CN114727674A

CN114727674A - Protective equipment for clean room or sterile environment

Info

Publication number: CN114727674A
Application number: CN202080073850.8A
Authority: CN
Inventors: 文森特·万内斯特
Original assignee: Bemi Cologne Co ltd
Current assignee: Bemi Cologne Co ltd
Priority date: 2019-11-22
Filing date: 2020-11-23
Publication date: 2022-07-08
Also published as: CA3153097A1; AU2020388260A1; US20220378126A1; BR112022005839A2; EP4062783A1; BE1027777A1; EP4041012A1; WO2021099631A1; ES2958221T3; EP4041012B1; EP4041012C0; BE1027777B1

Abstract

The present invention relates to a protective device for a clean room or sterile environment, comprising: an outer face (2) for contact with the surrounding environment; an inner face (3) arranged to be in contact with or oriented towards an operator. A method for packaging the protective device and a method for donning the protective device are also disclosed.

Description

Protective equipment for clean room or sterile environment

Technical Field

The present invention relates to the field of cleanrooms, in particular to protective equipment for cleanrooms or sterile environments, in particular to garments for cleanrooms or sterile environments, and even more particularly to coveralls for cleanrooms or sterile environments. By extension, most of such protective equipment is also suitable for use in medical and hospital environments.

The invention also relates to a method of packaging a protective device for a clean room or sterile environment according to the invention.

The invention also relates to a dressing method for putting on a protective device for clean rooms or sterile environments according to the invention.

The invention relates more particularly to a protective device for a clean room or sterile environment, comprising:

an exterior face for contact with an ambient environment,

an interior face arranged to be in contact with or oriented toward an operator.

Such protective equipment is used in clean room environments and laboratories, for example to manufacture pharmaceuticals or even biological, electronic and food materials in sterile or aseptic environments.

Clean rooms are used in many fields, such as electronics, micro-mechanics, optics, nanotechnology, as well as biotechnology, pharmacy, sterile compounding processes in pharmacies, medical equipment or even in the food industry.

Background

In order to guarantee a sterile and aseptic environment in the laboratory and more particularly in the clean room, they must be built according to very strict standards. For example, clean rooms must be supplied with large volumes of air filtered through high efficiency filters to dilute and remove particulates, bacteria, and chemicals from the room. The air also serves to pressurize the chamber and ensure that no contaminated air enters the clean room.

Furthermore, the cleaning chambers must be constructed of specially selected materials because they do not produce contaminants, particulates or chemical fumes, and the materials must also be easy to clean.

Finally, a person (i.e., an operator working in a clean room) must wear and carry special clothing, accessories, equipment, and tools to minimize the spread of the microorganisms and particulates (such as hair, skin particles, and clothing fibers, etc.) that they in turn produce.

For these reasons, in these types of rooms, the operator's body must be isolated in order to prevent contamination of the environment in which they are working or in order to prevent contamination of the products that they are manufacturing or working.

Document WO 2005065476 describes protective or work coveralls for use in hazardous conditions involving heat, fire, cold, etc. The coveralls include pockets located in the chest area of the operator's body. This bag comprises two openings: an upper opening and a lower opening. When an operator passes their hand first through the lower opening and second through the upper opening, the sleeves of the coveralls become inverted inside the pocket so the sleeves are pulled inside the pocket through the upper opening. The operator will then lift their legs into the bag via the upper opening and the closed bag.

When operators work in such sterile environments, they must follow a very specific protocol to don various items of protective equipment for the clean room or sterile environment before entering the clean room. Such a process is laborious and often requires the operator to perform unusual and very specific gestures and movements. For example, the operator cannot touch any external face of the protective equipment for clean rooms or sterile environments, otherwise there is a risk of contaminating the equipment and therefore having to go through the dressing process again.

Unfortunately, the coveralls as described in document WO 2005065476 cannot be used in a clean room environment because it does not meet the standards of a clean room. It comprises a variety of materials. In addition, the dressing process is complicated. When the protective equipment is removed from the bag to put it on, the operator will not be able to put on the coveralls without touching any of the exterior faces of the protective equipment.

Furthermore, existing protective equipment for clean rooms or sterile environments is therefore sterilised and supplied in packages which must be sealed but must also be able to withstand autoclaving. The equipment must also be both easy for the operator to open prior to entering the clean room, and strong enough to prevent tearing, which could result in the protective equipment coming into contact with the contaminated environment and therefore contaminants being subsequently introduced into the clean room. In most cases, the operator will not realize that this has occurred, taking into account the size of the contaminants.

Protective equipment for clean rooms or sterile environments is typically packaged in packages with lids that are sterile and separate, but disposable, in other words single-use, which is an important source of waste. However, in a clean room or sterile environment, everything that enters the room or environment must be removed and processed. In view of current climate concerns, the current trend is to reduce disposable packaging and associated waste without affecting the sterility of the coveralls.

Therefore, there is a real need for a protective apparatus that provides a clean room or sterile environment with the required level of sterility, which maintains its durability throughout the logistics phase and which takes into account cost and environmental constraints.

Disclosure of Invention

The object of the present invention is to overcome the drawbacks of the prior art by providing a device for clean rooms or sterile environments, the sterility of which is maintained throughout the logistics phase, while being less fragile, and having the potential to limit the environmental impact and the costs associated with logistics (decontamination, repackaging and storage) of the protective equipment.

In order to solve these problems, the present invention provides a protective equipment for clean rooms or sterile environments as described above, characterized in that it is packaged in a reusable and sterilizable bag, preferably made of fabric, having an opening provided with closing means.

It happens in a particularly unexpected way that the protection device for clean rooms or sterile environments, packaged in reusable and sterilizable bags (preferably made of fabric) according to the invention, provides a protection device with improved direct protection throughout the logistics, storage and opening phases.

It also occurs in a particularly unexpected and advantageous manner that the sterility of the protective equipment for clean rooms or sterile environments according to the invention is improved and maintained throughout the various logistic phases.

