GB2545249A - A flexible film isolator system - Google Patents

Abstract

A flexible film isolator system 10, comprising: a chamber 15 having a flexible floor 50, a ceiling 30 and at least one wall 20. The system further comprises a floor support 60 located outside of the chamber for supporting the flexible floor of the chamber. The floor support comprises: an array of holes on its upper surface 80 for contact with the flexible floor, and means to create reduced atmospheric pressure in the holes so as to hold the flexible floor against the floor support in substantially close contact therebetween. The system may further comprise means for controlling atmospheric pressure within the chamber such as by use of a pump. The chamber may additionally be supported by at least one support 40 arranged within or outside the chamber.

Description

A flexible film isolator system

The present invention relates generally to a flexible film isolator system and finds particular, although not exclusive, utility in providing protection to staff handling potentially hazardous pharmaceutical products.

Methods for protecting production staff from hazardous pharmaceutical dusts include the use of flexible film isolator systems. The system is a tent-like structure manufactured from translucent flexible plastic film within which the hazardous materials are handled via sealed arm sleeves with gloves mounted for gripping (“glove bags”). It avoids the operators having to wear protective air-fed suits and respirators.

It is known to operate the isolation enclosures at ambient pressure (i.e. the same as the air pressure within the room in which the enclosure is located). This is due to the very thin wall material deforming outwards, or indeed inwards, with pressure variations between the room and enclosure.

Some flexible film enclosures include “breather filters” which attempt to balance the pressure between the inside and outside of the enclosure to avoid, or at least reduce a change of enclosure shape. Even with such breather filters the enclosures need to change shape and therefore they are typically suspended from a support frame for example with the use of elastic bungee cords.

As the health hazards from more potent drug compounds are increasingly recognised it is known to create a negative air pressure within the flexible isolator enclosures. The phrase “negative air pressure” means a pressure less than the surrounding atmospheric pressure. This ensures that any, tears or damage which can occur in use result in room air flowing inwards into the isolator thus reducing the chance of dangerous dust particles escaping.

It is also known to use a stainless steel working table or work tray as the base with the flexible enclosure having walls and a ceiling attached thereto. When operating the flexible isolator at negative pressure it is known that the support frame and working table or tray must create a reliable and strong attachment to the flexible film enclosure. However, where the base of the isolator is formed from a stainless steel tray it means that the tray has to be cleaned every time a different product is used inside the isolator. In this regard, it is known that some researchers who handle very hazardous oncology related drugs change over the flexible enclosure on a daily basis.

To address this issue and reduce cleaning times and therefore changeover delays, a totally flexible enclosure (with flexible film base panel) is known which can be disposed after each procedure and replaced with a new one. Unfortunately, this means that even through the enclosure is placed on a table top the lower internal pressure means it is difficult to maintain the enclosure in a regular shape. This is especially troublesome for the floor of the enclosure which bulges upwards making it difficult for operators to place containers and the like without them falling over.

One way of ensuring a level floor or base upon which operators may place items is with a 6 sided flexible film enclosure whereby the roof and wall panels may be securely supported by a tab system to hold the flexible panels flat whilst operating at negative pressure and stretching the floor over a table with tabs or press studs to attach it thereto. Unfortunately, this system still cannot hold the base or floor panel in the isolator truly flat such that equipment inside the enclosure may cause damage to the enclosure base panel.

Some manufacturers of flexible film enclosures apply a double-sided adhesive pad between the work table and the underside of the flexible isolator but this makes enclosure change over slow and difficult and still results in portions or non-flat floor space.

To address these issues the invention provides, in a first aspect, a flexible film isolator system comprising a chamber having a flexible floor, a ceiling and at least one wall, the system further comprising a floor support located outside of the chamber for supporting the flexible floor of the chamber, the floor support including an array of holes underneath the flexible floor, the system including means to create a reduced atmospheric pressure in the holes so as to hold the flexible floor against the floor support in substantially close contact therebetween.

The phrase “reduced atmospheric pressure” means less then the atmospheric pressure immediately above the floor. This primarily means less than the pressure within the chamber but may also be less than the ambient pressure within the room or environment in which the apparatus is situated.

The floor support with holes allows the flexible floor of the chamber to be placed onto the “suction surface”. In use, a suction fan may be activated. The sides and roof (ceiling) panels may now be attached to a support structure and the base panel (flexible floor) will be perfectly flat. There is no need for the provision of press studs or the use of adhesive tape onto the film barrier, resulting in greater safety.

The at least one wall may be only one wall arranged in a circular manner in plan. However, the chamber may have any number of side walls such as 4, 6, 8 etc. making the plan shape rectangular, hexagonal, octagonal etc.

In one example, the chamber could be formed from a single piece of material in a substantially spherical shape such that when supported it has a “ceiling” portion, at least one wall and a “floor” portion.

The chamber may comprise more than one sheet of material. The various sheets may be bonded to one another.

The chamber may be sealable, or sealed, to substantially isolate its contents from the surrounding environment. In this regard it may, or may not, include sealable apertures for the placing of items within.

The at least one wall may include means for manipulating items within the chamber. This might include such features as access sleeves, arm ports and the like.

