Bag hanger for cleanroom environment

A bag hanger has a main bracket body with a first leg configured for mounting the main bracket body on a support and a second leg extending from the first leg that is configured for hanging a bag. The second leg includes an open-ended slot that is accessible at a distal end of the second leg, the open-ended slot being sized to receive at least one hangable portion of the bag.

BACKGROUND

A clean environment is an area designed, maintained, and controlled to prevent particle and microbiological contamination of products. Clean environments include, for example, restricted access barrier systems (RABS), cleanrooms and isolators. There are different levels of cleanliness in clean environments, generally in the range of a Class 100 (i.e., having 100 particles of 0.5 micron and larger, per cubic foot of air), to a Class 10,000.

Clean environments are used for a variety of purposes, such as in the manufacture of pharmaceutical products and electronics, such as semiconductors. Often, clean environments are used to work on extremely expensive and complex products, and it is not unusual that there be millions of dollars of product in a clean environment at any given time. Clean environments have to maintain a high level of cleanliness, or risk large financial losses. If a product being developed or manufactured in a clean environment becomes contaminated, the entire product in the clean environment must often be discarded.

The U.S. Food and Drug Administration (“FDA”) requires firms to assure that every element of the manufacturing environment and manufacturing process are proven to be acceptable to FDA requirements and industry standards. The FDA requires firms to operate in accordance with Current Good Manufacturing Practices (CGMP). To do this, firms are required to assure that products, personnel, training, ingredients, procedures and systems used in the manufacture of a drug product have undergone stringent testing. In light of the strict standards that clean rooms must satisfy, companies are very reluctant to introduce new products into their clean room that have not been extensively tested and proven reliable.

As shown in U.S. Pat. Nos. 10,279,976, 10,138,448, and U.S. Publ. Appl. No. 2020/0085982, and U.S. Publ. Appln. No. 2021/0284424, sterilizing wiper products have been developed that are used in clean environments. The wipers are contained in an enclosure such as a plastic bag, which can be sterilized prior to entry into the clean environment. The enclosure can then be opened inside the clean environment to dispense the wipers contained therein. Those references are hereby incorporated by reference in their entireties. However, those wiper products, as well as other product, are not readily retained in clean environments, and particularly in a RABS or isolator.

SUMMARY

The disclosure relates generally to a hanger and more particularly to a hanger for hanging a bag, such as when sterilizing and utilizing the bag in a clean environment. And, particularly for use in clean environments having more limited space or accessed by a user located outside of the clean environment, such as a RABS or isolator. This disclosure is further directed to a bag configured to be retained in the hanger.

The present disclosure relates to a bag hanger that comprises a main bracket body that has a first leg configured for mounting the main bracket body on a support and a second leg that extends from the first leg that is configured for hanging a bag. The second leg has an open-ended slot that is accessible at a distal end of the second leg. The open-ended slot is sized to receive at least one hangable portion of the bag.

In certain examples of the present disclosure, the main bracket body is a unitary one-piece member; the main bracket body is substantially L-shaped; the main bracket body has a substantially uniform thickness and width; the first leg includes one or more mounting holes; the open-ended slot is centered at the distal end of the second leg; and/or the main bracket body is formed of metal.

The present disclosure may also provide a bag hanger assembly that comprises at least one bag that has at least one hangable portion at one end thereof and a main bracket body. The main bracket body comprises a first leg configured for mounting the main bracket body on a support and a second leg extending from the first leg. The second leg has an open-ended slot that is accessible at a distal end of the second leg. The open-ended slot receives the at least one hangable portion of the bag, thereby hanging the bag from the main bracket body.

In one embodiment, the hangable portion of the bag is a valve with a neck and a head, the neck has a width smaller than a width of the open-ended slot and the head has a width that is larger than the width of the open-ended slot.

In another embodiment, the bag of the bag hanger assembly is for use in a clean environment.

This summary is not intended to identify essential features of the claimed subject matter, nor is it intended for use in determining the scope of the claimed subject matter. It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide an overview or framework to understand the nature and character of the disclosure.

