 50% is introduced into the decontamination chamber at normal pressure, and gasified hydrogen peroxide solution is introduced into the decontamination chamber, or A normal pressure decontamination process in which hydrogen peroxide water is introduced into the decontamination chamber and gasified;
A decontamination method for a prefilled syringe, comprising a post-decontamination step of discharging hydrogen peroxide from the decontamination chamber after the normal pressure decontamination step. After the normal pressure decontamination step and before the decontamination step,
Depressurization step of depressurizing the decontamination chamber to 2000 Pa or less, and introducing the gasified hydrogen peroxide solution into the decontamination chamber or introducing the hydrogen peroxide solution into the decontamination chamber The method for decontaminating a prefilled syringe according to claim 1, further comprising a vacuum decontamination step of alternately performing a gas supply step of gasification a plurality of times.

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