JP4917326B2 - Inner bag for flexible container, manufacturing method thereof and flexible container - Google Patents

Description

  The present invention relates to an inner bag for a flexible container, a manufacturing method thereof, and a flexible container. More specifically, a clean flexible container that can be used to transport an engineering plastic raw material typified by an optical resin used for optical disc substrate manufacturing or a pharmaceutical raw material typified by a pharmacopeia salt used for artificial dialysate manufacturing. About.

  In recent years, optical discs are shifting from CDs with a single-sided recording capacity of 700 MB to DVDs of about 5 GB, and next-generation discs of more than 20 GB following the DVD have been developed, and the capacity is rapidly increasing. As the recording density increases, in the process of producing optical disc substrates by molding resin, in order to obtain a stable molding yield and a high quality substrate, the demand for reducing foreign matter on the raw material resin has become increasingly severe. Yes.

In order to reduce the amount of foreign matter relative to the raw material resin, attention must be paid to the quality of the container itself for transporting the resin from the resin manufacturer to the customer, as well as reducing the amount of foreign matter in the resin itself.
In the case of a metal container such as a lorry or a hard container (generally stainless steel), the contact surface with the resin is subjected to mechanical polishing such as buffing or chemical polishing such as electrolytic polishing. After mirror finishing, it is common to use one that has been degreased and cleaned with ultrapure water. Since these containers are not disposable but are used repeatedly, foreign substances resulting from metal containers tend to gradually decrease as they continue to be used.
On the other hand, in order to achieve a reduction in the amount of foreign matter with a flexible container, it is difficult to use it repeatedly, and it is generally disposable.

The flexible container has a double structure composed of an outer bag and an inner bag. The inner bag is filled with a resin, and is loaded on a truck or a marine container for transportation. Considering the size of a general 20 ft container, the internal volume of the flexible container into which the resin is placed is 1000 liters to 1600 liters.
In order to realize a reduction in the amount of foreign substances in the contents in transportation by a flexible container, it is particularly necessary to strictly control the amount of foreign substances caused by the inner bag that is in direct contact with the resin.

In recent years, the number of artificial dialysis patients due to diseases such as kidney diseases has been increasing rapidly. In 2004, the number of dialysis patients in Japan reached 248,166, and the number of patients increased from the same period of the previous year was 10,456. The number of introduced patients is 35,084, and the number of dead patients is 22,715. This trend is also a global trend.
For this reason, the demand of the pharmaceutical raw material represented by the pharmacopoeia salt used for manufacture of an artificial dialysate is increasing every year, and the conveyance amount is also increasing. For this reason, due to the reduction in transport costs, the packaging containers used are also becoming larger and the amount of flexible containers used is increasing.
There is a strict demand for reducing the amount of foreign substances in pharmaceutical raw materials. In order to realize this, it was necessary to pay attention to the quality of the container itself that transports the pharmaceutical raw material from the raw material manufacturer to the customer's pharmaceutical manufacturer (factory) as well as reducing the amount of foreign substances in the pharmaceutical raw material itself. .

  This invention is made | formed in view of the above-mentioned problem, and it aims at providing the inner bag for flexible containers which can reduce the foreign material amount increase of the content at the time of transport.

According to the present invention, the following inner bag for flexible container, its manufacturing method, flexible container and the like can be provided.
1. A rectangular flexible container inner bag having a substantially rectangular main body portion and a cylindrical discharge portion at a lower portion thereof, or a cylindrical discharge portion at a lower portion and a cylindrical filling portion at an upper portion thereof, A square-type flexible device having a coupling portion for connecting the corner portion of the lower end of the main body portion of the outer bag corresponding to the corner portion at least in the vicinity of two opposite corner portions of the lower end portion of the main body portion. Container inner bag.
2. In the vicinity of at least two opposing portions of the upper end of the cylindrical discharge portion of the inner bag, there is a coupling portion for connecting the vicinity of the upper end of the cylindrical discharge portion of the outer bag corresponding to this portion. A square flexible container inner bag characterized by:
3. In the case where the upper part has a cylindrical filling part, at the lower end of the cylindrical filling part of the inner bag, at least near two opposite parts, the lower end of the cylindrical filling part of the outer bag corresponding to this part The square flexible container inner bag according to 1 or 2, further comprising a coupling portion for connecting the vicinity.

4). The upper end of the main body portion of the inner bag has at least two opposing corner portions, and has a coupling portion for connecting the vicinity of the upper end of the main body portion of the outer bag corresponding to the corner portion. The square-shaped flexible container inner bag of 3 to do.
5. The square flexible container inner bag according to any one of claims 1 to 4, wherein the coupling part is formed by providing a hole in an ear part made of a film adhesive tape.
6). The cylindrical filling portion of the inner bag has a length that allows the tubular filling portion to be twisted into a linear shape, and has a length that can be tied to form a knot. The rectangular flexible container inner bag as described.
7). 7. The rectangular flexible container inner bag according to 6, wherein a length of the cylindrical filling portion of the inner bag is 600 mm or more.

