JP3499509B2 - Fluid processing mechanism, filter booth used therefor, and filter management method requiring integrity test - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a filter, particularly a fluid treatment mechanism using a filter requiring an integrity test, a filter booth suitable for this treatment mechanism, and a filter management method.

[0002]

2. Description of the Related Art Nowadays, filters requiring integrity test are widely used in various fields such as manufacture of electronic parts such as medicines, foods, cosmetics and semiconductors. For example, in the process of manufacturing a drug, particularly in the process of filling a container with a drug, as a pre-step, the drug is aseptically filtered by a sterile filter. FIG. 6 is a schematic diagram showing an aseptic preparation unit that is a specific example of the drug manufacturing process. The aseptic preparation unit substantially prepares a preparation tank 101 for mixing and agitating the drug and the prepared drug. A sterilizing filter 102 for asepticizing, and a filling tank 103 for sending a sterilized drug to a filling device,
A filling machine 104 for filling a container (not shown) with the medicine from the filling tank 103. The respective devices are connected by a pipe 105, and the secondary side (downstream side) of the sterile filter is in a sterile state. Therefore, regarding the atmosphere of the working room equipped with these devices, the cleanliness of the class is 10,000 to 10 as the primary working space.
It is roughly divided into a dispensing chamber 106 of about 20,000 and a filling chamber 107 of class 100 to 1,000 as a working space on the secondary side.

A preparation tank 101 is arranged in a dispensing chamber 106, and a filling tank 103 and a filling machine 1 are provided in a filling chamber 107.
04 is coordinated. The sterilizing filter 102 may be arranged on the filling chamber 107 side, but it is often arranged on the dispensing chamber 106. This is because when the sterile filter 102 is arranged on the side of the filling chamber 107, the medicine may be exposed when the filter is replaced, and the cleanliness inside the filling chamber 107 may be adversely affected. Conceivable. In order to explain in more detail, first, the sterile filter 1
02 will be described with reference to FIG. Incidentally, this FIG.
Then, the aseptic filter is indicated by reference numeral 2. As shown in FIG. 4, aseptic filter 2 has a filtering part body 2a housed in a filter housing 2b.
A is exchanged. After the replacement, the filter housing 2b is fastened and fixed to the base 2c, and the filter body 2a is sealed in the filter housing 2b. When the filtration unit body 2 is replaced, the treatment agent such as a medicine may be spilled, which may contaminate the inside of the filling chamber 107.

Therefore, as shown in FIG.
In many cases, the sterile filter 102 (2) is coordinated with
In this case, when the filter housing 2b is opened and a new filtration unit body 2a is attached, there is a possibility that the filtration unit body 2a and the outlet side pipe 83 of the filter 2 are contaminated by particles, falling bacteria, or the like. . In order to reduce the possibility of this contamination, aseptic filter 102 (2) is provided in the vicinity of the air flow outlet 106a for supplying clean air (air kept at a predetermined cleanliness, the same applies below) into the dispensing chamber 106. You can also see an example of attaching. However, heat exchange occurs on the surface of the filter housing 2b due to the air flow, which may cause a problem during the integrity test performed after the filter replacement. That is, an integrity test for measuring bubble points, pressure drops, etc. is performed after the filter is replaced, but this integrity test needs to be performed within a predetermined temperature condition. However, if you continue to receive the airflow directly,
Due to the heat exchange, the temperature inside the filter decreases, and the problem that the predetermined temperature condition is not satisfied occurs.

[0005]

SUMMARY OF THE INVENTION The invention of the present application can prevent the filter and the outlet side pipe from being contaminated by particles, falling bacteria, etc. at the time of replacing the filter, and can be used for the integrity test of the filter. The present invention provides a fluid treatment mechanism that does not have an adverse effect, a filter booth used in the fluid treatment mechanism, and a method of managing a filter.

