Five-fingered glove spreader

Abstract

This utility model relates to pharmaceutical manufacturing, specifically to devices for ensuring the proper fit of gloves in isolators used in the production of sterile dosage forms. The device is designed to comply with Good Manufacturing Practice (GMP) regulations, where gloves should be straightened and fingers spread to ensure full contact with the sterilizing agent. 3 inc. fil., 6 fig., 2 others.

Description

[0001] Technical field

[0002] This utility model relates to pharmaceutical manufacturing, specifically to devices for ensuring the proper fit of gloves in isolators used in the production of sterile dosage forms. The device is designed to comply with Good Manufacturing Practice (GMP) regulations, requiring gloves to be straightened and fingers spread to ensure full contact with the sterilizing agent.

[0003] Technology Level

[0004] The prior art knows various devices for stretching and supporting gloves in pharmaceutical production isolators, aimed at ensuring sterility and preventing deformation of gloves during sterilization.

[0005] This is the Glove Stretcher for Isolators (EREA Pharma, France) solution known in open sources. This is a system for stretching and tightening isolator gloves, ensuring their biological decontamination in accordance with Appendix 1 of GMP. A significant drawback is the lack of movable elements for easy installation; the fixed design can make it difficult to don gloves of different sizes, leading to the risk of damage or incomplete finger extension.

[0006] Another well-known solution is Glove Extenders (Don Whitley Scientific, UK). These glove extenders are used during VHP sterilization to separate the fingers and prevent occlusions. A drawback is the lack of mobility of the fingers, particularly the thumb, which complicates the process of donning the glove. The design is not adapted to the anatomy of the hand, which can lead to uneven unfolding.

[0007] Also known on the market is the GS System Glove Support (Dynamic Design Pharma, USA). This glove support system is used for positioning gloves in barrier isolators during VHP biodecontamination. The disadvantage of this device is its focus on supporting the sleeve rather than the fingers, and the lack of movable elements to facilitate installation, which increases the time required.

[0008] Existing solutions provide basic support for glove shape but do not adequately address ease of installation, especially in sterile manufacturing environments. They are static, leading to difficulties donning the glove, risk of deformation, and incomplete contact with the sterilizing agent. Furthermore, similar solutions lack a spring-loaded thumb mechanism, limiting their applicability in GMP isolators.

[0009] Drawings

[0010] Fig. 1: Drawing of "Glove spacer (five fingers).

[0011] Fig. 2: 3D model of the assembled strut, showing the application of the strut.

[0012] Fig. 4: Photograph of the prototype.

[0013] Fig. 5: Photograph of the prototype.

[0014] Fig. 6: Photograph of the prototype.

[0015] The objective is to create a device that ensures the correct shape of gloves in isolators for the production of sterile preparations, prevents glove deformation, facilitates their installation and return to the working position, and complies with GMP requirements (fingers must be spread to ensure full contact with the sterilizing agent). This will simplify the biodecontamination process, reduce the risk of contamination, and improve the efficiency of visual glove inspection.

[0016] The essence of the utility model lies in the design of a five-fingered spreader consisting of a rod and finger elements, where the thumb is movable and returns to its working position using a spring. This ensures easy installation of the spreader in the glove (the thumb is retracted for insertion, then returns to its working position).

[0017] The novelty lies in its adaptation to pharmaceutical isolators: the device prevents finger sticking, ensures uniform contact with the sterilizing agent, and complies with GMP. The claimed utility model features a movable, spring-loaded thumb, a five-fingered design, and is made of plastic. The five-fingered spacer can be manufactured in various sizes while maintaining its universal properties. The most preferred size is 207.9 mm finger length, 101 mm finger width, and 302 mm overall height (see Fig. 1).

[0018] The use of this utility model simplifies the sterilization process, reduces preparation time, and prevents glove deformation. It is also worth noting that the spring provides a thumb deflection angle of at least 23 degrees to facilitate insertion into the glove.

[0019] The device includes a metal rod, which serves as the base for fixation in the isolator, and a five-fingered plastic element that imitates the shape of a hand. The thumb is connected to the base via a hinge and a spring, allowing it to be retracted for insertion into the glove and automatically returned to the extended position. The finger elements have rounded ends to prevent damage to the glove. The rod can be made of any metal resistant to corrosion and sterilization, preferably aluminum or stainless steel. The finger element is made of plastic with sufficient strength characteristics to ensure long-term reliable operation. The most preferred options are nylon, polyacetal, polypropylene, and Zedex ZX-100K engineering plastic.

[0020] The spacer is inserted into the glove, then the thumb is manually retracted, the device is inserted, and a spring returns the thumb to its working position, spreading the glove fingers. The glove is secured in the isolator, ensuring access of the sterilizing agent to all surfaces. After sterilization, the spacer is easily removed. The finger element is manufactured by milling sheet plastic on a milling machine using known tools and methods. First, the plastic part is molded, then the metal rod is machined, then the movable finger mechanism is assembled, and finally, sterility testing is performed.

[0021] The utility model can be used, for example, in isolators for the production of sterile injectable drugs, during VHP biodecontamination to ensure GMP conditions, in laboratories for drying and storing gloves without deformation.

[0022] The device can be manufactured on standard equipment and is used in pharmaceutical production.

Claims

1. A five-fingered glove spacer comprising a rod and a finger element with five fingers, characterized in that the thumb is made movable relative to the remaining fingers and is connected to the finger element by a hinge with a spring, wherein the spring is designed with the possibility of returning the thumb to a position spread relative to the remaining fingers.

2. A five-fingered glove spacer according to paragraph 1, characterized in that the finger element is made of plastic, and the rod is made of metal resistant to sterilization and corrosion.

3. A five-fingered glove spacer according to paragraph 1, characterized in that the length of the finger element is 207.9 mm, the width of the fingers is 101 mm.

4. A five-fingered glove spacer according to claim 1, characterized in that the spring provides a deflection angle of the thumb of 23 degrees to facilitate insertion into the glove.

Images