8). Ultra pure water in which the discharge part of the inner bag is sealed, and foreign matter having a particle size of 0.5 to 1.0 μm is adjusted to 5000 pieces / liter or less and foreign matter of 1.0 μm or more to 100 pieces / liter or less. Any one of 1 to 7 characterized in that the amount of increase in foreign matter when converted to 1 liter in water extracted after shaking 200 ml is satisfied with the range shown in the following (A) and (B) The inner bag for square type flexible containers as described in 2.
(A) Particle size of foreign matter: 0.5 to 1 μm ·· 3,000,000 or less

9. 9. The inner bag for a rectangular flexible container according to 8, wherein the foreign matter increase amount further satisfies a range shown in the following (C) to (E).
(C) Particle size of foreign matter: 1 to 2 μm ... 120,000 or less (D) 2 to 5 μm ... 40,000 or less (E) 5 to 10 μm・ ・ ・ ・ ・ ・ 12,000 or less

10. 10. The inner bag for a rectangular flexible container according to 9, wherein the foreign matter increase amount further satisfies a range shown in the following (F) to (I).
(F) Particle size of foreign matter: 10 to 15 μm ··· 1,000 or less (G) 15 to 25 µm ··· · 100 or less (H) 25 to 50 µm ··· 10 Below (I) 50μm or more ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ 0

11. The raw material is low-density polyethylene containing no additive or linear low-density polyethylene containing only an anti-blocking agent as an additive. The raw material is molded into a gusset tube by the inflation method, and the gusset tube is cut and heat sealed. Then, the method for manufacturing the inner bag for a rectangular flexible container, which is processed into a bag shape.
12 In forming the gusset tube by the inflation method, the extruder is started using a resin containing an additive, and then gradually switched to the raw material, and the film containing the resin at the start is not used. The manufacturing method of the inner bag for square type flexible containers of 11 description.

13. 13. The method for producing an inner bag for a square flexible container according to 11 or 12, wherein static elimination air is blown onto a surface of the gusset tube.
14 The method for manufacturing an inner bag for a square flexible container according to any one of 11 to 13, wherein the inner bag is manufactured in a clean room of class 10000 or less.
15. 15. The method for producing an inner bag for a square flexible container according to any one of 11 to 14, wherein air purified by a filter is used as the air for inflation and blow used in the inflation molding method.

16. A substantially rectangular main body part, a cylindrical discharge part at the lower part, or an outer bag having a cylindrical discharge part at the lower part and a cylindrical filling part at the upper part, and 1 to 10 inserted in the outer bag A rectangular flexible container comprising the inner bag according to any one of the above, wherein a connecting portion of the inner bag is connected to a portion of the outer bag corresponding to the connecting portion.
17. 17. The rectangular flexible flexible printed circuit board according to claim 16, wherein the connection is made by connecting a connecting string provided at a portion of the outer bag corresponding to the connecting portion of the inner bag and a connecting portion of the inner bag. container.
18. 18. The rectangular flexible container according to 17, wherein the coupling string is attached to a stitched portion of an outer bag.
19. 19. The rectangular flexible container according to claim 18, wherein the stitched portion of the outer bag is sewed by weaving a cut surface of the fabric constituting the outer bag so that the cut surface does not contact the inner bag.

20. When filling the contents from the cylindrical filling portion of the inner bag described in 6 or 7 above using a filling nozzle, the filling nozzle is inserted to the vicinity of the base of the cylindrical filling portion, and the contents are inserted. A method for using an inner bag of a rectangular flexible container characterized by filling.
21. Inside the rectangular flexible container characterized by twisting the cylindrical filling portion of the inner bag according to the above 6 or 7 into a linear shape, tying this into a knot, and connecting the knot and the upper part of the outer bag How to use the bag.

  In the inner bag for flexible containers of the present invention, the increase in the amount of foreign matter in the contents during transportation can be reduced.

  The inner bag for a flexible container of the present invention (hereinafter sometimes abbreviated as inner bag) has a substantially rectangular main body portion and a cylindrical discharge portion at the lower portion, or a cylindrical discharge portion and an upper portion at the lower portion. An inner bag for a rectangular flexible container having a cylindrical filling portion, at least in the vicinity of two opposite corners of the lower end of the main body portion of the inner bag, and corresponding to the lower end of the main body portion of the outer bag. It has the coupling | bond part for connecting with corner vicinity.

FIG. 1 is a perspective view of an inner bag for a flexible container according to the present invention, wherein (a) has only a cylindrical discharge portion, and (b) has a cylindrical discharge portion and a filling portion.
The inner bag 1 mainly includes a main body portion 11 and a cylindrical discharge portion 12 (a spout portion of the full gusset inner bag) formed in the lower portion thereof. The inner bag 1 ′ further includes a cylindrical filling portion 13 (a spout portion of the full gusset inner bag) formed on the upper portion of the main body portion 11.
The main body 11 is substantially rectangular. That is, the wall portion may be rounded depending on the weight of the contents during use, which means that it includes such a deformed shape.