Finally, a protection device for clean rooms or sterile environments is provided according to the invention, packaged in reusable and sterilizable bags having an opening provided with closure means, making it possible to dispense in a particularly advantageous manner with single-use packaging, plastic packaging and paper packaging, which are fragile, disposable, made of raw materials and therefore very expensive, firstly due to the cost of the packaging itself and secondly due to the fragility of the device, more susceptible to accidents causing contamination and resulting in the associated costs of cleaning and decontaminating the clean room.

The bag according to the invention forms a cavity with an opening.

Preferably, the bag comprises at least two walls connected to each other over a substantial part of its ends, and the bag comprises an opening (preferably a single opening) comprising at least one closure means.

Advantageously, the bag comprises at least three walls connected to each other over a substantial part of its ends, and the bag comprises an opening, preferably a single opening of at least one closure device.

Preferably, the bag may have, for example, a square, rectangular, hexagonal or even semicircular shape.

Advantageously, the protective equipment for clean rooms or sterile environments according to the invention is selected from: apparel (e.g., coveralls), aprons, sleeveless outerwear, head coverings (e.g., hood or face mask), at least one glove, at least one shoe cover, shoes, wood-backed shoes, masks, goggles, sleeves, underwear, boots. Preferably, the bag of the protective equipment according to the invention is connected to the inner or outer face via at least one fastening means allowing the bag to be attached.

Preferably, the pouch of the protective equipment according to the invention is connected to the inner face of the garment via at least one fastening means, allowing the pouch to be attached to the inner face of the garment.

The bag of the protective equipment according to the 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 bag from the surrounding environment while the garment is being worn by the operator.

In fact, the bag is initially in contact with the contaminated surrounding environment. The pouch, by being connected to the inner face of the garment packaged therein, enables the pouch to be enclosed in the garment when the garment is removed from the pouch and the garment to be worn by the operator is unfolded, thereby isolating the pouch from the surrounding environment and thus limiting the possibility of contamination of the clean room or sterile environment.

Advantageously, the at least one fastening means of the protective equipment for clean rooms or sterile environments according to the present invention is a temporary fastening means, such as a snap or a series of snap, zipper, hook and loop fastener means, optionally arranged on a sheet-like flap (pattern).

More advantageously, the at least one fastening means of the protective equipment for clean rooms or sterile environments according to the invention is a seam or weld.

Further embodiments of the shielding apparatus for clean rooms or sterile environments according to the invention are detailed in the presented claims.

The present invention also relates to a garment, and in particular to a coverall for use in a clean room or sterile environment.

When operators work in such sterile environments, they must don clothing, and in particular coveralls, according to a very specific scheme before entering the clean room. Such procedures are very laborious and often require the operator to dress in a way that is completely contrary to their habits and contrary to how they would instinctively dress.

Thus, existing coveralls are sterilized and supplied in sealed packages that must be both easy for an operator to open prior to entering the clean room and strong enough to avoid tearing, which can result in the coveralls coming into contact with a contaminated environment and thus contaminants being subsequently introduced into the clean room. In most cases, the operator will not realize that this has occurred, taking into account the size of the contaminants.

It is therefore easy to understand that, firstly, the staff, the operators and the coveralls they wear are the main source of contamination in the clean room or sterile environment, and, secondly, contamination is absolutely to be avoided, since it would lead to production stoppages, sterilization or even destruction of the ingredients and materials present, and that lengthy and expensive cleaning steps are carried out according to very specific protocols in order to reestablish a sterile and aseptic environment.

Thus, the operator must put on a garment, for example a coverall, without touching the external face intended to come into contact with the sterile environment, and in particular without touching the external face of the body portion, that is to say, stretching out from the pelvis, straightening the operator's legs up to their neck. This is followed by a treatment process in which certain parts of the coveralls are folded, wherein the operator steps on the bench, puts one leg into it without touching the ground, and then puts the other leg into it while ensuring that they do not release or touch anything. It is readily understood that this method of dressing requires dexterity, which requires a great deal of skill and years of training and practice, as the risk of contaminating the clean room is to be avoided.

Document EP2303044 discloses an apparatus for a clean room or sterile environment, wherein the garment is a garment for a clean room or sterile environment, comprising:

an exterior face for contact with an ambient environment,

an inner face arranged to be in contact with an operator,

a first sleeve and a second sleeve,

a body portion comprising a torso portion and leg portions, the first and second sleeves being connected to the body portion, preferably via a connecting end, the body portion comprising a head passageway section,

at least one gripping device in contact with the inner face at the body portion, preferably at the body portion.

Unfortunately, such garments according to the prior art are packaged in sterilized packaging material or packaging to meet the requirements of the clean room, especially in view of the stages of packaging, transporting, opening the packaging and thus the individual garments for the clean room or sterile environment. Impacts, tears and negligence may occur during any of these steps, resulting in contamination of the packaging material or package. Since this is not visible to the naked eye, it is only detected when the operator is subjected to inspection or when the product from the clean room is analyzed. Indeed, the packaging material or package used for the sterilization of this type of garments is a single-use (and therefore disposable) packaging material or package made of plastic.

There is therefore a real need to provide a garment for clean rooms or sterile environments, which garment has an improved and maintained sterility in the logistics stage and takes into account cost and environmental constraints.

The object of the present invention is to overcome the drawbacks of the prior art by providing a garment for clean rooms or sterile environments, the direct protection of which is improved, which maintains sterility during the logistics phase and makes it possible to limit the costs associated with the garment itself and subsequently with the decontamination process.

To solve these problems, the invention provides a garment for clean rooms or sterile environments as indicated above, characterized in that it comprises said pocket connected to said inner face of said garment via said fastening means and located on the inner face of said pocket, preferably opposite the opening of said pocket, allowing the attachment of the inner face of said pocket to said inner face of the body portion of said garment, preferably to the inner face of the torso portion of said garment.

It happens in a particularly unexpected way that the garment for clean rooms or sterile environments, packaged in reusable and sterilisable bags (preferably made of fabric) according to the invention, provides a protective device with improved direct protection throughout the logistics, storage and opening phases.