DETAILED DESCRIPTION

In describing the illustrative, non-limiting embodiments illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, the disclosure is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents that operate in similar manner to accomplish a similar purpose. Several embodiments are described for illustrative purposes, it being understood that the description and claims are not limited to the illustrated embodiments and other embodiments not specifically shown in the drawings may also be within the scope of this disclosure.

Referring to the figures, the present disclosure generally relates to a hanger or bracket10that is configured for hanging and suspending a product, and especially a container having an input/output port, e.g., a valve that forms an inlet or outlet for air, liquid or gas to the container. In one embodiment, the container20can be a bag or pouch. The design of the hanger10allows for easy hanging of the bag20and also easy retrieval of the bag20once hung on the hanger10. The hanger10may be formed as a unitary one-piece member and can be formed of, for example, a rigid metal or other rigid material and, when used in a clean environment, readily sterilizable. In one embodiment, the hanger10is made of a corrosion resistant metal such as316stainless steel to further reduce contamination. In addition, the hanger10can be electro-polished to fill or reduce pore size so that it can be more readily sterilized and reduce contamination. Other suitable materials can be used, such as aluminum.

The hanger10can be used to retain items that are used inside a clean environment, for example, a container20that holds wipers saturated with a disinfectant (e.g., bleach) that is used to clean surfaces and product inside the clean environment. The hanger10allows for easily hanging of the bag20in the clean environment so that the bags20can be sterilized and used inside the clean environment.

The hanger10comprises a main bracket body12that has a support mounting device and a product support device. The support mounting device is configured for mounting the main bracket body12on a support, such as a wall52of a cabinet, box, isolator50(FIG.6), and the like. The support mounting device can be, for example, a first leg14. The product support device is configured for hanging a product such as the bag20. The product support device can be, for example, a second leg16that extends from the first leg16at an angle. In an example, the second leg16extends from the first leg14at a substantially orthogonal at a 90-degree angle such that the main bracket body12has a general L-shape. The first and second legs14and16can be substantially flat and have generally the same width and thickness such that the main bracket body12has a uniform thickness and width. The first and second legs14and16can have the same or different lengths. In the embodiment shown, the first and second legs14,16are elongated and generally rectangular in shape.

The first leg14can have one or more mounting features30to mount the first leg14to the support. For example, the mounting features30can be one or more holes sized to receive a corresponding fastener, such as a mounting bolt or screw that pass through the holes into the support to fixedly secure the hanger10to the support. In other embodiments, a mounting hole is not provided but the hanger10can be attached to a wall (FIG.3a) by, for example, a seal that is suitable for use in a clean environment. In the example embodiment ofFIGS.1a,1b,2, two holes are provided in the first leg14. The holes are aligned vertically with one another. In the example embodiment ofFIG.5, the holes are offset with one another so that they are not vertically aligned. The offset embodiment provides greater support in the horizontal direction, for example to prevent side-to-side movement such as if the user inadvertently strikes the second leg16. It will be recognized, however, that other embodiments for securing the hanger10to the support are within the scope of the present disclosure. For example, the support mounting device need not be an elongated member with openings. Instead, the support mounting device can be a strap, adhesive or other fastening mechanism that reliably and fixedly attaches the product support device to the support.

In one example embodiment, the support extends substantially vertically and the first leg14extends parallel to the support, i.e., substantially vertically in the present example, and is mounted to the support. The hanger10can be placed at any suitable location inside the clean environment. When utilized in a RABS or isolator50, as shown for example inFIG.6, the hanger10can be placed on a vertical wall52located directly opposite the glove ports so that the user can readily reach, through the glove ports, the hanger10and the bag20positioned on the hanger10. The isolator wall52can be plastic (transparent or opaque), metal or other material. Or, the wall in a clean environment can be sheet rock, wood or other material. Accordingly, the user can open the bag20to access the wipers enclosed in the bag20, close the bag, and also remove and replace the bag as may be necessary. Of course, the hanger can be positioned at any suitable location within the clean environment. In addition, more than one hanger can be located within the clean environment, though the hangers10should be sufficiently spaced apart so that the bags20do not touch one another so that the bags can be vapor sterilized once introduced into the clean environment, as more fully discussed below and shown for example inFIG.6.