The inner bag for a flexible container of the present invention is connected to the vicinity of the corners of the lower end of the main body part of the outer bag corresponding to the corners, at least in the vicinity of two opposite corners of the lower end of the main body part of the inner bag. It has a joint part. In the inner bag of FIG. 1, the ear | edge part 31 for connecting with the corner | angular part vicinity of the main-body part lower part of the outer bag is formed.
FIG. 2 is a schematic perspective view showing a joint portion between the outer bag and the inner bag.
In FIG. 2, the inner bag 1 inserted into the outer bag 2 is coupled at the four corners of the lower end corner of the main body (the coupling portion is indicated by 21). In particular, as shown in this figure, it is preferable to have a coupling portion in the vicinity of the four corners of the lower end of the main body portion of the inner bag.
Thereby, since the positions of the corners of the inner bag and the outer bag can be matched, the capacity of the outer bag can be used effectively, and the filling amount of the container can be increased.

Conventionally, as a method for fixing an inner bag and an outer bag mounted inside a flexible container, there are a method using an adhesive tape and a method using an adhesive.
In such a fixing method, since the inner bag is fixed before sewing, there is a very high risk of contamination of the inner bag during sewing work.
As another fixing method, there is a method in which a fixing woven tape is attached to the inner bag side with an adhesive tape, and the woven tape is sewn to the outer bag. However, in the case of this method, there is a high risk that the adhesive tape holding the woven tape attached to the inner bag side peels off, or the inner bag film of the attachment portion is torn, causing foreign matter to be mixed.

  In the present invention, by forming the coupling portion in the inner bag, it can be fixed to the outer bag with the inner bag closed after sewing, so that foreign matter can be prevented from entering the inner bag. In addition, as for the material of the adhesive tape used to produce the joint part to be formed on the inner bag, a film adhesive tape having a tear strength that cannot be cut unless a cutting tool is used (typically vinyl By using the tape), it is possible to prevent dropping and fraying due to peeling of the adhesive tape. Therefore, the foreign material generated from this adhesive tape can be prevented.

In the present invention, the upper end of the cylindrical discharge portion of the inner bag is further connected to the vicinity of at least two portions facing each other and the vicinity of the upper end of the cylindrical discharge portion of the outer bag corresponding to this portion. It is preferable to have a joint. In particular, as shown in FIG. 3, it is preferable to have coupling portions 22 at all four points that are equally spaced on the circumference of the upper end of the discharge portion.
Also, after lifting the flexible container at the customer, open the bottom of the outer bag, pull out the inner bag, connect the inner bag to the filling port of the customer, and then drop the contents, As the amount decreases, the inner bag slides down from the outer bag, so-called “inner bag dropping” occurs. This is shown in FIG. The inner bag 1 falls off from the lower part of the outer bag 2 (dropping part 2 ′). In order to prevent this dropout, not only the lower end of the outer bag body and the lower end of the inner bag body are fixed, but also the cylindrical outlet (spout) at the lower part of the outer bag body and the cylindrical outlet ( It is preferable to fix the spout) at the same time.

  In addition, as shown in FIG. 3, it is preferable to fix at a total of 8 points in the vicinity of the four corners of the lower end of the main body portion of the inner bag and four points that are equally spaced on the periphery of the upper end of the discharge portion. This may increase the manufacturing cost. For this reason, from the viewpoint of improving the filling efficiency, preventing the dropout, and reducing the manufacturing cost, as shown in FIG. It is preferable that the points (the coupling portions 22) are fixed so as to be diagonal to each other.

When the upper portion has a cylindrical filling port (spout), as shown in FIG. 6, the upper corner of the outer bag main body and the upper corner of the inner bag main body (joint portion 23) are fixed and the cylindrical shape of the upper portion of the outer bag main body is fixed. It is preferable to fix the filling port (spout) and the cylindrical discharge port (spout) of the filling portion of the inner bag body at the same time (joint portion 24).
In view of the complexity of the manufacturing operation and the reduction of manufacturing cost, as shown in FIG. 7, the outer end of the cylindrical filling portion of the inner bag, which corresponds to this part, is located near at least two opposing parts. It is preferable to have a coupling portion 24 for connecting the vicinity of the lower end of the cylindrical filling portion of the bag.
Thereby, when setting a filling nozzle in the filling part of an inner bag, even if which operator sets, the positional relationship of an inner bag, an outer bag, and a nozzle can be match | combined rapidly. Further, it is possible to prevent the twisting of the upper part of the inner bag and the outer bag during filling.
In addition, as shown in FIG. 6, it is preferable to fix in all of the four corners near the upper end of the main body of the inner bag and four points that are equidistant on the periphery of the lower end of the filling portion, but for the reasons described above. As shown in FIG. 7, the two points on the upper end of the main body of the inner bag (the connecting portion 23) and the two points facing each other on the lower end of the filling portion (the connecting portion 24) are fixed to be diagonal to each other. It is preferable to do.