It also occurs in a particularly unexpected and advantageous manner that the sterility of garments for clean rooms or sterile environments according to the present invention is improved and maintained throughout multiple stages of logistics.

Finally, a garment for clean rooms or sterile environments according to the invention is provided, comprising a reusable and sterilizable pouch for its packaging, having an opening provided with closure means, making it possible to omit, in a particularly advantageous manner, single-use packaging, plastic packaging and paper packaging, which are fragile, disposable, made of raw materials and therefore very expensive, firstly due to the cost of the packaging itself and secondly due to the fragile equipment, more susceptible to accidents causing contamination and leading to the associated costs of cleaning and decontaminating the clean room.

Furthermore, the garment for clean rooms or sterile environments according to the invention comprises, on the one hand, a reusable sterile bag having an opening provided with closure means and, on the other hand, at least one gripping means in contact with an inner face in a body portion (preferably a torso portion) of the garment, so that it is possible, in a particularly advantageous manner, to provide a garment which maintains sterility and to provide a garment whose handling during dressing is easy by means of said at least one gripping means being directly exposed to the operator.

The pocket of the garment for clean rooms or sterile environments according to the invention, by being connected to the inner face of the garment and by being attached to the inner face via at least one fastening means, makes it possible in a particularly advantageous manner to isolate the pocket from the surrounding environment when the garment is worn by an operator.

In fact, the bag is initially in contact with the contaminated surrounding environment. The pouch is connected to the inner face of the body portion of the garment packaged therein, so that when the garment is removed from the pouch and unfolded for wearing by an operator following a simple protocol, it is possible to enclose the pouch in the coveralls, thus isolating the pouch from the surrounding environment and thus limiting the possibility of contaminating the clean room or sterile environment.

In a preferred embodiment, the garment for a clean room or sterile environment of the protective equipment according to the invention is a coverall, wherein the leg portion further comprises,

a first leg section and a second leg section, each leg section comprising a side flap, two longitudinal edges located on either side of the side flap of a leg section and provided with mutual closure means arranged to form the substantially tubular leg section when the mutual closure means of each longitudinal edge are joined together, the joined closure means of the first leg section facing the joined closure means of the second leg section and each preferably extending at least from a knee region to a crotch region and more preferably from a calf region or an ankle region to a crotch region,

and wherein the first leg section and the second leg section are connected to the body portion, preferably to the torso portion, via a connecting end.

In a preferred embodiment, said pockets comprised in the coveralls according to the invention are positioned in a body portion, preferably a torso portion, preferably a pelvic area portion, of said coveralls.

Advantageously, the shielding apparatus for a clean room or sterile environment according to the invention has:

a deployed position, in which said outer face of the coveralls is in contact with the surrounding environment and said inner face is arranged in contact with the operator, and in which a first inner face of the bag is placed against said inner face of the coveralls and a second inner face of the bag is arranged in contact with the operator, said closure device preferably being in an open position,

a folded position wherein

a. The mutual closure means of each leg section being in a mainly open position to form a crotch opening arranged to provide access to the interior of the body portion, an

b. The inner faces of the first and second leg segments are exposed to the exterior and the outer faces of the first and second leg segments are exposed to the outer face of the body segment,

c. the at least one gripping means is exposed to an operator in the vicinity of the closure means of the bag,

and wherein, in the folded position, the coveralls are packaged in the pockets.

Preferably, the protective equipment of the clean room or sterile environment according to the invention has, when in the folded position and packed in said bag:

a first closed position in which the opening of the bag is closed, an

A second open position wherein the opening of the bag is open and wherein the at least one gripping device is exposed to an operator.

Advantageously, the shielding apparatus for clean rooms or sterile environments according to the present invention has, in the deployed position, at least two gripping means in contact with said inner face at the body portion, preferably laterally positioned at the body portion.

Even more advantageously, the coveralls for shelters for clean rooms or sterile environments according to the invention have, in the folded position:

a. the mutual closure means of each leg section being in a predominantly open position to form a crotch opening arranged to provide access to the interior of the body portion, an

b. The inner faces of the first and second leg segments are exposed to the exterior and the outer faces of the first and second leg segments are exposed to the outer face of the body segment.

Preferably, the closure means of the first leg section and the closure means of the second leg section of the protective equipment for clean rooms or sterile environments according to the invention together form a continuous closure of the opening of the crotch portion and preferably comprise a continuous zipper for the first leg section and the second leg section.

Advantageously, the closing means of the bag of the protective equipment for clean rooms or sterile environments according to the invention are selected from the group consisting of zippers, hook and loop fastener means, a series of snaps, flap flaps.

In a particular embodiment of the protective equipment for clean rooms or sterile environments according to the invention:

the first sleeve and/or the second sleeve comprise, at a free end opposite to said connected end, self-tightening means, such as an elastic fabric wrist strap, a snap flap or hook and loop fastener means, or the like, and/or

The first leg segment and/or the second leg segment includes a self-cinching device, such as an elastic fabric ankle cuff, a snap flap, or a hook and loop fastener device, or the like, at a free end opposite the connected end.

Preferably, the protective device for clean rooms or sterile environments according to the invention has, in the folded position: the leg portions or the first and second leg segments are folded longitudinally onto themselves and transversely onto themselves in two or three portions.

In a preferred embodiment of the protective equipment for clean rooms or sterile environments according to the invention the fabric of the equipment and/or the bag comprises monofilament polyester.

By including monofilament polyester fabric, the protective equipment and/or bag has high to very high particulate filtration capacity, as well as a strong bacterial barrier.

Preferably, the fabric of the device and/or bag is made of monofilament polyester.

In another preferred embodiment of the protective equipment for clean rooms or sterile environments according to the invention, the fabric of the equipment and/or bags comprises polyester fibers and antistatic carbon fiber threads, preferably 90% to 99.5% polyester fibers, preferably 92% to 99.5% polyester fibers, advantageously 97% to 99.5% polyester fibers, particularly advantageously 99% polyester fibers and the antistatic carbon fiber threads are 10% to 0.5%, preferably 8% to 0.5%, preferably 3% to 0.5%, particularly advantageously 1% of the fabric. This results in a fabric with high to very high particulate filtration capacity and a strong bacterial barrier.

