Patent Application
20220378126
The present invention relates to the field of clean rooms, in particular to protective equipment for a clean room or sanitised environment, particularly to a garment for a clean room or sanitised environment and even more particularly to an overall for a clean room or sanitised environment. By extension, most of this protective equipment is also suitable for the medical and hospital environment.
The present invention also relates to a method for packaging protective equipment for a clean room or sanitised environment according to the present invention.
The present invention also relates to a dressing method for putting on protective equipment for a clean room or sanitised environment according to the present invention.
The present invention relates more particularly to protective equipment for a clean room or sanitised environment comprising:
Such protective equipment is used in clean room environments and in laboratories, for example to manufacture drugs or even biological, electronic and food materials in a sanitised or sterile environment.
Clean rooms are used in many fields such as electronics, micromechanics, optics, nanotechnologies and biotechnologies, pharmaceuticals, sterile compounding processes in pharmacy, medical equipment or even in the food industry.
To guarantee a sanitised and sterile environment in laboratories and more particularly in clean rooms, they must be constructed in compliance with very strict standards. For example, clean rooms must be supplied with large quantities of air filtered by high efficiency filters to dilute and remove particulates, bacteria and chemicals inside the room. Air is also used to pressurise the room and ensure that no contaminated air enters the clean room.
In addition, clean rooms must be constructed with materials chosen specifically because they do not generate contaminants, particulates or chemical fumes and the materials must also be easy to clean.
Finally, the people, i.e. operators working inside clean rooms, must wear and carry specific garments, accessories, equipment and tools to minimise the dispersion of micro-organisms and the particulates that they in turn generate such as hair, skin particles and clothing fibres.
For these reasons, in these types of room, the body of the operator must be isolated so as to prevent contamination of the environment they are working in or so as to prevent contamination of the product they are manufacturing or working on.
The document WO2005065476 describes a protective or work overall used in dangerous conditions involving heat, fire, cold, etc. The overall comprises a pouch located on the chest area of the operator's body. This pouch comprises two openings: one upper opening and one lower opening. The sleeves of the overall become inverted inside the pouch when the operator passes their hands through, first, the lower opening and, second, the upper opening so the sleeves are pulled inside the pouch through the upper opening. The operator will then lift their legs into the pouch via the upper opening and the closed pouch.
When an operator is working in such a sterile environment, they must, before entering a clean room, put on the various items of protective equipment for the clean room or sanitised environment, following a very specific protocol. Such procedures are painstaking and generally require the operator to perform unconventional and very specific gestures and movements. For example, the operator cannot touch any external face of protective equipment for a clean room or sanitised environment without risking contaminating this equipment and therefore having to undergo the dressing process again.
Unfortunately, an overall as described in document WO2005065476 cannot be used in a clean room environment because it does not meet the criteria for clean rooms. It comprises a variety of materials. In addition, the dressing method is complicated. The operator will not be able to put on the overall without touching any outer face of the protective equipment when removing it from the pouch to put it on.
In addition, existing protective equipment for a clean room or sanitised environment is therefore sterilised and supplied in packaging which must be sealed but which must also be able to withstand autoclaving. The equipment must also be both easy for the operator to open before entering the clean room and strong enough to prevent tearing, which could result in the protective equipment coming into contact with a contaminated environment and therefore contaminants being subsequently introduced into the clean room. In most cases, the operator will not be aware that this has happened, given the size of contaminants.
Protective equipment for a clean room or sanitised environment is typically packaged in packaging with a cover, which is sterilised and separate but disposable, in other words single-use, which is a significant source of waste. However, in a clean room or sanitised environment, everything that enters the room or environment must be removed and treated. The current trend, given current climate concerns, is to reduce disposable packaging and associated waste without compromising overall sterility.
There is therefore a real need to provide protective equipment for a clean room or sanitised environment with the required level of sterility, which retains its durability throughout the logistical stages and which takes into account cost and environmental limitations.
The aim of the present invention is to overcome the shortcomings of the state of the art by providing equipment for a clean room or sanitised environment whose sterility is maintained throughout the logistical stages while being less delicate and with the potential to limit the environmental impact and the costs associated with the logistics of protective equipment: decontamination, repackaging and storage.