In this invention, it is preferable that a coupling | bond part provides a hole in the ear | edge part produced with the adhesive tape made from a film. By this method, the ear portion can be formed relatively easily.
FIG. 8 is an enlarged view showing a state in which an ear portion is formed at one place on the lower end portion of the inner bag main body portion.
An ear portion 31 is formed in the vicinity of the lower corner portion of the main body portion 11. A hole 32 is opened in the ear 31.
A film-made adhesive tape is used for the production of the ear part, but depending on the material of this adhesive tape, there is a material having a risk of foreign matter contamination. Accordingly, an adhesive tape made of a material that may be mixed with a foreign substance, for example, a resin cloth, a woven fabric, a paper, or a resin film having a very low tear strength is inappropriate.
The adhesive tape that can be used is an adhesive tape typified by a vinyl film, which has high tear strength, specifically, has such a strength that it cannot be cut unless a cutting tool is used.
In order to increase the tensile strength and tear strength of the ear, it is possible to sandwich a resin film between the adhesive tapes when the ear is formed.

  It should be noted that the inner bag is not contaminated with foreign matters when the ear portion is manufactured. Specifically, the work area is a clean room managed in class 1000 or lower, and the ears are produced in this clean room by wearing anti-static work clothes and cleaned by a foreign matter removing adhesive roller. It is necessary to consider such as making the ears using the adhesive tape specified above at the specified position after spreading the inner bag on top.

  It is preferable that the cylindrical filling portion of the inner bag has a length that allows the tubular filling portion to be twisted into a linear shape after being filled with contents, and to be tied to form a knot. For example, in the case of an inner bag having one side of the main body portion of about 1150 mm, the length of the cylindrical filling portion is preferably 600 mm or more.

As described above, when the flexible container is lifted and the contents are discharged from the bottom, a phenomenon called “detachment of the inner bag” occurs, but before this, as shown in FIG. (The connecting cord 25 is sewn to the outer bag), there is a risk that the inner bag itself may fall out of the outer bag due to dropping off and the weight of the contents unless it is firmly fixed to the outer bag 2.
Therefore, after filling the contents, as shown in FIG. 9, the filling port 13 portion at the top of the inner bag is twisted (FIG. 9 (a)), and a knot 15 is made in that portion (FIG. 9 (b)). It is preferable to prevent the drop-out by tying with a connecting string 25 of the outer bag (FIGS. 9C and 9D).
When the upper part of the inner bag also has a cylindrical filling port (spout), it is preferable that the cylindrical filling port is twisted into a linear shape and has a length that can be tied to form a knot. For example, in the case of an inner bag in which one side of the main body is 1150 mm and the film thickness is about 75 μm, the length of the cylindrical filling port is preferably 600 mm or more.

Among the above-described inner bags of the present invention, when the cylindrical filling part is long, when filling the contents from the cylindrical filling part using the filling nozzle, the filling nozzle is replaced with the cylindrical filling part. It is preferable to fill the contents by inserting it to the vicinity of the base.
As shown in FIG. 10, when the filling nozzle 41 is not sufficiently inserted, the filling portion 13 is thinner than the main body diameter. As mentioned above, the state which does not enter into a flexible container generate | occur | produces. Therefore, in order to prevent this, it is preferable to insert the filling nozzle to the vicinity of the base of the cylindrical filling portion, that is, until the length of X in FIG.

  As described above, the inner bag of the rectangular flexible container of the present invention is used by being inserted into the outer bag. As the outer bag, the inner bag is connected to a joint portion formed on the inner bag and a portion corresponding to the joint portion. If it has a part, there will be no restriction | limiting in particular.

In the present invention, it is preferable that the inner bag and the outer bag are connected by tying a connecting string provided at a portion of the outer bag corresponding to the connecting portion of the inner bag and the connecting portion of the inner bag.
FIG. 11 is a diagram illustrating an example of the attachment portion of the stitching portion of the outer bag and the coupling string.
Thus, it is preferable that the coupling string 26 is attached to the stitching portion 27 of the outer bag 2, and the stitching portion 27 of the outer bag 2 is sewn by weaving the cut surfaces of the fabrics 2a and 2b constituting the outer bag. It is preferable to prevent the cut surface from coming into direct contact with the inner bag 1. As a result, it is possible to prevent contamination of the inner bag due to contact with the stitched portion of the outer bag and foreign matter contamination due to fraying of the raw fabric used for the outer bag.
Furthermore, after using the flexible container, the inner bag can be easily removed from the outer bag by unfastening the binding string provided at the outer bag portion tied to the inner bag connecting portion. Separation of the polyethylene resin and the polyethylene resin that is the raw material of the inner bag is facilitated, and recycling is also promoted.

The inner bag for a flexible container according to the present invention is such that the discharge part of the inner bag is sealed, and foreign matter having a particle diameter of 0.5 to 1.0 μm is 5000 pieces / liter or less and 100 foreign matters having a size of 1.0 μm or more. The amount of increase in foreign matter when converted to 1 liter in the water extracted after 200 ml of ultrapure water adjusted to less than 1 liter is shaken must satisfy the ranges shown in (A) and (B) below. preferable.
(A) 0.5 to 1 μm ······· 3,000,000 or less (B) 1 µm or more ·········· 130,000 or less By doing so, it can be used for transporting resins used in the optical field and for transporting pharmaceutical raw materials.