[0006]

The invention according to claim 1 of the present application is a primary side in which an apparatus for treating a fluid before passing through a filter 2 requiring an integrity test is arranged. The work space 6 and the secondary work space 7 in which a device for processing the fluid that has passed through the filter 2 is arranged are provided, and the secondary work space 7 is the primary work space 6. In the fluid treatment mechanism that is maintained at a higher degree of cleanliness, the filter 2 is arranged in the filter booth 8 that forms a space for housing the filter 2, and the filter 2 in the filter booth 8 is arranged.
The surrounding space is maintained at a predetermined cleanliness level that can prevent the filter 2 from being contaminated when the filter 2 is replaced, and at the time of the integrity test of the filter 2, the temperature condition of the filter 2 that conforms to the test is maintained. A fluid treatment mechanism is provided.

According to the invention of claim 2 of the present application, the filtering portion main body 2a is provided.
A filter 2 formed by partitioning and sealing a filter housing 2b into a filter housing 2b, and a filter disposition portion for accommodating the filter 2 requiring an integrity test; 83 and an air outlet 85 for ejecting clean air to the filter 2, and ejecting clean air to the filter 2 when the filter housing 2b is opened and the inside of the filter body 2a is replaced. Providing a filter booth that enables

According to the invention of claim 3 of the present application, the filtering portion main body 2a is provided.
In the method of managing the filter 2 in which the filter is housed in the filter housing 2b in a replaceable manner, when the filter 2 is arranged in the filter booth 8 and the filter body 2a is replaced, at least a new filter body is used. From the time when the filter housing 2b is installed to the time when the filter housing 2b is closed, clean air is allowed to flow into the filter 2 and, during the integrity test of the filter 2 performed after replacement, the flow of clean air is stopped or the same test is performed. Matching filter 2
Provided is a method of managing a filter, characterized in that the flow of clean air is stopped within a range in which the temperature condition of is maintained.

[0009]

BEST MODE FOR CARRYING OUT THE INVENTION Embodiments of the present invention will be described below with reference to the drawings. Figure 1 is a front view of the filter booth,
FIG. 2 is a right side view of the same. FIG. 3 is a schematic diagram of a fluid treatment mechanism using a filter, and FIG. 4 is a schematic diagram of the filter.

First, referring to FIG. 3, the overall structure of a fluid treatment mechanism using the filter according to this embodiment will be described. This fluid processing mechanism is implemented as an aseptic drug preparation unit. In this mechanism, the drug (hereinafter,
Preparation tank 1 for mixing and stirring a treatment agent)
A filter 2 for the prepared processing fluid (in this example, an aseptic filter that substantially sterilizes), a filling tank 3 for sending the sterilized processing fluid to a filling device, and processing from the filling tank 3. A filling machine 4 for filling a fluid (not shown) with a fluid. Each device is connected by a pipe 5, and the secondary side (downstream side) of the filter is in a sterile state. Therefore, regarding the atmosphere of the work room (clean room) equipped with these devices,
Cleanliness class 10,000 as the primary side work space 6
Dispensing room 6 of about 100,000 and working space 7 on the secondary side
Is divided into a filling chamber 7 of class 100 to 1,000. Although illustration is omitted, the dispensing chamber 6 and the filling chamber 7 are respectively provided with a cleaning means such as a clean air blowing device for keeping each chamber at a predetermined cleanliness.

The preparation tank 1 is arranged in the primary work space 6, and the filling tank 3 and the filling machine 4 are arranged in the secondary work space 7.
Are coordinated. The filter booth 8 is arranged in the primary side work space 6, and the filter 2 is arranged in the filter booth 8.

The filter 2, as shown in FIG.
The filter unit main body 2a connected to and fixed to is housed in the filter housing 2b, and the filter housing 2b is removed from the base 2c to replace the filter unit main body 2a. After replacement, the filter housing 2b is tightened and fixed to the base 2c, and the filter unit main body 2
a is hermetically sealed in the filter housing 2b. The filter 2 is replaced with the filter main body 2a periodically or as needed, but it is necessary to perform an integrity test prior to use after replacement.

In this example, a sterilizing filter that allows only a predetermined substance (for example, 0.2 μm or less) to pass through is used as the filter 2 to ensure a substantially sterilized state of the processing fluid that has passed through. In addition, the integrity test is a test for showing a predetermined filtration performance, and examples thereof include a bubble point test and a pressure drop test.

