WO2021099631A1

WO2021099631A1 - Protective equipment for a clean room or a sanitized environment

Info

Publication number: WO2021099631A1
Application number: PCT/EP2020/083032
Authority: WO
Inventors: Vincent Vanneste
Original assignee: Bemicron
Priority date: 2019-11-22
Filing date: 2020-11-23
Publication date: 2021-05-27
Also published as: EP4062783A1; BE1027777A1; AU2020388260A1; BE1027777B1; CA3153097A1; BR112022005839A2; EP4041012A1; US20220378126A1; CN114727674A; EP4041012C0; ES2958221T3; EP4041012B1

Abstract

The invention relates to protective equipment for a clean room or a sanitized environment, comprising: • an outer face (2) intended to be in contact with the surrounding environment; • an inner face (3) arranged to be in contact with or oriented towards an operator. Also disclosed are a method for packaging the protective equipment and to a dressing method for putting on said protective equipment.

Description

PROTECTIVE EQUIPMENT FOR CLEANROOM OR ASEPTIZED ENVIRONMENT

The present invention relates to the field of clean rooms, in particular to protective equipment for a clean room or aseptic environment, particularly to a garment for a clean room or aseptic environment and even more particularly to a suit for a clean room or aseptic environment. By extrapolation, most of this protective equipment is also suitable for the medical and hospital environment.

The present invention further relates to a method of packaging protective equipment for a clean room or aseptic environment according to the present invention.

The present invention also relates to a dressing method for coating protective equipment for a clean room or aseptic environment according to the present invention.

The present invention relates more particularly to protective equipment for a clean room or aseptic environment comprising:

• an exterior face designed to be in contact with the surrounding environment,

• a lower face arranged to be in contact with or oriented towards a manipulator.

Such protective equipment is used in clean room environments, in laboratories, for example making it possible to manufacture drugs or even biological, electronic or food material in an aseptic and sterile environment. Clean rooms are used in many fields such as electronics, micromechanics, optics, nanotechnologies and biotechnologies, pharmaceuticals, sterile compounding preparations in pharmacies, medical equipment and even in the food industry.

To ensure an aseptic and sterile environment in the laboratory and more particularly in the clean room, the latter must be built according to very strict standards. For example, the cleanroom should be supplied with a large amount of air filtered by high efficiency filters to dilute and remove particles, bacteria and chemicals inside the room. Air is also used to pressurize the room and ensure that no contaminated air enters the clean room.

In addition, the cleanroom must be constructed with materials chosen specifically not to generate contaminants, particles or chemical fumes and the materials must in addition be easy to clean.

Finally, concerning people, in other words the manipulators working inside clean rooms, they must wear special clothes, accessories, materials, tools to minimize the dispersion of microorganisms and particles that they themselves generate such as than hair, skin particles and clothing fibers.

For these reasons, in this type of room, it is necessary to isolate the user's body so that it does not contaminate the environment in which he works or that it does not contaminate the product he manufactures or on which he is working. work. Document WO2005065476 describes a protective or work suit used in dangerous conditions such as heat, fire, cold, etc. The suit comprises a pocket located on the thorax part of the body of the manipulator. This pouch has two openings: an upper opening and a lower opening. The sleeves of the suit are tucked inside the pocket when the operator passes his hands through, firstly, the lower opening and, second, the upper opening to pull the sleeves inside the pocket via the upper opening. The legs will then be raised by the manipulator in the pocket via the upper opening e † the closed pocket.

When a handler has to work in such a sterile environment, he must, before entering the clean rooms, put on the various protective equipment for a clean room or aseptic environment in accordance with a very specific protocol. Such procedures are † very tedious e † generally require the manipulator to perform unconventional movements e † very particular, for example the manipulator cannot touch any exterior face of protective equipment for a clean room or a sanitized environment under penalty to contaminate this † equipment and therefore have to renew its dressing operation.

Unfortunately, a combination as described in document WO2005065476 cannot be used in a clean room environment because it does not meet the criteria defining a clean room. It includes a variety of materials. In addition, the dressing procedure is difficult. The operator will not be able to put on the suit without touching any outside face of the protective equipment when removing it from the pocket to put it on. In addition, existing protective equipment for clean rooms or sanitized environments are † therefore sterilized and † supplied in packaging which must be airtight but which must also withstand autoclaving † in front of a par † be easy to open for the manipulator before entering the clean room e †, other by †, sufficiently resistant to avoid tearing which could result in the contact of the protective equipment with a contaminated environment e † therefore the subsequent introduction contaminants in the clean room, most of the time without the operator being able to realize it given the contaminants' loophole.

Protective equipment for clean rooms or sanitized environments is typically packaged in sealed packaging, sterilized and individually but disposable, in other words single use, which represents a significant source of waste. However, in a clean room or a sanitized environment, crazy † what comes in, must come out and be treated. The current trend, given the current climatic issues, is to reduce disposable packaging and associated waste without harming the sterility of the whole. There is therefore a real need to provide protective equipment for a clean room or aseptic environment having compliant sterility, resistant during the logistical stages and which takes into account the cost and environmental constraints.

The present invention has for bu † to overcome the drawbacks of the state of the art by providing equipment for a clean room or aseptic medium don † the sterility is maintained during the crazy logistical stages † by being less fragile and making it possible to limit the environmental impact and costs associated with the logistics of protective equipment: deconfaminafion, recondifionnemen † e † storage. To solve these problems, it is provided according to the present invention, a protective equipment for a clean room or aseptic environment as mentioned previously, characterized in that said protective equipment is packaged in a reusable and sterilizable pouch, preferably made of textile material, having an opening provided with closing means.

It has appeared in a particularly surprising manner that the protective equipment for a clean room or aseptic environment according to the present invention by being packaged in a reusable and sterilizable pouch, preferably of textile material, provides † a protective equipment which allows direct protection is improved during the logistical, storage and opening stages.

