High frequency welder welding method

Abstract

To provide a production method of an inner cap and outer cap for a sterile lock of a vinyl isolator, in which crack and peeling hardly occur.SOLUTION: A production method is configured to comprise: a step for, using a high frequency welder, producing an inner cap and outer cap for a sterile lock, by overlapping adhesion, or using a high frequency welder, producing a coupling sleeve for a vinyl isolator by overlapping adhesion; and a step for attaching the inner cap and outer cap produced by the overlapping adhesion, to the sterile lock of the vinyl isolator, or coupling the coupling sleeve produced by the overlapping adhesion and the vinyl isolator, in which the overlapping adhesion is configured to overlap patched parts of two vinyl films, from different directions, and then adhere the patched parts by the high frequency welder.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a method for welding the inner and outer caps of a vinyl isolator using a high frequency welder. [Background technology]

[0002] Vinyl isolators are primarily used for raising germ-free animals. They are manufactured by welding transparent polyvinyl chloride film into a bag shape using a high-frequency welder. In the conventional method, the chamber part of the vinyl isolator is laminated and glued, and the inner cap, outer cap, and connecting sleeve of the steril lock for loading and unloading goods are glued together using a round bar (a mold for high-frequency welding) (Non-Patent Documents 1-3).

[0003] Dr. Tanami, an authority on germ-free animal husbandry, introduces a method for manufacturing vinyl isolators in Non-Patent Document 2, describing the use of a vinyl sealer to bond vinyl membranes. According to Non-Patent Document 2, vinyl sealers, also known as Callanans or vinyl sealers, use high-frequency heat to complete the welding process. In addition to straight, uniform-sided rectangular sealers, some have circular or arc-shaped tooth profiles (see page 211, right column, 13). The last two lines in the lower right column on page 209 and the first line in the upper left column on page 210 of Non-Patent Document 2 state that a special vinyl sealer is required for circular bonding. Furthermore, Dr. Tanami states that sealing vinyl membranes requires empirical knowledge of the appropriate temperature and time required for sealing by placing a piece of vinyl on the vinyl sealer (see page 212, right column, (e)). Furthermore, because it is difficult to insert electrodes into an isolator using conventional machines, Non-Patent Document 2 teaches the use of patch bonding, as shown in Figure 11B on page 213. The overlap bonding shown in Figure 11A requires a specially designed machine and is difficult to achieve with a general high-frequency sewing machine. In particular, the inner and outer caps of the SterilLok part and the connecting sleeve are basically circular, and it is technically difficult to join vinyl to the circular SterilLok using a high-frequency welder with a straight bar. This is common knowledge in the field.

[0004] Fukuoka et al. reported on cases of contamination encountered during basic research on periodontal disease using germ-free animals (Non-Patent Document 4). According to Fukuoka et al., many of the contamination cases they encountered were thought to be caused by broken instruments, with many cases of breakage of vinyl tyre-type connecting sleeves being particularly common. These breakages were thought to be caused by perforations by sharp instruments or cracks in the vinyl joints. Regarding such breakage, Fukuoka et al. devised a method for inspecting vinyl sleeves for damage using electrical resistance measurements, which they reported in the same document.

[0005] Compared to general consumer goods, the market for vinyl isolators is not large, and their production is a niche market limited to specific businesses and companies, and within those businesses, they are often produced by specific experienced craftsmen and technicians. Furthermore, as Tanami states, it requires experience, such as applying a piece of vinyl to the vinyl sealer and empirically knowing the appropriate temperature and time required for sealing (Non-Patent Document 2). [Prior art documents] [Non-patent literature]

[0006] [Non-Patent Document 1] Trexler, PC, Reynolds, LI, 1957, Flexible film apparatus for rearing and use of germfree animals, Appl. Microbiol., 5: 406-412 [Non-patent document 2] Junichiro Tanami, 1961, Some issues regarding sterile vinyl breeding apparatus and germ-free animals, Modern Media, Vol. 7, 206-216 [Non-patent document 3] Miyagawa, M., 1973, Germ-free animals - Applications to medicine and biology, Ishiyaku Publishing Co., Ltd., III) Plastic germ-free breeding equipment, 1. How to make the equipment, Chapter 4. Germ-free breeding methods, pp. 57-63 [Non-patent document 4] Fukui et al., 1989, Study on a new damage inspection method for vinyl connecting sleeves used in germ-free animal breeding, Journal of the Japanese Society of Periodontology, Vol. 19, No. 1, 41-46 Summary of the Invention [Problem to be solved by the invention]

[0007] The present inventors have been manufacturing vinyl isolators for many years and have also been involved in germ-free animal experiments using them for many years. During this time, they have observed occasional cracking and peeling at the adhesive joints of Steryl Lock caps manufactured using a patchwork adhesive process. Although cracking and peeling occurred rarely and with low reproducibility, investigations revealed that the vinyl chloride material itself was not the cause. Initially, the cause was not easily identified, but further investigations and studies revealed that cracking and peeling did not occur when manufactured by experienced craftsmen or engineers, but tended to occur occasionally when patchwork adhesive was performed by less experienced technicians. Therefore, the present inventors suspected that there might be a problem with the patchwork adhesive used in manufacturing Steryl Lock caps and connecting sleeves, and investigated an adhesive method that is less prone to cracking and peeling. In one embodiment, the present invention aims to provide a method for manufacturing a vinyl isolator, including a manufacturing process for an inner cap and / or outer cap for Steryl Lock of a vinyl isolator, and / or a manufacturing process for a connecting sleeve for a vinyl isolator, which is less prone to cracking and peeling. Another object of the present invention is to provide a method for determining an adhesion threshold or a quality control method for manufacturing a vinyl isolator by attaching an inner cap or outer cap for a steril lock of the vinyl isolator to the steril lock or connecting a connecting sleeve to the vinyl isolator. [Means for solving the problem]

