IES86317B2 - Goggle strap for aseptic environments - Google Patents

Abstract

A goggle strap for use in aseptic environments is described. The strap is designed to improve the donning process and allow for sterilization prior to re-use and also allow for traceability. <Figure 1>

Description

Title Goggle Strap 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 and a pair of goggles.

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, usually through one of the following methods; steam autoclave, gamma irradiation or ethylene oxide gas.

These garments are donned in an airlock or ante-room prior to entry into the sterile environment. The garments must be donned using aseptic techniques, meaning that the operator must attempt to don them without touching the exterior surface of the item or allowing the items exterior surface to touch any other surface. Should this occur the item is regarded as contaminated and must be discarded and another item selected for donning.

This stipulation for aseptic technique can lead to stress for the operator, who must perform this exacting technique multiple times per day and also can lead to high costs for discarded items.

Of particular concern in the pharmaceutical and research industries is the use of goggles to contain the particles released from the face and eyes. Typically, these are supplied with rubber or neoprene straps. This presents a number of problems for the user. The nature of the straps can make them difficult to adjust, and requires extensive handling and adjustment when donned. The strap materials themselves, i.e. rubber and neoprene, can become sources of particle release after a number of sterilization cycles.

The invention describes a goggle strap (1) that can alleviate both problems, allowing for an easier donning process that maintains the sterility of the goggle and thereby reduce the costs associated with discarded items. The invention also allows for the goggles to be laundered by competent cleanroom laundries and re-sterilised before delivery back to the user for re-use.

In a preferred embodiment, the strap ¢1) is constructed using a cleanroom fabric which is typically 98-100% polyester with a woven carbon grid to prevent the build-up of static charges. These fabrics are used to manufacture other commonly used clearnoom garments and are non-linting, unlike the rubber and neoprene straps previously mentioned. This allows the invention to deliver an improved performance over existing goggles by reducing the particulate associated with the goggles used. At either end (2) (6) of the strap are sewn in sections of elastic (3) (5) which extend during the donning process and contract once in place to hold the goggles onto the users face. At the rear of the strap there Is a loop of fabric (4) which serves as a first grasping point during the donning process and also the method of placing the strap around the head without contaminating the strap itself.

The rear of the strap is wider to accommodate a label (7) for the identification of the goggle both to the user and to the laundry. This identification label (8) may carry a unique identifier such as a number, barcode, transponder chip(9) or other identifying method.

The strap (1) may be affixed to a goggle by any of a number of methods including being sewn on or attached using a buckle, Velcro, stud fasteners or similar.

To don the goggle the user performs the following; 1. Remove the goggle from the sterile pack using the fabric loop (4) 2. Holding the strap (1) vertically, place the goggle against the face 3. Using the fabric loop (4), extend the strap behind the head 4. Release the loop (4) Unlike other goggle straps the user does not contact the strap itself, maintaining the sterility of the strap.

Claims (3)

1. Claims ί. A goggle strap (1), comprised of cleanroom compatible material which is typically 98-100% 5 polyester with a woven carbon grid, with elastic (3) (5) at both ends (2) (6) and a fabric loop (4) at the rear to facilitate donning.
2. 2. A goggle strap, according to claim 1, with a traceability element (7) comprising but not limited to a barcode, transponder chip, unique number or other unique identifier.
3. 3. A goggle strap, according to claims 1 & 2, with an attachment method comprising but not 10 limited to sewing on, buckles, stud fasteners, Velcro or other attachment method.