Pre-filled Syringe Sterilization via Vaporized Hydrogen Peroxide

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Solution Overview

Problem

Current drug delivery systems, particularly for ophthalmic applications, face challenges in ensuring accurate dosing and minimizing adverse effects such as intraocular inflammation and infection due to contamination and improper sterilization methods.

Innovation Solution

The use of pre-filled syringes sterilized with vaporized hydrogen peroxide to reduce bacterial content and minimize the risk of ocular infections during the administration of anti-VEGF agents for treating angiogenic eye disorders.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional sterilization methods are used for drug delivery devices, then the sterilization process is simpler and faster, but the rate of intraocular inflammation and infection increases

Engineering Contradiction:

Improverate of intraocular inflammation and infectionVSAvoidsterilization process complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by transitioning from traditional sterilization methods to vaporized hydrogen peroxide sterilization, which operates at lower temperatures and uses different chemical parameters to achieve superior sterilization efficacy. This change in sterilization parameters reduces intraocular inflammation and infection rates while maintaining process feasibility

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent utilizes vaporized hydrogen peroxide, a strong oxidant, to sterilize the drug delivery device. The oxidizing action of hydrogen peroxide effectively eliminates bacterial contamination and reduces the risk of ocular infections, directly addressing the reliability issue while providing a controlled sterilization process

Inventive Principle:

Principle #38Strong oxidants (Accelerated oxidation)

2Reliability

If pre-filled syringes are used to reduce contamination risk, then the sterilization effectiveness improves, but the device complexity and manufacturing difficulty increase

Engineering Contradiction:

Improvesterilization effectivenessVSAvoidmanufacturing difficulty

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent applies preliminary action by pre-filling the syringe with the drug substance and pre-sterilizing the entire assembly before use. This eliminates the need for complex assembly procedures at the point of administration and ensures that the device is ready for immediate use with guaranteed sterility, thereby improving reliability without proportionally increasing manufacturing complexity

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent merges the drug substance, the syringe, and the sterilization process into a single integrated pre-filled syringe system. This combination ensures that all components are sterilized together as a complete system, eliminating potential contamination points from assembly and simplifying the overall manufacturing process

Inventive Principle:

Principle #5Merging (Combining)

3Reliability

If vaporized hydrogen peroxide sterilization is used, then the bacterial content is significantly reduced, but the cost and process time increase

Engineering Contradiction:

Improvebacterial content reductionVSAvoidsterilization process time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent replaces traditional mechanical or thermal sterilization systems with a vaporized chemical sterilization system using hydrogen peroxide. This substitution allows for more effective bacterial reduction through chemical oxidation while enabling faster cycle times compared to traditional autoclaving or dry heat methods, thus reducing the loss of time

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The method significantly decreases the likelihood of intraocular inflammation and infection, reducing adverse effects like redness, pain, and sensitivity to light, while ensuring precise and accurate drug delivery.

Implementation Method 1

sterilizing the pre-filled syringe with vaporized chemicals to remove contaminants and other biological agents present on the pre-filled syringe. The vaporized chemicals include vaporized hydrogen peroxide (VHF)

Methodology Applied

Scientific EffectVaporized hydrogen peroxide sterilization: Oxidation

Data Source

PatentUS20230080971A1Methods for delivering agents with pre-filled syringes to minimize intraocular inflammation

Publication Date: 2023.03.16 REGENERON PHARMACEUTICALS INC

AI summary

A method of treating an eye disorder in a patient that may include administering a medicament to the patient with a prefilled syringe, wherein the administration of the medicament with the prefilled syringe is configured to treat the eye disorder and decrease a rate of likelihood of an ocular infection to the patient's eye.