It has also appeared, in a particularly surprisingly advantageous manner, that the sterility of protective equipment for a clean room or a sanitized environment according to the present invention is improved and maintained during the various logistical stages.

Finally, providing protective equipment for a clean room or aseptic environment according to the present invention, packaged in a reusable sterilizable pouch which has an opening provided with closure means, makes it particularly advantageous to dispense with packaging, plastic packaging, packaging. papers which are † single-use, fragile, disposable, consumers of raw materials e † which therefore represent a significant cost, one by † the cost of the packaging in tan † that such, e † the other by † As this is fragile in use, it is more prone to an accident leading to contamination and therefore linked to a cost of cleaning and deconfaminafion of 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 each other e † the pouch comprises an opening, preferably a single opening comprising at least one closure means.

Preferably, the pouch can be for example square, rectangular, hexagonal or even half-moon shape.

Advantageously, the protective equipment for a clean room or aseptic environment according to the present invention is chosen from the group comprising a garment, for example a jumpsuit, an apron, a chasuble, a headgear, for example a hat or a balaclava, at least one glove, at least one shoe cover, one shoe, one hoof, one mask, glasses, cuffs, underwear, boots. Preferably, the pouch of the protective equipment according to the present invention is connected to the inner face or to the outer face by at least one fastening means allowing the pouch to be secured.

Preferably, the pouch of the protective equipment according to the present invention is connected to the inside face of a garment by at least one fixing means allowing the pouch to be secured to the inside face of said garment. The pouch of the protective equipment according to the present invention by being connected to the inside face of a garment e † by being secured to this inside face by means of at least one fixing means makes it possible in a particularly advantageous manner to d '' isolate the pouch from the surrounding environment when the garment is worn by the operator.

Indeed, initially the pouch is in contact with the surrounding environment which is contaminated. The pouch, being connected to the inside face of a garment conditioned therein, allows, when removing the garment from the pouch e † of the unfolding of the garment for dressing the manipulator, 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 sanitized environment.

Advantageously, the at least one means of fixing the protective equipment for the white room or sanitized environment according to the present invention is a temporary fixing means, for example a press stud or a series of press studs, a zipper, hook-and-loop means †, optionally arranged on a flap tab.

More advantageously, the at least one means of securing the protective equipment for a clean room or sanitized environment according to the present invention is a seam or a weld.

Other embodiments of the protective equipment for a clean room or sanitized environment according to the present invention are indicated in the appended claims. The present invention also relates to a garment, and in particular to a suit for a clean room or aseptic environment.

When a manipulator has to work in such a sterile environment, he must, before entering the rooms white, put on clothes, and in particular coveralls, respecting a very specific protocol. Such procedures are very tedious and usually require the manipulator to dress completely contrary to what he is used to doing and contrary to the way he would dress instinctively.

The existing coveralls are therefore sterilized e † supplied in airtight packaging which must on the one hand be easy for the operator to open before entering the clean room e †, on the other hand, sufficiently resistant to avoid tear which could result in contact of the suit with a contaminated environment e † therefore the subsequent introduction of contaminants into the clean room, most of the time without the operator being able to realize it given the size of the contaminants.

It is therefore easy to understand that, on the one hand, the operators and the overalls they wear are the main sources of contamination in clean rooms or sanitized environments and on the other hand the contamination is absolutely to be avoided because if such contamination were to take place, it would result in † a production stop, sterilization or even destruction of the ingredients and materials present e † long e † costly cleaning steps according to a very specific protocol to supply again a sterile and aseptic environment.

Thus, the manipulator must then put on clothes, such as coveralls without touching the outer face intended to be in contact with the sterile environment e † especially, without touching the outer face of the body part, ie. say extending from the pelvis, up the manipulator's legs to his neck. It therefore follows a manipulation during which certain parts of the suit are folded up, where the manipulator climbs on a bench, puts on one leg without touching the ground, then the other leg while being careful not to let go or touch anything. It is easily understood that this dressing procedure requires gymnastics requiring great dexterity and long years of training and practice tan the risk of contaminating a clean room is to be avoided.

We know from document EP2303044 an equipment for a clean room or aseptic environment in which said garment is a garment for a clean room or aseptic environment comprising:

• a lower face arranged to be in contact with a manipulator,

• a first e † a second round,

• a body part comprising a trunk part and a leg part, said first e † second sleeves being connected to the body part, preferably to the trunk part by a linked end, said body part comprising a section head passage,

• at least one gripping means in contact with said inner face in the body part, preferably in the trunk part.

Unfortunately, such a garment according to the prior art, is packaged in an envelope or sterilized packaging to meet the requirements of clean rooms, particularly in view of the stages of packaging, transport, delivery, opening of packages e † therefore clothing for individual clean room or sanitized environment which is its † autan † of stages during which shocks, cuts, negligence can occur resulting in their contamination even if this is not visible to the naked eye but will be detected only when the manipulator will undergo controls or that the products coming from the clean room will be analyzed. In fact, sterilized envelopes or packaging for this type of garment are † single-use (and therefore disposable) e † envelopes or packaging made of plastic.

There is therefore a real need to provide a garment for a clean room or aseptic environment having an improved sterility e † maintained during the logistical stages e † which takes into account the environmental cost constraints e †.

The purpose of the present invention is to overcome the drawbacks of the state of the art by providing a garment for a clean room or aseptic environment which has improved direct protection and which sterility is maintained during the logistical stages. allowing to limit the costs associated with the garment in fan † that such e † subsequently associated with the processes of deconfaminafion.

To solve these problems, it is provided according to the present invention, a garment for a clean room or aseptic environment as indicated above, characterized in that said garment comprises said pocket connected to said underside of said garment by the two fixing means e † located on the underside of said pouch, preferably opposite the opening of said pouch, allowing the interior face of said pouch to be secured to said interior face of the body part of said garment, preferably at the inner face of the trunk portion of said garment.