In another embodiment of the protective equipment for clean rooms or sterile environments according to the invention, the fabric of the equipment and/or the bag is a non-woven fabric. Advantageously, the fabric of the apparatus and/or bag comprises high density polyethylene fibers randomly arranged and compressed. Preferably, the fabric of the device and/or bag is a fabric comprising a prepreg comprising a thermosetting resin such as polyester fibres or thermoplastic polymers impregnated with a reinforcement, e.g. fabric, fibres.

The invention also relates to a method of packaging a protective device for a clean room or sterile environment, the method comprising:

decontaminating the protective equipment in an area outside the sterile area and transferring the decontaminated protective equipment to the sterile area,

decontaminating the reusable and sterilizable bags in an area outside the sterile area and transferring said decontaminated containment apparatus to the sterile area,

opening the bag in a sterile area,

placing the shielding device in the sterile area in the bag and operating the closing means to close the bag in the sterile area.

Optionally, sterilizing the protective equipment packaged in the bag.

In practice, in order to decontaminate the protective equipment, the personnel place the protective equipment (such as aprons, gowns, coveralls, boots) in the washing machines in an area outside the sterile area (such as the clean room, etc.). The protective equipment, once cleaned and thus decontaminated, is placed in a sterile area, such as a clean room or the like. For reusable and sterilizable bags, the same steps are carried out in the same washing process as the washing of the shielding device or in a washing process separate from the washing of the shielding device, whether or not attached to the shielding device.

As another part of this decontamination process, after the shielding equipment and the reusable and sterilizable bags are cleaned and transferred to the sterile field, the shielding equipment and the reusable and sterilizable bags are dried in a dryer located in the sterile field.

The shielding equipment and the reusable and sterilizable bags are then placed in the sterile field in the area where packaging is to be performed. The reusable and sterilizable pouch is opened and the shielding device is placed within the reusable and sterilizable pouch. Once this step is performed, the reusable and sterilizable pouch remains closed in the sterile area.

Optionally, as a precaution, an additional step of sterilizing the shielding device packaged in a reusable and sterilizable bag is carried out.

Preferably, the method of packaging a protective device for a clean room or sterile environment, wherein the protective device is a garment, according to the invention comprises:

an inner face arranged to be in contact with an operator,

a first sleeve and a second sleeve,

at least one gripping device in contact with said inner face at the body portion, preferably at the body portion,

and wherein a fold of the garment is provided between decontaminating the garment and placing it in the pocket, the fold comprising the steps of:

exposing at least one grasping device to the outside by grasping the at least one grasping device;

folding the outer face of the leg portion onto the outer face of the body portion, keeping at least the first grip means exposed,

folding the side portions of the leg portion onto itself in the longitudinal direction of the leg portion, keeping at least the first gripping means exposed,

folding into sections in the transverse direction by folding the leg portions longitudinally, keeping at least the first gripping means exposed,

the step of placing the garment into the pocket comprises: turning the bag around the folded garment while maintaining the at least one first gripping means adjacent the opening of the bag and closing the closing means of the bag to package the garment and gripping means therein.

Advantageously, the method for packaging protective equipment for clean rooms or sterile environments according to the invention, wherein the garment is a coverall, wherein the leg sections comprise a first leg section and a second leg section, each leg section comprising a side flap, two longitudinal edges on either side of the side flap of a leg section and being provided with mutual closure means arranged to form said substantially tubular leg section when the mutual closure means of each longitudinal edge are joined together, said mutual closure means of the first leg section facing said joined closure means of the second leg section and each preferably extending at least from a knee region to a crotch region and more preferably from a calf region or an ankle region to a crotch region, and wherein said first leg section and said second leg section are connected to said body portion via connecting ends, preferably to the torso portion, the method being characterized in that the folding of the side portions of the leg portions in the longitudinal direction of the leg portions is on itself a folding of the side portions of the first leg segment and a folding of the side portions of the second leg segment, the closure means of the first leg segment being in an open position and the closure means of the second leg segment being in an open position to keep the first grip means exposed.

Further embodiments of the method of packaging a protective device for a clean room or sterile environment according to the invention are detailed in the presented claims.

The invention also relates to a dressing method for putting on a protective device for a clean room or sterile environment according to the invention, comprising the following steps:

-opening the closing means of the bag,

grasping the shielding device before optionally separating the temporary fastening means of the bag from the shielding device, an

Putting on the protective equipment.

Advantageously, the dressing method according to the invention for putting on a protective device for a clean room or sterile environment, wherein said protective device is a garment, comprises:

an exterior face for contact with an ambient environment,

an inner face arranged to be in contact with an operator,

a first sleeve and a second sleeve,

the method according to the invention further comprises:

grasping the first grasping means via a first hand of an operator,

removing the garment from the pocket using the first gripping means and positioning the garment such that the body portion of the garment is accessible via an opening formed by the periphery of the body portion, preferably via an opening formed by the periphery of the torso portion,

placing the second arm of the operator in the second sleeve and, after releasing the first gripping means, placing the first arm of the operator in the first sleeve,

passing an operator's head into the opening of the body portion and then into the head passage section, an

Turning the leg portions so that their outer faces are thus exposed to the outside and the inner faces are exposed to the operator's legs;

in a preferred embodiment of the method of donning protective equipment for clean rooms or sterile environments according to the invention, wherein the garment is a coverall, wherein the leg sections comprise a first leg section and a second leg section, each leg section comprising a side flap, two longitudinal edges on either side of the side flap of a leg section and being provided with mutual closure means arranged to form said substantially tubular leg section when the mutual closure means of each longitudinal edge are joined together, said mutual engagement closure means of a first leg section facing said engagement closure means of a second leg section and each preferably extending at least from a knee region to a crotch region and more preferably from a calf region or an ankle region to a crotch region, and wherein said first leg section and said second leg section are connected to said body section via connecting ends, preferably to said torso portion, wherein said overturning step of said leg portions is an overturning of the leg segments, the closing means of the leg segments being in an open position, so that the outer faces of the leg segments are thus exposed to the outside and the inner faces are exposed to the legs of the operator.