[0008] The inventors conducted extensive research to solve the above-mentioned problems. They measured the thickness of the adhesive surface of cracked and peeled caps, and measured the thickness of the adhesive surface when the tuner memory of the high-frequency welder was changed for both patch and lap bonding. They then performed strength tests on each thickness. They then processed inner and outer caps manufactured using lap bonding and compared their pressure resistance with inner and outer caps manufactured using the conventional patch bonding method. Surprisingly, the adhesive surface thickness of cracked caps manufactured using patch bonding averaged approximately 0.4 mm, while the adhesive surface thickness of peeled caps averaged approximately 0.68 mm, while the adhesive surface thickness of normal caps averaged approximately 0.55 mm. In other words, the cracks and peeling appear to have different causes. The cracks were caused by excessive welding during cap manufacturing, while the peeling was likely caused by insufficient welding during cap manufacturing. Furthermore, when comparing patch bonding with lap bonding using high-frequency welders, the patch bonding using tuner memory of 15 and 20 resulted in a bonded surface thickness of 0.5 mm, and no cracks or peeling were observed. However, with regard to patch bonding, when the high-frequency welder tuner had a high memory, the bonded surface was thin and cracked during strength testing, while when a low memory tuner was used, the bonded surface was thick and peeled during testing. From these results, it was estimated that uneven bonding occurs when manufacturing caps using patch bonding, which can affect cracking and peeling. Furthermore, it was found that the adhesion threshold for patch bonding is extremely narrow, and uneven bonding can easily cause cracking and peeling.

[0009] Therefore, the inventors attempted lap bonding, a method not previously used, to manufacture inner and outer caps for Sterillock and connecting sleeves for vinyl isolators. Specifically, an octagonal cap was fabricated using lap bonding with a straight bar. This cap fit Sterillock as shown in Figure 3. This demonstrates that a straight bar can be used to fabricate various diameters, which previously required a round bar. To the inventors' knowledge, there are almost no precedents for fabricating outer and inner caps for vinyl isolators with a straight bar, which previously required a round bar. Furthermore, with lap bonding using a straight bar, surprisingly, the thickness of the bonded surface changed along with the tuner memory value, and no cracks or peeling were observed in strength tests. Furthermore, surprisingly, outer and inner caps fabricated using lap bonding were found to be superior in pressure resistance tests to outer and inner caps fabricated using patch bonding. This led to the completion of the present invention, which incorporates these techniques as one embodiment. Furthermore, the inventors have established a method for determining the adhesion threshold for caps or connecting sleeves manufactured by seam bonding, and a quality control method using this method, and have completed the present invention, which includes these as one embodiment.