It appeared particularly surprisingly that the garment for clean room or aseptic environment according to the present invention by being packaged in a reusable and sterilizable pouch, preferably of textile material, provided † protective equipment giving direct protection. † improved during the logistical, storage and opening stages. It has also appeared in a particularly surprisingly advantageous manner that the sterility of the garment for a clean room or aseptic environment according to the present invention is improved and maintained during the various logistical stages.

Finally, providing a garment for a clean room or aseptic environment according to the present invention, comprising a reusable pouch e † sterilizable for its packaging which has an opening provided with closure means makes it particularly advantageous to dispense with packaging, plastic packaging, packaging. papers which are † single-use, fragile, disposable, consumers of raw materials e † which therefore represent a significant cost, one by † the cost of the packaging in tan † that such, e † the other by † As this is fragile in use, it is more prone to an accident leading to contamination and therefore linked to a cost of cleaning and deconfaminafion of the clean room.

In addition, the garment for a clean room or aseptic environment according to the present invention, one by † comprising the reusable, sterile pouch e † which has an opening provided with closure means e †, the other by † comprising at least one gripping means in contact with the underside in the body part, preferably in the trunk part, of the garment makes it possible, in a particularly advantageous manner, to provide a garment with the sterility is maintained and to provide a garment without † handling during dressing is facilitated by means of said at least one gripping means which is directly exposed to the manipulator.

The pouch of the garment for a clean room or aseptic environment according to the present invention by being connected to the underside of the garment e † by being integral with this inner face by means of at least one fastening means allows in a particularly advantageous manner isolate the pouch from the surrounding environment when the garment is worn by the operator.

Indeed, initially the pouch is in contact with the surrounding environment which is contaminated. The pouch, being connected to the inner face of the body part of the garment conditioned therein, allows, when removing the garment from the pouch e † of the unfolding of the latter for dressing the manipulator according to a facilitated protocol , to enclose the pouch in the suit, thus isolating it from the surrounding environment and consequently limiting the possibility of contamination of the clean room.

In a preferred embodiment, the garment of said protective equipment for a clean room or sanitized environment according to the present invention is a combination in which said leg portion further comprises:

• a first e † a second leg section, each leg section comprising a flank, two longitudinal edges on the other side of said flank of the leg section e † provided with mutual closure means arranged to form said section substantially tubular leg when the mutual closure means of each longitudinal edge are engaged together, said engaged mutual closure means of the first pheasant leg section facing said engaged closure means of the second leg section e † extend each preferably at least from a knee area to a crotch area e † more preferably from a soft † or ankle area to a crotch area, • e † wherein said first e † second leg sections by a linked end are connected to said body part, preferably to said trunk part.

In a preferred embodiment, said pouch included in the suit according to the present invention is positioned in a body part, preferably in a trunk part, preferably in a small pelvis part of said suit.

Advantageously, the protective equipment for a clean room or aseptic environment according to the present invention has:

• a deployed position in which said outer face of the combination is in contact with the surrounding environment e † said inner face is arranged to be in contact with a manipulator e † in which a first inner face of the pocket is † against said inner face of the combination e † a second inner face of the pouch es † arranged to be in contact with a manipulator, said closure means preferably being in the open position,

• a folded position in which: a) said mutual closure means of each leg section are in a predominantly open position, forming a crotch opening arranged to give access to the inside of the body part, e † b) the inner face of the first and second leg sections are exposed outwardly and said outer face of the first and second leg sections are exposed towards the outer face of said body section, c) said at least one gripping means exposed towards the manipulator near the means for closing said pouch, e † in which said combination is packaged in the folded position in said pouch.

Preferably, the protective equipment for a clean room or aseptic environment according to the present invention present in the folded position and packaged in said pouch:

• a first closed position in which said opening of said pocket is closed, e †

• a second open position in which said opening of said pocket es † open e † in which said at least one gripping means es † exposed towards the manipulator.

Advantageously, the protective equipment for a clean room or aseptic environment according to the present invention has, in the deployed position, at least two gripping means, in contact with said inner face, in the body part, preferably located laterally, preferably in the body part.

Even more advantageously, the combination of the protective equipment for a clean room or aseptic environment according to the present invention, has in the folded position: a) said mutual closure means of each section of the leg which is in the predominantly open position, forming a crotch opening designed to give access to the inside of the body part, e † b) the underside of the first and second leg sections are exposed outwardly and said exterior face of the first and second leg sections is exposed towards the exterior face of said body section.

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 sanitized environment according to the present invention, together form a continuous closure of an opening. of the crotch, and preferably include a continuous zipper for the first and second leg sections.

Advantageously, the means for closing the pouch of the protective equipment for a clean room or sanitized environment according to the present invention are chosen from a zipper, self-gripping means, a series of press studs, a flap tab. .

In a particular embodiment of the protective equipment for a clean room or aseptic environment according to the present invention:

• the first and / or the second sleeve include self-gripping means † at a free end, opposite said linked end, such as elastic fabric cuffs, a pressure tab or hook-and-loop means, and / or

• the first and / or the second leg section comprise self-locking means † at a free end, opposite to said linked end, such as ankles in elastic fabrics, a pressure tab or self-gripping means.

Preferably, the protective equipment for a clean room or aseptic environment according to the present invention has in the folded position, the leg part or the first and second leg sections folded longitudinally on itself (s) itself (s) ) e † transversely on itself (s) in two or three parts.

In a preferred embodiment of the protective equipment for a clean room or aseptic environment according to the present invention, the textile material of the equipment and / or of the pouch comprises monofilamen † polyester.

By comprising a monofilamen † polyester textile material, the protective gear and / or the pouch has high, to very high particulate filtration capacity, as well as a high bacteriological barrier.

Preferably, the textile material of the equipment and / or the pouch consists of monofilamen polyester †.