To solve these problems, the present invention provides protective equipment for a clean room or sanitised environment as mentioned above, characterised in that said protective equipment is packaged in a reusable and sterilisable pouch preferably made of fabric, having an opening provided with closure means.
It transpired in a particularly unexpected manner that the protective equipment for a clean room or sanitised environment according to the present invention, being packaged in a reusable and sterilisable pouch, preferably made of fabric, provides protective equipment with improved direct protection throughout the logistics, storage and opening stages.
It also transpired in a particularly unexpected and advantageous manner that the sterility of the protective equipment for a clean room or sanitised environment according to the present invention is improved and maintained throughout the various logistical stages.
Finally, the provision of protective equipment for a clean room or sanitised environment according to the present invention, packaged in a reusable and sterilisable pouch which has an opening provided with closure means makes it possible in a particularly advantageous manner to dispense with single-use packaging, plastic packaging and paper packaging, which is delicate, disposable, made from raw materials and therefore very expensive, first due to the cost of the packaging itself, and second due to the fact that the equipment, being delicate, is more susceptible to an accident causing contamination and leading to the associated costs of cleaning and decontaminating the clean room.
The pouch according to the present invention forms a cavity with an opening.
Preferably, the pouch comprises at least two walls joined over a majority of their ends to one another and the pouch comprises an opening, preferably a single opening, comprising at least one closure means.
Advantageously, the pouch comprises at least three walls joined over a majority of their ends to one another and the pouch comprises an opening, preferably a single opening comprising at least one closure means.
Preferably, the pouch may have, for example, a square, rectangular, hexagonal or even semi-circular shape.
Advantageously, the protective equipment for a clean room or sanitised environment according to the present invention is selected from the group consisting of a garment, for example an overall, an apron, a tunic, a head covering for example a hairnet or hood, at least one glove, at least one shoe cover, a shoe, a clog, a mask, goggles, sleeves, an undergarment, boots. Preferably, the pouch of the protective equipment according to the present invention is connected to the inner face or to the outer face via at least one fastening means allowing said pouch to be attached.
Preferably, the pouch of the protective equipment according to the present invention is connected to the inner face of a garment via at least one fastening means allowing the pouch to be attached to the inner face of the garment.
The pouch of the protective equipment according to the present invention, by being connected to the inner face of a garment and by being attached to this inner face via at least one fastening means, makes it possible in a particularly advantageous manner to isolate the pouch from the surrounding environment when the garment is being worn by the operator.
Indeed, the pouch is initially in contact with the surrounding environment which is contaminated. The pouch, by being connected to the inner face of a garment packaged therein, makes it possible, when removing the garment from the pouch and unfolding the garment to be worn by the operator, to enclose the pouch in the garment, thus isolating it from the surrounding environment and consequently limiting the possibility of contamination of the clean room or the sanitised environment.
Advantageously, the at least one fastening means of the protective equipment for a clean room or sanitised environment according to the present invention is a temporary fastening means, for example, a press stud or a series of press studs, a zip, hook-and-loop fastener means, optionally arranged on a flap.
More advantageously, the at least one fastening means of the protective equipment for a clean room or sanitised environment according to the present invention is a seam or a weld.
Other embodiments of the protective equipment for a clean room or sanitised environment according to the present invention are detailed in the attached claims.
The present invention also relates to a garment, and in particular to an overall for a clean room or sanitised environment.
When an operator is working in such a sterile environment, they must, before entering a clean room, put on garments, and in particular overalls, following a very specific protocol. Such procedures are very painstaking and usually require the operator to dress in a way that is completely contrary to what they are used to and contrary to how they would instinctively dress.
Existing overalls are therefore sterilised and supplied in sealed packaging, which must be both easy for the operator to open before entering the clean room and strong enough to avoid tearing, which could result in the overall coming into contact with a contaminated environment and therefore contaminants being subsequently introduced into the clean room. In most cases, the operator will not be aware that this has happened, given the size of contaminants.