In one example embodiment of the disclosure, the product mounting feature, i.e., the second leg16, is designed to engage the bag20for hanging the same. For example, the product mounting device may have a mounting feature, for example an open-ended slot32with an open distal end and a proximal end38. The slot32is accessible at the distal end34of a distal portion33of the second leg16, as best seen inFIGS.1a,1c, and2. The slot32may be generally centered at the distal end34of the second leg16. Thus, the slot32extends from the distal end34of the second leg16at least partially inward toward the first leg14, thereby forming a first elongated finger17and a second elongated finger19at a distal portion33of the second leg16. In the embodiment shown, the slot32has a uniform width such that the inner sides of the fingers17,19are substantially parallel to one another. However, in other embodiments the slot32can be tapered or stepped to be slightly wider at the open distal end and narrower at the proximal end, to readily receive a hangable portion22of the bag. In still further embodiments, as shown inFIG.1d, the distal ends of the fingers17,19can be angled upward slightly or as much as orthogonally to the top surface of the second leg16to form tabs18. In one embodiment, the tab18is at an angle of approximately 15-45 degrees to the respective finger17,19, and more preferably at about 20 degrees to the respective finger17,19. It will be recognized that the product support device need not be an elongated member with a slot, but other suitable embodiments are suitable.

The open-ended slot32is sized to receive at least one hangable portion22of the bag20, as best seen inFIG.3c. The slot32is sized so that the hangable portion22can readily be slidably received in the slot32. The slot32has a large enough gap so that there is not significant resistance as the hangable portion22is slidably received in the slot. But, the slot32is small enough to reliably hold the hangable portion22. In addition, the slot32(and fingers17,19) are sufficient long so that the hangable portion22does not inadvertently fall out of the slot32. In one embodiment, the length of the slot32is greater than the diameter of the hangable portion22and there is a preset distance from the hangable portion22to the tabs18.

The hangable portion22of the bag20may be, for example, a valve24that has a neck26and a head28. The valve24is securely and reliably affixed to the bag20. The neck26of the valve24can have a width or diameter that is less than the width W (FIG.1c) of the open-ended slot32such that the neck26can be received in the slot32. The head28of the valve24can be wider than the neck26and wider than the width W of the slot32such that the bottom surface of the head28can rest on the upper surface36of the second leg16of the hanger10when the bag20is hung thereon, as seen inFIGS.3a-3c. And because the slot32of the hanger10is open-ended at the distal end34of the second leg16, the bag20can be easily placed on and removed from the hanger10by sliding the hangable portion22of the bag20in and out of the slot34. The bag20can be fully received in the slot and come to a stop at the proximal end38of the slot32. The proximal end38stops forward progress of the bag20when the hangable portion22(e.g., the head28) contacts the proximal end38. In some embodiments, the slot32can extend the entire length of the second leg16, so that the bag20comes to rest when the bag contacts the support.

It is noted that the hanger can be utilized with suitable container20, such as those shown in U.S. Publ. No. 2020/0085982, which is incorporated by reference in its entirety. In one embodiment, the containers20shown inFIGS.3a-3c,4a-4bare utilized.

In use, to introduce the bag20into a cleanroom, the wiper is placed between plastic layers and the layers are hermetically heat sealed to enclose the wiper. At the same time, a fill port24, such as a one-way valve24is heat sealed to the plastic layers. The bag can be irradiation sterilized, then a disinfectant such as sterilized bleach can be aseptically filled into the bag through the valve or fill port24. The bag can then be double bagged (successively enclosed in two bags that are each then hermetically sealed) and placed in a lined carton for delivery to the end user. On site, the user removes the double bags and places the container20inside the clean environment.

