JP3363453B2 - Filter package forming method and filter package - Google Patents

Description

TECHNICAL FIELD The present invention relates to a filter package including a filter immersed in a liquid, and a method of forming such a filter package. The invention is particularly concerned with the contents being sanitized, preferably sterilized (steri).
lized) filter package.

BACKGROUND ART Filters are generally stored and shipped wet, that is, immersed in a suitable liquid in a package. There are several reasons to package a filter this way. Some filters are not readily wettable by the liquid they are trying to filter, and therefore such filters typically
Prewetted with another liquid with low surface tension
d) and prepare the filter for filtration. As a user service, some filter manufacturers perform pre-wetting at the factory where the filters are manufactured. To prevent the pre-wetted filter from drying out during storage or shipping, the filter is packaged in a sealed bag containing a suitable liquid that keeps the filter wet until it is about to be used.

Other types of filters, such as ultrafiltration and reverse osmosis membranes, are not "pre-wet" by the manufacturer, but nonetheless, they are permselective propellers.
erties) in order to maintain their erties) and are transported to the user in a wet condition. Such filters are typically stored and shipped in packages containing a humectant such as glycerin which keeps the filter wet.

Another reason for packaging the filter in a wet state is that it is easier to keep the filter clean than when packaging the filter in a dry state. Therefore, even filters that do not need to be pre-moistened or kept moist to maintain the filtration properties of the filter may be packaged moist for cleanliness reasons.

Hydrogen peroxide or other bactericides are typically added to the liquid in the package to provide a suitable shelf-life to the filter package, including wet filters, and are purchased from the time of manufacture. Prevent the growth of bacteria until a person opens the package.

Even with relatively small amounts of bactericide (typically around 3% for hydrogen peroxide), bactericide is an undesirable contaminant in some applications, especially in semiconductor manufacturing. Therefore, it has a long shelf life and contains substantially no contaminants.
s), there is a need for a filter package containing a wet filter.

DISCLOSURE OF THE INVENTION An object of the present invention is to provide a filter package that includes a filter and a noncontaminating liquid that is substantially free of contaminants and that has a long shelf life without using a bactericide. .

Another object of the present invention is to provide a method of manufacturing such a filter package.

The filter package according to the present invention comprises a container, a filter enclosed in the container, and a non-contaminating liquid placed in the container and immersing the filter. The non-polluting liquid is preferably substantially free of substances that are regarded as contaminants for the filter, such as germicides. For example, the contaminant level for non-contaminated liquids is at most ppb (parts p
er billion) range is preferred. In a suitable embodiment, the non-polluted liquid has an initial resistivity of at least 18 MΩ.
-Cm of deionized water.

The rigidity of the container can be any desired degree. In one form of the invention, the container comprises a thin wall flexible bag. The bag may include a venting mechanism to allow vapor to escape from the bag when heated. In another form of the invention, the container comprises a rigid container such as a filter housing.

The filter in the container is only wetted by water, i.e. its surface is in contact with water, or the filter is wetted by water, i.e. its pores substantially contain the water in the container. May be infiltrated into.

The filter package manufacturing method according to the present invention includes disposing the filter and the liquid in the container in a state where the filter is immersed in the liquid. The liquid and filter are
It is then sterilized and preferably sterilized while in the container. If necessary, the container should be hermetically sealed (he
rmetically sealed).

The contents of the filter package of the present invention are at least sanitized, i.e. non-spore produci
ng) of all or almost all of the microorganisms have been killed, but it is preferred that the contents of the package be completely sterile. As used herein, "sterilization" is included within the scope of the term "disinfection". Therefore, the disinfectant filter package according to the present invention may be completely sterilized,
Further, it may be sterilized without being completely sterilized.

Disinfection can be done without damaging or degrading the filter or container. In a suitable aspect,
The sterilization is performed by heating the liquid in the container and the filter. When heat disinfection occurs, the container may be degassed during disinfection, allowing liquid vapors to escape from the container and prevent build-up that can damage the container.

The filter package according to the present invention is not limited to a filter package having a particular type of filter. For example, the filter may be hydrophilic or hydrophobic, and the filter may be a filter that filters gases, liquids, slurries or mixtures of more than one phase. The mechanism by which the filtration is done is not important. Examples of various types of filters that can be used in the present invention include particulate filters, particularly those used in the semiconductor industry, coalescers, ultrafiltration and reverse osmosis membranes.

If desired, the filter may be pre-wetted before being dipped in the liquid in the container so that it is completely wetted by the liquid to be dipped.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic elevation view of a filter package according to the present invention before disinfection.

2 is a schematic front view of the filter package of FIG. 1 after being hermetically sealed.

FIG. 3 is a partial cross-sectional view of the degassing mechanism of the aspect of FIG.

FIG. 4 is a schematic front view of a filter package in which the gas venting mechanism is formed of a semipermeable membrane.

FIG. 5 is a schematic plan view of an assembly including a plurality of filter packages connected to a common vent filter.

6 and 7 are side views of different types of vent filters that can be used with the present invention.

FIG. 8 shows a filter package according to the present invention (fo
1 is a sectional front view of a filter assembly capable of being rmed into).

FIG. 9 is a partial cross-sectional view illustrating the use of a flexible tube to connect the filter assembly to the degassing filter.

FIG. 10 is a partial cross-sectional view illustrating a method of venting a filter housing both upstream and downstream of a filter element.

FIG. 11 is a partial cross-sectional exploded view of a portion of a filter assembly having a filter membrane mounted directly on the fluid port of the filter assembly.

12 is a partial cross-sectional view of the outlet of the filter assembly of FIG. 11 as it appears during disinfection.

BEST MODE FOR CARRYING OUT THE INVENTION FIGS. 1 and 2 schematically explain a method for manufacturing a filter package according to the present invention. The filter 10 and the non-polluting liquid 30 are placed in a container such as the bag 20, and the filter 10 is immersed in the non-polluting liquid 30. After closing the bag 20 to prevent liquids or microorganisms from entering the bag, the filter 10 and uncontaminated liquid 30 are sterilized and preferably sterilized in the bag 20. The bag 20 is then preferably hermetically sealed to obtain a complete filter package, as shown in FIG.

Prior to being placed in the bag 20, the filter 10 may be pre-wetted to be readily wetted by the fluid used and ready for user use. Alternatively, the filter 10 may be packaged without pre-wetting, depending on the characteristics of the filter 10, the end use of the filter and the requirements of the purchaser. However, if it is important to clean the filter 10 to a high degree, and if the dry filter 10 cannot be easily wetted by the non-contaminating liquid 30, the non-contaminating liquid 30 will easily penetrate the pores of the filter 10. It is preferable to pre-wet the filter 10 so that it is possible.