Advantageously, the dressing method for a clean room or sterile environment according to the invention further comprises gripping the second gripping means via a second hand of the operator to position the coveralls such that the body portion of the coveralls is accessible via the opening or crotch section of the body portion.

Preferably, the dressing method for a clean room or sterile environment according to the invention further comprises closing the opening in the crotch region.

Further embodiments of the method of putting on a coverall for a clean room or sterile environment according to the invention are detailed in the presented claims.

Other features, details and advantages of the present invention will appear from the detailed description which follows, which is not to be taken in a limiting sense, and which refers to the accompanying drawings.

Drawings

Figure 1 is a front view of a protective device according to the invention, wherein the garment is a coverall.

Figure 2A is a top view of a protective apparatus according to the present invention, wherein the garment is a coveralls in a partially folded position.

Figure 2B is a top view of a variant of the protective equipment according to the invention, in which the garment is a coveralls in a partially folded position.

Figure 3 is a top view of the protective equipment according to the invention, wherein the garment is a coveralls in a partially folded position, wherein longitudinal folding has taken place.

Fig. 4 is a top view of a bag according to the present invention, wherein the protective equipment is packaged.

Fig. 5 is a side view of a wood-soled shoe for use in a clean room or sterile environment according to the present invention.

Figure 6 is a front view of a protective boot for a clean room or sterile environment according to the present invention.

Fig. 7 is a view of a plurality of articles of protective equipment for a clean room or sterile environment according to the present invention.

Figure 8 is a front view of a pant-type containment apparatus for a clean room or sterile environment according to the present invention.

In the drawings, the same or similar elements have the same reference numerals.

Detailed Description

Fig. 1 shows a protective equipment 1 for a clean room or sterile environment according to the invention, and more particularly a coverall 7 for a clean room or sterile environment, which coverall 7 comprises an outer face 2 for contact with the surrounding environment and an inner face 3 arranged for contact with a user or operator.

The coveralls 7 comprise a first leg section 9 and a second leg section 10, each of the first leg section 9 and the second leg section 10 comprising a side flap and two longitudinal edges on either side of the side flap of the leg section, each of the two longitudinal edges being further provided with mutual closure means arranged to form a substantially tubular leg section when the mutual closure means of each longitudinal edge are joined together. Furthermore, the interengaging closure devices of the first leg segment face the interengaging closure devices of the second leg segment, and each preferably extends at least from the knee region to the crotch region (not shown), and more preferably from the lower leg region or ankle region to the crotch region (not shown).

Although not shown in the described figures, the closure means of the first leg segment and the closure means of the second leg segment together form a continuous closure of the crotch opening. The closure means is selected from the group consisting of zippers, hook and loop fastener means, snaps, flap drops or other equivalent or similar means.

The coveralls 7 further include first sleeves 12, second sleeves 13, and a body portion 14. The first sleeve 12 is connected to the body portion 14 via a connecting end 12a, and the second sleeve 13 is also connected to the body portion 14 via a connecting end 13 a. The first leg section 9 and the second leg section 10 are connected to the body portion 14 via connection ends 9a and 10a, respectively. Finally, the body portion 14 of the coveralls 7 includes a head channel section 15.

In the embodiment shown in fig. 1, the coveralls 7 comprise a face mask provided with openings for the eyes, above or below which openings e.g. a mask or goggles can be placed.

According to the invention and as shown in figure 1, the coveralls 7 comprise a pocket 4, which pocket 4 is connected to the inner face 3 of the coveralls 7 via fastening means 8. The fastening means 8 are located on the inner face of the bag 4 and preferably opposite the opening 5 of the bag 4. This advantageously allows the interior face of the pouch 4 to be attached to the interior face 3 of the body portion 14 of the coveralls 7.

Thus, in the folded and packaged position, the interior face 3 of the coveralls 7 is connected to the interior face of the pouch 4 such that only the exterior face of the pouch 4 is in contact with the surrounding environment, as shown in fig. 4. When the operator wants to put on the coveralls 7, they will, before doing so, open the closure means 6 of the opening 5 of the pocket 4 and remove the coveralls 7 from the pocket 4 using the gripping means 16. After this step is performed, when the coveralls 7 are removed from the pockets 4, an inversion, flipping of the faces of the pockets 4 will occur.

Particularly advantageously, first, the outer face of the bag 4 exposed to the surrounding environment will become the inner face of the bag 4. Secondly, when the coveralls 7 are worn by the operator, the pockets 4 attached to the interior face 3 of the coveralls 7 will thus end up within the coveralls 7.

The pockets 4 of the protective equipment 1 according to the invention and more particularly the pockets 4 of the coveralls 7 thus make it possible to achieve a double isolation of possible contaminants. The isolation is first achieved by the inversion of the outer face of the bag 4, eventually inside the bag 4, the contaminants thus being contained in the bag 4. The restraint is also achieved by restraining the pockets 4 inside the coveralls 7.

In the embodiment of fig. 1, the first sleeve 12 comprises, at the free end opposite to the connecting end 12a, self-constriction means 17, the self-constriction means 17 being in the form of an elastic fabric wrist band. The second sleeve 13 also comprises, at the free end opposite the connecting end 13a, self-constriction means 17, the self-constriction means 17 being in the form of an elastic fabric wrist band. The elastic fabric wrist band shown in fig. 1 may also be replaced by snap-tab flaps, or hook and loop fastener means, or other conventional cinching means.