[0010] The present invention includes the following embodiments. [1] A method for manufacturing a vinyl isolator by manufacturing an inner cap or outer cap for a steril lock of a vinyl isolator and attaching it to the steril lock of the vinyl isolator, or a method for manufacturing a vinyl isolator connected to a connecting sleeve by manufacturing a vinyl isolator and connecting it to the vinyl isolator, i) using a high frequency welder to produce inner and outer caps for Sterillock by lap bonding, or using a high frequency welder to produce connecting sleeves for vinyl isolators by lap bonding; ii) A process of attaching the inner cap and outer cap manufactured by overlap bonding to the steril lock of the vinyl isolator, or connecting the connecting sleeve manufactured by overlap bonding to the vinyl isolator. Including, The above-mentioned manufacturing method involves overlapping and bonding two pieces of vinyl film together at their seams from different directions and bonding them together with a high-frequency welder. [2] The manufacturing method according to embodiment 1, in which bonding is performed using a high-frequency welder with a straight bar. [3] A manufacturing method according to embodiment 2, wherein the attached inner cap or outer cap, or the connected connecting sleeve, is circular. [4] A method for determining the adhesion threshold of a seam bond for manufacturing an inner cap or outer cap for a steril lock of a vinyl isolator and attaching it to the steril lock to manufacture a vinyl isolator, or for manufacturing a connecting sleeve for a vinyl isolator and connecting it to a vinyl isolator to manufacture a vinyl isolator connected to the connecting sleeve, comprising: i) a step of overlapping and seaming two vinyl films from the same direction using a high-frequency welder to prepare a seam-bonded vinyl film; ii) measuring the total thickness of the glued vinyl film; iii) a step of measuring pressure resistance, which includes carrying out a pressure test in which a specified pressure is applied to the seam-bonded vinyl film and checking whether cracks or peeling occur; iv) a step of judging the vinyl film as defective if its pressure resistance is less than a practical pressure, as acceptable if its pressure resistance is equal to or greater than a practical pressure, and as acceptable if no cracks or peeling occurs even when the specified pressure is applied; v) if the seam-bonded vinyl film, i.e., the first seam-bonded vinyl film, is determined to be defective in step iv), preparing a seam-bonded vinyl film, i.e., a second seam-bonded vinyl film, having a total thickness different from that of the first seam-bonded vinyl film, provided that if the first seam-bonded vinyl film cracks at the specified pressure, a second seam-bonded vinyl film having a total thickness greater than that of the first seam-bonded vinyl film is prepared, and if the first seam-bonded vinyl film peels at the specified pressure, a second seam-bonded vinyl film having a total thickness less than that of the first seam-bonded vinyl film is prepared, and repeating steps i) to iv) with the prepared second seam-bonded vinyl film; vi) by repeating the above steps i) to v), a step of determining the total thickness or the range of the total thickness of the vinyl film that is less likely to crack and / or peel off, A method for determining the adhesion threshold of a seam bond. [5] A method for manufacturing a vinyl isolator connected to a connecting sleeve by manufacturing an inner cap or outer cap for a steril lock of a vinyl isolator and attaching it to the steril lock, or by manufacturing a connecting sleeve for a vinyl isolator and connecting it to the vinyl isolator, i) a step of overlapping and seaming two vinyl films from the same direction using a high-frequency welder to prepare a seam-bonded vinyl film; ii) measuring the total thickness of the glued vinyl film; iii) a step of measuring pressure resistance, which includes performing a pressure test on the seam-bonded vinyl film by applying a specified pressure to the film and checking whether cracks or peeling occur; iv) a step of judging the vinyl film as defective if its pressure resistance is less than a practical pressure, as acceptable if its pressure resistance is equal to or greater than a practical pressure, and as good if no cracks or peeling occurs even when the specified pressure is applied; v) if the seam-bonded vinyl film, i.e., the first seam-bonded vinyl film, is judged to be defective in step iv), a seam-bonded vinyl film, i.e., a second seam-bonded vinyl film, having a total thickness different from that of the first seam-bonded vinyl film is prepared, provided that if the first seam-bonded vinyl film cracks at the specified pressure, a second seam-bonded vinyl film having a total thickness greater than that of the first seam-bonded vinyl film is prepared, and if the first seam-bonded vinyl film peels at the specified pressure, a second seam-bonded vinyl film having a total thickness less than that of the first seam-bonded vinyl film is prepared, and steps i) to iv) are repeated for the second seam-bonded vinyl film prepared; vi) a step of determining a total thickness or a range of total thickness that is unlikely to cause cracks and / or peeling by repeating the above steps i) to v), and determining an adhesion threshold for seam bonding; vii) A process for manufacturing an inner cap or an outer cap for a steril lock by seam bonding using a high-frequency welder, or a process for manufacturing a connecting sleeve for a vinyl isolator by seam bonding using a high-frequency welder, in which the seam bonding is performed by overlapping the seams of two vinyl films from the same direction and bonding them with a high-frequency welder. viii) measuring the total thickness of the two vinyl films after they have been joined by seam bonding; ix) a quality control step of evaluating whether the total thickness of the two vinyl films after the joining is the total thickness that is unlikely to cause cracks and / or peeling determined in step vi) or is within the range of total thicknesses, and adopting the total thickness of the two vinyl films after the joining if it is the total thickness that is unlikely to cause cracks and / or peeling or is within the range of total thicknesses; x) attaching the inner cap or outer cap adopted in step ix) to the vinyl isolator or connecting a connecting sleeve to the vinyl isolator to manufacture the vinyl isolator; The method comprising: [6] The method according to embodiment 4 or 5, wherein the thickness that is resistant to cracking and / or peeling is a total thickness that, when two 0.5 mm thick vinyl chloride films are used, results in a total thickness of 0.55±0.05 mm after the two vinyl films are spliced ​​and bonded. [7] A method for manufacturing a vinyl isolator by manufacturing an inner cap or outer cap for a steril lock of a vinyl isolator and attaching it to the steril lock, or a method for manufacturing a vinyl isolator connected to a connecting sleeve by manufacturing a vinyl isolator and connecting it to a vinyl isolator, i) a step of overlapping and seaming two pieces of vinyl chloride film, each having a thickness of 0.5 mm, from the same direction using a high-frequency welder; ii) measuring the total thickness of the two vinyl chloride films after they have been joined by seam bonding; and iii) A quality control process to evaluate whether the total thickness of the two vinyl films after the joints are glued together is 0.55mm ± 0.05mm, and adopt it if it is within this range; iv) a step of manufacturing an inner cap or an outer cap for a steril lock of a vinyl isolator or a connecting sleeve for a vinyl isolator using the vinyl film adopted by step iii); and v) attaching the inner cap or outer cap of step iv) to the vinyl isolator to manufacture the vinyl isolator, or connecting a connecting sleeve to the vinyl isolator to manufacture a vinyl isolator connected to the connecting sleeve; The method comprising: [Effects of the Invention]

[0011] In one embodiment, the present invention has the advantage of providing inner and outer caps for sterilized locks on vinyl isolators that do not or are resistant to cracking or peeling, thereby providing vinyl isolators fitted with the inner and / or outer caps that do not or are resistant to cracking or peeling, or vinyl isolators connected to connecting sleeves that do not or are resistant to cracking or peeling. Also, in one embodiment, the present invention has the advantage of providing connecting sleeves for vinyl isolators that do not or are resistant to cracking or peeling, and thereby providing vinyl isolators connected to connecting sleeves that do not or are resistant to cracking or peeling. [Brief explanation of the drawings]

[0012] [Figure 1] This is a photo of the outer cap with a crack. I put tweezers through the crack and wrote the date next to it. [Figure 2] High frequency welding method is shown. The top is patch welding, and the bottom is lap welding. [Figure 3] This is a photo of the octagonal outer cap. The octagonal outer cap was attached to the cylindrical steril lock member on the outer surface of the vinyl isolator. [Figure 4] FIG. 1 is a schematic diagram of a vinyl isolator. [Figure 5] The procedure for loading and unloading into the chamber via the steril lock is shown. [Figure 6] FIG. [Figure 7] FIG. 10 is a schematic diagram of the sterilization procedure when connecting a connecting sleeve to a steril lock. [Figure 8] This is a photograph of the connecting sleeves connected together. 1 is the chamber, 2 is the steril lock, 3 and 5 are vinyl tape, 4 is the connecting sleeve, and 6 is the sterilization can. DETAILED DESCRIPTION OF THE INVENTION

[0013] In one embodiment, the present invention provides a method for manufacturing a vinyl isolator by fabricating an inner cap or outer cap for a steril lock and attaching it to the steril lock, or a method for manufacturing a vinyl isolator by fabricating a connecting sleeve for a vinyl isolator and attaching it to the steril lock to manufacture a vinyl isolator connected to the connecting sleeve. This manufacturing method may include i) using a high-frequency welder to manufacture an inner cap or outer cap for the steril lock by lap bonding, or i) using a high-frequency welder to manufacture a connecting sleeve for a vinyl isolator by lap bonding. In lap bonding, two vinyl films are overlapped and bonded together from different directions. That is, unless otherwise specified in this specification, lap bonding refers to a bonding method in which two vinyl films are overlapped and bonded together from different directions. An example is shown on the right side of Figure 2. Next, the inner cap or outer cap for the steril lock of the vinyl isolator manufactured by lap bonding can be attached to the steril lock to manufacture the vinyl isolator. Alternatively, a vinyl isolator connected to a connecting sleeve can be manufactured by connecting a connecting sleeve manufactured by lap bonding to the vinyl isolator.