The filter 10 may be pre-wetted using any known method suitable for the type of filter 10. For example, the standard pre-wetting method recommended by the manufacturer of the filter 10 is suitable. A general method of pre-wetting is to immerse the entire filter 10 in a container containing a pre-wetting liquid having a low surface tension such as isopropyl alcohol or methyl alcohol, and allow the pre-wetting liquid to permeate the filter medium. is there. To remove any particulate contaminants from the prewetting liquid, it is preferable to filter the prewetting liquid prior to use. If the pre-wetting liquid becomes a contaminant in the fluid system in which the filter 10 is to be used, then the pre-wetting liquid may be filtered using a suitable non-contaminating liquid such as deionized water.
It is preferred to flush out. Cleaning of the filter 10 with a non-polluting liquid can be done using conventional methods. After the filter 10 has been pre-wetted and optionally washed, it is placed in the bag 20 before it has the potential to dry.

The bag 20 or other container in which the filter 10 is packaged is not limited to a particular type and can be either a rigid container or a flexible container. It has a filter 10,
And any size and shape such that the filter 10 can completely enclose the non-contaminating liquid 30 in which it is immersed. If the filter 10 is sufficiently durable to withstand the forces it may be subjected to during storage and shipping, the flexible, thin-walled bag 20 will be inexpensive to manufacture and easy to seal and handle. Therefore, it is particularly suitable as a container.

The bag 20 is impermeable to non-contaminating liquids 30 and microorganisms, and meets the conditions that occur during disinfection without decomposing or releasing contaminants into the non-contaminating liquids 30. It can be formed of a material that can withstand. In addition, bag 20 contains non-contaminating liquid 30
It is preferably impermeable to vapors of other gases and to liquids that bag 20 may come into contact with during storage or shipping. High temperature thermoplastic fluoropolymers are particularly suitable for use as a bag material because they are strong and lightweight, easy to seal, and resistant to sterilization temperatures. Examples of suitable materials for the bag 20 when the non-polluting liquid 30 is water include PFA (perfluoroalkoxy), FEP
(Fluorinated ethylene propylene), PVDF (polyvinylidene fluoride) and ECTFE (ethylene chlorotrifluoroethylene). Also, non-polymerizable materials such as metal foils may be used, such as a combination of one or more materials such as aluminum foil and laminates of Mylar films.

For example, when performing sterilization using heating, nuclear irradiation, ozone, or ultrasonic waves, the bag 20
Need not be transparent to light. However,
It is easier to seal the bag 20 if the bag 20 is made of a transparent or translucent material and the level of the filter 10 and the non-contaminating liquid 30 is visible to the person making the seal.

The type of non-contaminating liquid 30 placed in bag 20 and its purity can be selected according to the characteristics of filter 10 and the fluid system in which filter 10 is used. A suitable non-polluting liquid is ultra high purity deionized water having an initial resistivity of at least 18 MΩ-cm, more preferably at least 18.1 MΩ-cm. The initial resistivity of deionized water is the resistivity when placed in bag 20 prior to use. Because of the presence of air, material inside the filter 10, or bag 20 where it may come into contact with the deionized water during filter package assembly, the resistivity of the deionized water is After being placed, it drops somewhat from the initial resistivity. However, the level of contaminants in the deionized water in bag 20 during disinfection is at most ppb (parts per part).
billion) range is preferred. For this reason, during disinfection, the bag 20 is basically a filter 10, a non-contaminating liquid.
It is preferred to include only 30 and any air or other gas that may be present on the surface of the non-polluting liquid 30. bag
There is no fungicide in 20. When the non-polluting liquid 30 is introduced into the bag 20, the filter 10 and the bag 20 prevent the gas in the air from dissolving in the non-polluting liquid 30.
It may be placed in an atmosphere of a gas having a low solubility in 30. For example, when the non-polluting liquid 30 is deionized water, the non-polluting liquid 30 may be introduced into the bag 20 in a nitrogen gas atmosphere to prevent CO _{2 in} the air from dissolving in the non-polluting liquid 30. . However, in general, the gases present in normal clean air are not contaminants to the filter 10,
It is typically not necessary to prevent them from coming into contact with the non-contaminating liquid 30.

The filter 10 may be of any type and shape that can be sterilized. For example, filter 10 is pleated (plea
ted) filter media or non-pleated filter media, and conventional equipment, eg, filter 10
May include a sealing member (such as an O-ring) for connecting to the fluid system, a perforated core, an outer cage, one or more end caps, and the like. The filter 10 may be in the form of a cartridge intended to be installed in the housing. Alternatively, it may be pre-installed within the housing as long as the housing does not prevent pre-wetting and disinfection. For example, the filter 10 may be placed in a housing having an opening through which the pre-wetting liquid and then the non-contaminating liquid 30 is introduced and in thorough contact with the filter 10.

If the filter 10 is used within a short time after packaging (eg, during the same day), it is sufficient to subject the contents of the bag 20 to a higher degree of disinfection rather than sterilization. However, in order to maximize the shelf life of the filter package, it is preferable to subject the entire contents of bag 20 (including filter 10 and non-contaminating liquid 30) to sterilization.

Any known disinfection method may be used that does not introduce contaminants into the bag 20 or damage the filter 10 or the bag 20, such as nuclear radiation, ultraviolet light, ozone, heating, or ultrasound. . It is preferable to heat the non-contaminating liquid 30 to the sterilization temperature for sterilization because it is simple, reliable, and inexpensive. There are various heating methods, for example, bag 20 is autoclaved, microwaved,
It may be done in an oven, a pressure cooker, or placed in a container of boiling water or other liquid at sterilization temperature. During disinfection, filter 10 to prevent the pores of filter 10 from drying out during the disinfection process.
It is preferable to immerse 10 in the non-contaminating liquid 30 in the bag 20 before and after disinfection. Most of it (at least 50 of its volume
%) Is more preferable. Most preferably, the entire filter 10 is immersed in the non-contaminating liquid 30. If the filter 10 is not buoyant to the non-contaminating liquid 30, the bag
Simply fill 20 with a sufficient amount of non-contaminating liquid 30 and filter 10
Can be completely immersed. If the filter 10 floats in the non-polluting liquid 30, so that the filter 10 is completely submerged, for example to prevent the filter 10 from floating on the surface,
Holding the filter 10 below the surface of the non-contaminating liquid 30, such as by pinching the bag 20 from the outside, using clamps located below the surface of the non-contaminating liquid 30 and above the top of the filter 10. Preferably. During disinfection, it is preferable to take care that the bag 20 does not come into contact with any material at a temperature that causes thermal deformation of the bag 20 or the filter 10. Also, care should be taken not to boil and dry the interior of bag 20. The disinfection conditions, such as heating temperature and length of time the heating is performed, may be standard conditions. An example of suitable conventional sterilization conditions in an autoclave is about 1 at 15 psi gauge pressure.
There is an hour at a temperature of 20 ° C. To reduce the risk of contamination, disinfection is preferably carried out in a clean room.