In another preferred embodiment of the protective equipment for a clean room or sanitized environment according to the present invention, the textile material of the equipment and / or of the pouch comprises polyester and antistatic carbon yarn, preferably between 90 e † 99.5% polyester, preferably between 92 e † 99.5% polyester, advantageously between 97 e † 99.5% polyester, particularly advantageously 99% polyester as well as antistatic carbon yarn, between 10 e † 0.5% of the textile, preferably 8 e † 0.5%, preferably between 3 e † 0.5%, particularly advantageously 1%. This gives the textile a filtration capacity high to very high particulate matter as well as a high bacteriological barrier.

In another embodiment of the protective equipment for a clean room or sanitized environment according to the present invention, the textile material of the equipment and / or the pouch is a non-woven textile material. Advantageously, the textile material of the equipment and / or of the pouch comprises high density polyethylene fibers arranged randomly compressed. Preferably, the textile material of the equipment and / or of the pouch is a textile material comprising a prepreg comprising a thermosetting resin such as a polyester or a thermoplastic polymer impregnating a reinforcement, the reinforcement being for example a fabric, fibers.

Other embodiments of the protective equipment for a clean room or sanitized environment according to the present invention are indicated in the appended claims.

The present invention also relates to a method of packaging protective equipment for a clean room or aseptic environment comprising:

I. decontamination of said protective equipment in an area external to an aseptic area, e † transfer of said decontaminated protective equipment to an aseptic area,

II. decontamination of a reusable pouch e † sterilizable in an area external to an aseptic area e † transfer of said decontaminated protective equipment to an aseptic area III. an opening in the aseptic zone of said pouch,

IV. placing said protective equipment in said aseptic zone in said pouch and actuating said closure means to close said pouch in aseptic zone,

V. optionally, sterilization of said protective equipment packaged in said pouch.

Indeed, so that the deconfaminafion of the protective equipment, the protective equipment such as an apron, a gown, a suit, a boot is inserted by the personnel in a washing machine from an external zone to an aseptic zone. , such as a clean room. Protective equipment, when washed and therefore decontaminated, is collected in an aseptic area, such as a clean room. The same steps are carried out for the reusable and sterilizable pouch, whether or not it is attached to the protective equipment, during the same washing or during separate washing as that of the protective equipment.

Also in this decontamination process, after washing and transfer of the protective equipment and the reusable and sterilizable pouch in an aseptic area, the protective equipment and the reusable and sterilizable pouch are dried in a dryer present in the area. aseptic.

The protective equipment and the reusable and sterilizable pouch are then placed in an area where packaging is carried out in the aseptic area. The reusable and sterilizable pouch is opened and the protective equipment is placed inside the reusable and sterilizable pouch. When this step is carried out, the reusable and sterilizable pouch is still closed in the aseptic zone.

Optionally, an additional sterilization step of the protective equipment packaged in the reusable sterilizable pouch is performed as a precaution.

Preferably, the method of packaging protective equipment for a clean room or aseptic environment according to the present invention in which said protective equipment is a garment, comprises:

_• an inner face arranged to be in contact with a manipulator,

_• a first e † a second round,

_• a body part comprising a trunk part and a leg part, said first e † second sleeves being connected to the body part, preferably to the trunk part by a linked end, said body part comprising a section head passage,

_• at least one gripping means in contact with said inner face in the body part, preferably in the trunk part, e † in which a folding of the garment is provided between its decontamination and its placement in said pouch, said folding comprising the steps of:

_• exposure of at least one gripping means to the outside by gripping it,

_• folding an outer face of a leg part onto an outer face of a body part, keeping at least said first gripping means exposed, _• folding of a lateral part of said leg part on itself in a longitudinal direction of said leg part while keeping at least said first gripping means exposed,

_• folding by folding in several parts said leg portion thus folded longitudinally in a transverse direction while maintaining at least said first gripping means exposed, said placing of said garment in said pocket comprising an inversion of said pocket around said folded garment while maintaining said at at least a first gripping means near the opening of said pouch and a closure of said closure means of said pouch in order to condition the garment therein and the gripping means at the bottom.

Advantageously, the method of packaging protective equipment for a clean room or aseptic environment according to the present invention in which said garment is a combination in which said leg portion comprises a first and a second leg section, each section of the leg. leg comprising a flank, two longitudinal edges on either side of said flank of the leg section e † provided with mutual closure means arranged to form said substantially tubular leg section when the mutual closure means of each longitudinal edge its † engaged together, said mutually engaged closure means of the first pheasant leg section † facing said engaged closure means of the second leg section e † each preferably extend at least from one knee area to one area crotch e † more preferably from a soft † or ankle area to a crotch area, said first e † second leg sections by u born linked end are connected to said body part, preferably to said trunk part, said method being characterized in that said folding of said lateral part of the leg part on itself in a longitudinal direction of said leg part is † a folding of a side part of a first leg section with † the closing means † in the open position e † a folding of a side part of a second leg section with † the closing means its † in the open position keeping said first gripping means exposed. Other embodiments of the method of packaging protective equipment for a clean room or aseptic environment according to the present invention are indicated in the appended claims.

The present invention further relates to a dressing method for coating protective equipment for a clean room or aseptic environment according to the invention, comprising the steps of:

_• opening desdifs means for closing said pocket,

_• seizure of protective equipment before possibly disconnecting temporary means of securing said pouch to said protective equipment e †

_• donning of said protective equipment. Advantageously, the dressing method for coating protective equipment for a clean room or aseptic environment according to the invention in which the protective equipment is a garment which comprises: • an exterior face designed to be in contact with the surrounding environment,

• an inner face arranged to be in contact with a manipulator,

• a first and a second round,

• a body part comprising a trunk part and a leg part, said first and second sleeves being connected to the body part, preferably to the trunk part by a linked end, said body part comprising a passage section of head,

• at least one gripping means in contact with said inner face in the body part, preferably in the trunk part, the method according to the present invention further comprises:

• a seizure of said first gripping means by a first hand of a manipulator,

• removal of said garment from said pouch using said first gripping means and positioning of said garment so that the body part of said garment is accessible via an opening formed by the periphery of the body part, preferably of the part trunk,

• threading of a second arm of the manipulator in a second sleeve and after having released the first gripping means, threading of a first arm of the manipulator in a first sleeve,

• a passage of the manipulator's head in said opening of said body part, and then in the head passage section, and • a turning of the leg part so that the outside face of these thirsts then exposed towards the outside and the lower face exposed towards the legs of the manipulator.