[0014] Vinyl films used in vinyl isolators, such as polyvinyl chloride films, are flexible, highly elongated, and generally transparent or highly transparent. Furthermore, vinyl films used in vinyl isolators can be bonded using high-frequency electromagnetic waves and are easy to handle. The vinyl film used may be, but is not limited to, a film with a thickness of 0.3 to 1 cm, e.g., 0.4 to 0.8 cm, e.g., 0.4 to 0.6 cm, or e.g., 0.5 to 0.55 mm. The dimensions and shape can be designed according to the intended vinyl isolator. Known or commercially available vinyl films can be used, including, but not limited to, those manufactured by Achilles. When manufacturing a vinyl isolator, vinyl sheets are bonded (also known as adhesive or welding) using a vinyl bonding machine. The vinyl bonding machine melts and bonds the bonding sites using high-frequency heat. High-frequency heat is typically applied using a high-frequency welder. Known or commercially available high-frequency welder devices can be used in the manufacturing method of the present invention. Examples include, but are not limited to, Seidensha Electronics' KV-3000 series, such as the KV-3000T, KV-4000 series, and KV-5000 series. To stabilize operation and improve reproducibility, devices such as the KV-3000T are equipped with tuner memory, allowing specific conditions to be selected. Those skilled in the art will be able to select and use an appropriate tuner memory.

[0015] In some embodiments, the high frequency welding can be performed with a straight bar, which is a common configuration for high frequency welding equipment. In some embodiments, the method of the present invention does not involve the use of a circular or arc-shaped bar. That is, in some embodiments, the method of the present invention excludes (is not included in) high frequency welding using a circular or arc-shaped bar.

[0016] In one embodiment, the present invention provides a method for determining a seam adhesion threshold for manufacturing an inner cap or outer cap for a steril lock of a vinyl isolator and attaching it to the steril lock to manufacture a vinyl isolator, or for manufacturing a connecting sleeve for a vinyl isolator and connecting it to a vinyl isolator to manufacture a vinyl isolator connected to the connecting sleeve, the method comprising: i) a step of overlapping and gluing two vinyl films together from the same direction using a high-frequency welder to prepare a glued vinyl film; ii) measuring the total thickness of the glued vinyl film; iii) a step of measuring pressure resistance, which includes performing a pressure test on the seam-bonded vinyl film by applying a specified pressure to the film and checking whether cracks or peeling occur; iv) a step of judging the vinyl film as defective if its pressure resistance is less than a practical pressure, as acceptable if its pressure resistance is equal to or greater than a practical pressure, and as good if no cracks or peeling occurs even when the specified pressure is applied; v) if the seam-bonded vinyl film, i.e., the first seam-bonded vinyl film, is determined to be defective in step iv), a seam-bonded vinyl film, i.e., a second seam-bonded vinyl film, having a total thickness different from that of the first seam-bonded vinyl film is prepared, and steps i) to iv) are repeated for the prepared second seam-bonded vinyl film; and vi) repeating the above steps to determine a total thickness or a range of total thicknesses that are less likely to crack and / or peel. In step v), if the first seam adhesive vinyl film cracks at the specified pressure, a second seam adhesive vinyl film having a total thickness greater than that of the first seam adhesive vinyl film can be prepared. Alternatively, if the first seam adhesive vinyl film peels at the specified pressure, a second seam adhesive vinyl film having a total thickness less than that of the first seam adhesive vinyl film can be prepared. This allows the range of total thicknesses that are less likely to crack and / or peel to be determined.

[0017] In one embodiment, the present invention provides a method for producing a vinyl isolator by manufacturing an inner cap or outer cap for a steril lock of a vinyl isolator and attaching it to the steril lock, or by manufacturing a connecting sleeve for a vinyl isolator and connecting it to a vinyl isolator, thereby producing a vinyl isolator connected to the connecting sleeve. i) a step of overlapping and seaming two vinyl films from the same direction using a high-frequency welder to prepare a seam-bonded vinyl film; ii) measuring the total thickness of the glued vinyl film; iii) a step of measuring pressure resistance, which includes performing a pressure test on the seam-bonded vinyl film by applying a specified pressure to the film and checking whether cracks or peeling occur; iv) a step of judging the vinyl film as defective if its pressure resistance is less than a practical pressure, as acceptable if its pressure resistance is equal to or greater than a practical pressure, and as good if no cracks or peeling occurs even when the specified pressure is applied; v) if the seam-bonded vinyl film, i.e., the first seam-bonded vinyl film, is determined to be defective in step iv), preparing a seam-bonded vinyl film, i.e., a second seam-bonded vinyl film, having a total thickness different from that of the first seam-bonded vinyl film, and repeating steps i) to iv) for the prepared second seam-bonded vinyl film; vi) a step of determining a total thickness or a range of total thickness that is unlikely to cause cracks and / or peeling by repeating the above steps i) to v), and determining an adhesion threshold for seam bonding; vii) A process for manufacturing an inner cap or an outer cap for a steril lock by seam bonding using a high-frequency welder, or a process for manufacturing a connecting sleeve for a vinyl isolator by seam bonding using a high-frequency welder, in which the seam bonding is performed by overlapping the seams of two vinyl films from the same direction and bonding them with a high-frequency welder. viii) measuring the total thickness of the two vinyl films after they have been joined by seam bonding; ix) a quality control step of evaluating whether the total thickness of the two vinyl films after the joining is the total thickness that is unlikely to cause cracks and / or peeling determined in step vi) or is within the range of total thicknesses, and adopting the total thickness of the two vinyl films after the joining if it is the total thickness that is unlikely to cause cracks and / or peeling or is within the range of total thicknesses; x) attaching the inner cap or outer cap adopted in step ix) to a vinyl isolator to manufacture a vinyl isolator, or connecting a connecting sleeve to a vinyl isolator to manufacture a vinyl isolator connected to the connecting sleeve. However, in step v), if the first seam adhesive vinyl film cracks at the specified pressure, a second seam adhesive vinyl film can be prepared having a total thickness greater than that of the first seam adhesive vinyl film, or if the first seam adhesive vinyl film peels at the specified pressure, a second seam adhesive vinyl film can be prepared having a total thickness less than that of the first seam adhesive vinyl film. This makes it possible to determine a range of total thicknesses that are less likely to crack and / or peel.

