IES86319Y1 - Gowning system for aseptic environments - Google Patents

Abstract

ABSTRACT A set of garments, namely a coverall with integrated, self-adjusting hood (1) and face mask (2) and a set of boots plus a method of presenting same for gowning and a method of gowning that facilitates easy donning whilst maintaining the sterility of the garments.

Description

Title Gowning System for Aseptic Environments Description Many industries require their operations to be carried out in clean environments. These include the Pharmaceutical, Biotechnology, Semiconductor and Microelectronic industries and also areas such as healthcare, aerospace, research and medical device manufacture.

These clean environments are achieved through the use of cleanrooms. A cleanroom is defined as an area where airborne contamination is controlled to within specific limits. These limits are set out in the standard ISO 14644. Contamination can be described as anything other than the product being manufactured or process being performed. Common contaminants include dust, skin and hair cells, bacteria, viruses, fungi and other types including aerosol particles. Contamination from outside the cleanroom is generally prevented from entering through the use of filters on the air handling system, positive air pressure and material handling protocols.

The largest source of contamination within a cleanroom environment is the human operator. As a living organism humans continually release particles of skin and hair, aerosol particles in our breath and also fabric particles from the clothes we wear. A single particle can carry numerous potential bacterial contaminants. To prevent these particles from contaminating a cleanroom the users must don particular garments manufactured using particular fabrics that have a high filtration effect and serve to contain any particles released within the garment. Typically, these garments comprise a coverall that covers the torso, arms and legs; a separate hood to cover the head and neck and contain the hair; a face mask to filter particles from breath; and a pair of boots that extend to just below the knee.

Certain cleanrooms are involved in the manufacture of items so sensitive to contamination that they must be prepared in a sterile environment. This is typically referred to as aseptic manufacturing. when operating such cleanrooms the users must wear garments that have been sterilized. These garments are donned in an airlock or ante-room prior to entry into the sterile environment.

The donning of these garments presents the problem to be solved. The garment must be donned without the user touching the exterior surface of the garment or allowing the exterior surface of the garment to touch any other surface. To achieve this, users must be highly competent and undertake a series of complex manoeuvres involving dexterity and balance including simultaneously attempting to hold the garments arms and legs in positions such that they do not touch the floor or any other surface while stepping into the garments legs without allowing the trailing leg to touch the floor. Achieving this is a difficult operation and should the user touch the exterior of the garment or should the exterior surface of the garment touch any other surface at any stage during the operation the garment must be discarded. At this point the user must select another sterile garment and repeat the process from the beginning. This gowning process can be required multiple times each day per user. This wastage of garments can lead to high costs for the companies involved and also lead to frustration and stress for the users attempting to comply with the constraints of an aseptic gowning protocol.

S863l9 The invention discussed comprises a set of garments, namely a coverall (fig.1) with integrated, self adjusting hood (1) and face mask (2) and a set of boots (fig 2)p|us a method of presenting same for gowning (fig 3) and a method of gowning that facilitates easy donning whilst maintaining the sterility of the garment.

In a preferred embodiment, the coverall consists of an inner and outer surface, a front torso section (3) including a face mask portion (2), a rear torso section (21) including a hood section (1), a left (15) and right (4) sleeve and a left (11) and right (8) leg. The coverall carries a number of stud fasteners, or similar attachments, at locations on the sleeves(5)(14), waist (6)(13), thigh (7)(12) area and ankles (18)(19) which are utilized during the folding and preparation of the garment. Advantageously, on the inner face of the waist section the coverall carries a band of fabric (32) which is a different colour to the main fabric of the coverall and is used during the gown process to denote to the user the rear of the garment.

Attached to this inner waist section is a flap of fabric (31) which is used during the gown process as the first grasping point. A small loop of fabric (18a)(19a) is attached on the inner face of each ankle, next to a fastening stud (18)(19), that serves as a further grasping point during the gowning process. The front torso section (3), when donned, is connected to the rear torso section (21) by means of a zipper on each side of the body (16)(17)that travel from the waist of the garment up into the hood section (1), securing the face mask portion (2) in place. Each zipper carries a small fabric loop as a grasping point. The ankles carry studs (9)(10) to adjust the fit. The waist section has a band of elastic (20) to adjust the fit. The rear of the hood has bands of elastic (22)(23) that automatically adjust the fit of the hood to the users head.