In a preferred embodiment of the dressing method for coating protective equipment for a clean room or sanitized environment according to the present invention, wherein said garment is a combination in which said leg portion comprises a first and a second section. leg, each leg section comprising a flank, two longitudinal edges on either side of said flank of the leg section e † provided with mutual closure means arranged to form said substantially tubular leg section when the means of mutual closure of each longitudinal edge are engaged together, said engaged mutual closure means of the first pheasant leg section facing said engaged closure means of the second leg section e † each preferably extends at least one knee area to a crotch area e † more preferably from a soft † or ankle area to a crotch area e † in which the said s first and second leg sections by a linked end are connected to said body portion, preferably to said trunk portion, wherein said step of turning said leg portion over is a turning of the donated leg sections. closure means are † in the open position so that the exterior face thereof is then exposed to the exterior and the interior face exposed toward the legs of the manipulator.

Advantageously, the dressing method for a clean room or aseptic environment according to the present invention further comprises a grasp of a second gripping means by a second hand of the manipulator in order to position the combination so that the body part of the suit either accessed through the opening of the body part or a crotch section.

Preferably, the dressing process for a clean room or aseptic environment according to the present invention further comprises closing said opening in said crotch zone.

Other embodiments of the dressing process for coating a combination for a clean room or aseptic environment according to the present invention are indicated in the appended claims.

Other characteristics, details e † advantages of the invention will emerge from the detailed description given below, without limitation e † in pheasant † with reference to the accompanying drawings.

Figure 1 is a front view of protective equipment according to the invention in which the garment is a combination.

Figure 2A is a top view of protective equipment according to the invention in which the garment is a combination in a partially folded position.

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

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

FIG. 4 is a top view of the pouch according to the invention in which the protective equipment is packaged. FIG. 5 is a side view of shoes for a clean room or aseptic environment according to the invention.

FIG. 6 is a front view of protective boots for a clean room or aseptic environment according to the invention. FIG. 7 is a view of multiple protective equipment for a clean room or aseptic environment according to the invention.

FIG. 8 is a front view of protective equipment such as pants for a clean room or aseptic environment according to the invention. In the figures, identical or similar elements bear the same references.

FIG. 1 illustrates protective equipment 1 for a clean room or aseptic environment according to the invention and more particularly a combination 7 for a clean room or aseptic environment comprising an outer face 2 intended to be in contact with the surrounding environment and an inner face 3 arranged to be in contact with a user or a manipulator.

The combination 7 comprises a first 9 and a second 10 leg section, each of which comprises a sidewall and two longitudinal edges on either side of the sidewall of the leg section, each of them 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. Further, the engaged mutual closure means of the first leg section faces the engaged mutual closure means of the second leg section and, the mutual closure means each preferably extends at least one knee area. to a crotch area (not shown) and more preferably from a soft † or ankle area to a crotch area (not shown).

Although not illustrated 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 chosen from a zipper, self-gripping means, press studs, a flap tab or even other equivalent or similar means.

The combination 7 also includes a first sleeve 12, a second sleeve 13 and a body part 14. The first sleeve 12 is connected to the body part 14 by a linked end 12a, the second sleeve 13 is also connected to the body part. body 14 by a linked end 13a. The first leg section 9 and the second leg section 10 are connected to the body part 14 respectively by a linked end 9a and 10a. Finally, the body part 14 of the suit 7 comprises a head passage section 15.

In the embodiment as illustrated in Figure 1, the combination 7 comprises a hood provided with an opening for the eyes above or below which can be placed a mask or glasses for example.

The combination 7 according to the present invention and as illustrated in FIG. 1 comprises a pocket 4 which is connected to the inner face 3 of the suit 7 by fixing means 8. The fixing means 8 are located on the inner face. of the pouch 4 and preferably opposite the opening 5 of the pouch 4. This advantageously allows the interior face of the pouch 4 to be secured to the interior face 3 of the body part 14 of the suit 7. Thus, in the folded and conditioned position, the lower face 3 of the combination 7 is † connected to the interior face of the pouch 4 so that only the exterior face of the pouch 4 is † in contact with the surrounding environment such as 'illustrated in FIG. 4. When the manipulator is going to put on the combination 7, he will first of all do this, open the closing means 6 of the opening 5 of the pocket 4, remove the combination 7 from the pocket 4 using of the gripping means 16. After completion of this step, when the combination 7 is out of the pocket 4, an inversion, a reversal of the faces of the pocket 4 will take place.

Particularly advantageously, firstly, the outer face of the pocket 4, which was exposed to the surrounding environment, will become the inner face of the pocket 4. On the other hand, the pocket 4 by being connected to the inner face 3 of the combination 7, will therefore be found inside the combination 7 when the latter is worn by the manipulator.

Consequently, the pouch 4 of the protective equipment 1 e † more particularly of the combination 7 according to the present invention makes it possible to achieve double insulation from any contaminants. The first insulation being produced by turning the outside face of the pouch 4 which is found inside the pouch 4, the contaminants are therefore contained in the pouch 4. The second insulation being produced by confining the pouch 4 inside the combination 7. In the embodiment of FIG. 1, the first sleeve 12 comprises self-locking means 17 at a free end, opposite the linked end 12a, in the form of a handle † made of elastic fabric. The second handle 13 comprises at the free end, opposite the linked end 13a, also self-locking means 17, in the form handle † in elastic fabric. The elastic fabric cuffs as shown in Figure 1 can also be replaced by a pressure tab, or self-gripping means †, or other conventional tightening means.