[0018] In one embodiment, the thickness that is less likely to cause cracking and / or peeling in a seam-bonded film can be a total thickness of 0.55±0.05 mm after two 0.5 mm thick vinyl chloride films are used. Even if the thickness of the vinyl chloride film is not necessarily 0.5 mm, a thickness that is less likely to cause cracking and / or peeling corresponding to the thickness of the vinyl chloride film can be appropriately determined using the method of the present invention. In this specification, this thickness is referred to as a thickness that corresponds to a total thickness of 0.55±0.05 mm after two 0.5 mm thick vinyl chloride films are used. This corresponding thickness is also encompassed within the present invention.

[0019] In one embodiment, the present invention provides a method for producing a vinyl isolator by manufacturing an inner cap or outer cap for a steril lock of the vinyl isolator and attaching it to the steril lock, or a method for producing a vinyl isolator by manufacturing a connecting sleeve for the vinyl isolator and connecting it to the vinyl isolator, thereby producing a vinyl isolator connected to the connecting sleeve. i) A process of overlapping and gluing two pieces of vinyl chloride film, each having a thickness of 0.5 mm, from the same direction using a high-frequency welder; ii) measuring the total thickness of the two vinyl chloride films after they have been joined by seam bonding; and iii) A quality control process to evaluate whether the total thickness of the two vinyl films after the joints are glued together is 0.55mm ± 0.05mm, and adopt it if it is within this range; iv) a step of manufacturing an inner cap or an outer cap for a steril lock of a vinyl isolator or a connecting sleeve for a vinyl isolator using the vinyl film adopted by step iii); and v) attaching the inner cap or outer cap of step iv) to the vinyl isolator to manufacture the vinyl isolator, or connecting a connecting sleeve to the vinyl isolator to manufacture a vinyl isolator connected to the connecting sleeve; may include:

[0020] A vinyl isolator typically has an air intake, a rearing room (also called a chamber), and an exhaust port. The air supplied through the air intake must be sterile, and a filter is typically used for this purpose. The filter is designed to remove microorganisms and viruses from the outside air, ensuring sterility. The filter material may be FG-50 or a HEPA filter. Sterile air is supplied through the air intake and supplied to the germ-free animals kept in the rearing room, and then exhausted through the exhaust port. A trap may be installed in the exhaust port. Gloves may be connected to the rearing room for internal operations. Operations inside the rearing room are generally performed using gloves. Vinyl isolators also typically have a sterilizing lock for the introduction and removal of animals and food. In some cases, vinyl isolators may also have a germicidal trap. A sterilizing lock typically has two vinyl tubes attached to the outer cap, which can be closed with a rubber stopper or similar. To sterilize the Sterillock, remove the rubber stopper, spray sterilant from one vinyl tube, wait for the mist to come out of the other vinyl tube, then replace the rubber stopper, spray a certain amount of sterilant, then spray the sterilant into the rubber stopper and close the nozzle. See Figure 4 for the general configuration of a vinyl isolator.

[0021] In a sterile environment, objects are generally transferred into and removed from the animal enclosure via a steril lock. The steril lock has caps on both sides. When transferring an object, the outer cap is opened, the outer surface of the object and the interior of the enclosure are sterilized, and then the outer cap is closed. After sterilizing the interior of the steril lock, the inner cap is opened and the object is transferred. The inner cap can then be closed. When transferring an object, the interior of the steril lock is sterilized, the inner cap is opened, and the object is transferred into the sterilized steril lock. The inner cap is then closed, and the outer cap is opened. After the object is transferred, the outer cap is closed. The interior of the steril lock can also be sterilized. See Figure 5 for an example. For example, in the case of a cylindrical steril lock, the cylindrical steril lock body (hard vinyl chloride portion) and the inner cap can be sealed and fixed with a rubber band. Examples of rubber bands that can be used include, but are not limited to, silicone rubber bands, such as JIC's JV-1005. The cylindrical steril lock body and the outer cap can also be sealed and fixed with a rubber band or vinyl tape. Commercially available vinyl tape can be used.