Furthermore, according to the embodiment of the protective equipment 1 and more particularly of the coveralls 7 of fig. 1, in the deployed position, the coveralls 7 have: wherein the exterior face 2 of the coveralls 7 is in contact with the ambient environment and the interior face 3 is arranged to be in contact with an operator. A first interior face of the pouch 4 rests against the interior face 3 of the coveralls and a second interior face of the pouch 4 is arranged to be in contact with or oriented towards an operator. The closure means 6 of the opening 5 of the bag 4 is preferably in the open position. It is obviously possible for the closure means 6 to be in the closed position, in particular to isolate the exterior face of the pocket 4 inside the pocket 4 when the coveralls 7 are in the deployed position.

The coveralls 7 according to the present invention comprise at least one gripping means 16, which gripping means 16 is positioned in contact, preferably laterally, with the inner face 3 in the body portion 14. In the variant shown in figure 2a, the coveralls 7 according to the invention comprise two gripping means 16, which gripping means 16 are positioned laterally in contact with the inner face 3 of the body portion 14, on either side of the opening 11. In another variant shown in fig. 2b, the coveralls 7 according to the present invention include gripping means 16, which gripping means 16 are in contact with the inner face 3 in the body portion 14.

Figures 2A and 2B show two embodiments of a coveralls 7 according to the present invention in a partially folded position. The inner face 3 of the first leg section 9 and the second leg section 10 is exposed to the outside, exposed to the surrounding environment. The outer faces 2 of the first and

second leg sections

9, 10 are exposed to the outer face 2 of the body portion 14. This particular arrangement according to the invention forms an opening 19, which opening 19 itself is arranged for providing access to the inside of the body portion 14 and preferably to the inside of the torso portion of the coveralls 7.

In this way, at least one gripping device 16 is exposed to the operator.

In the embodiment of fig. 2A, the coveralls 7 according to the present invention include two gripping devices 16 exposed to the operator.

In the embodiment of fig. 2B, the coveralls 7 according to the present invention include a gripping device 16 that is exposed to the operator.

In a further embodiment, not shown, the gripping means 16 of the coveralls 7 according to the present disclosure may be part of the material of the interior face 3 of the coveralls 7 and thus exposed to the operator. Furthermore, the inner face 3 of the coveralls 7 or different parts of the material of the protective apparatus 1 for clean rooms or sterile environments may have different colors, textures or patterns to allow the operator to identify them as gripping means 16.

Indeed, the grip devices 16 according to fig. 2A and 2B are present on the inner face 3 of the coveralls 7, and the action of partially turning the leg sections over the body section makes it possible to expose them to the outside and therefore to the operator.

It is therefore easy to understand from the coveralls 7 according to the present invention that the steps of the folding method must be followed in order to maintain the sterility of the coveralls 7, in particular after removal of the coveralls 7 by the operator and their cleaning, decontamination and subsequent repackaging.

Particularly advantageously, the coveralls 7 according to the invention (including the bags 4) make it possible to dispense with single-use packaging and to make it possible to clean and repackage it directly in their protective bags 4, which themselves can be cleaned, sterilized and reused.

In this folding step, the operator folds the outer faces of the first and

second leg sections

9, 10 downwards by passing the opened crotch section over the outer face of the body portion 14, while keeping the at least one gripping means 16 exposed.

The second step of the folding process is shown in figure 3. In this step, the first leg section 9 is folded longitudinally onto itself and the second leg section 10 is also folded longitudinally onto itself while exposing both gripping means (16) to the operator. Furthermore, the final step of folding the coveralls according to the present invention is shown in FIG. 3 using arrows. In fact, the coveralls 7 according to the invention thus folded will then be folded transversely onto themselves in two or three portions or even more, if necessary, depending on the size of the coveralls. The coveralls 7 thus folded are then packed in pockets 4, and the pockets 4 may access the body portion 14 of the coveralls 7. Once folded and packaged, the bag 4 containing the coveralls 7 as shown in FIG. 4 may be sterilized, for example, in an autoclave.

Before putting on the coveralls 7 according to the present invention, the user opens the closure device 6 of the opening 5 of the pocket 4, grasps the first grasping device 16 with a first hand and the second grasping device 17 with a second hand, and removes the coveralls 7.

In this way, the coveralls 7 are obtained in a partially folded position as shown in FIG. 2A. The coveralls 7 are positioned such that the body portion 14 is accessible via the opening 19 of the crotch portion of the coveralls, via the waist section. The operator then places his second arm into the second sleeve 13 after releasing the second gripping means 16 and his first arm into the first sleeve 12 after releasing the first gripping means 16. They then pass their head through the opening in the body portion 14 via the waist section and then through the head passage section 15 until their head reaches the mask.

Then, they turn the

leg sections

9, 10 over such that the outer faces of the first and

second leg sections

9, 10 are exposed to the outside and the inner faces of the first and

second leg sections

9, 10 are exposed to the operator's legs. The operator then places his feet in the foot tunnel sections comprising the pre-engaged zippers and closes said opening 19 so as to completely isolate his body from the external environment.

Fig. 5 shows a wooden-sole shoe as a protective device for a clean room or sterile environment according to the present invention. The wooden-soled shoe as shown comprises a series of press studs 8, wherein a first part of the male stud is located on the wooden-soled shoe and a second part of the female stud is located on the pocket 4, the reverse being obviously possible. Thus, the sandals may be attached to the bag 4 and positioned inside the bag 4 such that during removal, the sandals will be removed and the bag 4 will turn over on itself as explained above in order to isolate the contaminants within the bag 4.

Figure 6 shows a protective boot according to the invention as a protective device for clean rooms or sterile environments. The boot shown comprises a series of snap fasteners 8, of which a first part of the male fastener is located on the boot and a second part of the female fastener is located on the pocket 4, the opposite being obviously possible. Thus, the protective boot may be attached to the pouch 4 and positioned inside the pouch 4 such that during removal the protective boot will be removed and the pouch 4 will turn over on itself as explained above in order to isolate contaminants within the pouch 4.

