Integrated Tamper-Evident Closure for Aseptic Ophthalmic Solutions

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Solution Overview

Problem

The preparation and compounding of ophthalmic drugs are challenging due to the difficulty in maintaining aseptic conditions during the assembly of separate bottle, cap, and nozzle components, which often require handling under sterile conditions and can be time-consuming and labor-intensive.

Innovation Solution

A closure assembly with a cap and spout integrated in a fixed but removable connection, featuring a tamper-evident indicator member that provides visual indication of cap removal, allowing for aseptic handling and droplet dispensing of medical solutions without direct contact with the nozzle, while enabling secure attachment to the bottle neck.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If separate bottle, cap, and nozzle components are used, then assembly flexibility is improved, but maintaining aseptic conditions becomes more difficult and labor-intensive

Engineering Contradiction:

Improveassembly flexibilityVSAvoiddifficulty of maintaining aseptic conditions

Core Design Contradiction:

Adaptability or versatilityVSEase of operation

Solution Approach 1:

The patent combines the cap and nozzle into a single integrated closure assembly that is pre-assembled in a sterile state. The nozzle is permanently attached to the cap body, forming one unified component that maintains aseptic conditions during handling and assembly to the bottle.

Inventive Principle:

Principle #5Merging (Combining)

2Adaptability or versatility

If separate components are assembled manually, then customization is improved, but preparation time and labor costs increase

Engineering Contradiction:

Improvecustomization capabilityVSAvoidpreparation speed

Core Design Contradiction:

Adaptability or versatilityVSProductivity

Solution Approach 1:

The cap and nozzle are pre-assembled into an integrated closure assembly during manufacturing under controlled sterile conditions. This preliminary assembly eliminates the need for manual assembly during ophthalmic drug preparation, significantly reducing preparation time and labor requirements while maintaining sterility.

Inventive Principle:

Principle #10Preliminary action

3Ease of operation

If the cap is made removable for access, then usability is improved, but tamper evidence and sterility protection become more difficult

Engineering Contradiction:

ImproveaccessibilityVSAvoidtamper evidence capability

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent incorporates a tamper-evident indicator that changes color or provides visual indication when the cap is removed or tampered with. This allows the system to maintain both removability for access and reliable evidence of tampering to ensure solution sterility.

Inventive Principle:

Principle #32Color changes

Data Source

PatentUS12195241B1Tamper evident integrated closure

Publication Date: 2025.01.14 MEDICAL DEVICE ENGINEERING LLC

AI summary

A closure for a medical solution containing bottle, including a cap having a shroud disposed in closing relation to the neck and access opening of the bottle. The cap is removably connected to the bottle and may include a shrouded tamper evident indicator member connected to an interior surface of the shroud, at least initially inwardly of an open end of thereof in a non-visually observable location. Upon removal of the cap from the bottle and replacement thereof, the indicator member will be disposed exteriorly of the shroud in a visually observable location on the bottle. The closure may also include a spout integrated into the cap in a fixed, removable connection therewith, such that the spout is movable with the cap into closing relation of cap to the bottle neck and access opening.