If the filter 10 is of the type having a blind end cap and an open end cap, then open above the blind end cap so that air escapes from the center of the filter 10 through the open end cap and is replaced by non-contaminating liquid 30. Filter 10 in bag 20 so that end caps are placed
Is preferably arranged.

In some cases, heating the filter 10 during disinfection
Extractable non-contaminating liquid from filter 10 30
Leaching can occur. To reduce the amount of leaching, the filter 10 is hot deionized water (preferably about 160-200 ° F, preferably 165 ° F = about 74 ° C) before being inserted into the bag 20 so that the extract is leached prior to disinfection. ℃
It may be pretreated by immersing in.

The upper end of the bag 20 is preferably closed during and after disinfection to prevent contaminants from entering the bag 20. Any suitable method that does not introduce contaminants, eg
The upper end can also be closed by heat sealing. However, even though the bag 20 is preferably closed, the overall hermetically seam during disinfection.
It is preferably closed in such a way that the vapor and air of the non-polluting liquid 30 can leave the bag 20 while preventing dust, microbes and other contaminants from entering. When the disinfection is performed by heating, the pressure in the bag 20 may increase due to the vapor pressure of the non-contaminating liquid 30, the boiling of the non-contaminating liquid 30, and / or the gas in the non-contaminating liquid 30 coming out of the solution. Ah If the bag 20 is hermetically sealed during disinfection, for example, to make the wall of the bag 20 thick enough to withstand internal pressure without damage, or to reduce the expansion of the bag 20 when heated, an autoclave. It is preferable to carry out steps to ensure that the rising pressure in the bag 20 does not burst the bag 20 or damage the bag 20, such as by pressurizing the inside of the bag with air. However, thickening the wall of the bag 20 increases cost and makes the bag 20 unwieldy, while autoclave pressurization reduces heating efficiency in the autoclave. Therefore, a suitable method of preventing damage to the bag 20 due to increased internal pressure is
The bag 20 is provided with a degassing mechanism 40 that allows the vapor and other gases of the non-contaminating liquid 30 generated during heating that may cause the bag 20 to deform or burst.

The degassing mechanism 40 is any position (lo) that allows vapor of the non-contaminating liquid 30 or other gas to escape from the bag 20.
cation) can be installed on the bag 20. There is a degassing mechanism 40 on top of the bag 20 where air and other gases collect during heat disinfection.
It is preferable to arrange the bag 20. Degassing mechanism 40
Bags of 30 non-contaminated liquid vapors and other gases during disinfection
It can be configured in any way that allows the emission from 20. FIG. 3 shows an example of the degassing mechanism 40 in detail. It has a vent hole 41 formed in the wall of the bag 20.
And a hollow gas vent tube 42 that penetrates the gas vent hole 41 and connects the inside and the outside of the bag 20. The vent tube 42 may be omitted, but it provides a convenient way to connect the vent hole 41 to external hardware. The degassing tube 42 is fixed to the bag 20 by a nut 44 arranged inside the bag 20 that is screwed to an “external thread” formed on the inner end of the degassing tube 42. The nut 43 is integrally on the outer end of the vent tube 42 on the outside of the bag 20.
Has been formed. A sealing member such as an elastic (O) ring 45 is provided near the outer periphery of the gas vent hole 41 between the wall of the bag 20 and one of the nuts 43 and 44 to hermetically seal the periphery of the gas vent hole 41. Is arranged around the degassing tube 42 of FIG. The O-ring 45 is in sealing contact with the bag 20 by tightening the nuts 43, 44 (into
sealing contact) Pressed. The O-ring 45 may be located either inside or outside the bag 20, but is preferably outside the bag 20 because the O-ring 45 may introduce contaminants.

The vent tube 42 and the nuts 43 and 44 are made of any corrosive material that can withstand the temperatures encountered during disinfection.
It can also be formed from ion resistant materials.
Examples of suitable materials include polymers such as FEP, PFA, PVDF and ECTFE, and metals such as stainless steel.

The degassing tube 42 is sealably attached to the bag 20 using a wide variety of other methods, such as the use of bulkhead fittings, for example. Furthermore,
The vent tube 42 may be permanently joined to the bag 20 by methods such as welding. However, it is often advantageous for the vent tube 42 to be removable from the bag 20 so that the vent tube 42 can be reused with another bag.

Another possible type of degassing mechanism is a semipermeable membrane sheet that is permeable to water vapor but impermeable to liquid water and microorganisms, such as PTFE (polyester) that forms the cross section of bag 20. Tetrafluoroethylene) film, etc. FIG. 4 shows that the degassing mechanism consisting of the PTFE semipermeable membrane 47 forms the wall cross section of the bag 20, and the remaining part of the bag 20 is PFA.
Is shown. The semipermeable membrane 47 is on the top of the bag 20,
It is arranged at substantially the same position as the degassing mechanism 40 of FIG. The disinfection is performed using this bag 20 in the same manner as in the case of the bag 20 shown in FIG.

Alternatively, a semipermeable membrane that is permeable to water vapor but impermeable to liquid water or microorganisms, such as PTFE.
The entire bag 20 may be formed of a membrane or the like, and in this case, a separate degassing mechanism is unnecessary. However, since water vapor may pass through the bag 20 during storage and condense on the outside of the bag 20, which may make the bag 20 unwieldy, it is preferable to use a material that is permeable to water vapor. The degree of taste is low. In addition, over time, all non-contaminating liquids are pervaporated from bag 20 and filter 1
0 remains completely dry.

By providing the degassing mechanism 40, the wall of the bag 20 can be made very thin, as little internal pressure is applied to the wall of the bag 20 during disinfection. For example, a PFA with a wall thickness of 0.002 to 0.030 inches, for example, a 0.005 inch PFA bag,
It has been found to work well in an autoclave for sterilization at a gauge pressure of 15 psi. It is advantageous to reduce the wall thickness of the bag 20 in order to reduce material costs and facilitate the sealing of the bag 20.