As shown in FIGS. 1 and 2, the filter booth 8 is provided with a frame portion 81 which forms a partitioned space for housing the filter 2, and the space partitioned from the outside by the frame portion 81 is the filter. It becomes the arrangement portion 80. In this example,
The frame portion 81 is composed of a housing whose upper, lower, left, right and rear portions are closed. The front surface of the frame portion 81 serves as a working opening 81a. This working opening 81
A door 81b that can be opened and closed is provided at a.
When the filter is closed, the filter arrangement portion 80 is shielded from the outside. In this example, two doors 81b are provided on the left and right sides, and glass windows are provided at the centers of the doors 81b so that the inside can be seen. In FIG. 1, the inside seen through the glass windows is indicated by a solid line. The filter arrangement portion 80 in the frame portion 81 is a space where filter replacement work can be performed, and in this example, a sufficient space is secured upward assuming the case where the filter housing 2b is pulled up and replaced. is doing.

The filter booth 8 has an inflow pipe 82 for introducing the treatment fluid into the filter 2 arranged in the working opening 81a, an outflow pipe 83 for letting out the treated fluid from the filter 2, and a filter housing. An air bleeding pipe 84 in 2b and an air ejection port 85 for ejecting clean air to the filter 2 are provided. In this example, the pipe 84 connected to the filter housing 2b is arranged, but these pipes 82, 83, 84 can be appropriately selected and used according to the type of filter. Also, in this example,
Although these pipes 82, 83, 84 are guided to the outside of the filter booth 8 from the rear wall of the frame portion 81, they may be guided to the outside from appropriate positions such as up, down, left and right.

The air discharge port 85 may be provided at a position where the clean air can be jetted to the filter 2, but in this example, the filter 2 is sandwiched between the work opening 81a and the opposite side (frame portion). It is provided on the rear side of 81). As a result, the clean air discharged from the air discharge port 85 passes around the filter 2 and is discharged to the outside from the working opening 81a. The clean air discharged from the air discharge port 85 may correspond to the cleanliness required for the processing fluid. In this example, the cleanliness of the primary side work space 6 (class 10,000 to 100, 000) Air having a higher degree of cleanliness is discharged. As a configuration for that, a hepa filter 85a, a blower fan 85b, and a pre-filter 85c are arranged on the upstream side of the air outlet 85.

In this example, three filters 2 are provided, but the number of the filters 2 installed can be changed to an appropriate number of one or more. Further, although one air outlet 85 is common to the three filters 2, clean air may be ejected for each filter 2 or for each appropriate number of filters 2.

The discharge (air flow) of clean air from the air discharge port 85 is performed by a person operating the operation switch panel 9, but discharges when the door is opened and discharges when the door is closed. Discharge and stop may be automatically switched according to opening and closing of the door, such as stopping. The operation switch 9 is also provided with a switch for blinking the illumination 86 in the filter booth 8,
Also in this case, the blinking may be automatically switched according to the opening / closing of the door.

A drain pan 87 is arranged below the filter 2. The drain pan 87 receives the processing fluid that has spilled when the filter 2 is replaced, and discharges it to the outside of the filter booth 8. As a result, the filter booth 8
Also, it is possible to prevent the cleanliness of the primary working space 6 in which it is installed from being lowered by the processing fluid.

Next, a method of managing filters in this fluid treatment mechanism will be described. First, the treatment agent is prepared in the preparation tank 1 of the primary side work space 6. In this example,
Since the aseptic filter 2 is passed through, the treating agent is completely dissolved or homogenized by the stirrer. As this agitator, for example, CLEARMIX (trademark) manufactured by the applicant of the present application can be used. The treatment agent prepared in the preparation tank 1 is sent to the filter 2 via the pipe 5,
After being sterilized substantially by passing through a 0.2 μm filter 2, the filling tank 3 of the secondary side working space 7
Is sent to the filling machine 4 and filled in the container.