In addition, according to the embodiment of the protective equipment 1 e † more particularly of the combination 7 of FIG. 1, the combination 7 has, in the deployed position in which the outer face 2 of the combination 7 is † in contact with the surrounding environment e † the inner face 3 is † arranged to be in contact with a manipulator. The first inner face of the pouch 4 is † against the inner face 3 of the combination e † the second inner face of the pouch 4 is † arranged to be in contact with or oriented towards a manipulator. The closing means 6 of the opening 5 of the pocket 4 are preferably in the open position. It is obviously conceivable that the closure means 6 are in the closed position, in particular to isolate the outer faces of the pocket 4, inside the pocket 4 when the combination 7 is in the deployed position.

The combination 7 according to the present invention comprises at least one gripping means 16 in contact with the inner face 3 in the body part 14, preferably located laterally. In the variant illustrated in Figure 2a, the combination 7 according to the invention comprises two gripping means 16 in contact with the inner face 3 in the body part 14, located laterally, on the other side of the opening 1 1. In the other variant illustrated in Figure 2b, the combination 7 according to the invention comprises a gripping means 16 in contact with the inner face 3 in the body part 14.

Figures 2A e † 2B illustrate two embodiments of the combination 7 according to the present invention in the partially folded position. The inner face 3 of the first leg section 9 e † of the second leg section 10 are exposed outwards, towards the surrounding environment. The outer face 2 of the first leg section 9 and the second leg section 10 are exposed towards the outer face 2 of the body part 14. This particular arrangement according to the present invention forms an opening 19 itself arranged to give access to the inside of the body part 14 and preferably to the inside of the trunk part of the suit 7.

In this way, the at least one gripping means 16 is exposed towards the manipulator. In the embodiment of FIG. 2A, the combination 7 according to the invention comprises two gripping means 16 exposed towards the manipulator.

In the embodiment of FIG. 2B, the combination 7 according to the invention comprises a gripping means 16 exposed towards the manipulator.

In yet another embodiment not illustrated, the gripping means 16 of the combination 7 according to the present invention may be parts of material of the interior face 3 of the combination 7 and therefore exposed towards the manipulator. In addition, the different parts of material of the inner face 3 of the suit 7 or of the protective equipment 1 for clean rooms or sanitized environments may be of different color, texture or pattern to facilitate their identification by the manipulator as being the gripping means 16. In fact, the gripping means 16 according to the figures

2A ef 2B are † present on the underside 3 of the suit 7 ef the fact of partially turning over the leg sections on the body section allows them to be exposed outwards and therefore towards the manipulator. It is therefore easy to understand from the combination 7 according to the present invention that the folding process steps must be observed in order to maintain the sterility of the combination 7, in particular following the removal of the combination 7 by the operator and its cleaning, decontamination. e † subsequent reconditioning.

Particularly advantageously, the combination 7 according to the present invention comprising the pouch 4 makes it possible to dispense with single packaging e † to be cleaned e † repackaged directly in its protective pouch 4, itself cleanable, sterilizable and reusable. .

During this folding step, the handler folds down the outer face of a first 9 e † of a second 10 leg section by passing an open crotch section over an outer face of a body part 14 in now the at least one gripping means 16 exposed.

The second step of the folding process is that illustrated in figure 3. In this step, the first leg section 9 is folded back longitudinally on itself and the second leg section 10 is also folded back longitudinally on itself while leaving the two gripping means (16) exposed towards the manipulator. In addition, the last step of folding the combination according to the invention is illustrated by arrows in FIG. 3. In fact, the combination 7 according to the invention thus folded will then be folded transversely on itself in two or three parts. or more if necessary, depending on the size of the suit. The suit 7 thus folded is then packaged in the pouch 4 accessible in the body part 14 of the suit 7. Once folded and packaged, the pouch 4 containing the suit 7 as illustrated in FIG. 4 can for example be sterilized. , for example, in an autoclave. When a user intends to put on a suit 7 according to the invention, he opens the closing means 6 of the opening 5 of the pocket 4, he grasps the first gripping means 16 by a first hand and the second gripping means 17 by the second hand and remove the combination 7.

In this way, he obtains a combination 7 in a partially folded position as illustrated in FIG. 2A. The suit 7 is positioned so that the body part 14 is accessible through the opening 19 in the crotch of the suit, through the waist section. The manipulator then puts on after having released the second gripping means 16 his second arm in a second sleeve 13 and, after having released the first gripping means 16, he threads the first arm into the first sleeve 12. He then passes his head through an opening of the body part 14 through the waist section and then into the head passage section 15 before ending up in the hood.

He then turns the leg sections 9, 10 over so that the outer face of the first leg section 9 and the second leg section 10 are exposed outwardly and so that the inner face of the first leg section 9 and the second leg section 10 are exposed towards the legs of the manipulator. Then, the manipulator positions his foot in the foot passage section which has the pre-engaged zipper and closes said opening 19 to completely isolate his body from the external environment.

Figure 5 illustrates clogs as protective equipment for a clean room or sanitized environment according to the present invention. The shoes as illustrated include a series of press studs 8, a first part of the male button of which is located on the clogs and a second part of the female button is located on pocket 4, the reverse is obviously possible. Thus the shoes can be fixedly attached to the pouch 4, and positioned inside the pouch 4 so that upon removal, the clogs will be removed and the pouch 4 will be turned over on itself as explained above for isolate the contaminants inside the pouch 4.

Figure 6 illustrates protective boots as protective equipment for a clean room or sanitized environment according to the present invention. Protective boots as illustrated include a series of snaps 8 of which a first part of the male button is located on the boots and a second part of the female button is located on the pocket 4, the reverse is obviously possible. Thus the protective boots can be fixedly attached to the pouch 4, and positioned inside the pouch 4 so that upon removal, the protective boots will be removed and the pouch 4 will be turned over on itself as explained. previously to isolate the contaminants inside the pouch 4.

FIG. 7 illustrates gloves, shoe covers, a cap and a hood as protective equipment for a clean room or a sanitized environment according to the present invention. Protective equipment as illustrated may include a means of attachment 8 to the pocket 4, such as a press stud. Thus they can be fixedly attached to the pouch 4, and positioned inside the pouch 4 so that upon removal, the protective equipment will be removed and the pouch 4 will be turned over on itself as explained previously. to isolate contaminants inside pouch 4.