Fig. 7 shows gloves, shoe covers, hoods and face masks as a protective device for clean rooms or sterile environments according to the present invention. The shown protective device may comprise means 8 for fastening to the bag 4, such as snaps or the like. Thus, it may be attached to the bag 4 and placed inside the bag 4, such that during removal the shielding device will be removed and the bag 4 will turn over on itself as explained above in order to isolate the contaminants within the bag 4.

Fig. 8 shows a pair of trousers according to the invention, comprising a first leg section 9 and a second leg section 10. The illustrated trousers comprise an inner face 3 and an outer face 2 and also a pocket 4 according to the invention.

Thus, the operator can put on the trousers and the pockets 4 as described above are located inside the trousers, so that it is possible to isolate firstly the contaminations in the pockets 4 and secondly the contaminations in the inner parts of the trousers, which are isolated from the surroundings.

It will be understood that the invention is in no way limited to the embodiments described above and that many modifications may be made thereto without departing from the scope of the claims presented.

Claims

1. A protective apparatus (1) for a clean room or sterile environment, comprising:

an outer face (2), the outer face (2) being for contact with the surrounding environment;

an inner face (3), said inner face (3) being arranged to be in contact with or oriented towards an operator,

characterized in that said protection device (1) is packaged in a reusable and sterilizable bag (4), said bag (4) preferably being made of fabric, said bag (4) having an opening (5) provided with closing means (6).

2. A protective equipment (1) for a clean room or sterile environment according to claim 1, selected from the group consisting of: such as a garment for a coverall (7), an apron, a head covering such as a hood or face mask, at least one glove, at least one shoe cover, shoes, a sandal, a mask, goggles, sleeves, underwear, boots.

3. Protective equipment (1) for a clean room or sterile environment according to claim 1 or 2, wherein the bag (4) is connected to the inner face (3) or the outer face (2) via at least one fastening means (8) allowing the bag (4) to be attached.

4. A protective apparatus (1) for a clean room or sterile environment according to claim 3, wherein the bag (4) is connected to the interior face (3) of the garment via at least one fastening means (8) allowing the bag (4) to be attached to the interior face (3) of the garment.

5. A protective equipment (1) for clean rooms or sterile environments according to claims 1 to 4, wherein the at least one fastening means (8) is a temporary fastening means, such as a snap or a series of snap, zipper, hook and loop fastener means, optionally arranged on a flap.

6. A protective equipment (1) for a clean room or sterile environment according to any one of claims 1 to 4, wherein said at least one fastening means (8) is a seam or weld.

7. Protective equipment (1) for a clean room or sterile environment according to any one of claims 2 to 6, wherein the suit is a suit for a clean room or sterile environment comprising:

an outer face (2), the outer face (2) being for contact with the surrounding environment,

an inner face (3), the inner face (3) being arranged to be in contact with an operator,

a first sleeve (12) and a second sleeve (13),

a body part (14), the body part (14) comprising a torso part and leg parts, the first sleeve (12) and the second sleeve (13) being connected to the body part, preferably via a connection end, the body part (14) comprising a head passage section (15),

at least one gripping device (16), said at least one gripping device (16) being in contact with said inner face (3) at said body portion (14), preferably in contact with said inner face (3) at said body portion,

characterized in that the garment (7) comprises the pocket (4), the pocket (4) being connected to the inner face (3) of the garment (7) via the fastening means (8), the fastening means (8) being located on the inner face of the pocket (4), preferably opposite the opening (5) of the pocket (4), allowing the inner face of the pocket (4) to be attached to the inner face (3) of the body portion (14) of the garment (7), preferably to the inner face of the torso portion of the garment.

8. A protective equipment (1) for a clean room or sterile environment according to claim 7, wherein said garment for a clean room or sterile environment is a coveralls (7), wherein said leg portion further comprises:

a first leg section (9) and a second leg section (10), each leg section comprising a side flap, two longitudinal edges on either side of the side flap of the leg section and provided with mutual closure means arranged to form the generally tubular leg section when the mutual closure means of each longitudinal edge are joined together, the mutual closure means of the first leg section facing the joined closure means of the second leg section and each preferably extending at least from a knee region to a crotch region and more preferably from a lower leg region or an ankle region to a crotch region,

and wherein the first leg section (9) and the second leg section (10) are connected to the body portion (14), preferably to the torso portion, via a connection end.

9. A protective equipment (1) for a clean room or sterile environment according to claim 7 or 8, said protective equipment (1) having:

a deployed position, in which the outer face (2) of the garment (7) is in contact with the surrounding environment and the inner face (3) is arranged in contact with the operator, and in which a first inner face of the bag (4) is against the inner face (3) of the garment (7) and a second inner face of the bag (4) is arranged in contact with the operator, the closing means (6) being preferably in an open position,

a folded position, wherein:

a. the inner face (3) of the leg portion is exposed to the outside and the outer face (2) of the leg portion is exposed to the outside of the body section, preferably the torso portion, forming an opening (19), the opening (19) being arranged to provide access to the interior of the body portion, preferably the torso portion.

b. Said at least one gripping means (16) being exposed to an operator in the vicinity of the closing means of the bag,

and wherein the garment (7) is packed in the pocket (4) in the folded position.

10. A protective equipment (1) for a clean room or sterile environment according to any one of claims 7 to 9, in a folded position and packed in the bag (4), the bag (4) having:

a first closed position in which the opening (5) of the bag (4) is closed, and

a second open position, wherein the opening (5) of the bag (4) is open, and wherein the at least one gripping device (16) is exposed to an operator.

11. Guard device (1) for clean rooms or sterile environments according to any of claims 7 to 10, having, in the unfolded position, at least two gripping means (16), said at least two gripping means (16) being in contact with the inner face (3) at the body portion (14), preferably at the sides, preferably in the body portion (14).

12. A protective apparatus (1) for a clean room or sterile environment according to any one of claims 8 to 11, wherein the coveralls have in a folded position:

b. The inner faces (3) of the first and second leg sections (9, 10) are exposed to the outside, and the outer faces (2) of the first and second leg sections (9, 10) are exposed to the outer faces (2) of the body sections.