The boots (fig 2) consist of a sole (28) and a leg portion (26). There is a buckle (29) or similar adjustment feature to adjust fit at the instep. A zip (25) runs from the rear of the ankle to the rear of the top of the leg section. The top of the leg section (30) carries an elastic cuff or similar adjustment feature. There is a small loop of fabric (27) at the rear of the ankle that serves as a first grasping point for donning. A similar small loop of fabric is placed at the rear top of each side (24a)(24b) of the leg section to form a second grasping means for donning.

The garments must be supplied in a sterile condition for use. This requires them to packaged in a sealed bag to maintain sterility until use. This operation is typically carried out by a manufacturer or, in the case of reusable garments, by a cleanroom laundry provider. The invention also relates to a method of presenting the garments for use in the following manner for the coverall; -unzipping the zips (16)(17)to the waist -attaching the stud at the left wrist (14) to the point at the left hip (13) -attaching the stud at the right wrist (5) to the point at the right hip (6) -folding the right leg (8) upwards towards the crotch, exposing the inner surface over the outer fabric surface and attaching the stud at the ankle (19a) to the point at the thigh (7) of the right leg section - folding the left leg (11) upwards towards the crotch, exposing the inner surface over the outer fabric surface and attaching the stud at the ankle (18a) to the point at the thigh (12) of the left leg section -grasping the waist section and lifting the garment vertically, allowing the inner surface of the front (3) and rear torso (21) sections to fold over the lower portion of the garment -placing the garment flat on a surface and folding the left side in followed by folding the right side in -folding the garment upwards one or more times to fit the proposed packet or bag -placing the fabric flap (31) at the waist (32) on the outside of the folded garment -placing the folded garment into the packet or bag and sealing.

The invention also describes a method of presenting the boots for use, comprising the following steps; -unzipping the zip (25) down to the ankle -folding the leg section (26) -placing the boots into a packet or bag for sealing.

Advantageously, the invention also describes a method of donning the garments that minimizes the risk of the user contaminating the garments during the donning process.

Donning the coverall comprises the following steps; ~ open the sterile bag -grasp the fabric flap (31) and remove the garment from the bag -using the coloured waist section (32) that denotes the rear of the garment, orient the garment correctly and grip one hand on the exposed inner surface on the left -release the fabric flap(31) and grip the other hand on the exposed inner surface on the right -insert right leg into pre-shortened leg (8) -insert left leg into pre-shortened leg (11) -slide hands around and insert into sleeves (4)(15) -shrug coverall up onto shoulders, releasing sleeve studs (5)(14)in the process —slide hands into the inner surface of the hood (1) and pull onto head -grasp the fabric loop of each zipper (16)(17)and zip upwards towards the hood (1), securing the face mask section (2) into place -grasp the fabric loop ( 19a) on the inside of the right leg —pull the pre-shortened right leg free from the securing point and lower to the ankle, exposing the outer surface -grasp the fabric loop (18a) on the inside of the left leg -pull the pre-shortened left leg free from the securing point and lower to the ankle, exposing the outer surface Then the user completes the donning process by donning the boots using the following procedure; -open the sterile bag -grasp the fabric tag (27) on the rear ankle of the first boot and remove from bag -grasp the fabric tag (24a) or (24b) at the top of the boot and hold the leg section vertically -step into the boot -holding the top fabric (24a) or (24b) tag vertically, zip the rear zip (25) upwards to the top of the boot -repeat for the other boot In an optional embodiment, the hood may have alternate adjustment methods such as the use of stud fasteners, fabric tie tapes or straps and buckles. in a further optional embodiment, the sleeves and ankles may have optional adjustment methods including a combination of knitted cuffs, stud closures, elastic, Velcro or similar.

In a further embodiment the face mask section of the front torso portion may be replaced with a further section of similar fabric to the main body of the coverall.

The present invention has been described in general and in detail by way of examples. Persons of skill in the art understand that the invention is not limited to the specific embodiments disclosed. Modification and variations of the general concept may be made without departing from the scope of the invention as defined by the following claims.