It is therefore easy to understand first that the staff, the operators and the overalls they wear are the main sources of contamination in clean rooms or sanitised environments and second that contamination is absolutely to be avoided, because contamination would lead to a standstill in production, the sterilisation or even the destruction of the ingredients and materials present and lengthy and costly cleaning steps following a very specific protocol in order to re-establish a sterile and sanitised environment.
Thus, the operator must put on the garments, for example overalls, without touching the outer face intended to be in contact with the sterile environment and especially, without touching the outer face of the body portion, that is to say extending from the pelvis, up the operator's legs to their neck. A handling process therefore follows during which certain portions of the overall are folded, where the operator steps onto a bench, puts one leg in without it touching the ground, then puts the other leg in while ensuring they do not release or touch anything. It is easy to understand that this dressing method requires contortions requiring great skill and many years of training and practice since the risk of contaminating a clean room is to be avoided.
Document EP2303044 discloses equipment for a clean room or sanitised environment wherein said garment is a garment for a clean room or sanitised environment comprising:
Unfortunately, such a garment according to the prior art is packaged in sterilised wrapping or packaging to meet the requirements of clean rooms, not least given the stages of packaging, transport, delivery, opening of packages and therefore individual garments for a clean room or sanitised environment. Shocks, tears and negligence may occur during any of these steps, resulting in contamination of the wrapping or packaging. Since this is not visible to the naked eye, it will only be detected when the operator undergoes checks or when the products from the clean room are analysed. Indeed, the sterilised wrapping or packaging for this type of garment is single-use (and therefore disposable) wrapping or packaging made of plastic.
There is therefore a real need to provide a garment for a clean room or sanitised environment with improved and maintained sterility during the logistical stages and which takes into account cost and environmental limitations.
The purpose of the present invention is to overcome the shortcomings of the state of the art by providing a garment for a clean room or sanitised environment whose direct protection is improved, whose sterility is maintained during the logistical stages and making it possible to limit the costs associated with the garment itself and subsequently associated with the decontamination processes.
To solve these problems, the present invention provides a garment for a clean room or sanitised environment as indicated above, characterised in that said garment comprises said pouch connected to said inner face of said garment via said fastening means and located on the inner face of said pouch, preferably opposite the opening of said pouch, allowing the attachment of the inner face of said pouch to said inner face of the body portion of said garment, preferably to the inner face of the trunk portion of said garment.
It transpired in a particularly unexpected manner that the garment for a clean room or sanitised environment according to the present invention, being packaged in a reusable and sterilisable pouch, preferably made of fabric, provides protective equipment with improved direct protection throughout the logistics, storage and opening stages.
It also transpired in a particularly unexpected and advantageous manner that the sterility of the garment for a clean room or sanitised environment according to the present invention is improved and maintained throughout the various logistical stages.
Finally, the provision of a garment for a clean room or sanitised environment according to the present invention, comprising a reusable and sterilisable pouch for its packaging which has an opening provided with closure means makes it possible in a particularly advantageous manner to dispense with single-use packaging, plastic packaging and paper packaging, which is delicate, disposable, made from raw materials and which is therefore very expensive, first due to the cost of the packaging itself, and second due to the fact that the equipment, being delicate, is more susceptible to an accident causing contamination and leading to the associated costs of cleaning and decontaminating the clean room.
In addition, the garment for a clean room or sanitised environment according to the present invention, on the one hand comprising the reusable, sterile pouch which has an opening provided with closure means and, on the other hand comprising at least one gripping means in contact with the inner face in the body portion, preferably in the trunk portion, of the garment makes it possible, in a particularly advantageous manner, to provide a garment whose sterility is maintained and to provide a garment whose handling during dressing is facilitated by means of said at least one gripping means which is directly exposed to the operator.
The pouch of the garment for a clean room or sanitised environment according to the present invention, by being connected to the inner face of the garment and by being attached to this inner face via at least one fastening means, makes it possible in a particularly advantageous manner to isolate the pouch from the surrounding environment when the garment is being worn by the operator.