The inner bag for flexible containers of the present invention preferably further satisfies the ranges shown in the following (C) to (E), and particularly preferably satisfies the ranges shown in the following (C) to (I).
(C) 1-2 [mu] m ... 120,000 or less (D) 2-5 [mu] m ... 40,000 or less (E) 5-10 [mu] m ... ······ 10,000 or less (F) 10 to 15 µm ·········· 1,000 or less (G) 15 to 25 µm ··········· 100 or less (H) 25 to 50 µm・ ・ ・ ・ ・ 10 or less (I) 50μm or more ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ 0

  By satisfying the ranges shown in the above (C) to (E) or (C) to (H), it is particularly suitable for transporting pharmaceutical raw materials such as pharmacopoeia salts. Hereinafter, the foreign substance range will be specifically described.

Pharmacopoeia salt is used for hydrolysis, salting out, and capsule polishing in the manufacturing process of nutrients such as cryogen and vitamins as well as raw materials for medical products such as physiological saline and Ringer's solution. Then, it is overwhelmingly mostly for artificial dialysate.
The pharmacopoeia salt used as a raw material for a medical product may be used as a solution when used in a medical product manufacturer, or as a granule without being dissolved.

When the pharmacopoeia salt is dissolved and used as a solution, the pharmaceutical manufacturer uses a special filter or the like to remove the foreign matter in the manufacturing stage, and then conducts a strict foreign matter inspection.
In addition, since various tests are being conducted based on the 14th revised Japanese Pharmacopoeia Law (The Pharmacoeia Futureentition) stipulated in the Pharmaceutical Affairs Law managed by the Ministry of Health, Labor and Welfare (Japan) Even if there are adhered foreign substances, they are discovered by the management of the pharmaceutical manufacturer, and the risk that the foreign substances will be mixed into the drug is very low.

However, if the product is used as it is without being melted, it is difficult to inspect the foreign substance at the pharmaceutical manufacturer, so if there is foreign matter or adhering foreign matter in the pharmacopoeia salt, there is a high risk that the foreign matter will be mixed into the pharmaceutical product. .
Of course, various tests based on the 14th revised Japanese pharmacy law are carried out even when they are used as they are, but the 14th revised Japanese pharmacy law does not have inspection regulations on foreign substances, and there is a risk that foreign substances will be mixed in. Is still expensive.
In addition, the 14th Amendment of the Japanese Pharmacopoeia Law only provides for plastic containers used for pharmaceutical containers, and no provision for packaging containers for pharmaceutical raw materials.

Plastic containers used for pharmaceuticals also have provisions for acute toxicity tests, cytotoxicity tests, hemolysis tests, sensitization tests, ashing tests, dissolution tests, etc., and reference values related to the size and number of foreign substances themselves. There is no provision for the test method.
Therefore, foreign matter management of the pharmacopoeia salt which is the raw material for the pharmaceutical is very important, and foreign matter management is also important for the flexible container used for the packaging and transportation and the inner bag.

  However, until now, pharmaceutical manufacturers and pharmaceutical raw material manufacturers that produce pharmacopoeia salt have been designated as raw materials and foreign materials, especially for flexible containers and inner bags used for packaging and transportation represented by pharmacopoeia salt. There was nothing to do. Therefore, it seems that many flexible container manufacturers did not control the size and number of foreign matters in the inner bag after molding.

Therefore, the present inventors investigated the foreign matter increase amount when the pharmacopoeia salt was dissolved in order to set the foreign matter increase amount of the inner bag suitable for the transportation of the pharmaceutical raw material.
The typical composition components (in 100 milliliters) of the artificial dialysis drug are as follows.
Sodium chloride: 19.84 grams Potassium chloride: 0.52 grams Calcium chloride (dihydrate): 0.90 grams Magnesium chloride (hexahydrate): 0.53 grams Sodium acetate (trihydrate): 16.67 grams Glucose: 7.00 grams

This artificial dialysis drug is diluted by adding 34 liters of pure water to 10 liters of the drug to obtain a dialysate for an artificial kidney device. Therefore, the pharmacopeia salt contained in this dialysate is about 6 percent.
Therefore, a 6% solution of pharmacopoeia salt is prepared and foreign matter is confirmed. Dissolve 12 grams of dialysis salt from Naikai Shigyo Co., Ltd. in 200 milliliters of ultrapure water to make a 6% solution.
Ultrapure water used at this time is filtered through a membrane filter having a pore size of 0.3 μm or less, and foreign matter having a particle size of 0.5 to 1.0 μm is 5000 pieces / liter or less and foreign matter having a size of 1.0 μm or more is 100%. Adjust to not more than pieces / liter, and use one having an electric conductivity of 10 MΩ or more.