When the filter 2 is replaced, the door 81b of the filter booth 8 installed in the primary working space 6 is opened to open the working opening 81a. Next, the filter housing 2b is opened, the old filtration unit main body 2a is removed, the filter housing 2b is reassembled, and the stationary cleaning (CIP) operation is performed. After that, the filter housing 2b is opened, and a new filtration unit body 2a is attached,
The filter housing 2b is closed, and finally the door 81b of the filter booth 8 is closed. During the replacement work of the filter 2, the operation switch 9 is operated so that the air discharge port 85
The clean air maintained at a predetermined cleanliness is air-flowed. The clean air is used until the filter housing 2b is closed after the new filtration unit main body 2a is attached to the minimum necessary amount, but may be from the time when the filter housing 2b is opened to the time when the filter housing 2b is closed.
It may be set between the time when the door 81b is opened and the time when it is closed.
That is, the primary side work space 6 is a space having a cleanliness degree lower than the cleanliness degree around the filter required for the replacement work of the filter 2, and at least during the installation work of the new filtration unit body 2a By the flow, the cleanliness is made higher than that in the working space 6 on the primary side.

Thus, when replacing the filter 2,
In particular, during the installation work of the new filtration unit main body 2a, the cleanliness inside the filter housing 2b is maintained by airflowing clean air, and due to particles, falling bacteria, etc., the new filtration unit main body 2a and the outlet side piping 83
Will not be contaminated. The cleanliness of this clean air can be changed according to the sterility required for the treatment agent, but it is appropriate that the cleanliness of the clean air is higher than that of the primary side work space 6. More preferably,
It is suitable that the cleanliness of the secondary work space 7 is set to the same level, and class 100 to 1,000 is suitable.

Next, in the integrity test, the flow of clean air from the air outlet 85 is stopped. As a result, the filter housing 2 by the flow of clean air
The heat exchange on the surface b is prevented, and the filter 2 can be maintained within a predetermined temperature condition (for example, 23 ° C. ± 1 ° C.) required in the integrity test. The flow of clean air may be continued within the range where this temperature condition can be maintained, but the flow of clean air at that time is more than that at the time of filter replacement required to keep the inside of the filter booth 8 at a positive pressure. Keep the temperature conditions of the filter that meet the integrity test of the filter, such as using weak wind force. Further, the air discharge port 85 is provided with a temperature adjusting means such as a heater so that a predetermined temperature condition (for example, 2 degrees Celsius) required in the integrity test is obtained.
The air maintained within the range of 3 degrees ± 1 degree) may be discharged. If the above conditions are satisfied, the operation can be performed without providing the door 81b. That is, the flow of the air may be regulated so that the clean air may hit the filter 2 when the filter is replaced. The entire booth does not have to be hermetically sealed, and a part of the booth is always released for work. It may be.

The filter booth 8 for accommodating the filter 2 can be installed in the primary side work space 6 as described above, or an independent filter installation other than the primary side and secondary side work spaces can be provided. The work space may be arranged in a work space which should be called a work space, but may be arranged in the secondary work space 7 as shown in FIG. The secondary work space 7 is a space having a higher degree of cleanliness than the space around the filter 2, and a new filtration unit body 2a is not contaminated when the filter is replaced.
On the contrary, the secondary working space 7 may be contaminated by the processing liquid that may spill when the filter is replaced. Therefore, a means for receiving the processing liquid such as drain is indispensable, but the air flow from the air discharge port 85 is unnecessary,
The fan 85b is not operated and is stopped or is rotated in reverse to form an exhaust port. Further, in general, the higher the cleanliness of the space, the higher the atmospheric pressure is, so the pressure is higher than that in the closed filter booth 8. Therefore, when the door 8b is opened, the air in the secondary working space 7 flows into the booth through the working opening 81a. Therefore, 2
The filter booth 8 installed in the secondary work space 7 may not be provided with an air discharge port, or the work opening 81a.
It is also possible to provide a discharge passage for the air flowing into the booth from.

