JP7364884B2 - isolator - Google Patents

Description

The present invention relates to an isolator for decontaminating piping in which an opening is provided.

An isolator is known in which a flammable gas is supplied to a nozzle provided in the isolator through a melting gas supply pipe, and the neck of an ampoule is melted and sealed with the combustion gas injected from the nozzle. When decontaminating the isolator, it is also necessary to decontaminate the nozzle and closing gas supply pipe. Therefore, the decontamination gas in the isolator is supplied to the melt closing gas supply pipe through a communication pipe equipped with a pump, and the decontamination gas is circulated from the nozzle into the isolator to decontaminate the nozzle and the melt closing gas supply pipe. (Patent Document 1).

Japanese Patent Application Publication No. 2003-126224

However, if the piping is extremely thin and the amount of fluid flowing through the piping is small, or if a pump cannot be installed to circulate the decontamination gas inside the isolator through the piping, it is necessary to circulate sufficient decontamination gas through the piping. There was a problem that decontamination could not be carried out sufficiently.

The present invention provides an opening in the isolator even when the piping having an opening inside the isolator is extremely thin and the amount of fluid flowing through the piping is small, or when a pump cannot be installed to circulate the gas inside the isolator through the piping. The objective is to enable the decontamination of piping that has

An isolator according to a first aspect of the present invention includes an airtight chamber, a nozzle for spraying silicone oil onto a syringe in the airtight chamber, a processing liquid supply passage for supplying the silicone oil to the nozzle, and the processing liquid supply passage. a pump for feeding the silicone oil within the pump; a processing liquid supply means provided upstream of the pump for supplying the silicone oil into the processing liquid supply passage; and a processing liquid supply means provided upstream of the pump for supplying the silicone oil into the processing liquid supply passage. a decontamination liquid supply means for supplying a decontamination liquid into the processing liquid supply passage; a switching means for switching the liquid supplied to the processing liquid supply passage; and a control means for controlling the operation of the pump and the switching means ; The control means is characterized in that during decontamination or aeration in the airtight chamber, the pump is operated to cause the decontamination liquid to flow within the processing liquid supply passage and to be sprayed from the nozzle.

A second aspect of the present invention is an isolator according to the first aspect, further comprising cleaning liquid supply means provided upstream of the pump and supplying cleaning liquid into the processing liquid supply passage, and wherein the control means controls the pump. After the decontamination liquid is activated to flow through the processing liquid supply passage and sprayed from the nozzle, the cleaning liquid is circulated within the processing liquid supply passage and sprayed from the nozzle.

According to the present invention, even when the piping having an opening inside the isolator is extremely thin and the amount of fluid flowing through the piping is small, or when a pump cannot be installed to circulate the gas inside the isolator through the piping, the piping can be Decontamination can be carried out.

FIG. 1 is a plan view showing the configuration of an isolator that is an embodiment of the present invention. FIG. 2 is a schematic cross-sectional view of the application section showing the configuration of piping (fluid passages) provided in the isolator. It is a figure showing the circulation state of decontamination gas during decontamination work using a first circulation passage, a second circulation passage, and a third circulation passage. FIG. 6 is a diagram showing the flow state of decontamination liquid and aeration air during decontamination work in the processing liquid supply passage during aeration work. FIG. 6 is a diagram showing the flow state of cleaning liquid (sterilized water) and aeration air during cleaning work of the processing liquid supply passage during aeration work.

Embodiments of the present invention will be described below with reference to the drawings. FIG. 1 is a plan view showing the configuration of an isolator that is an embodiment of the present invention.

The isolator 10 includes a device that sprays a processing liquid supplied through piping (flow path) from a nozzle inside an airtight chamber 12 in a sterile state. The isolator 10 of this embodiment constitutes a part of a syringe aseptic filling line, for example, and applies a processing liquid such as a lubricating liquid to an article such as a syringe S that is transported in an airtight chamber 12 where aseptic filling is performed (see Fig. (see 2). The syringe S is conveyed into the airtight chamber 12 of the isolator 10 by a neck conveyor 14 that engages with the finger flange portion from a pre-process (not shown) with its barrel tip facing down. The syringes S transported into the airtight chamber 12 are delivered to the carry-in wheel 16 with the intervals thereof being made constant by, for example, an in-feed screw 14A.

The syringe S on the carry-in wheel 16 is delivered to the reversing wheel 18 via the conveyance wheel 17. In the reversing wheel 18, the syringe S is turned upside down and held with the tip facing up, and delivered to the processing conveyor 20.