In this solution, the amount of increase in foreign matter per liter was measured using a liquid fine particle counter (manufactured by HIAC ROYCO, liquid fine particle measuring instrument, type: M-8000A / ABS2). It was.
(A) Particle size of foreign matter 0.5 to 1.0 μm: 4,000,000 to 5,000,000 (B) 1.0 to 2.0 μm: 400,000 to 500,000 (C) Same as 2.0 to 5.0 μm: 100,000 to 150,000 (D) Same as 5.0 to 10.0 μm: 20,000 to 30,000 (E) Same as 10.0 to 15.0 μm: 2 1,000 to 3,000 (F) 15.0 to 25.0 μm: 1,000 to 1,500 (G) 25.0 to 50.0 μm: 100 to 150 (H) 50.0 μm More than: 0

  Based on this measurement result, the use of an inner bag that satisfies the above range for the size and increase in the number of foreign substances obtained by the same test method, it is highly possible that the pharmacopoeia salt that is the raw material for pharmaceuticals is contaminated with foreign substances. Can be prevented.

Measurement of foreign matter in the inner bag is performed by the following method. Measurement is performed in a clean room of class 100 or lower.
Put 200 milliliters of ultrapure water in the sealed inner bag and shake well. Ultrapure water used at this time is filtered through a membrane filter having a pore size of 0.3 μm or less, and foreign matter having a particle size of 0.5 to 1.0 μm is 5000 pieces / liter or less and foreign matter having a size of 1.0 μm or more is 100%. Adjust to not more than pieces / liter, and use one having an electric conductivity of 10 MΩ or more.
After shaking, the water extracted from the inner bag is evaluated with a liquid fine particle counter (for example, HIAC ROYCO Co., Ltd., in-liquid particle counter / type: M-8000A / ABS2). At this time, pay attention to the cleaning of the measurement container and make adjustments to obtain reproducibility.
The obtained foreign matter increase amount is converted into a value per liter of ultrapure water.

The inner bag generally has a capacity of 1000 to 1600 liters. For example, when a PC resin having an apparent bulk specific gravity of 0.66 is filled, it corresponds to about 650 kg to about 1000 kg. Preferably it is 1150 liters-1300 liters.
Moreover, the internal volume of the flexible container which puts a pharmaceutical raw material has a preferable internal volume corresponding to the filling weight of 500 kg to 1,000 kg.
The thickness of the inflation film constituting the inner bag is not particularly limited, but is usually about 65 to 75 μm.

The inner bag of the present invention is made of, for example, low-density polyethylene (LDPE) containing no additive, or linear low-density polyethylene (LLDPE) containing only an antiblocking agent as an additive, and the raw material is obtained by an inflation method. It can be manufactured by forming into a gusset tube, cutting the gusset tube, heat sealing it and processing it into a bag shape.
FIG. 12 shows the inner bag manufacturing process. From the roll of gusset tube 14 in which the inflation film is gusset-folded, a portion corresponding to a cylindrical discharge portion or filling portion (a spout portion of a full gusset inner bag) is first sealed, and then unnecessary portions outside the seal are cut and removed. Take up once in a roll. After that, the gusset tube that has been sealed and molded is unwound and cut at a predetermined position.
As low density polyethylene which does not contain an additive, what is used for a medical infusion pack etc. can be used, for example.

  A conventionally well-known form can be used about the shaping | molding method of the gusset tube by an inflation method. At this time, the extruder is started using a resin containing additives such as an antioxidant and an antiblocking agent, and then gradually switched to the above-mentioned raw materials, and the film containing the resin at the time of starting may not be used. preferable. Thereby, even a large-diameter gusset tube as in the present invention can be manufactured using the above raw materials.

  After forming into a gusset tube, it is preferable to spray static elimination air on the surface. Moreover, it is preferable to manufacture in a clean room of class 10000 or less, and it is preferable to use air purified by a filter as the air for blown blow used in the blow molding method. As a result, the amount of foreign matter adhering to the inner bag can be reduced. As the air cleaning filter, it is preferable to use an HRPA filter having a performance capable of collecting 99% or more of foreign matters having a particle diameter of 0.3 μm or more. Alternatively, it is preferable to use a more stringent ULPA filter.

In addition, it is preferable to pay attention to the following points, for example, so that no foreign matter adheres to the inner bag.
In the inflation process, contaminated air discharged from the machine that is generated to rotate the screw of the extruder (typically, it includes wear powder generated from the V-belt and wear debris powder generated from the machine itself. In order to prevent exhaust air from being discharged and circulated in the work place, an exhaust duct is attached and the air is exhausted outside the room.
At the time of molding and sealing in the inner bag processing process, a molding machine is used that does not allow air in the processing chamber to enter the film (gusset tube).
At the time of molding and sealing, the bag (inner bag) is connected and only wound in a roll shape. When the inner bag is not cut on the filling port side, the unsealed side can never be opened. Workers in the inner bag processing process wear anti-static work clothes.