Prevent microbes and other contaminants from entering the bag 20 through the vent holes 41 during or after disinfection, thus preventing permeation of bacteria or other microorganisms therethrough during or after disinfection. Gas vent filter 46
Airtightly connect to the degassing tube 42 to
It is preferable to force all air that enters the degassing tube 42 from the outside of the chamber through the degassing filter 46. As used herein, the term "venting filter" means any type of filter that allows the passage of non-contaminating liquid vapors, and the venting filter does not have to be a filter used exclusively for venting. Preferably, the vent filter 46 allows the passage of air. One example of a suitable venting filter 46 is a sterilizing grade filter used for air filtration. Sterile grade filters or filter media typically have a removal rating of 0.2 μm. Depending on the environment in which the bag 20 is placed after sterilization, a degassing filter may not be necessary or different removal grade filters may be used, i.e. non-sterile grade filters. If the non-polluting liquid 30 in the bag 20 is water, the degassing filter 46 is hydrophobic, i.e., hydrophobic so that it does not become wet during disinfection, as wetting can interfere with gas flow through the degassing filter 46. , The critical wetting surface tension is about
A filter of less than 50 dynes / cm is preferred. In addition, if the non-polluting liquid 30 is water, even if the bag 20 is turned upside down, the hydrophobic degassing filter 46 prevents the non-polluting liquid 30 from leaking from the bag 20 and facilitates storage of the bag 20. And However, a hydrophilic degassing filter can be used if it can prevent the degassing filter 46 from getting wet during disinfection. Vent filter 46
Can have any shape and can be pleated or non-pleated. An example of a suitable venting filter is Pa
It is a DFA4001FRP filter assembly manufactured by LL. The filter has a dual-layer filter media made of PTFE, an inner core and end caps made of polypropylene and has a critical wet surface tension of less than 30 dynes / cm.
Such filters, when unwetted, are impermeable to liquid water but have a surface tension of 30 dynes / cm.
It is permeable to less than liquids. Vent filter 46
Can be installed in any manner that provides a seal that prevents microorganisms from bypassing the vent filter 46, which may be permanently bonded to the bag 20 or releasably bonded. However, it is better to attach them detachably.
This is preferable because the degassing filter 46 can be reused. For example, as shown in FIG. 3, the degassing filter 46 and the degassing tube 42 can be connected by a screw connection.

The non-polluting liquid 30 can be introduced into the bag 20 in any desired manner. For example, the non-contaminating liquid 30 can be introduced through its open end prior to closing the bag 20 and can also be uncontaminated after the bag 20 is closed and before the vent filter 46 is attached to the vent tube 42. The liquid 30 can be introduced through the gas vent tube 42 of the gas vent mechanism.

The bag 20 is preferably hermetically sealed after the contents of the bag 20 have been sterilized. The hydrophobic degassing filter not only prevents water and microorganisms from entering the bag 20, but also prevents leakage from the bag 20, so it is not essential to hermetically seal the bag 20.
The hermetic seal allows the degassing mechanism 40 to be removed from the bag 20, facilitating handling of the bag 20.
Prior to sealing, it is preferable to cool the bag 20 to a manageable temperature. During cooling, the vent filter 46 prevents microorganisms and other contaminants from entering the bag 20 and keeps the contents of the bag 20 sterile. Any known method of hermetically sealing the bag 20 can be used. bag
Heat sealing is particularly suitable when 20 is composed of a polymeric material. Other methods such as ultrasonic sealing and vibration welding can also be used. The bag 20 may be sealed at any desired position, for example, below the surface of the non-contaminating liquid 30,
It is also possible to exclude all air from the inside of the bag 20. It is preferable that the bag 20 does not contain any air on the liquid surface of the non-contaminating liquid 30 after sealing, but the air in the bag 20 is sterilized and 100% relative humidity.
The air that is left inside does not contaminate or dry the filter 10, so even if air remains, it is harmful (detrimenta
l) not. After sealing the bag 20, the degassing mechanism 40
The upper portion of the bag 20 including the can be removed from the lower portion of the bag 20 and collected for reuse. When it is not necessary to reuse the degassing mechanism 40, the degassing mechanism 40 may be left attached to the bag 20, but in this case, the water vapor passing through the degassing mechanism 40 is condensed on the outer surface of the bag 20 during storage. It is preferable to disable that "venting" as it may create a pool of water around bag 20. In the embodiment shown in FIG. 1, a seal is formed around the gas vent hole 41 by heat sealing or the like.
By separating 41 from the inside of bag 20, degassing mechanism 40 can be disabled.

It is preferred to simultaneously disinfect multiple filters 10 individually contained in bags 20 or other containers. Instead of providing each of the plurality of bags 20 with its own vent filter, as shown schematically in FIG.
20 gas vent tubes 42 to manifold 51 and hose
By means of 52, one gas vent filter 50 can be connected.
The vent filter 50 is selected to be large enough to provide air filtration for all bags 20. The entire assembly of bags 20 and degassing filter 50 can be placed in an autoclave at one time as a batch for disinfecting filter 10.

Alternatively, the plurality of filters 10 are
The 10 may be placed in a single bag 20 as shown in FIG. 1 so that they can be disinfected simultaneously.

6 and 7 show that the bag 20 passes through it during disinfection.
Another example of a gas venting filter capable of venting the gas is shown. The degassing filter 60 shown in FIG. 6 includes a commercially available filter holder and a filter medium 64 disposed inside the filter holder.
Including sheets and. The filter holder generally has a cylindrical housing that includes a base 61 and a cover 62 between which a filter media 64 can be placed. Base 61 and cover 62
Enclose the cover 62 and are sealed to each other by a nut 63 attached to an “male screw” formed on the base 61. One or both of base 61 and cover 62 may include a perforated support plate that supports filter media 64. The filter holder is usually purchased without the filter media 64, which is installed by the user. When the filter holder is assembled, the first fluid port 61a and the second fluid port 62a communicating with opposite sides of the filter medium 64 extend from the base 61 and the cover 62, respectively. The base 61 is partially cut away in the figure to show the first fluid port 61a. This and other types of filter holders that allow the filter media to be installed and replaced by the user are available from a variety of sources, such as Cole-Parmer instrument, Inc. (Niles, IL). The filter material 64 supported by the filter holder may have any desired characteristics. Suitable filter media used in the present invention 64
One example is a hydrophobic, sterile grade membrane filter medium made of PTFE.

The bag 20 of this embodiment has a center hole 65 extending in the length direction thereof.
It comprises a hollow vent tube 65 with a. A hollow annular flange 66 having an outer diameter larger than that of the gas vent tube 65 is formed at the inner end of the gas vent tube 65.
The vent tube 65 extends through a hole in the wall of the bag 20 and places a flange 66 inside the bag 20. Sealing members such as the O-ring 67, the washer 68, and the nut 69 are used for the bag 20.
Is attached to the degassing tube 65 outside the. The nut 69 is threadingly engaged with an "male thread" formed on the degassing tube 65. Nut 6
When 9 is tightened, washer 68 is urged towards flange 66, resulting in compression of bag 20 between O-ring 67 and flange 66, which causes O-ring 67 to close to bag 20.
Is pressed into sealing contact with and forms a seal around the hole in bag 20. The O-ring 67 is, for example, a washer 68.
May be away from the washer, or washer with adhesive etc.
May be glued to 68. The degassing tube 65 is connected to the fluid port 61a of the filter holder by any suitable method.
Fluidly connect to either
ed). For example, the inner hole 65a of the gas vent tube 65 may be formed by a "female screw" that meshes with a male screw formed in the fluid port. Alternatively, the vent tube 65 and one of the fluid ports of the vent filter 60 can be connected by a hollow connector such as a pipe or flexible tube.

Venting filters, including filter holders that can be assembled and disassembled by the user, have a number of useful attributes.
s). Filter holders are available in a variety of sizes, allowing the user to select a filter holder that can support a filter medium with a surface area suitable for the application. The filter medium is easily installed by the user in the filter holder, so that the filter holder can be reused.
The filter medium can be discarded or replaced when needed, and the filter holder can be used economically. In addition, the user has a great deal of freedom in selecting the filter media for use with the filter holder.