[0022] A connecting sleeve can be used to connect two vinyl isolators. Alternatively, a connecting sleeve can be used to connect a vinyl isolator to a sterilization can or a transport can. A schematic diagram of a connecting sleeve is shown in Figure 6. The connecting sleeve has two connecting ports, one on the left and one on the right. The central portion can be made of a vinyl membrane. A disinfection port can be provided in the central vinyl portion. The central vinyl portion can also optionally have a window for access. The connecting ports of the connecting sleeve can have the same or approximately the same dimensions (diameter) as the steril lock to be connected. The connecting ports of the connecting sleeve can be made of the same material as the steril lock, for example, hard polyvinyl chloride, or aluminum, but the material is not limited to these. The left and right connecting ports and the central vinyl portion of the connecting sleeve can be sealed and fixed with vinyl tape. For example, they can be sealed and fixed by wrapping vinyl tape three or more times. If the central vinyl portion of the connecting sleeve is larger in diameter than the steril lock, for example, the central vinyl portion can be composed of three or five vinyl portions. Furthermore, the three or five vinyl portions can be welded using a high-frequency welder. The welding can be done by lap bonding or seam bonding, i.e., in one embodiment, lap bonding is used to produce connecting sleeves for vinyl isolators, and in another embodiment, seam bonding is used to produce connecting sleeves for vinyl isolators.

[0023] In this specification, "manufacturing an inner cap or outer cap for a Sterillock on a vinyl isolator using high-frequency welding" refers to the manufacturing of the inner cap itself and the manufacturing of the outer cap itself. This is different from the operation of sealing and fixing the inner cap or outer cap to the Sterillock body (hard vinyl chloride portion) using rubber bands or vinyl tape. In this specification, attaching an inner cap or outer cap to a vinyl isolator is referred to as "attaching" the inner cap or outer cap to the vinyl isolator. Similarly, "manufacturing a connecting sleeve for a vinyl isolator using high-frequency welding" refers to the manufacturing of the connecting sleeve itself. This is different from the operation of sealing and connecting the connecting sleeve to the vinyl isolator (i.e., the Sterillock portion of the vinyl isolator) using rubber bands or vinyl tape. In this specification, attaching the connecting sleeve to the vinyl isolator is referred to as "connecting" the connecting sleeve to the vinyl isolator.

[0024] A HEPA (High Efficiency Particulate Arrestance) filter is a filter that can capture particles with high efficiency, and is defined by the JIS Z 8122 standard as an air filter that has "a particle collection rate of 99.97% or more for particles with a particle size of 0.3 μm at the rated air flow rate, and an initial pressure loss of 245 Pa or less."

[0025] The vinyl isolator may be standard, large, or small. The fasteners may be of various sizes depending on the purpose. In some embodiments, the vinyl isolator is a device for large animal housing, such as monkeys, pigs, chickens, dogs, or cats. In some embodiments, the vinyl isolator may be a device commercially available from SICK Corporation, or may be an equivalent thereof.

[0026] Vinyl isolators are also commonly used with sterilization canisters to transfer their contents into and out of the isolator. The sterilization canisters can be attached to the isolator so that their contents can be transferred into and out of the isolator while maintaining sterility. Vinyl isolators are also commonly used with transport canisters to transport germ-free animals into and out of the isolator. The transport canisters can be attached to the isolator so that germ-free animals can be transferred into and out of the isolator while also maintaining sterility.

[0027] A sterilization can be attached to a vinyl isolator, for example, by the following method: (i) Remove the outer cap of the vinyl isolator. (ii) Disinfect the steril lock and connecting sleeve. (iii) Attach the connecting sleeve to the steril lock and secure it with vinyl tape (sealing). (iv) Disinfect the other side of the connecting sleeve and the lumirror film part of the sterilization can. (v) Connect the connecting sleeve to the sterilization can and secure it with vinyl tape (sealing). Disinfection can be carried out by spraying, for example, Expore (manufactured by CLEA Japan), Neopore (manufactured by CLEA Japan), Acrofine (manufactured by SICK), or peracetic acid. A schematic diagram of the sterilization procedure when connecting the connecting sleeve to the steril lock is shown in Figure 7.

[0028] A transport can can be attached to a vinyl isolator, for example, by the following method: (1) Disinfect the transport can and the dedicated connecting sleeve. (2) Attach the connecting sleeve to the sterilized transport can and seal it with vinyl tape. (3) Remove the outer cap of the isolator. (4) Disinfect the steril lock. (5) Disinfect the inside and outside of the connecting sleeve attached to the transport can. (6) Attach the open side of the sterilized sleeve to the steril lock and seal it with vinyl tape. (7) Gently push the transport can into the steril lock and remove the air from inside the connecting sleeve. (8) Disinfect the inside of the connecting sleeve via the spray nozzle of the connecting sleeve. Disinfection can be done using a means such as a spray gun. Disinfection should be continued until the sleeve becomes cylindrical. (9) Remove the spray gun and gently push the inside of the transport can into the steril lock to remove the disinfectant from the sleeve. (10) Repeat step (8), replace the rubber stopper, and leave it for several hours. (11) Check that there are no dents in the connecting sleeve and remove the cap inside the vinyl isolator. (12) Push the transport canister through the steril lock into the isolator. (13) Flip the connecting sleeve around the cap sealing the transport canister inside out to expose the transport canister cap. (14) Roll up the tape securing the transport canister cap, then remove the transport canister cap. (15) Transfer the animals from the transport canister into the vinyl isolator, or transfer the animals in the vinyl isolator into the transport canister. Then, attach the inner cap to the steril lock and secure it with a rubber band. (16) Remove the tape on the steril lock side of the connecting sleeve and remove the transport canister. (17) Disinfect the steril lock and outer cap, attach the outer cap to the steril lock, and seal with vinyl tape. (18) Push the outer capister into the steril lock, remove the air from the steril lock, and spray with disinfectant. (19) Push the inner capister into the steril lock again, remove the air from the steril lock, spray with disinfectant just enough to cause the outer cap to swell, and seal with a rubber stopper. (20) After spraying the disinfectant using a spray gun or other means, replace the rubber stopper and leave the inner and outer caps in an inflated state for several hours.