Indeed, the pouch is initially in contact with the surrounding environment which is contaminated. The pouch, being connected to the inner face of the body portion of the garment packaged therein, makes it possible, when removing the garment from the pouch and unfolding it to be worn by the operator following a simple protocol, to enclose the pouch in the overall, thus isolating it from the surrounding environment and consequently limiting the possibility of contamination of the clean room or the sanitised environment.
In a preferred embodiment, the garment of said protective equipment for a clean room or sanitised environment according to the present invention is an overall, wherein said leg portion further comprises,
In a preferred embodiment, said pouch comprised in the overall according to the present invention is positioned in a body portion, preferably in a trunk portion, preferentially in a pelvic region portion of said overall.
Advantageously, the protective equipment for a clean room or sanitised environment according to the present invention has:
Preferably, the protective equipment for a clean room or sanitised environment according to the present invention has when in the folded position and packaged in said pouch:
Advantageously, the protective equipment for a clean room or sanitised environment according to the present invention has, in the unfolded position, at least two gripping means in contact with said inner face, in the body portion, preferably located laterally, preferably in the body portion.
Even more advantageously, the overall of the protective equipment for a clean room or sanitised environment according to the present invention, has in the folded position:
Preferably, the closure means of the first leg section and the closure means of the second leg section of the protective equipment for a clean room or sanitised environment according to the present invention, together form a continuous closure of an opening of the crotch, and preferably comprise a continuous zip for the first and second leg section.
Advantageously, the closure means of the pouch of the protective equipment for a clean room or sanitised environment according to the present invention are selected from a zip, hook-and-loop fastener means, a series of press studs, a flap.
In a particular embodiment of the protective equipment for a clean room or sanitised environment according to the present invention:
Preferably, the protective equipment for a clean room or sanitised environment according to the present invention has, in the folded position, the leg portion or the first and second leg sections folded longitudinally onto itself/themselves and transversely onto itself/themselves in two or three portions.
In a preferred embodiment of the protective equipment for a clean room or sanitised environment according to the present invention, the fabric of the equipment and/or of the pouch comprises monofilament polyester.
By comprising a monofilament polyester fabric, the protective equipment and/or the pouch has a high to very high particulate filtration capacity, as well as a strong bacteriological barrier.
Preferably, the fabric of the equipment and/or the pouch is made of monofilament polyester.
In another preferred embodiment of the protective equipment for a clean room or sanitised environment according to the present invention, the fabric of the equipment and/or of the pouch comprises polyester and antistatic carbon thread, preferably between 90 and 99.5% polyester, preferentially between 92 and 99.5% polyester, advantageously between 97 and 99.5% polyester, particularly advantageously 99% polyester as well as antistatic carbon thread, between 10 and 0.5% of the fabric, preferably 8 and 0.5%, preferentially between 3 and 0.5%, particularly advantageously 1%. This lends the fabric a high to very high particulate filtration capacity as well as a strong bacteriological barrier.
In another embodiment of the protective equipment for a clean room or sanitised environment according to the present invention, the fabric of the equipment and/or of the pouch is a non-woven fabric. Advantageously, the fabric of the equipment and/or the pouch comprises high density polyethylene fibres arranged and compressed randomly. Preferably, the fabric of the equipment and/or of the pouch is a fabric comprising a prepreg comprising a thermosetting resin such as a polyester or a thermoplastic polymer impregnating a reinforcement, the reinforcement being a fabric, fibres, for example.
Other embodiments of the protective equipment for a clean room or sanitised environment according to the present invention are detailed in the attached claims.
The present invention also relates to a method for packaging protective equipment for a clean room or sanitised environment comprising:
Indeed, to decontaminate the protective equipment, the protective equipment such as an apron, a gown, an overall, a boot is placed by staff into a washing machine in an area outside a sanitised area, such as a clean room. Protective equipment, once washed and therefore decontaminated, is placed inside a sanitised area, such as a clean room. The same steps are carried out for the reusable and sterilisable pouch whether or not it is attached to the protective equipment, during the same wash or during separate washes from that of the protective equipment.