The vent filter 70 shown in FIG. 7 includes a commercially available disposable filter unit-called a syringe filter because the filter unit is suitable for mounting on a medical syringe. It includes a filter medium (not shown) sealed within a plastic housing having a first fluid port 71 and a second fluid port 72 that communicate with opposite sides of the filter medium. Syringe filters are available with a variety of filter media. One example of a suitable filter material for a syringe filter used for venting a filter package according to the present invention is a hydrophobic sterile grade membrane filter material. Syringe filters typically include in their housing a perforated support plate on one or both sides of the filter media. The degassing filter 70 may be connected to the bag 20 by any suitable method, for example, a degassing tube 65 as shown in FIG. Syringe filters are available with a variety of fittings, and the structure of the vent tube 65 and the type of vent filter 70 can be selected so that both can be connected directly to each other. In FIG. 7, the first fluid port 71 of the degassing filter 70 is provided with an “external thread”, which is attached to the “external thread” formed on the outer end of the degassing tube 65.
Alternatively, the degassing filter 70 may include a degassing tube, such as by a flexible hose or connecting tube.
It may be indirectly connected to 65.

When disinfection is complete, degas filters 60 and 70 should be in bag 20.
Can be left on, or after bag 20 is sealed,
It may be removed as shown in FIG.

If the degassing mechanism is a semipermeable membrane and the membrane 47 is impermeable to microorganisms, as in the embodiment of FIG. 4, then no degassing filter is required.

When the filter is heated in a chamber such as an autoclave or an oven for sterilization, the degassing mechanism may degas either inside or outside the chamber. In general, it is easier to vent gas inside the chamber, i.e. when the vent mechanism is located inside the chamber with the filter.
In this case, it is preferable that the degassing mechanism be made of a material that can withstand the state of the inside of the chamber during disinfection.

As mentioned above, the container of the filter package according to the present invention may be a rigid container. The sterilization of the filter in the rigid container such as the filter housing can be performed in substantially the same manner as the sterilization of the filter in the flexible container such as the flexible bag. A rigid container is a substantially constant shape and size even if it is not supported, in contrast to a flexible container such as a flexible bag that is easily deformed and crushed by its own weight unless it is supported from inside or outside. To maintain. The rigid container of the filter package according to the present invention may be formed of any desired material such as metal or polymeric material. The filter to be sterilized in a rigid container may be pre-wetted prior to being sterilized and may be pre-treated in hot deionized water to leach the extract. The pre-wetting and pre-treatment may be done either before or after the filter is placed in the container. However, if the container is a filter housing, it is usually easier to place the filter within the housing to form the filter assembly prior to pre-wetting and pretreatment. Pre-wetting and pre-treatment can be done by dipping the filter assembly in a suitable liquid or by flushing the liquid through the filter housing. After pre-wetting and pre-treatment of the filter,
If so, the filter housing or other rigid container containing the filter is filled with a non-contaminating liquid, such as ultrapure deionized water, and the filter is immersed. The rigid container and filter are then sterilized by any suitable method, including, for example, any of the methods described above for use in sterilizing a filter in a flexible bag, such as sterilization by heating in an autoclave. .

When a filter in a rigid container, such as a filter housing, is sterilized by heating, the container may be sealed or vented. Therefore, if the wall of the container is strong enough to withstand the internal pressure created in the container during heating of the non-contaminated liquid, close all fluid ports or other openings in the container to completely seal the container during heating. You may stop. If the container has a relatively thin wall, the internal pressure of which when heated may damage the thin wall,
It may be vented by a suitable venting mechanism. Degassing may occur at any suitable location on the container.
When the container is a filter housing, the container typically comprises a plurality of fluid ports, such as an inlet, an outlet or an air vent, the housing being provided with gas through one or more of these fluid ports or upon heating. It can be vented through another opening that is specifically intended for venting. Fluid ports or other openings that are not used for degassing, when heated, use conventional closures (pipe plugs, pipe plugs,
It can be closed with a pipe cap, tube cover, etc.). To prevent contaminants from entering the container through the fluid port during heating or when heating is complete and the container is cooling, a vent filter, e.g., FIGS.
One of the degassing filters used in the embodiment of FIG. 7 may be connected to the degassing fluid port. As with the embodiments (embodiments) described above, the degassing filter preferably has a sterilizing grade filter material, and if desired,
The filter material may be hydrophobic to prevent leakage of non-contaminating liquid from the container via the fluid port to which the vent filter is connected.

To remove all free air from the container when heating,
It is preferable that the container is filled with the non-contaminating liquid as much as possible. It may be beneficial to agitate the container or to introduce the non-polluting liquid from one or more ends of the container to help free air escape to the outside of the container during the introduction of the non-polluting liquid. Alternatively, the fluid port may be suctioned at one end of the container and the non-contaminating liquid may be introduced through the fluid port at the other end of the container. Most of the filters (at least 50 by volume)
%), And most preferably the entire filter is dipped in a non-contaminating liquid at the beginning of disinfection.

When disinfecting a filter in a vented rigid container, eg, a filter housing having a vent, the level of non-contaminating liquid in the container is usually reduced by vaporization of the non-contaminating liquid. When the container is cooled after being heated, air can enter the container through the degassing filter and form an air pocket at the top of the container above the level of non-contaminating liquid. However, the air after passing the degassing filter has no fine inclusions, 100% relative humidity, which does not contaminate or dry the filter,
It is not inconvenient for some air to remain in the housing after cooling, as in the case where the container is a flexible bag. Preferably at least 50% of the filter is soaked, more preferably at least 90% of the filter is soaked, and even more preferably the container is in any attitude.
e) so that substantially 100% of the filter is immersed,
It is preferred that a sufficient amount of uncontaminated liquid remains in the container upon completion of cooling.

The degassing filter may be shipped to the user along with the filter package while still attached to the container upon completion of disinfection. Alternatively, the gas vent filter may be removed and replaced with a closure to hermetically seal the container and the gas vent filter may be reused. When removing the degassing filter, the removal is preferably done in such a way that contaminants do not enter the container. If the degassing filter is a hydrophobic filter and remains attached to the container, the hydrophobic filter can prevent non-contaminating liquids from leaking out of the container, so It is possible but not required to close the mouth.