The user places the bag20on the hanger10inside the clean environment by sliding the neck26of the hangable portion22into the slot32. When used in an isolator or RABS, the user opens the isolator and places the bag20on the hanger10. The isolator can then be closed and sterilized (including the hanger10and the bags20), such as by vaporized hydrogen peroxide (VHP) sterilization. Each hanger10holds a single bag20at a distance from the isolator wall so that the bag20does not touch the walls of the isolator. In particular, the proximal end38of the slot32is set at a predetermined distance from the first leg14so that the bag20cannot touch the wall of the isolator. The proximal end38prevents the neck26from moving beyond the predetermined distance when the neck26is fully received in the slot32. In addition, when multiple hangers are provided, each hanger is separated so that the bags20do not touch each other. In those ways, the bags20hang freely and the vapor can completely surround and sterilize the entire bag20.

Once the interior of the isolator is vapor sterilized, the user can access the bag20through the glove ports of the isolator. The user can then open the bag and retrieve the wipers saturated in cleaning solution, and use the wipers to clean a surface, equipment or product located inside the isolator. Once the bag is empty of wipers, the user can remove it from the hanger and place a new bag, or the empty bag can be replaced at the next cleaning cycle for the isolator.

In embodiments having raised tabs18, the head28is lifted over the tabs18while sliding the bag20in and out of the slot34. The tabs18prevent the head28of the hangable portion22from inadvertently coming free of the slot34, such as if the bag is inadvertently bumped. It should be understood that the hangable portion22of the bag20can be any structure that can engage the second leg16of the main bracket body12for hanging the bag20therefrom. And although the second leg16of the hanger10is shown as supporting a single bag20, the length of the second leg16can be extended to hold and hang multiple bags20, depending on the application to be made.

FIG.4ashows the bag20in more detail. The top layer of the bag20includes an opening and a cover23, such as a press and seal cover, that surrounds or covers the opening. The cover23can have a pull tab or access tab25that the user can pull to open the cover to access the wipers contained inside the bag. The user can then remove a wiper through the opened cover and bag opening. Once a wiper is removed, the user can close the cover. As further illustrated, the cover23is positioned so that the user can open it with one hand. That is, the cover23is opened by pulling down on the access tab25. Since the hanger is holding the bag20from the top end of the bag, the hanger10supports the bag as the user is pulling downward on the access tab25.

The hanger10makes it easier for the user to remove wipers from the bag20. When the bag20is installed on the hanger, the bag20hangs freely yet reliably on the hanger10, without the user having to hold the bag20. The user can then access the access tab25to easily open the cover23. As the user pulls to remove a wiper, the tab18prevents the bag20from inadvertently coming off of the hanger10. This is particularly useful since the user is wearing gloves, such as through a glove port on the isolator.

The proximal end38of the slot32also makes it easier for the bag20to be opened with one hand in the isolator. The proximal end38supports the valve24as the user is pulling downward on the access tab25. Accordingly, the user can press inward (toward the first leg14) on the bag as the access tab25is being opened, and forward motion is prevented by the proximal end38of the slot. The proximal end38of the slot can be at a predetermined distance from the first leg14to support that operation, and so that the bag has sufficient space to reliably hang on the hanger10without the hanger contacting the bag20or otherwise inadvertently pushing the bag20off of the hanger10.

FIG.4bshows another embodiment, the peel and seal cover25need not be provided. Instead, the user can access the wipe by having a notch or perforation in the side of the bag20. Accordingly, the user can tear open the bag by pulling on the side of the pouch at the notch. Thus, in use, the technician pulls the bag along the perforation to tear the two layers of the pouch open to access the saturated wipe contained therein.