In the processing conveyor 20, static electricity is removed from the syringe S and a lubricant for the plunger is applied to the inside of the barrel. The processing conveyor 20 has, for example, an elliptical trajectory, and the syringe S is conveyed with the barrel tip facing upward and the outer barrel on the finger flange side being gripped by a gripper. A static eliminator 20A that removes static electricity from the syringe S and an applicator 20B that applies silicone oil as a lubricant are provided in the straight line portion of the trajectory. In the processing conveyor 20 of this embodiment, the syringes S are intermittently conveyed, and each treatment is performed in units of, for example, 12 syringes. In addition, in the application section 20B of the processing conveyor 20, nozzles 21 (for example, 12) for applying lubricant corresponding to the number of syringes S in the processing unit are provided along the trajectory of the processing conveyor 20.

The syringe S that has undergone the static elimination process and the coating process is transferred to the reversing wheel 22. In the reversing wheel 22, the syringe S is turned upside down again and held with the tip facing down. The syringe S whose top and bottom have been returned to their original state is delivered to the inspection wheel 24 via the conveyance wheel 23.

The inspection wheel 24 is provided with an inspection camera 24A, and the quality of the syringe S is determined from an image of the syringe S. Syringes S determined to be defective in the same inspection are delivered to the reject conveyor 26 and discharged from the isolator 10. On the other hand, the syringe S determined to be non-defective in the same inspection is transferred from the inspection wheel 24 to the carry-out wheel 28, and sent to the next process, such as a filling process, by the neck conveyor 30.

FIG. 2 is a schematic cross-sectional view showing the configuration of piping (fluid passage) in the application section 20B provided in the isolator 10. Each nozzle 21 in the airtight chamber 12 is arranged so as to spray the lubricating liquid (silicone oil) upward into the outer cylinder of the syringe S that is conveyed upward, and stores the lubricating liquid through the processing liquid supply passage 32. It is connected to a tank (processing liquid supply means) 34. Silicone oil is supplied from above to the tank 34 as a lubricating fluid as needed. A valveless plunger pump 36 is provided in the middle of the processing liquid supply passage 32, and when lubricating liquid is supplied, the silicone oil in the tank 34 is sent to each nozzle 21 by the valveless plunger pump 36. Further, the nozzle 21 is, for example, an air-assisted spray nozzle, and pressurized air is supplied through an air supply passage 37 that includes a valve 37A and a filter 37B.

The isolator 10 is provided with a circulation mechanism 38 for decontaminating and aerating the airtight chamber 12. The circulation mechanism 38 is a mechanism that circulates decontamination gas such as hydrogen peroxide (H ₂ O ₂ ) and air for aeration through the airtight chamber 12, and circulates the decontamination gas/air through an inlet arranged on the top side. The decontamination gas/air is supplied into the airtight chamber 12 through the HEPA filter 40A, and is recovered from the airtight chamber 12 through the outlet HEPA filter 40B disposed on the bottom side, and is then recirculated through the first circulation passage 42. It is supplied into the airtight chamber 12 from the top side.

The first circulation passage 42 is provided with a blower 44 for circulating the decontamination gas/air described above. In this embodiment, an evaporator 46 for vaporizing a hydrogen peroxide solution is provided between the blower 44 and the inlet HEPA filter 40A, and the hydrogen peroxide solution is supplied from a hydrogen peroxide solution supply source during decontamination. , vaporized as a decontamination gas. Note that a valve 42A is provided between the evaporator 46 and the inlet HEPA filter 40A, and a valve 42B is provided between the outlet HEPA filter 40B and the blower 44.

In the first circulation passage 42, an aeration supply passage 48 that supplies air for aeration is connected between the valve 42A and the inlet HEPA filter 40A. The aeration supply passage 48 is provided with a heater 48A, a blower 48B, and a valve 48C from the upstream side, and the air supplied from the air supply source is heated by the heater 48A and can be supplied into the airtight chamber 12. Furthermore, in the first circulation passage 42, a discharge passage 50 is connected between the outlet HEPA filter 40B and the valve 42B. The discharge passage 50 is a passage for discharging decontamination gas to the outside of the airtight chamber 12 during aeration, and is provided with a blower 50B via a valve 50A. Note that the gas discharged from the discharge passage 50 is rendered harmless using a catalyst (not shown).