Figure 8 illustrates pants according to the present invention comprising a first 9 leg section and a second 10 leg section. The pants as shown have one side interior 3 and an exterior face 2, e † also includes the pocket 4 according to the present invention.

Thus the manipulator can put on the pants e † the pocket 4 as presented above, being located inside the pants allows to isolate the contaminants, a first time in the pocket 4 e † a second time in the inner part pants that are isolated from the surrounding environment.

It is of course 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 appended claims.

Claims

1. Protective equipment (1) for clean room or sanitized environment comprising:

_• an outer face (2) designed to be in contact with the surrounding environment,

_• a lower face (3) arranged to be in contact with or oriented towards a manipulator, characterized in that said protective equipment (1) is packaged in a reusable and sterilizable pouch (4), preferably of textile material, having an opening (5) provided with closing means (6).

2. Protective equipment (1) for a clean room or aseptic environment according to claim 1, which es † selected from the group comprising a garment for example a jumpsuit (7), an apron, a headwear for example a charlotte or a hat. balaclava, at least one glove, at least one shoe cover, one shoe, one hoof, one mask, glasses, cuffs, underwear, boots.

3. Protective equipment (1) for a clean room or aseptic environment according to claim 1 or 2, wherein said pouch (4) is connected to said inner face (3) or to said outer face (2) by at least one. fixing means (8) allowing the securing of said pouch (4).

4. Protective equipment (1) for a clean room or aseptic environment according to claim 3, wherein said pouch (4) is connected to said inner face (3) of a garment by at least one fastening means (8). allowing said pouch (4) to be secured to said inner face (3) of said garment.

5. Protective equipment (1) for a clean room or sanitized environment according to claim 1 to 4, wherein said at least one fixing means (8) is a temporary fixing means, for example. a press stud or a series of press studs, a zipper, aufo-grippan † means, possibly arranged on a flap tab.

6. Protective equipment (1) for a clean room or sanitized environment according to one of claims 1 to 4, wherein said at least one fixing means (8) is a seam or a weld.

7. Protective equipment (1) for a clean room or aseptic environment according to one of claims 2 to 6, wherein said garment is a garment for a clean room or aseptic environment comprising:

• an outer face (2) designed to be in contact with the surrounding environment,

• an inner face (3) arranged to be in contact with a manipulator,

• a first (12) and a second (13) round,

• a body part (14) comprising a trunk part and a leg part, said first (12) and second (13) sleeves being connected to the body part, preferably to the trunk part by one end bonded, said body portion (14) comprising a head passage section (15),

• at least one gripping means (16) in contact with said inner face (3) in the body part (14), preferably in the trunk part, characterized in that said garment (7) comprises said pouch (4) ) connected to said inside face (3) of said garment (7) by said fixing means (8) e † located on the inside face of said pouch (4), preferably opposite the opening (5) of said pouch (4), allowing the internal face of said pouch (4) to be secured to said underside (3) of the body part (14) of said garment (7), preferably at the underside of the trunk part of said garment.

The protective equipment (1) for a clean room or sanitized environment according to claim 7, wherein said garment for a clean room or sanitized environment is a combination (7) wherein said leg portion further comprises:

_• a first (9) e † a second (10) leg section, each leg section comprising a side, two longitudinal edges on either side of said side of the leg section e † provided with closure means mutual arranged to form said substantially tubular leg section when the mutual closure means of each longitudinal edge are engaged together, said mutual closure means engaged of the first pheasant leg section facing said engaged closure means of the second pheasant leg section. leg e † each preferably extend at least from a knee area to a crotch area e † more preferably from a soft † or ankle area to a crotch area, e † wherein said first (9) e † second (10) leg sections by a linked end are † connected to said body portion (14), preferably to said trunk portion.

9. Protective equipment (1) for a clean room or aseptic environment according to claim 7 or 8, which has: a deployed position in which said outer face (2) of said garment (7) is in contact with the surrounding environment e † said inner face (3) is † arranged to be in contact with a manipulator e † in which a first inner face of the pocket (4) is † against said inner face (3) of said garment (7) e † a second lower face of the pocket (4) is arranged to be in confacf with a manipulator, lesdifs closing means (6) preferably being in the open position,

_• a stowed position in which: a. The inner face (3) of the leg portion is exposed outwardly and the outer face (2) of the leg portion is exposed toward the outer face of said body section, preferably said trunk portion, forming an opening (19) arranged to provide access to the interior of the body portion, preferably to the interior of the trunk portion b. said at least one gripping means (16) exposed towards the manipulator near the closure means of said pouch, and in which said garment (7) is packaged in the folded position in said pouch (4).

10. Protective equipment (1) for a clean room or aseptic environment according to any one of claims 7 to 9, in the folded position and packaged in said pouch (4), said pouch (4) having:

_• a first closed position in which said opening (5) of said pocket (4) is closed, and

_• a second open position in which said opening (5) of said pocket (4) is open and in which said at least one gripping means (16) is exposed towards the manipulator.

11. Protective equipment (1) for a clean room or aseptic environment according to one of claims 7 to 10, having in the deployed position, at least two gripping means (16) in contact. with said underside (3), in the body part (14), preferably located laterally, preferably in the body part (14).

12. Protective equipment (1) for a clean room or aseptic environment according to one of claims 8 to 11, wherein said combination has in the folded position a) the mutual closure means of each leg section which is in predominantly position. open, forming a crotch opening arranged to provide access to the interior of the body part, e † b) the inner face (3) of the first (9) e † second (10) leg sections facing towards the exterior e † said exterior face (2) of the first (9) e † second (10) leg sections are exposed towards the exterior face (2) of said body section,

13. Protective equipment (1) for a clean room or aseptic environment according to one of claims 8 to 12, wherein the closure means of the first leg section e † the closure means of the second leg section together form a continuous closure of a crotch opening, e † preferably include a continuous zipper for the first and second leg section.