It is noted that the hanger is described for holding the bag20in a clean environment so that the bag can be readily vapor sterilized and the wipers can be readily retrieved by the user for use in the clean environment. However, it will be recognized that the hanger10can be utilized for any other suitable purpose. For example, the hanger10can hold the bag20as the bag is being aseptically processing the bag20, such as to aseptically fill the bag20with a solution, such as a cleaning solution (e.g., bleach or alcohol). The hanger10makes it easier for the user to aseptically fill the bag20with the solution. When the bag20is installed on the hanger, the bag20hangs on the hanger10with the valve24facing upward so that it can be easily accessed by the user. The bag20hangs freely yet reliably on the hanger10, without the user having to hold the bag20. The user can then access the valve24with both hands, if necessary, to more easily fill the bag. This is particularly useful since the user is wearing gloves, such as through a glove port on the isolator. The hanger10makes it easier for the user to fill the bag with solution since the user can insert a tube into the valve and the hanger10cooperates with the head28to hold the valve in position at the top surface36of the second leg16.

The proximal end38of the slot32also makes it easier for the bag20to be filled in the isolator by supporting the valve24as the user is filling it with solution. Accordingly, the user can press inward (toward the first leg14) on the bag, and forward motion is prevented by the proximal end38of the slot. The proximal end38of the slot can be at a predetermined distance from the first leg14to support that operation, and so that the bag has sufficient space to reliably hang on the hanger10(when empty and when filled) without the support contacting the bag20or otherwise pushing against the bag that might otherwise inadvertently push the bag20off of the hanger10. Once the bag is filled, the user slides it off of the hanger and places a new bag on the hanger for aseptic processing.

It is noted that the hanger10is shown and described for use in an isolator. However, other suitable uses can be made, such as in any area, room or location, whether or not a clean environment.

It is further noted that in one embodiment shown and described, the hangable portion22is a valve that is used to attach the bag20to the hanger10. In addition, the valve24can be used to fill (aseptically) solution into the bag20onto the wiper. However, it will be recognized that the hangable portion22need not be a valve, but can be a fastening device that does not permit solution to be aseptically filled into the bag. And, the hanger and hangable portion need not have the shape shown, but rather the hanger can comprise a first fastening mechanism and the hangable portion can comprise a second fastening mechanism that releasably engages the first fastening mechanism, whereby the bag can hang freely by the first and second fastening mechanisms.

It is also noted that the support mounting device and the product support device are shown and described as separate features of a single unitary body12. However, the support mounting device and the product support device can be part of the same feature. For example, there can be a single leg16can include one or more mechanisms (such as openings or a fastening mechanism) to mount the second leg16to the support. In addition, while the support mounting device and the product support device are shown directly formed with one another, they can be indirectly formed with one or more intermediary members therebetween.

It will be apparent to those skilled in the art having the benefit of the teachings presented in the foregoing descriptions and the associated drawings that modifications, combinations, sub-combinations, and variations can be made without departing from the spirit or scope of this disclosure. Likewise, the various examples described may be used individually or in combination with other examples. Those skilled in the art will appreciate various combinations of examples not specifically described or illustrated herein that are still within the scope of this disclosure. In this respect, it is to be understood that the disclosure is not limited to the specific examples set forth and the examples of the disclosure are intended to be illustrative, not limiting.

As used in this specification and the appended claims, the singular forms “a”, “an” and “the” include plural referents, unless the context clearly dictates otherwise. Similarly, the adjective “another,” when used to introduce an element, is intended to mean one or more elements. The terms “comprising,” “including,” “having” and similar terms are intended to be inclusive such that there may be additional elements other than the listed elements.

Additionally, where a method described above or a method claim below does not explicitly require an order to be followed by its steps or an order is otherwise not required based on the description or claim language, it is not intended that any particular order be inferred. Likewise, where a method claim below does not explicitly recite a step mentioned in the description above, it should not be assumed that the step is required by the claim.

It is noted that the description and claims may use geometric or relational terms, such as such as L-shaped, down, downward, top, bottom, angled, elongated, parallel, orthogonal, etc. These terms are not intended to limit the disclosure and, in general, are used for convenience to facilitate the description based on the examples shown in the figures. In addition, the geometric or relational terms may not be exact. For instance, walls may not be exactly perpendicular or parallel to one another because of, for example, roughness of surfaces, tolerances allowed in manufacturing, etc., but may still be considered to be perpendicular or parallel.