As another part of this decontamination process, after washing and transferring the protective equipment and the reusable and sterilisable pouch in a sanitised area, the protective equipment and the reusable and sterilisable pouch are dried in a dryer located in the sanitised area.
The protective equipment and the reusable and sterilisable pouch are then placed in an area where packaging is carried out in the sanitised area. The reusable and sterilisable pouch is opened and the protective equipment is placed inside the reusable and sterilisable pouch. Once this step has been performed, the reusable and sterilisable pouch remains closed in the sanitised area.
Optionally, an additional step of sterilising the protective equipment packaged in the reusable and sterilisable pouch is carried out as a precaution.
Preferably, the method of packaging protective equipment for a clean room or sanitised environment according to the present invention wherein said protective equipment is a garment, comprises:
Advantageously, the method for packaging protective equipment for a clean room or sanitised environment according to the present invention wherein said garment is an overall wherein said leg portion comprises a first and a second leg section, each leg section comprising a flank, two longitudinal edges on either side of said flank of the leg section and provided with mutual closure means arranged to form said substantially tubular leg section when the mutual closure means of each longitudinal edge are engaged together, said mutual engaged closure means of the first leg section facing said engaged closure means of the second leg section and each preferably extending at least from a knee area to a crotch area and more preferably from a calf or ankle area to a crotch area and wherein said first and second leg sections are connected via a linked end to said body portion, preferably to said trunk portion, said method being characterised in that said folding of said side portion of said leg portion onto itself in a longitudinal direction of said leg portion is a folding of a side portion of a first leg section whose closure means are in an open position and a folding of a side portion of a second leg section whose closure means are in an open position keeping said first gripping means exposed.
Other embodiments of the method for packaging protective equipment for a clean room or sanitised environment according to the present invention are detailed in the attached claims.
The present invention also relates to a dressing method for putting on protective equipment for a clean room or sanitised environment according to the invention, comprising the steps of
Advantageously, the dressing method for putting on protective equipment for a clean room or sanitised environment according to the invention, wherein said protective equipment is a garment comprising:
In a preferred embodiment of the dressing method for putting on protective equipment for a clean room or sanitised environment according to the present invention, wherein said garment is an overall wherein said leg portion comprises a first and a second leg section, each leg section comprising a flank, two longitudinal edges on either side of said flank of the leg section and provided with mutual closure means arranged to form said substantially tubular leg section when the mutual closure means of each longitudinal edge are engaged together, said mutual engaged closure means of the first leg section facing said engaged closure means of the second leg section and each preferably extending at least from a knee area to a crotch area and more preferably from a calf or ankle area to a crotch area and wherein said first and second leg sections are connected via a linked end to said body portion, preferably to said trunk portion, where said inverting step of said leg portion is an inversion of the leg sections, whose closure means are in an open position so that the outer face thereof is thus exposed to the outside and the inner face exposed to the legs of the operator.
Advantageously, the dressing method for a clean room or sanitised environment according to the present invention further comprises gripping a second gripping means via a second hand of the operator to position the overall so that the body portion of the overall is accessible via the opening of the body portion or a crotch section.
Preferably, the dressing method for a clean room or sanitised environment according to the present invention further comprises closing said opening in said crotch area.
Other embodiments of the dressing method for putting on an overall for a clean room or sanitised environment according to the present invention are detailed in the attached claims.
Other characteristics, details and advantages of the invention will emerge from the detailed description given below, not being limited thereto and with reference to the attached drawings.
In the figures, identical or similar elements bear the same references.
The overall 7 comprises a first 9 and a second 10 leg section, each of which comprises a flank and two longitudinal edges on either side of the flank of the leg section, each of which is also provided with mutual closure means which are arranged to form the substantially tubular leg section when the mutual closure means of each longitudinal edge are engaged together. In addition, the mutually engaged closure means of the first leg section face the mutually engaged closure means of the second leg section, and the mutual closure means each preferably extends at least from a knee area to a crotch area (not shown) and more preferably from a calf or ankle area to a crotch area (not shown).