The means to create a reduced atmospheric pressure in the holes may be a pump.

The perimeter of the floor may be outward of the floor’s junction with the at least one wall so as to form a flange. In other words, the floor portion may have an area larger then the area of the chamber just above where the chamber meets the floor. This might be created by a flange added onto the chamber near the base of the at least one wall.

The flange may project radially outward of the at least one wall in the range 20 to 50 mm.

The flange may provided around the entire perimeter of the at least one wall/chamber or may be only provided at one or more discrete points. In one example it may be provided in two discrete portions approximately opposite one another in plan.

This flange helps to reduce lifting of the floor at the junction with the at least one wall. The flange may include connection means for releasably attaching it to the side of the support to hold it in place.

The floor support may include a substantially planar surface against which the floor contacts, the surface including the holes. The holes may have an approximate diameter in the range of 2 to 10mm the holes may be substantially circular, although linear slits are also contemplated.

The flexible film isolator system may further comprise means for controlling the atmospheric pressure within the chamber. This may be useful for reducing the atmospheric pressure within the chamber such that it is less than the ambient atmospheric pressure within the room in which the chamber is situated. The means for controlling the atmospheric pressure may be the pump used to create the reduced atmospheric pressure in the holes in the floor support. For instance, a hole may be provided in the floor of the chamber such that air is drawn out of the chamber and through the holes. Alternatively the pump may be connected to a valve provided in the chamber wall or ceiling. With the provision of appropriate filters this may protect operators. The valve may be in direct or indirect fluid connection with at least one of the holes.

Alternatively, or additionally, a separate pump may be used, or the means for controlling the atmospheric pressure within the chamber may comprise a valve, such as a one-way valve, between the chamber and the room. The one-way valve may allow gas to only enter or exit the chamber.

The flexible film isolator system may further comprise at least one support for supporting the chamber. The at least one support may be arranged within the chamber, and/or arranged outside the chamber.

The above and other characteristics, features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention. This description is given for the sake of example only, without limiting the scope of the invention. The reference figures quoted below refer to the attached drawings.

Figure 1 is a schematic elevational view of a flexible film isolator system; and

Figure 2 is a schematic plan view of a different flexible film isolator system.

The present invention will be described with respect to certain drawings but the invention is not limited thereto but only by the claims. The drawings described are only schematic and are non-limiting. Each drawing may not include all of the features of the invention and therefore should not necessarily be considered to be an embodiment of the invention. In the drawings, the size of some of the elements may be exaggerated and not drawn to scale for illustrative purposes. The dimensions and the relative dimensions do not correspond to actual reductions to practice of the invention.

Furthermore, the terms first, second, third and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequence, either temporally, spatially, in ranking or in any other manner. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that operation is capable in other sequences than described or illustrated herein.

Moreover, the terms top, bottom, over, under and the like in the description and the claims are used for descriptive purposes and not necessarily for describing relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that operation is capable in other orientations than described or illustrated herein.

It is to be noticed that the term “comprising”, used in the claims, should not be interpreted as being restricted to the means listed thereafter; it does not exclude other elements or steps. It is thus to be interpreted as specifying the presence of the stated features, integers, steps or components as referred to, but does not preclude the presence or addition of one or more other features, integers, steps or components, or groups thereof. Thus, the scope of the expression “a device comprising means A and B” should not be limited to devices consisting only of components A and B. It means that with respect to the present invention, the only relevant components of the device are A and B.

Similarly, it is to be noticed that the term “connected”, used in the description, should not be interpreted as being restricted to direct connections only. Thus, the scope of the expression “a device A connected to a device B” should not be limited to devices or systems wherein an output of device A is directly connected to an input of device B. It means that there exists a path between an output of A and an input of B which may be a path including other devices or means. “Connected” may mean that two or more elements are either in direct physical or electrical contact, or that two or more elements are not in direct contact with each other but yet still co-operate or interact with each other. For instance, wireless connectivity is contemplated.

Reference throughout this specification to “an embodiment” or “an aspect” means that a particular feature, structure or characteristic described in connection with the embodiment or aspect is included in at least one embodiment or aspect of the present invention. Thus, appearances of the phrases “in one embodiment”, “in an embodiment”, or “in an aspect” in various places throughout this specification are not necessarily all referring to the same embodiment or aspect, but may refer to different embodiments or aspects. Furthermore, the particular features, structures or characteristics of any embodiment or aspect of the invention may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments or aspects.

Similarly, it should be appreciated that in the description various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Moreover, the description of any individual drawing or aspect should not necessarily be considered to be an embodiment of the invention. Rather, as the following claims reflect, inventive aspects lie in fewer than all features of a single foregoing disclosed embodiment. Thus, the claims following the detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment of this invention.

Furthermore, while some embodiments described herein include some features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form yet further embodiments, as will be understood by those skilled in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practised without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

In the discussion of the invention, unless stated to the contrary, the disclosure of alternative values for the upper or lower limit of the permitted range of a parameter, coupled with an indication that one of said values is more highly preferred than the other, is to be construed as an implied statement that each intermediate value of said parameter, lying between the more preferred and the less preferred of said alternatives, is itself preferred to said less preferred value and also to each value lying between said less preferred value and said intermediate value.