However, in the integrity test, if the door is left open, heat in the filter 2 will be exchanged by the air in the secondary side working space 7, and a predetermined amount required in the integrity test will be generated. Temperature conditions (for example, 23 degrees Celsius ± 1 degree)
May not be maintained. Therefore, the door 8b is closed so that the filter is not cooled and the integrity test is performed. In this way, when the filter is arranged on the secondary side with high cleanliness, it is not contaminated by particles or falling bacteria when the filter is replaced,
On the contrary, there is a possibility that the secondary work space is contaminated by the chemicals and the like spilling from the filter. Also, it has a high degree of cleanliness 2.
The secondary space has a relatively low temperature, and there is a high possibility that the temperature condition of the filter integrity test will not be satisfied. Therefore, when the filter booth 8 is arranged in the secondary side work space 7, a drain is provided in the filter booth for discharging the processing fluid spilled at the time of filter replacement to the outside, and the drain is opened at the time of filter replacement to replace the filter. Later, it is necessary to provide the filter booth with a door that shuts off the atmosphere in the secondary work space from the atmosphere in the filter booth.

In the above embodiments, the aseptic pharmaceutical preparation unit has been described as an example, but the present invention is not limited to the above embodiments, and for example, foods, cosmetics,
It can be used in various fields such as chemistry and manufacturing of electronic parts such as semiconductors. The cleanliness of the primary and secondary work spaces (clean rooms) can be changed to a cleanliness according to the field of use. The treatment agent that passes through the filter may be a gas as well as a liquid,
If a filter can be used, it can be appropriately changed and implemented. The size of the filter particles such as the filter mesh,
It can be implemented by changing it according to the field of use.

[0027]

According to the invention of the present application, it is possible to prevent the filter and the outlet side pipe from the filter from being contaminated by the environment of the working space in which the filter is installed, such as particles and falling bacteria, when the filter is replaced. In addition, it is possible to provide a fluid treatment mechanism that does not adversely affect the integrity test of the filter, a filter booth used in the fluid treatment mechanism, and a filter management method.

[Brief description of drawings]

FIG. 1 is a front view of a filter booth according to an embodiment of the present invention.

FIG. 2 is a sectional view of a filter booth according to an embodiment of the present invention.

FIG. 3 is a schematic diagram of a fluid treatment mechanism according to an embodiment of the present invention.

FIG. 4 is a schematic diagram of a filter of the fluid treatment mechanism according to the embodiment of the present invention.

FIG. 5 is a schematic diagram of a fluid treatment mechanism according to another embodiment of the present invention.

FIG. 6 is a schematic diagram showing a conventional aseptic preparation unit.

[Explanation of symbols]

2 filters 2a Filter unit body 2b filter housing 5 piping 6 Primary side work space 7 Secondary side work space 8 filter booth 82 plumbing 83 plumbing 85 Air outlet

Claims (3)

(57) [Claims] 1. A filter (2) requiring integrity testing.
A working space (6) in which a device for treating the fluid before passing through the filter is arranged, and a device for treating the fluid after passing through the filter (2). A filter (2) in a fluid treatment mechanism comprising a coordinated secondary work space (7), wherein the secondary work space (7) is kept at a higher degree of cleanliness than the primary work space (6). The filter (2) is arranged in a filter booth (8) that forms a space for housing the filter, and the space around the filter (2) in the filter booth (8) is replaced when the filter (2) is replaced. The fluid treatment mechanism is characterized in that the filter (2) is maintained at a predetermined cleanliness level capable of preventing contamination of the filter (2) and that the temperature condition of the filter (2) conforming to the test is maintained during the integrity test of the filter (2). 2. A filter arrangement for accommodating a filter (2) for which an integrity test is required, wherein the filter body (2a) is partitioned and sealed in a filter housing (2b). Installation part, piping (82, 83) for leading in and out the processing fluid to and from this filter (2), and filter (2)
To the filter (2) when the filter housing (2b) is opened to replace the filter body (2a) inside. A filter booth that can be ejected. 3. A method of managing a filter (2), wherein a filter body (2a) is replaceably sealed in a filter housing (2b), wherein the filter (2) is installed in a filter booth (8). When replacing the filtration unit body (2a), at least
Clean air flows to the filter (2) between the time when the new filter unit body (2a) is attached and the time when the filter housing (2b) is closed. A method of managing a filter, characterized in that the flow of air is stopped or the flow of clean air is stopped within a range in which the temperature condition of the filter (2) that conforms to the same test is maintained.