FIG. 8 illustrates one aspect of a filter package according to the present invention in which the rigid container containing the filter 80 during disinfection is the filter housing. The illustrated filter package consists of a disposable filter assembly available from Pall under the DFA trademark. The assembly includes a housing 90, which includes a first fluid port 91, a second fluid port 92, and manual vents 93 and 94 that can be used to vent gas or liquid from the housing 90.
A filter 80 disposed inside the housing 90 includes a pleated filter element 81 surrounding a hollow perforated core 82, a blind end cap 83 sealed to one end of the filter element 81, the other end of the filter element 81 and a second end. And an open end cap 84 sealed to the fluid port 92 of the. It may include a perforated cage (not shown) surrounding the filter element 81. The illustrated filter 80 is intended primarily for radially inward flow,
Therefore, the first fluid port 91 usually functions as an inflow port, and the second fluid port 92 usually functions as an outflow port. However, the functions of these two fluid ports may be reversed.
Filter 80 and housing 90 may be formed of any material that is able to withstand the conditions (such as temperature) that it is exposed to during disinfection. For example, the filter element 81 of the illustrated filter 80 comprises PTFE filter media and the core 82, end caps 83, 84 and housing 90 are formed from polypropylene. Such a filter assembly can be sterilized by heating in an autoclave.

During heat disinfection in the autoclave and subsequent cooling, the housing 90 allows the vapor generated by heating to escape to the outside of the housing 90 while preventing microorganisms or other contaminants from entering the housing 90. For this purpose, it is preferably connected to a hydrophobic sterile grade degassing filter. The degassing filter can be connected to either one or more fluid ports in the housing 90. In the illustrated filter assembly, the housing 90 is preferably vented from at least the fluid port connected to the open end cap 84. Allows vapors and other gases of the non-polluting liquid 30 generated within the core 82 of the filter 80 to flow upwards and out of the filter 80 through the open end cap 84 and not be trapped inside the core 82. As such, it is preferably positioned higher than the blind end cap 83 during disinfection. The non-degassed fluid port can be opened by a stopper, cap or other suitable closure.
It may be sealed off during disinfection.

The degassing filter 70 of the present embodiment is a commercially available syringe filter similar to that shown in FIG. 7, but any other type of degassing filter, such as another type as shown in FIG. 3 or FIG. It may be a filter. The illustrated vent filter 70 has two fluid ports 71, 72, one 71 of which is a "male thread" formed on a second fluid port 92 of the housing 90.
It is formed with "female thread" that can be screwed directly to. Instead of being directly connected to the fluid outlet of the housing 90,
The vent filter 70 may be connected to the fluid port by a connecting material such as a threaded adapter or flexible polymer tube 96, as shown in FIG.
When using tubing 96, the vent filter 70 is a hose barb designed to connect to the tubing.
arb) connector may be provided. The degassing filter 70
Is connected to a commercially available adapter 97 that has a hose barbed connector at its outer end and is screwed over the fluid port 92.
You may be tted with). After disinfection and cooling of the filter assembly, place the tube at the position between the fluid port 92 and the vent filter 70 (as indicated by the dashed line in FIG. 9).
96 is heated to hermetically seal the housing 90 and the tube 96
The tubing 96 is a convenient means of connecting the filter housing of the filter assembly to the degassing filter because it can be melted while closed. The tubing 96 can be cut outside the melted portion and the short tubing 96 can remain attached to the housing 90, and the degassing filter 70 can then remove the tubing 96.
Can be removed from the outer edge of and reused. The tube 96 can be used not only with a syringe filter, but also with the other types of degassing filters described above. During disinfection, tube 96 may contain air, and some or all of tube 96 may be filled with a non-contaminating liquid.
As a result, when the non-contaminating liquid in the housing 90 is boiled and removed, the liquid in the tube 96 can flow into the housing 90 and replace the boiled-out non-contaminating liquid.

During heating sterilization, if only one of the fluid ports of the filter housing 90 is degassed (across the filter element 81 between the communication side of the inlet 91 and the communication side of the outlet 92 (ac
ross) Differential pressure may occur. Such a differential pressure
If the steam produced by the heating is large enough to move through the filter element 81, the steam passing through the filter element 81 causes dewetting of the portion of the filter element 81. Simultaneously degassing the housing 90 both upstream and downstream of the filter element 81 to prevent steam from being moved through the filter element 81, i.e. via two or more fluid ports, an inlet port. It is preferable to degas the region communicating with the outlet and the region communicating with the outlet. For example, inlet 91 and outlet
Both 92 may be vented at the same time, or one or both of the outlet 92 and the vents 93, 94 may be vented at the same time. FIG. 10 stylically illustrates one embodiment in which the filter assembly is vented from upstream and downstream of the filter element. The filter assembly in the figure is identical to the disposable filter assembly of FIG. 8, although only the end of the outlet is shown. During disinfection, for example, a tee fitting 98 that joins the tube 96 for the outlet 92 to the tube 96 for the outlet-side air vent 94, and the flexible polymer tube 96 allows the outlet 92 and the outlet to be The side vent 94 is connected to a vent filter 70 in the form of a sterile grade syringe filter. The outlet 92 includes a hose barbed adapter 97 as in the embodiment of FIG. Remove the cap of the air vent 94 and remove the tube 96 from the air vent 94.
You can also connect to. Air vent 94 as needed
Can be attached to a hose barbed adapter similar to that attached to outlet 92. The disinfection treatment can be carried out under the same conditions as in the above-mentioned embodiment. Outlet 92 and outlet air vent 94 at the completion of disinfection and cooling
The tube 96 for both can be cut, for example, by heating the tube 96 along the dash-dotted line, melting the tube 96 closed and hermetically sealing the housing 90. One or more venting filters can be connected to multiple fluid ports in the housing in any other desired manner. For example, multiple vent filters can be connected directly to the housing 90 in the manner shown in FIG.

During disinfection, the orientation of the housing 90 is not important, but when the housing 90 is oriented as shown in Figure 10, vapor rises to the top of the housing 90,
It is preferable because gas can be easily released from the fluid ports 92 and 94.

The degassing filter shown in FIGS. 6 and 7 is shown in FIG.
Using a method similar to that shown in Figure 1, multiple filter packages can be simultaneously degassed via a single degassing filter.

According to another aspect of the invention, the vent filter used during filter disinfection may include a filter media attached directly to the fluid outlet of the filter housing or other container. FIG. 11 shows a part of one embodiment of a filter package according to the present invention which uses such a gas vent filter. The illustrated filter package is formed from a commercially available filter assembly, such as the filter assembly commercially available from Pall under the name "LDFF", although many other types of filters may be used. it can. The filter assembly includes a rigid cylindrical polymer housing 100 with an outlet 101 and an outlet side air vent 110 at one end of the housing 100, each having a hollow hole communicating with the interior of the filter housing 100. Have. Housing 100
The opposite end (not shown) of FIG. 1 has inlets and inlet vents similar in construction to outlet 101 and outlet vent 110. A cylindrical filter (not shown) is arranged inside the housing 100 along a flow path connecting the inflow port and the outflow port 101. Similar to the filter 80 shown in FIG. 8, the filter of the illustrated filter assembly has a blind end cap at one end and an open end cap sealed to the outlet 101 at the other end. The air vent communicates with the interior of the housing 100 that surrounds the filter. The individual fluid ports, namely the inlet port, the outlet port 101 and the air vent, can be sealed by a cap-like closure and a nut that is formed away from the closure and secures the closure to the fluid port. For example, the outlet air vent 110 includes a blind closure 111 having an open lower end that fits over the outer end of the air vent 110. The nut 112 slides over the top of the closure 111 and meshes with a "male thread" formed in the air vent 110 to hold the closure 111 in place. Outlet 101 has a similar blind closure (not shown) and a nut 10 that holds the blind closure in place.
Can be sealed with 6.