Although not shown in the figures described, the closure means of the first leg section and the closure means of the second leg section together form a continuous closure of the opening of the crotch. The closure means are selected from a zip, hook-and-loop fastener means, press studs, a flap or other equivalent or similar means.
The overall 7 also comprises a first sleeve 12, a second sleeve 13 and a body portion 14. The first sleeve 12 is connected to the body portion 14 via a linked end 12a, the second sleeve 13 is also connected to the body portion 14 via a linked end 13a. The first leg section 9 and the second leg section 10 are connected to the body portion 14 via a linked end 9a and 10a respectively. Finally, the body portion 14 of the overall 7 includes a head passage section 15.
In the embodiment as shown in
The overall 7 according to the present invention and as shown in
Thus, in the folded and packaged position, the inner face 3 of the overall 7 is connected to the inner face of the pouch 4 so that only the outer face of the pouch 4 is in contact with the surrounding environment such as shown in
Particularly advantageously, first the outer face of the pouch 4, which was exposed to the surrounding environment, will become the inner face of the pouch 4. Second, the pouch 4, being connected to the inner face 3 of the overall 7, will therefore end up inside the overall 7 when the latter is worn by the operator.
Consequently, the pouch 4 of the protective equipment 1 and more particularly of the overall 7 according to the present invention makes it possible to achieve double isolation of possible contaminants. Isolation is first achieved by the inversion of the outer face of the pouch 4 which ends up inside the pouch 4, with the contaminants therefore being contained in the pouch 4. Containment is also achieved by the containment of the pouch 4 inside the overall 7.
In the embodiment of
In addition, according to the embodiment of the protective equipment 1 and more particularly of the overall 7 of
The overall 7 according to the present invention comprises at least one gripping means 16 in contact with the inner face 3 in the body portion 14, preferably located laterally. In the variant shown in
In this way, the at least one gripping means 16 is exposed to the operator.
In the embodiment of
In the embodiment of
In yet another embodiment not shown, the gripping means 16 of the overall 7 according to the present invention can be parts of material of the inner face 3 of the overall 7 and therefore exposed to the operator. Furthermore, the different parts of material of the inner face 3 of the overall 7 or of the protective equipment 1 for a clean room or sanitised environment can be of different colours, textures or patterns to allow the operator to identify them as being the gripping means 16.
Indeed, the gripping means 16 according to
It is therefore easy to understand from the overall 7 according to the present invention that the steps of the folding method must be followed in order to maintain the sterility of the overall 7, in particular following removal of the overall 7 by the operator and its cleaning, decontamination and subsequent repackaging.
Particularly advantageously, the overall 7 according to the present invention comprising the pouch 4 makes it possible to dispense with single-use packaging and for it to be cleaned and repackaged directly in its protective pouch 4, which can itself be cleaned, sterilised and reused.
During this folding step, the operator folds down the outer face of a first 9 and a second 10 leg section by passing an open crotch section over an outer face of a body portion 14 while keeping the at least one gripping means 16 exposed.
The second step of the folding method is as shown in
Before putting on an overall 7 according to the invention, the user opens the closure means 6 of the opening 5 of the pouch 4, grips the first gripping means 16 with a first hand and the second gripping means 17 with the second hand and removes the overall 7.
In this way, an overall 7 in the partially folded position is obtained as shown in
They then invert the leg sections 9, 10 so that the outer face of the first leg section 9 and the second leg section 10 are exposed to the outside and so that the inner face of the first leg section 9 and the second leg section 10 are exposed to the legs of the operator. Then, the operator places their foot in the foot passage section which comprises the pre-engaged zip and closes said opening 19 in order to completely isolate their body from the external environment.
Thus the operator can put on the trousers and the pouch 4 as described above, and being located inside the trousers makes it possible to isolate the contaminants, first in the pouch 4 and second in the inner portion of the trousers which is isolated from the surrounding environment.
It is understood that the present invention is in no way limited to the embodiments described above and that many modifications can be made thereto without departing from the scope of the attached claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| BE2019/5827 | Nov 2019 | BE | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/083032 | 11/23/2020 | WO |