The use of the term “at least one” may mean only one in certain circumstances.

The principles of the invention will now be described by a detailed description of at least one drawing relating to exemplary features of the invention. It is clear that other arrangements can be configured according to the knowledge of persons skilled in the art without departing from the underlying concept or technical teaching of the invention, the invention being limited only by the terms of the appended claims.

In Figure 1, a schematic elevational view of a flexible film isolator system 10 is shown. It comprises an enclosure defining a chamber 15 therewithin. Sidewalls 20 are present together with a ceiling or roof 30. A floor 50 is present at the base of the enclosure 10. The side walls 20, ceiling 30 and floor 50 are attached to one another such that they form a substantially air-tight chamber 15 within. The enclosure 10 is supported at the upper comers where the side walls 20 meet the ceiling 30 by supports 40. These supports 40 may be attached to legs (not shown) or otherwise attached to a structure which holds them in place.

The enclosure 10 is arranged on a support 60 which in this case is a table-like structure having an upper surface 80 comprising holes (not shown) through which a fluid, such as the ambient atmosphere, may be drawn. This is effected by a pump (not shown) attached to an outlet 70 attached to the holes.

In use, the enclosure 10 is arranged on top of the support such that the floor 50 is in contact with the upper surface 80 of the support 60. The upper corners are then attached to the support structure to maintain the shape of the enclosure and form a chamber 15 therewithin. The pump is then switched on and the floor smoothed-out such that it has a substantially smooth surface within the chamber 15.

Via gloves bags and the like (not shown) an operator may manipulate items provided within the chamber 15. To introduce into, and retrieve items from, the chamber 15 a sealable door (not shown) may be provided in a sidewall 20.

Figure 1 also shows a flange 55 which is part of the floor 50 and which extends outside of the chamber 15. This flange also contacts with the upper surface 80 of the support 60 and may also overlie the holes. Additionally or alternatively, the flange may include Velcro (RTM) or poppers or the like to releasably attach it to the upper surface 80.

This is better seen in Figure 2 where a plan view shows the outline of the upper surface 80 of the support. The chamber 15 is defined by the sidewalls 20. The sidewalls 20 meet the floor 50 at a junction indicated 53. The base or floor 50 extends with a flange 55 outside the perimeter of the sidewalls 20. The outer perimeter of the flange 55 is indicated by a broken line 52. The broken line is within the boundary of the upper surface 80 of the support 60 on three sides (upper, right and lower as shown in Figure 2). Flowever, on the left hand side of the support 60 the flange 55 extends over the edge of the support. In the former, the flange may be drawn to the upper surface by the reduced pressure in the holes and/or releasably attached to the support 60. In the latter, the flange 55 may be bent down and releasably attached to the side of the support 60.

Figure 2 also includes enclosure supports 42, one at each comer of the chamber 15. The supports shown at the upper end of Figure 2 are arranged outside of the flange 55; however, the supports 42 at the lower end of Figure 2 are arranged to stand on the flange 55 to further assist in holding down the enclosure 10 to avoid it rising around the perimeter of the sidewalls 20 where they meet the floor 50.

Claims (14)

1. A flexible film isolator system comprising a chamber having a flexible floor, a ceiling and at least one wall, the system further comprising a floor support located outside of the chamber for supporting the flexible floor of the chamber, the floor support including an array of holes underneath the flexible floor, the system including means to create a reduced atmospheric pressure in the holes so as to hold the flexible floor against the floor support in substantially close contact therebetween.

2. The flexible film isolator system according to claim 1, wherein the chamber is sealable, or sealed, to substantially isolate its contents from the surrounding environment.

3. The flexible film isolator system according to either one of claims 1 and 2, wherein the at least one wall includes means for manipulating items within the chamber.

4. The flexible film isolator system according to any preceding claim, wherein the means to create a reduced atmospheric pressure in the holes is a pump.

5. The flexible film isolator system according to any preceding claim, wherein the perimeter of the floor is outward of the floor’s junction with the at least one wall so as to form a flange.

6. The flexible film isolator system according to any preceding claim, wherein the floor support includes a substantially planar surface against which the flexible floor contacts, the surface including the holes.

7. The flexible film isolator system according to any preceding claim, further comprising means for controlling the atmospheric pressure within the chamber.

8. The flexible film isolator system according to claim 7, when dependent either directly or indirectly on claim 4, wherein the means for controlling the atmospheric pressure within the chamber is the pump.

9. The flexible film isolator system according to any preceding claim, further comprising a one-way valve to allow gas to exit from the chamber.

10. The flexible film isolator system according to claim 9, wherein the valve is in fluid connection with at least one of the holes.

11. The flexible film isolator system according to any preceding claim, further comprising at least one support for supporting the chamber.

12. The flexible film isolator system according to claim 11, wherein the at least one support is arranged within the chamber.

13. The flexible film isolator system according to claim 11, wherein the at least one support is arranged outside the chamber.

14. A flexible film isolator system substantially as hereinbefore described with reference to the accompanying drawings.