Furthermore, this embodiment includes a decontamination/cleaning mechanism for decontaminating/cleaning the nozzle 21, the processing liquid supply passage 32, the tank 34, the air supply passage 37, and the like. The decontamination/cleaning mechanism includes, for example, a decontamination/cleaning liquid supply passage 52 connected to the processing liquid supply passage 32 between the tank 34 and the valveless plunger pump 36. The decontamination/cleaning liquid supply passage 52 is branched into a decontamination liquid supply passage (decontamination liquid supply means) 52A and a cleaning liquid supply passage (cleaning liquid supply means) 52B, and the decontamination liquid supply passage 52A is connected to a decontamination liquid supply source. The cleaning liquid supply passage 52B is connected to a cleaning liquid supply source. In this embodiment, a hydrogen peroxide solution (H ₂ O ₂ ) is used as the decontamination solution, and sterilized water ( _H2O ) is used. Note that valves (switching means) 54A and 54B are provided in the decontamination liquid supply passage 52A and the cleaning liquid supply passage 52B, respectively.

Further, the decontamination/cleaning mechanism of the present embodiment includes a processing liquid supply passage 32 between the tank 34 and the valveless plunger pump 36, and second circulation passages 56A and 56B each having one end connected to the upstream side of the tank 34. Equipped with. The other ends of the second circulation passages 56A and 56B are communicated into the airtight chamber 12, respectively. The second circulation passage 56A is provided with a valve 58A and a decontamination pump 58B that sends gas from the processing liquid supply passage 32 side to the airtight chamber 12 side, and the second circulation passage 56B is provided with a valve 58C, a valve 58D (switchable means) are provided.

Furthermore, the decontamination/cleaning mechanism of this embodiment includes a third circulation passage 60 that communicates between the valve 37A of the air supply passage 37 and the filter 37B and the inside of the airtight chamber 12. The third circulation passage 60 is provided with a decontamination pump 60A and a valve 60B, and the decontamination pump 60A sends decontamination gas from the airtight chamber 12 side to the air supply passage 37 side. In addition, the blower 44, blowers 48B, 50B, decontamination pumps 58B, 60A, valveless plunger pump 36 and heater 48A are driven, and each valve 37A, 42A, 42B, 48C, 50A, 54A, 54B, 58A, 58C, 58D, 60B The opening/closing of these is controlled by, for example, a control unit (control means) 62.

When the isolator 10 is operated and the syringe S is intermittently conveyed within the airtight chamber 12, the valve 58D is opened and the valveless plunger pump 36 is driven to supply silicone oil to the nozzle 21, while the valve 37A is opened and pressurized air is supplied to the nozzle 21 through the air supply passage 37. As a result, silicone oil is sprayed from the nozzle 21 into the outer cylinder of the syringe S. At this time, the blower 44, blowers 48B, 50B, decontamination pumps 58B, 60A, and heater 48A are stopped, and the valves 42A, 42B, 48C, 50A, 54A, 54B, 58A, 58C, and 60B are all closed. Closed.

Next, decontamination work and aeration work in the isolator of this embodiment will be explained with reference to FIGS. 3, 4, and 5. Note that it is desirable that the processing liquid supply passage 32 that has been used once be discarded without being reused. In this embodiment, it is replaced with an unused processing liquid supply passage 32, and the silicone oil is removed from the nozzle 21. It is also necessary to decontaminate the replaced treatment liquid supply passage 32 before the treatment liquid is sprayed into the outer cylinder of the syringe S. Furthermore, in the states shown in FIGS. 3 to 5 where decontamination and aeration are performed, the tank 34 is cleaned and silicone oil is removed.

FIG. 3 shows the state of flow of decontamination gas during decontamination work using the first circulation passage 42, the second circulation passages 56A, 56B, and the third circulation passage 60. The part drawn with a thick solid line in FIG. 3 is the part decontaminated by the hydrogen peroxide gas from the evaporator 46. In the decontamination work shown in FIG. , decontamination pumps 58B and 60A are driven. As a result, the hydrogen peroxide gas supplied through the evaporator 46 is circulated through the first circulation passage 42, the second circulation passages 56A, 56B, and the third circulation passage 60, and is circulated through the part drawn with a thick solid line in FIG. 12, the vicinity of the tank 34, the air supply passage 37, the first circulation passage 42, etc.) are decontaminated.

FIG. 4 shows the flow state of the decontamination liquid and aeration air during the decontamination work in the processing liquid supply passage 32 during the aeration work of the isolator 10 performed after the decontamination work shown in FIG. 3 is completed. In FIG. 4, a portion drawn with a thick solid line indicates a portion where hydrogen peroxide solution is supplied through the decontamination/cleaning liquid supply passage 52, and air is circulated through a portion drawn with a thick dashed line. At this time, the valveless plunger pump 36 is driven in the treatment liquid supply passage 32, and the hydrogen peroxide solution supplied from the decontamination liquid supply passage 52A is supplied to the nozzle 21 through the treatment liquid supply passage 32 by the valveless plunger pump 36. be done. Further, the valve 37A is opened, pressurized air is supplied to the nozzle 21 through the air supply passage, and the hydrogen peroxide solution held in the processing liquid supply passage 32 for a predetermined period of time is sprayed together with the air from the nozzle 21 into the airtight chamber 12. Ru.