Hereinafter, the present invention will be described more specifically with reference to examples.
Example 1
(1) Preparation of inner bag The extruder was started using resin (LDPE F019 by Ube Maruzen Polyethylene Co., Ltd.) containing additives, such as antioxidant and an antiblocking agent. After that, it is gradually switched to linear low-density polyethylene (manufactured by Prime Polymer Co., Ltd., LLDPE 0144N, anti-blocking agent 3 wt%), which is the raw material resin for the inner bag, so that the film containing the resin at the start-up is not mixed In order to make it, the thing which passed 30 minutes or more after the complete switch which is sufficient time was used. The obtained film was processed into the shape and dimensions shown in FIG. The film thickness is 75 μm. Further, the hatched portion in the lower part of the figure indicates a seal part.

(2) Inner bag evaluation In a Class 1000 clean room, ultra-pure with a foreign particle size of 0.5 to 1.0 μm adjusted to 5000 / liter or less and a foreign material of 1.0 μm or more to 100 / liter or less. 200 ml of water was placed in the inner bag prepared in (1) above. After shaking for 5 minutes, the size and number of foreign matter contained in the recovered 150 ml of water was determined by measuring the particle size in the liquid [HIAC ROYCO Co., Ltd., liquid particle counter / type: M-8000A / ABS2]. It measured using.
The results are shown in Table 1.

Comparative Example 1
The inner bag was produced and evaluated in the same manner as in Example 1 except that the inner bag was produced using a film collected 3 minutes after the raw material resin was completely switched.
The results are shown in Table 2.

Evaluation Example The inner bag produced in Example 1 and Comparative Example 1 was evaluated as follows.
Ultrapure water prepared by adjusting the foreign matter having a particle size of 0.5 to 1.0 μm to 5000 pieces / liter or less and the foreign matter having a particle size of 1.0 μm or more to 100 pieces / liter or less was placed in the inner bag and shaken for 5 minutes. Thereafter, 150 ml of the collected water was mixed with 3 kg of polycarbonate (made by Idemitsu Kosan Co., Ltd., MD1500) and left for 24 hours. This polycarbonate is used as a material for substrates of optical disks such as CDs and DVDs.
Then, it put into the clean dryer (Matsui Seisakusho make, DMD II-50-2), and dried at 120 degreeC for 4 hours. A CD-ROM substrate was injection-molded using the polycarbonate containing foreign substances derived from the inner bag thus obtained.

The injection molding machine used was SD40ER made by Sumitomo Heavy Industries. The molding conditions were a cylinder temperature of 350 ° C., a fixed mold mirror surface temperature of 80 ° C., a movable mold mirror surface temperature of 87 ° C., a sprue temperature of 60 ° C., a cut punch temperature of 40 ° C., and a molding cycle of 4.7 seconds.
Five of the CD-ROM substrates thus produced were put into a constant temperature and humidity chamber, and accelerated and deteriorated at 90 ° C., 90% RH, 100 hours. About this sample, the presence or absence of a polarization defect was evaluated. Specifically, using a polarizing optical microscope, it was confirmed whether or not each substrate had a polarization defect exceeding 10 μm in diameter due to hydrolysis of polycarbonate.
The results are shown in Table 3.

  Thus, it was found that the number of polarization defects can be reduced by using the inner bag of the present invention. From this result, it is clear that even if the content is polycarbonate used as an optical disk raw material, it can be conveyed without contamination by using the inner bag of the present invention.

  The flexible container inner bag and the rectangular flexible container of the present invention can reduce the increase in the amount of foreign substances in the contents during transportation, and are therefore suitable for transporting resins, various additives, etc. for optical applications, or pharmaceutical raw materials. Can be used.

It is a perspective view of the inner bag for flexible containers of this invention, (a) has only a cylindrical discharge part, (b) has a cylindrical discharge part and a filling part. It is a schematic perspective view which shows the joint location of an outer bag and an inner bag. It is a schematic perspective view which shows the joint location of an outer bag and an inner bag. It is a figure which shows the mode of dropping of an inner bag. It is a schematic perspective view which shows the joint location of an outer bag and an inner bag. It is a schematic perspective view which shows the joint location of an outer bag and an inner bag. It is a schematic perspective view which shows the joint location of an outer bag and an inner bag. It is the elements on larger scale which show a mode that the ear | edge part was formed in one place of the lower end part of an inner bag main-body part. It is a figure which shows the connection of the filling port of an inner bag, and the binding string of an outer bag, (a) is the state which twisted the filling port of the inner bag, (b) is the state which formed the knot in the part, (c (D) is a figure which shows the state which tied it with the binding string of the outer bag. . It is a figure which shows the relationship between the insertion position of a filling part and a filling nozzle at the time of filling the contents. It is a figure which shows the example of the attachment part of the stitching | suture part of an outer bag, and a coupling string. It is a figure which shows the manufacturing process of the inner bag of this invention. 3 is a plan view showing the shape of the inner bag produced in Example 1. FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1, 1 'Inner bag 11 Main body part 12 Discharge part 13 Filling part 14 Gusset tube 15 Knot 2 Outer bag 2a, 2b Fabric | dye 21-24 Binding part 25, 26 Binding string 27 Sewing part 31 Ear part 32 Hole 4 Fishing tackle 41 Filling nozzle

Claims (19)