[0029] That is, the steril lock and connecting sleeve play an important role in the vinyl isolator for connecting it to a transport can or a sterilization can. Gloves also play an important role in the internal operation of germ-free animals. The connecting sleeve also plays an important role for connecting chambers of the vinyl isolator or for connecting a chamber to a transport can or a sterilization can. The vinyl isolator can be manufactured by a conventionally known method, for example, the method described in Non-Patent Document 2, the entire contents of which are incorporated herein by reference. [Example]

[0030] The present invention will be further illustrated by the following examples, although the scope of the present invention is not limited to these examples in any way.

[0031] The inner and outer caps of the Sterillock vinyl isolator were manufactured by high-frequency welding. Welding was carried out using two welding methods as shown in Figure 2. Patch bonding is a welding method in which the patch edges of two films are aligned in the same direction. Lap bonding is a method in which the patch edges of two films (vinyl material) are overlapped and bonded from different directions.

[0032] The thickness of the adhesive surface of each cracked and peeled cap was measured at approximately 10 points using a vernier caliper (N15, Mitutoyo Corporation, Kanagawa Prefecture). A normal outer cap was used as a control.

[0033] A comparison of patch and lap bonding using a high-frequency welder (KV-3000T, Seidensha Electronics) with different tuner registers was performed on the 12-cm edge of a 0.5-mm-thick, 30-cm-long, and 12-cm-wide vinyl film (0.5-mm transparent red vinyl sheet, Achilles Co., Ltd., Tokyo). The upper electrode of the high-frequency welder was used as a patch bond, with a 0.5-cm-wide and 15-cm-long straight bar for patch bonding, and a 0.5-cm (width) x 15-cm (length) and 1.0-cm x 15-cm straight bar for lap bonding. The current was applied for 2.5 seconds, and the tuner register was changed to six conditions: 5, 10, 15, 20, 25, and 30. Two to three lower layers were bonded on each top surface, and the thickness of the bonded surface was measured, and tensile strength tests were performed using both hands.

[0034] The inner and outer caps were fabricated using overlap bonding. The sides of the caps were glued in the same way as with patch bonding. Since overlap bonding was not possible with round bars, the top plate was fabricated into an octagonal shape using a straight bar. The straight bar was 5 mm thick, 3 cm wide, and 30 cm long. A standard round bar is 5 mm thick and 30 cm in diameter (15 cm radius). The flange of the outer cap was also fabricated into an octagonal shape using a straight bar. To compare pressure resistance, an overlap-bonded outer cap was attached to one side of the Steryllock, wrapped with filament tape, and then secured with a double wrap of wire. A rubber stopper with a British valve for bicycle tubes was attached to one side of the cap pipe to serve as a pressure port, and a rubber stopper with a silicone tube was attached to the remaining pipe to measure internal pressure. Pressure was applied using a pressure compressor (ACP-50, Ryobi Ltd., Hiroshima), and internal pressure was measured using a multi-environment measuring instrument (Testo 435, Testo Co., Ltd., Kanagawa Prefecture). The test cap was attached to the opposite side of the Steryllock. The pressure resistance test for the lap-bonded outer cap was performed by wrapping filament tape around it and then doubling the wire around it. Pressure was applied and stopped at a target pressure of 20 kPa, and the pressure (resistance pressure) was recorded. The pressure was then released for approximately five minutes, and then re-applied. This cycle of pressure application and release was repeated 10 times, and the average was used as the pressure resistance result. The pressure resistance of the patch-bonded outer cap was also measured in the same way as for the lap-bonded outer cap. The patch-bonded outer cap also cracked or peeled when pressure was applied, and the pressure was recorded. The inner cap has a flange, so it cannot be secured with tape. Therefore, it was secured with a band. The test cap was secured with a double wire. Ten pressure measurements were attempted for the lap-bonded inner cap, aiming for a target pressure of 16 kPa. The patch-bonded inner cap was measured at the pressure at which it cracked or peeled 7 times, and the average values ​​were compared. The results are shown below.

[0035] 1.Measurement of the thickness of the adhesive surface of the cracked and peeled cap The average thickness of the 10 cracked cap adhesive surfaces was 0.40 ± 0.04 mm, the average thickness of the 12 peeled cap adhesive surfaces was 0.69 ± 0.03 mm, and the average thickness of the 22 intact cap adhesive surfaces was 0.55 ± 0.05 mm (Table 1).

[0036] [Table 1]

[0037] 2. Comparison of joint bonding and lap bonding using a high-frequency welder The thickness of the adhesive surface of tuner memory 5 in the patch bonding was 0.8 mm, and that of memory 10 was 0.73 mm, and all peeled off in the strength test. The thickness of the adhesive surface of memory 15 and memory 20 was 0.5 mm, and no cracks or peeling occurred in the strength test. The thickness of the adhesive surface of memory 25 and memory 30 was 0.3 mm, and all cracked in the strength test.

[0038] The thickness of the adhesive surface for tuner scale 5 on a 0.5 cm wide linear bar with lap adhesion was 1.0 mm, 0.9 mm for scale 10, 0.8 mm for scale 15, 0.7 mm for scale 20, 0.56 mm for scale 25, and 9.48 mm for scale 30. No cracking or peeling occurred in the strength test under any of the conditions. When a 1 cm wide linear bar was used, the thickness of the adhesive surface for tuner scale 5 was 1.0 mm, 0.9 mm for scale 10, 0.8 mm for scale 15, 0.7 mm for scale 20, 0.6 mm for scale 25, and 0.5 mm for scale 30, and no cracking or peeling occurred in the strength test (Table 2).

[0039] [Table 2]

[0040] 3. Pressure resistance test of overlapping adhesive inner cap and outer cap The lap-bonded cap showed no cracking or delamination when pressure was applied at a target pressure of 20 kPa. The pressure was 22.03 ± 1.41 kPa after 10 pressure cycles. The outer cap with a patch bond cracked after all 10 pressure cycles, with an average pressure of 13.37 ± 4.06 kPa. The inner cap with a lap-bonded cap showed no cracking or delamination after pressure was applied at a target pressure of 16 kPa. The inner cap with a patch bond cracked after all 7 pressure cycles, with an average pressure of 12.46 ± 4.99 kPa (Table 3).