Any one or more fluid ports in the housing 100 may be vented during disinfection. For the reasons given in the embodiment of FIG. 8, it is preferred that at least the outlet 101 is vented to prevent steam from collecting in the hollow center of the filter during disinfection. Outlet 101 in this embodiment
The degassing filter for use with comprises a sheet of filter media 102 mounted directly on the outer open end of outlet 101. The filter media 102 is not limited to a particular type, but is capable of allowing vapors to escape from the housing 100 during disinfection while preventing microorganisms and other contaminants from entering the housing 100.
Sterile grade filter media is preferred. If desired, the filter media 102 may be hydrophobic so that when the housing 100 is tilted, the non-contaminating liquid filling the housing 100 is prevented from leaking from the housing 100. Membrane filtration media is particularly suitable as filtration media 102 because the membrane can be sufficiently thin and flexible and can easily conform to the shape of the outlet 101 without tearing. One example of a suitable membrane filtration material is sterile grade PTFE membrane. Examples of other membrane materials are polyvinylidene fluoride and hydrophobic nylon. The thickness of the filter medium 102 is not limited and can be selected based on the strength required for the filter medium 102. Typically, the thickness is 0.0254-0.127 mm. Due to the physical strength of the filter media 102, it is permeable to vapors of non-contaminating liquids and stiffer than the filter media 102.
r), It is preferable to provide a support material 103 adjacent to the outer surface of the filter medium 102 and for preventing the filter medium 102 from expanding outward during sterilization. A similar support material 103 may be positioned adjacent the inner surface of the filter media 102 to prevent the filter media 102 from deforming inward as well. In this embodiment, the support material 10
3 consists of a thin sheet of porous, non-woven fluoropolymer fabric that is permeable to non-contaminating liquid vapors. Examples of other possible support members are thin perforated plates, porous woven fabrics and porous meshes. Generally, the support material 103
Need not function more than physically support the filter media 102, ie, the support media 103 need not remove particles from the fluid passing through the support media 103 during disinfection. The support 103 is preferably sufficiently porous so that it does not cause any significant pressure drop.

The filter media 102 and support media 103 may be of any convenient size, but each individually has a surface area that is at least as large as the cross-sectional area of the holes in outlet 101 so that they can completely cover the holes. It is preferable to have They are,
The sheet can be cut into a convenient shape.

The filter media 102 and support material 103 may be any desired method of preventing microorganisms and other contaminants from circumventing the filter media 102-e.g., A bond, or a retention filter media 102 surrounding the outlet 101. It can be attached to the outlet 101 by a mechanical connector (ring, hose clamp, etc.).
The bond can damage the filter media 101 or the housing 100 and allow contaminants to enter, so
Mechanical connection is preferable to joining. In the illustrated embodiment, the housing 100 is filled with a non-contaminating liquid and the housing 100
After immersing the inner filter in a non-polluting liquid, the filter media 102 and support material 103 are placed over the top of the outlet 101 and then held in place by the open end cap closure 104. The closure 104 slides over the outer end of the outlet 101, slides over the closure 104, and is retained by a nut 106 that meshes with a "male thread" formed in the outlet 101.
FIG. 12 shows the appearance of the outlet 101 during disinfection. Filter material 102
Is sufficiently thin and flexible that the filter media 102 is
Laid over, the nut 106 is screwed onto the filter media 102 without damaging the portion of the filter media 102 that covers the outer ends of the holes in the outlet 101. The open end closure 104 is first manufactured at the open end (man
can be cut or cut at the blind end of the blind closure, such as the closure 111 of the outlet air vent 110, or punched at the outer end of the blind closure.
ng perforations) to form the closure 104. To facilitate sliding the open end closure 104 on both the filter media 102 and the support media 103, one or more axial slits 105 are cut into the outer wall of the closure 104 to extend the closure 104 radially. Good.

The other fluid port of housing 100 may comprise a vent filter of the type used for outlet 101, or another type of vent filter.

The illustrated filter assembly can be sterilized under conditions similar to any of the embodiments described above. When the filter assembly is sterilized by heating in an autoclave, the outlet 101 is attached to the housing 100 so that steam generated during heating rises toward the outlet 101 and can be easily vented from the housing 100.
Is preferably raised relative to the rest of the. Upon completion of cooling the filter assembly after disinfection, filter media
If 102 is hydrophobic, the hydrophobic filter media 102 may prevent water from leaking out of the housing 100, leaving the open end closure 104 over the outlet 101 and allowing the housing 100 to the user. May be transported. However, in order to avoid inadvertently puncturing the filter media 102 during handling of the filter assembly, the open end closure 104 may be replaced by a filter media 10 such as the blind closure 111 of the outlet air vent 110.
It is preferable to replace 2 with a blind closure or other member that can protect it. The open end closure 104 can be easily replaced by unscrewing the nut 106 from the outlet 101, removing the open end closure 104 without removing the filter media 102 and moving the blind closure onto the filter media 102. At this time, the support 103 may leave the filter 102 in place at the top, or the support 103 may be removed to allow the blind closure to slide over the outlet 101. The blind closure may be loosely mounted on the outlet 101, or the blind closure may be pressed tightly against the outlet 101 by tightening the nut 106 to hermetically seal the housing 100. When the user tries to use the filter package, the user removes the nut 106 and the blind closure, and then (if there is one)
The support material 103 and the filter material 102 are peeled off from the outlet 101. Outlet 10 of filter media 102 without the use of a bonding agent.
Since it is attached to 1, the filter medium 102 can be easily separated from the outflow port 101 without leaving any residue.

Similarly, the filter media may be attached directly to the outer ends of the vent tubes 42 and 65 used in the embodiment of FIGS. 1-7 where the container of the filter package comprises the flexible bag 20. For example, the membrane filtration material and support material may be placed in place on the outer end of the vent tube and held in place by an open end closure and nut similar to those used in the embodiments of FIGS. 11 and 12. . Similarly, the filter media can be attached directly to any of the fluid ports of the filter assembly shown in FIG.

A degassing filter that includes a filter media attached directly to the fluid outlet of the container is advantageous in that the cost of the device is extremely low, as it can be easily assembled by the user from inexpensive hardware.

  The invention is further described by the following examples.

Example 1 A rectangular PFA membrane measuring 6 "x 18" and 0.005 "thick was folded in half and then heat sealed along two edges to measure 3" x 18 ". An elongated bag with one open end was obtained. A vent hole was used to open a vent hole near the open end of the bag and a vent tube similar to that shown in Figure 3 was sealingly connected to the bag at the vent hole.