Claims (5)

Claims

1. A set of garments, namely a coverall with integrated, self adjusting hood (1) and face mask (2) and a set of boots plus a method of presenting same for gowning and a method of gowning that facilitates easy donning whilst maintaining the sterility of the garment.

2. A coverall, according to claim 1, comprising an inner and outer face, rear torso section (21) with hood portion (1), front torso section (3)with face mask portion (2) , left (15) and right (4) sleeve, left (11) and right (8) ieg, whose rear and front torso portions are connected together using two independent zippers (16) (17); with studs or similar attachment methods at points on the garment (5) (14) (19) (18) to facilitate attaching the sleeve and leg portions to the garment (6) (13) (7) (12); with elastic portions (22) (23) in the hood section to facilitate self adjustment when donned; with a section of fabric (32) at the rear of the inside of the waist that is a different colour to the rest of the garment to designate the rear of the garment and facilitate correct orientation of the garment for donning; with a fabric flap (31) at the waist section to provide a first grasping means; with grasping means on the inside of each ankle (183) (19a) such as a fabric loop or similar.

3. A pair of boots, according to claim 1, comprising a sole (28) and leg (26) section, with eiastic at the top hem (30), a zip (25) running the length of the rear of the leg section, fabric grasp points (27) at the ankle and top hem (24a) (2413) and adjustment method (29) such as buckles, studs or similar at the instep and top hem (30).

4. A method of presenting the garments, according to claims 1 to 3, for the user, beginning with the coverall, comprising the steps of: -unzipping the zips (16)(17)to the waist -attaching the stud at the left wrist (14) to the point at the ieft hip (13) -attaching the stud at the right wrist (5) to the point at the right hip (6) -folding the right leg (8) upwards towards the crotch, exposing the inner surface over the outer fabric surface and attaching the stud at the ankle (19a) to the point at the thigh (7) of the right leg section - folding the left leg (11) upwards towards the crotch, exposing the inner surface over the outer fabric surface and attaching the stud at the ankle (18a) to the point at the thigh (12) of the left leg section -grasping the waist section and lifting the garment vertically, allowing the inner surface of the front (3) and rear torso (21) sections to fold over the lower portion of the garment -placing the garment flat on a surface and folding the left side in followed by folding the right side in —folding the garment upwards one or more times to fit the proposed packet or bag -placing the fabric flap (31) at the waist (32) on the outside of the folded garment -placing the folded garment into the packet or bag and sealing; followed by presenting the boots, comprising the steps of; -unzipping the zip (25) down to the ankie -folding the leg section (26) -placing the boots into a packet or bag for sealing.

5. A method of donning the garments, beginning with the coverall, according to claims 1 to 4, comprising the steps of: - open the sterile bag -grasp the fabric flap (31) and remove the coverall from the bag -using the coloured waist section (32) that denotes the rear of the coverall, orient the garment correctly and grip one hand on the exposed inner surface on the left -release the fabric flap(31) and grip the other hand on the exposed inner surface on the right -insert right leg into pre-shortened leg (8) -insert left leg into pre-shortened leg (11) -slide hands around and insert into sleeves (4)(15) -shrug coverall up onto shoulders, releasing sleeve studs (5)(14)in the process -slide hands into the inner surface of the hood (1) and pull onto head - grasp the fabric loop of each zipper (16)(17)and zip upwards towards the hood (1), securing the face mask section (2) into place -grasp the fabric loop (19a) on the inside of the right leg -pull the pre-shortened right leg free from the securing point and lower to the ankle, exposing the outer surface -grasp the fabric loop (18a) on the inside of the left leg -pull the pre-shortened left leg free from the securing point and lower to the ankle, exposing the outer surface; followed by donning the boots, comprising the steps of: -open the sterile bag -grasp the fabric tag (27) on the rear ankle of the first boot and remove from bag —grasp the fabric tag (243) or (24b) at the top of the boot and hold the leg section verticaliy -step into the boot -holding the top fabric (243) or (24b) tag vertically, zip the rear zip (25) upwards to the top of the boot -repeat for the other boot.