[0041] [Table 3]

[0042] Consideration The average thickness of the adhesive surface of cracked caps was approximately 0.4 mm, while the average thickness of the adhesive surface of peeled caps was approximately 0.68 mm. On the other hand, the average adhesive surface thickness of normal caps was approximately 0.5 mm. In other words, cracks and peeling appear to have different causes. On the one hand, cracks are caused by excessive welder welding, while peeling is thought to be caused by insufficient welder welding. Furthermore, when comparing patch and lap welds, patch welds with tuner memory values ​​of 15 and 20 had a 0.5 mm adhesive surface thickness and no cracks or peeling were observed. However, the adhesive surface with high memory was thin and cracked during strength testing, while the adhesive surface with low memory was thick and peeled during testing. These results suggest that uneven adhesion in patch welds affects cracking and peeling. For lap welds, the adhesive surface thickness changed with the tuner memory value, and no cracks or peeling were observed during strength testing (two-handed tensile testing). In a pressure resistance test of the outer cap and inner cap that had been lap bonded, it was confirmed that lap bonding had better pressure resistance than joint bonding.

[0043] After that, a high-quality inner or outer cap was attached to the Sterillock to manufacture a vinyl isolator. Connecting sleeves can also be manufactured and evaluated in the same manner, and can be connected to the vinyl isolator.

[0044] The pressure applied to the connecting sleeve during use is basically the same as that of the inner cap and outer cap, and therefore the required specifications and standards are also the same as those of the inner cap and outer cap for SterilLock. Furthermore, connecting sleeves have traditionally been manufactured using the same methods as the inner cap and outer cap for SterilLock. Therefore, connecting sleeves, which are made of the same materials and have the same required standards as the inner cap and outer cap, can also be manufactured by welding using the same method as above, their quality evaluated, and connected to vinyl isolators. In this case, it is reasonably understood by those skilled in the art that connecting sleeves manufactured and evaluated using the same method as above will also be free from cracking and peeling, just like the inner cap and outer cap.

[0045] Vinyl isolators were initially manufactured by germ-free animal researchers, and vinyl film was independently produced by individual laboratories or research institutes through trial and error. Later, with the participation of expert processors, the majority of vinyl isolators were manufactured using overlap bonding. However, the outer cap, inner cap, and connecting sleeve required the use of round bars to fit the round sterilized locks, and therefore, patch bonding using round bars was primarily used. This method frequently resulted in insufficient adhesive bonding, which was a troubling issue for the inventors. Furthermore, round bars could only achieve standard curves, and if a different curve was desired, a round bar had to be specifically designed or custom-ordered to fit the desired curve.

[0046] In this study, we surprisingly confirmed that the adhesion threshold for seam bonding is extremely narrow, based on the relationship between the total thickness of the two vinyl sheets and the risk of cracking or delamination. Furthermore, the adhesion threshold for seam bonding that can be tolerated without cracking or delamination was narrower than expected. The cracking and delamination observed in the inner and outer caps for Sterillock in the case of seam bonding were likely due to uneven adhesion during seam bonding. Therefore, we fabricated an octagonal cap for lap bonding using a straight bar. This cap fit Sterillock, as shown in Figure 3. This indicates that a straight bar can be used to fabricate various diameters that previously required a round bar. We also confirmed that the adhesion threshold for lap bonding is wide and has high pressure resistance. Both seam bonding and lap bonding ultimately involve bonding the seams of two vinyl sheets together. Therefore, there is no rational reason to expect the resulting adhesive strength to differ between seam bonding and lap bonding. Our results were unexpected and unpredictable. Based on this surprising and unexpected finding, it is expected that by using overlap adhesive on the outer and inner caps and connecting sleeves for Steril-Lock, it will be possible to avoid cracks and peeling in the outer and inner caps of Steril-Lock and the connecting sleeves of vinyl isolators, thereby eliminating unexpected accidents. [Industrial Applicability]

[0047] It is possible to manufacture a vinyl isolator with a sterilized lock having an inner cap or outer cap that does not or is resistant to cracking or peeling, and / or a vinyl isolator connected to a connecting sleeve that does not or is resistant to cracking or peeling. This also makes it possible to realize a vinyl isolator with fewer contamination accidents.

[0048] The disclosures of the documents cited herein are not considered relevant to the patentability of this invention, but are hereby incorporated by reference in their entirety. More particularly, all referenced documents are hereby incorporated by reference to the same extent as if each individual document was specifically and individually indicated to be incorporated by reference. [Explanation of symbols]

[0049] 1 vinyl isolator 2. Vinyl film 3. Gloves 4. Sterilrock 5. Air filter 6 Air outlet trap 7. Germicidal Trap

Claims

[Claim 1] A method for manufacturing a vinyl isolator by manufacturing an inner cap or an outer cap for a steril lock of a vinyl isolator and attaching it to the steril lock of the vinyl isolator, or a method for manufacturing a vinyl isolator connected to a connecting sleeve by manufacturing a connecting sleeve for a vinyl isolator and connecting it to the vinyl isolator, i) using a high frequency welder to produce inner and outer caps for Sterillock by lap bonding, or using a high frequency welder to produce connecting sleeves for vinyl isolators by lap bonding; ii) A process of attaching the inner cap and outer cap manufactured by overlap bonding to the steril lock of the vinyl isolator, or connecting the connecting sleeve manufactured by overlap bonding to the vinyl isolator. Including, The lap bonding is performed by overlapping two pieces of vinyl film together at different angles and bonding them together with a high-frequency welder, and the bonding is performed with a high-frequency welder using a straight bar.

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