A pleated filter (AB1F0013EH1 filter, available from Pall under the trade name "Super-Cheminert", with a single layer filter made of PTFE) in isopropyl alcohol at room temperature (about 25 ° C) Pre-wet by soaking for 5 minutes. The isopropyl alcohol was then removed by flushing the filter with deionized water for at least 5 minutes. Next, transfer the filter to a tank of warm deionized water and
A leaching treatment was performed at 60 ° C. for 60 minutes. The filter was then placed in the bag through the open end and the end was sealed using a heat sealer.

Ultrapure deionized water (initial resistivity 18 MΩ-cm) was introduced into the bag through a degassing tube and the filter was completely submerged. Next, a hydrophobic sterile grade PFA filter (Pall, model DFA4001FRP) was sealingly connected to the degassing tube as a degassing filter.

The bag is then placed in the autoclave for 15 psi.
The contents of the bag were sterilized by heating for 1 hour under standard sterilization conditions of about 120 ° C. at a gauge pressure of ∘. After 1 hour, the bag was removed from the autoclave and cooled in air to a "safe handling temperature". The bag was then hermetically sealed below the water surface using a heat sealer to obtain a completed filter package. Upon sealing, the top of the bag containing the vent tube and the vent filter was removed from the bottom of the bag containing the filter. The vent tube, associated hardware, and vent filter were removed from the top of the bag for reuse and the top of the bag was discarded.

Example 2 This example is shown in FIG. 8 for obtaining a sterile filter package.
The sterilization process of the filter assembly as shown in FIG. The filter assembly consists of a filter 80 and a rigid polymer housing 90 and is a disposable filter assembly available from Pall under the DFA trademark.

The filter 80 is pre-wet by passing isopropyl alcohol through the housing 90 at room temperature (about 25 ° C). Isopropyl alcohol is introduced from the inflow port 91,
It is discharged from the outflow port 92. Then filter housing 90
The isopropyl alcohol is removed by rinsing the column with deionized water for 5 minutes. Deionized water can then be drained from the housing 90.

The outlet air vent 94 is closed, the outlet 92 is closed with a threaded cap 95, and ultra high purity deionized water (initial resistivity 18 MΩ-cm) allows air to escape from the inlet air vent 93. As described above, the air is introduced from the inlet 91 into the housing 90 while opening the inlet side air vent 93 and uprighting the housing 90. When the ultra high purity deionized water reaches the top of the inlet 91, the inlet side air vent 93 is closed and the inlet 91 is closed by the cap 95. Next, the housing 90 is reversed and the outlet side air vent 94 and the outlet 92
Open and, if necessary, additional ultrapure deionized water is added to the housing 90 through the outlet 92 to completely fill the housing 90 and expel any air from the housing 90. In this state, the filter 80 is completely immersed in the ultra high purity deionized water in the housing 90. A vent filter 60 with a filter holder and hydrophobic sterilizing grade membrane filter media 64, as shown in FIG. 6, with the closure for the outlet air vent 94 removed, is shown in FIG.
And a T-shaped fitting 98 for mounting on both the outlet 92 and the outlet side air vent 94. The uppermost end of the tube 96 is attached to the fluid port 61a of the gas vent filter 60.

Next, the filter assembly and degassing filter 60 are placed in an autoclave and run at approximately 120 ° C at a gauge pressure of 15 psi.
Heat to sterilize the entire filter assembly. During sterilization,
The housing 90 has an outlet 92 located higher than the inlet 91.
Is substantially perpendicular to. At the end of this period,
The filter assembly and degassing filter 60 are removed from the autoclave and cooled in air to safe handling temperatures. The tube 96 is then heated by heating the tube 96 at a position between the fitting 98 and the filter assembly.
And seal the assembly to obtain a complete filter package. When the user tries to use the assembly,
The tube 96 can be easily removed from the filter assembly by the user. The degassing filter 60 can be reused with the same or different filter media as the filter media 64.

─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Peri, Joseph, A. De Ruiter Union Valley Valley Road New York, New York, USA 65 Box 549 (56) Reference JP-A-1-249715 (JP, A) 59-175065 (JP, U) (58) Fields investigated (Int.Cl. ⁷ , DB name) B65B 55/22 B65D 81/22

Claims (16)

(57) [Claims] 1. A flexible bag (2) for a filter (10).
0), the bag (20) is at least partially filled with the first liquid (30), and the entire filter (10) is immersed in the first liquid (30).
The first liquid (30) and the filter (10) are sterilized in the bag (20) while being immersed in the bag, the bag (20) is hermetically sealed, and substantially all free gas is removed from the bag. A method for forming a filter package, characterized in that it is excluded from (20). 2. The method of claim 1, further comprising moving air from the central portion of the filter (10) with the first liquid (30). 3. Prior to placing the filter (10) in the bag (10), the filter (10) is pre-wet with a second liquid having a lower surface tension than the first liquid (30).
The method for forming a filter package according to claim 1 or 2. 4. The method of forming a filter package according to claim 1, further comprising letting steam escape from the bag (20) during sterilization. 5. A method of forming a filter package according to claim 4, including allowing steam to escape from the bag (20) through a filter medium. 6. The method of forming a filter package according to claim 4, further comprising allowing the vapor to escape through the opening (41) of the bag (20). 7. A method for forming a filter package according to claim 6, including allowing the vapor to escape through a semipermeable membrane (47) forming a part of the bag (20). 8. The method according to claim 1, wherein after the sterilization, before the bag (20) is sealed, the first liquid (30) is cooled to prevent microorganisms from entering the bag (20). The method for forming a filter package according to any one of 1. 9. The method comprising placing the filter (10) in water at a temperature of at least 160 ° F. (71.1 ° C.) to leach extract from the filter (10) prior to disinfection. 9. The method for forming a filter package according to claim 8. 10. The filter according to claim 1, wherein the filter (10) is arranged such that its open end is higher than its opposite end during disinfection so that gas escapes through said open end.
A method for forming a filter package according to item. 11. The method of claim 1 comprising substantially filling all pores of the filter (10) with the first liquid.
The method for forming a filter package according to any one of 1. 12. A flexible bag (20) impermeable to microorganisms and liquid water, a filter (10) enclosed in the bag (20), and at least partially the bag (20). A filter package comprising water (30) for filling and totally submersing the filter (10), wherein substantially all free gas is excluded from the bag and hermetically sealed. 13. The filter package according to claim 12, wherein the water (30) is disposed in a central portion of the filter (10). 14. The filter package according to claim 12, wherein the water (30) and the filter (10) are sterilized. 15. A ventilation mechanism (40) on the bag (20).
A filter package according to any one of claims 12 to 14, wherein is included to allow the water vapor to escape from the bag (20). 16. The filter package according to claim 12, wherein the filter (10) comprises a filter cartridge.