Date of Publication :5th November 2025

Abstract: This study addresses the need for a safer and more efficient ampule-breaking solution in healthcare settings. Ampules, widely used for medication storage, provide a sterile environment that safeguards drugs from contamination. Traditional methods of opening ampules, including knives, gloves, cloth, and basic devices, often lead to safety risks, glass contamination, and inefficiency. To overcome these issues, a user-centered design (UCD) approach was adopted to develop an innovative ampule breaker. This device prioritizes user safety, minimizes contamination, and simplifies the ampule-opening process by capturing broken glass particles and ensuring a clean, controlled break. Finite Element Analysis (FEA) of borosilicate glass ampules was conducted to assess different breaking mechanisms and optimize stress distribution. The ampule breaker’s ergonomic design allows healthcare professionals to handle various ampule sizes (1-5 ml) efficiently, addressing key regulatory and material considerations. With an integrated cap collection system, this solution reduces injury risks and contamination, enhancing clinical workflows. The IPR was filed for the device, and it will soon be brought to the market after the required regulatory clearances and certifications.

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