13. A shielding apparatus (1) for a clean room or sterile environment according to any one of claims 8 to 12, wherein the closure means of the first leg section and the closure means of the second leg section together form a continuous closure of the crotch opening and preferably comprise a continuous zipper for the first leg section and the second leg section.

14. A protective apparatus (1) for a clean room or sterile environment according to any one of claims 1 to 13, wherein the closing means (6) of the bag (4) is selected from the group consisting of a zipper, a hook and loop fastener means, a series of snaps, a flap.

15. A protective equipment (1) for a clean room or sterile environment according to any one of claims 7 to 14, wherein:

the first sleeve (12) and/or the second sleeve (13) comprises, at a free end opposite to the connecting end, self-tightening means (17), such as an elastic fabric wrist strap, a snap flap or hook and loop fastener means, and/or

The first leg section (9) and/or the second leg section (10), when present, comprises self-constriction means (18), such as elastic fabric ankle cuffs, snap-tab flaps or hook-and-loop fastener means, at a free end opposite the connected end.

16. Guard device (1) for clean rooms or sterile environments according to any of claims 8 to 15, having in the folded position: the leg portions or the first leg section (9) and the second leg section (10) are folded longitudinally onto themselves and transversely onto themselves in two or three parts.

17. A method of packaging protective equipment for a clean room or sterile environment, comprising:

decontaminating the reusable and sterilizable bags in an area outside the sterile area and transferring the decontaminated containment device to the sterile area,

opening the bag in a sterile area,

Optionally, sterilizing the protective equipment packaged in the bag.

18. Method of packaging a protective equipment (1) for a clean room or sterile environment according to claim 17, wherein said protective element is a garment comprising:

a first sleeve (12) and a second sleeve (13),

a body part (14), the body part (14) comprising a torso part and a leg part, the first sleeve (12) and the second sleeve (13) being connected to the body part, preferably via a connecting end, the body part (14) comprising a head passage section (15),

exposing the at least one gripping device (16) to the outside by gripping the at least one gripping device (16),

folding the outer face (2) of the leg portion onto the outer face (2) of the body portion (14), keeping at least said first gripping means (16) exposed,

folding the side portions of the leg portion onto itself in the longitudinal direction of the leg portion, keeping at least the first gripping means (16) exposed,

folding into sections in the transverse direction by folding the leg portions longitudinally, keeping at least the first gripping means (16) exposed,

the step of placing the garment into the pocket comprises: turning the pouch around the folded garment while maintaining the at least one first gripping device proximate the opening of the pouch, and closing the closure device of the pouch to package the garment and gripping device therein.

19. Method of packaging a protective equipment (1) for a clean room or sterile environment according to claim 18, wherein the garment is a coverall (7), wherein the leg sections comprise a first leg section (9) and a second leg section (10), each leg section comprising a side flap, two longitudinal edges, both longitudinal edges being on either side of the side flap of the leg section and being provided with mutual closure means arranged to form a substantially tubular leg section when the mutual closure means of each longitudinal edge are joined together, the mutual engagement closure means of the first leg section facing the engagement closure means of the second leg section and each preferably extending at least from a knee region to a crotch region and more preferably from a lower leg region or an ankle region to a crotch region, the first leg section (9) and the second leg section (10) being connected to the body section (14) via connecting ends, preferably to the torso portion, the method being characterized in that folding the side portions of the leg portions in the longitudinal direction of the leg portions onto themselves is the folding of the side portions of the first leg segment with the closure device in the open position and the folding of the side portions of the second leg segment with the closure device in the open position, leaving the first grip means (16) exposed.

20. A dressing method for putting on a protective equipment (1) for a clean room or sterile environment according to any one of claims 1 to 19, comprising the steps of:

-said closing means (6) opening said bag (4),

Putting on the protective equipment.

21. Method of putting on a protective equipment (1) for a clean room or sterile environment according to claim 20, wherein the protective equipment is a garment comprising:

an outer face (2), the outer face (2) being arranged to be in contact with the surrounding environment,

a first sleeve (12) and a second sleeve (13),

the method comprises the following steps:

grasping the first grasping means via a first hand of an operator,

removing the garment (7) from the pocket (4) using the first gripping means (16) and positioning the garment (7) such that the body portion (14) of the garment (7) is accessible via an opening formed by the periphery of the body portion, preferably via an opening formed by the periphery of a torso portion,

-placing the second arm of the operator in a second sleeve (13) and, after releasing the first grip device (16), placing the first arm of the operator in a first sleeve (12),

-passing the head of an operator into the opening of the body part (14) and then into the head passage section (15), and

the leg portions are turned so that their outer face (2) is thus exposed to the outside and the inner face (3) is exposed to the legs of the operator.

22. Method of putting on a protective equipment (1) for a clean room or sterile environment according to claim 21, wherein the garment is a coverall, wherein the leg sections comprise a first leg section (9) and a second leg section (10), each leg section comprising a side flap, two longitudinal edges, both longitudinal edges being on either side of the side flap of the leg section and being provided with mutual closure means arranged to form a substantially tubular leg section when the mutual closure means of each longitudinal edge are joined together, the mutual engagement closure means of the first leg section facing the engaged closure means of the second leg section and each preferably extending at least from a knee region to a crotch region and more preferably from a lower leg region or an ankle region to a crotch region, and wherein, the first leg section (9) and the second leg section (10) are connected to the body portion (14), preferably to the torso portion, via connecting ends, wherein the turning step of the leg portions is a turning of the leg sections (9, 10), the closing means of the leg sections being in an open position, such that the outer face (2) of the leg sections is thus exposed to the outside and the inner face (3) is exposed to the legs of an operator.

23. A dressing method for a clean room or sterile environment according to claim 21 or 22, further comprising gripping second gripping means (16) via a second hand of the operator to position the coveralls (7) such that the body portion (14) of the coveralls (7) is accessible via the opening (11) or crotch section of the body portion.

24. A dressing method for a clean room or sterile environment according to claim 22 and any one of claim 23 when dependent on claim 22, further comprising closing said opening (11) in said crotch region.