14. Protective equipment (1) for a clean room or aseptic environment according to one of claims 1 to 13, wherein said closure means (6) of said pouch (4) are chosen from a zipper, automatic means. -agrippan †, a series of press studs, a flap tab.

15. Protective equipment (1) for a clean room or aseptic environment according to one of claims 7 to 14, wherein: • the first (12) and / or the second (13) handle comprise self-locking means (17) at a free end, opposite to said linked end, such as elastic fabric cuffs, a pressure tab or means aufo- agrippan †, and / or

• the first (9) and / or the second (10) leg section, when it is present, comprise self-locking means (18) at a free end, opposite to said linked end, such as fabric ankles elastic, a snap tab or hook-and-loop devices †.

16. Protective equipment (1) for a clean room or aseptic environment according to one of claims 8 to 15, having, in the folded position, the leg part or the first (9) e † second (10) folded leg sections (s) longitudinally on itself (s) e † transversely on itself (s) in two or three parts.

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

II. decontamination of a reusable pouch e † sterilizable in an area external to an aseptic area e † transfer of said deconfaminated protective equipment to an aseptic area

III. an opening in the aseptic zone of said pouch, IV. placing said protective equipment in said aseptic zone in said pouch and actuating said closure means to close said pouch in aseptic zone,

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

• an inner face (3) arranged to be in contact with a manipulator,

• a first (12) and a second (13) round,

• at least one gripping means (16) in contact with said inner face (3) in the body part (14), preferably in the trunk part, e † in which a folding of the garment is provided between its decontamination e † its placement in said pouch, said folding comprising the steps of:

• exposure of at least one gripping means (16) outwards by gripping it, • folding an outer face (2) of a leg part onto an outer face (2) of a body part (14), keeping at least said first gripping means (16) exposed,

• folding of a lateral part of said leg part on itself in a longitudinal direction of said leg part while keeping at least said first gripping means (16) exposed

• folding by folding in several parts said leg portion thus folded longitudinally in a transverse direction while maintaining at least said first gripping means (16) exposed, said placement of said garment in said pocket comprising an inversion of said pocket around said folded garment in maintaining said at least one first gripping means near the opening of said pouch e † a closure desdifs closing means of said pouch in order to condition the garment therein e † the gripping means at the bottom.

19. The method of packaging a protective equipment (1) for a clean room or aseptic environment according to claim 18, wherein said garment is a combination (7) wherein said leg portion comprises a first (9) e † a second (10) leg section, each leg section comprising a sidewall, two longitudinal edges on either side of said sidewall of the leg section e † provided with mutual closure means arranged to form said leg section substantially tubular when the mutual closure means of each longitudinal edge are engaged together, said engaged mutual closure means of the first pheasant leg section facing said engaged closure means of the second leg section e † each extend from preferably at least one knee area to a crotch area and more preferably from a soft † or ankle area to a crotch area, said first (9) and second (10) leg sections through one end linked its † connected to said body part (14), preferably to said trunk part, said method being characterized in that said folding of said lateral part of the leg part on itself in a longitudinal direction of said part leg is a bending of a side part of a first leg section don † the closing means is † in the open position e † a bending of a side part of a second leg section don † the means closure sound † in the open position while maintaining said first gripping means (16) exposed.

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

• opening desdifs closing means (6) of said pocket (4),

• seizure of protective equipment before possibly disconnecting temporary means of attachment of said pouch to said protective equipment e †, putting on said protective equipment

21. A dressing method for coating a protective equipment (1) for a clean room or aseptic environment according to claim 20, wherein said protective equipment is a garment comprising

• an inner face (3) arranged to be in contact with a manipulator, • a first (12) and a second (13) round,

• a body part (14) comprising a trunk part and a leg part, said first (12) and second (13) sleeves being connected to the body part, preferably to the trunk part by a linked end, said body portion (14) comprising a head passage section (15),

• at least one gripping means (16) in contact with said lower face (3) in the body part (14), preferably in the trunk part, said method comprising:

• a seizure of said first gripping means by a first hand of a manipulator

• a refrai † of said garment (7) of said pouch (4) using said first gripping means (16) and positioning of said garment (7) so that the body part (14) of said garment (7) self † accessible through an opening formed by the perimeter of the body part, preferably the trunk part

• a threading of a second arm of the manipulator in a second sleeve (13) e † after having released the first gripping means (16), a threading of a first arm of the manipulator in a first sleeve (12),

• a passage of the manipulator's head in said opening of said body part (14), e † then in the head passage section (15), e †

• a turning of the leg part so that the outer face (2) thereof is then exposed to the outside and the inner face (3) exposed towards the legs of the manipulator.

22. A dressing method for coating protective equipment (1) for a clean room or sanitized environment according to claim 21, wherein said garment is a coverall in which said leg portion comprises a first (9) and a second (10). ) leg section, each leg section comprising a flank, two longitudinal edges on either side of said flank of the leg section e † provided with mutual closure means arranged to form said substantially tubular leg section when the legs mutual closure means of each longitudinal edge are engaged together, said engaged mutual closure means of the first pheasant leg section facing said engaged closure means of the second leg section e † each preferably extends at least d 'a knee area to a crotch area e † more preferably from a soft † or ankle area to a crotch area e † in which said first (9) e † second (1 0) leg sections by a linked end are connected to said body part (14), preferably to said trunk part, where said step of turning over said leg part is a turning of the sections (9, 10) leg don † the means of closure are † in the open position so that the outer face

(2) of these is † then exposed to the outside † the inside face

(3) exposed towards the manipulator's legs.

23. A method of dressing for a clean room or aseptic environment according to claim 21 or 22, further comprising, gripping a second gripping means (16) by a second hand of the manipulator to position the combination (7) so that the body part (14) of the suit (7) is accessible via the opening (11) of the body part or a crotch section.

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