Further, during aeration work on the isolator 10, the valve 48C is opened, the blower 48B and the heater 48A are driven, and aeration air is supplied into the airtight chamber 12 through the aeration supply passage 48, with the valve 42B open. The blower 44 is driven and aeration air is circulated through the first circulation passage 42 . Furthermore, when the valve 37A is opened, the blower 50B is driven, and a portion of the air in the airtight chamber 12 is exhausted. Note that, at this time, the driving of the decontamination pumps 58B and 60A is stopped, and the valves 54B, 58A, 58C, 58D, and 60B are closed. That is, in the aeration work of the isolator 10, the processing liquid supply passage 32 is decontaminated and the inside of the airtight chamber 12 is aerated.

FIG. 5 shows the flow state of the cleaning liquid and air for aeration during the cleaning operation of the processing liquid supply passage 32, which is performed after the decontamination operation of the treatment liquid supply passage 32 in the aeration operation of the isolator 10 shown in FIG. 4 is completed. In the cleaning operation of the processing liquid supply passage 32, the valve 54A, which was opened during the decontamination operation of the processing liquid supply passage 32, is closed, and the valve 54B is opened. However, the other operating states (driving states of the blower, pump, and blower, and opening/closing states of the valves) are maintained in the state in which the processing liquid supply passage 32 is being decontaminated. In FIG. 5, the part drawn with a thick broken line indicates the part to which cleaning liquid (sterilized water) is supplied through the decontamination/cleaning liquid supply passage 52, and air is circulated through the part drawn with a thick dashed line. In the cleaning operation of the processing liquid supply passage 32, the processing liquid supply passage 32 is cleaned and the inside of the airtight chamber 12 is aerated.

As described above, according to this embodiment, when the processing liquid supply passage is narrow and the supply amount of fluid flowing through the passage is small, or when a dedicated pump that circulates the decontamination gas in the isolator through the passage is used. Even if it is not provided, the processing liquid supply passage and the nozzle following it can be effectively decontaminated with a simple configuration. Furthermore, since the decontamination liquid used for decontaminating the piping is sprayed from the nozzle during aeration in the isolator, it is possible to prevent the decontamination liquid from remaining in the isolator.

In this embodiment, the processing solution supply passage was decontaminated during aeration of the airtight chamber of the isolator, but the processing solution supply passage may also be decontaminated during the decontamination work of the airtight chamber. . In this embodiment, a syringe is taken as an example of the article processed within the isolator, but the article processed within the isolator may be an article other than the syringe. Further, in this embodiment, silicone oil is supplied to the nozzle as a lubricant and is sprayed, but a treatment liquid other than the lubricant may be sent to the nozzle through a treatment liquid supply passage.

A vacuum suction device for preventing the treatment liquid (silicone oil) from scattering may be arranged around the application section. Furthermore, the pump provided in the processing liquid supply passage is not limited to a valveless plunger pump, as long as it can be used to send liquid at a minute flow rate.

10 Isolator 12 Airtight chamber 21 Nozzle 32 Processing liquid supply passage 34 Tank (processing liquid supply means)
36 Valveless plunger pump (pump)
52A Decontamination liquid supply passage (Decontamination liquid supply means)
52B Cleaning liquid supply passage (cleaning liquid supply means)
54A, 54B, 58D valve (switching means)
62 Control unit (control means)
S syringe (article)

Claims (2)

an airtight room,
a nozzle that sprays silicone oil onto the syringe in the airtight chamber;
a processing liquid supply passage that supplies the silicone oil to the nozzle;
a pump for feeding the silicone oil in the processing liquid supply passage;
a processing liquid supply means provided upstream of the pump and supplying the silicone oil into the processing liquid supply passage;
a decontamination liquid supply means provided upstream of the pump and supplying the decontamination liquid into the processing liquid supply passage;
switching means for switching the liquid supplied to the processing liquid supply passage;
comprising a control means for controlling the operation of the pump and the switching means,
The isolator is characterized in that, during decontamination or aeration in the airtight chamber, the control means operates the pump to circulate the decontamination liquid in the processing liquid supply passage and spray it from the nozzle. comprising a cleaning liquid supply means provided upstream of the pump and supplying cleaning liquid into the processing liquid supply passage,
The control means operates the pump to cause the decontamination liquid to flow in the processing liquid supply passage and spray from the nozzle, and then circulate the cleaning liquid in the processing liquid supply passage and spray it from the nozzle. The isolator according to claim 1, characterized in that:

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