A rectangular flexible container inner bag having a substantially rectangular main body portion and a cylindrical discharge portion at a lower portion thereof, or a cylindrical discharge portion at a lower portion and a cylindrical filling portion at an upper portion thereof, A square-type flexible device having a coupling portion for connecting the corner portion of the lower end of the main body portion of the outer bag corresponding to the corner portion at least in the vicinity of two opposite corner portions of the lower end portion of the main body portion. A container inner bag,
The inner bag, by using the resin containing the additive starting the extruder, then gradually to the linear low density polyethylene including low density polyethylene containing no additives, or as additives anti-blocking agents only A flexible container inner bag that is an inner bag that is molded into a gusset tube by the inflation method, cut and heat sealed, and processed into a bag shape without using a film containing resin at the start .   In the vicinity of at least two opposing portions of the upper end of the cylindrical discharge portion of the inner bag, there is a coupling portion for connecting the vicinity of the upper end of the cylindrical discharge portion of the outer bag corresponding to this portion. The rectangular flexible container inner bag of Claim 1 characterized by these.   In the case where the upper part has a cylindrical filling part, at the lower end of the cylindrical filling part of the inner bag, at least near two opposite parts, the lower end of the cylindrical filling part of the outer bag corresponding to this part The rectangular flexible container inner bag according to claim 1 or 2, further comprising a coupling portion for connecting the vicinity.   The upper end of the main body portion of the inner bag has at least two opposing corner portions, and has a coupling portion for connecting the vicinity of the upper end of the main body portion of the outer bag corresponding to the corner portion. The square flexible container inner bag according to claim 3.   The square flexible container inner bag according to any one of claims 1 to 4, wherein the coupling part is formed by providing a hole in an ear part made of a film adhesive tape.   6. The cylindrical filling portion of the inner bag has a length capable of forming a knot by twisting the cylindrical filling portion into a linear shape. Crab-shaped flexible container inner bag according to crab.   The length of the cylindrical filling part of the said inner bag is 600 mm or more, The square type flexible container inner bag of Claim 6 characterized by the above-mentioned.   The square flexible container inner bag according to any one of claims 1 to 7, wherein static elimination air is blown onto a surface of the gusset tube.   The square flexible container inner bag according to any one of claims 1 to 8, which is manufactured in a clean room of class 10000 or less.   The square flexible container inner bag according to any one of claims 1 to 9, wherein air purified by a filter is used as inflation blow air used in the inflation molding method. Ultra pure water in which the discharge part of the inner bag is sealed, and foreign matter having a particle size of 0.5 to 1.0 μm is adjusted to 5000 pieces / liter or less and foreign matter of 1.0 μm or more to 100 pieces / liter or less. The amount of increase in foreign matter when converted to 1 liter in water extracted after shaking 200 ml is filled with the range shown in the following (A) and (B): The inner bag for square type flexible containers in any one.
(A) Particle size of foreign matter: 0.5 to 1 μm ·· 3,000,000 or less The inner bag for a rectangular flexible container according to claim 11, wherein the foreign matter increase amount further satisfies the ranges shown in the following (C) to (E).
(C) Particle size of foreign matter: 1 to 2 μm ... 120,000 or less (D) 2 to 5 μm ... 40,000 or less (E) 5 to 10 μm・ ・ ・ ・ ・ ・ 12,000 or less The inner bag for a rectangular flexible container according to claim 12, wherein the foreign matter increase amount further satisfies a range shown in the following (F) to (I).
(F) Particle size of foreign matter: 10 to 15 μm ··· 1,000 or less (G) 15 to 25 µm ··· · 100 or less (H) 25 to 50 µm ··· 10 Below (I) 50μm or more ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ 0 A substantially rectangular main body, and a cylindrical discharge part at the bottom, or an outer bag having a cylindrical discharge part at the bottom and a cylindrical filling part at the top,
A rectangular flexible container comprising the inner bag according to any one of claims 1 to 13 inserted in the outer bag,
A rectangular flexible container comprising a connecting portion of the inner bag and a portion of the outer bag corresponding to the connecting portion.   15. The corner according to claim 14, wherein the connection is made by connecting a connecting string provided at a portion of the outer bag corresponding to a connecting portion of the inner bag and a connecting portion of the inner bag. Type flexible container.   The square flexible container according to claim 15, wherein the connecting string is attached to a stitched portion of an outer bag.   17. The rectangular flexible container according to claim 16, wherein the stitched portion of the outer bag is sewed by weaving a cut surface of the fabric constituting the outer bag so that the cut surface does not contact the inner bag. . In the case of filling the contents using a filling nozzle from the cylindrical filling portion of the inner bag according to claim 6 or 7,
A method for using an inner bag of a rectangular flexible container, wherein the filling nozzle is inserted to the vicinity of the base of a cylindrical filling portion to fill the contents. Twist the cylindrical filling portion of the inner bag according to claim 6 or 7 and tie it to make a knot,
A method for using an inner bag of a rectangular flexible container, wherein the knot and an upper portion of an outer bag are joined.

Images