Sterile Drape System for Non-Sterile Container Introduction

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Solution Overview

Problem

The challenge is to introduce a non-sterile container with a sterile liquid into a sterile environment without sterilizing the container's exterior surfaces, as existing methods like long transfer tubes are inconvenient and wasteful.

Innovation Solution

A cap and drape system that encloses the non-sterile container, featuring a sealing mechanism, a nozzle for fluid communication, and a splash guard, allowing the container to be safely and efficiently introduced into a sterile environment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a long transfer tube is used to deliver liquid from a non-sterile container into a sterile environment, then the container can be positioned outside the sterile environment, but the device complexity increases and liquid wastage occurs

Engineering Contradiction:

Improvecontainer positioningVSAvoidtransfer tube system

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

A sterile drape acts as an intermediary barrier that allows the non-sterile container to be introduced into the sterile environment without direct contact between the non-sterile container exterior and the sterile field. The drape creates a sterile enclosure that mediates between the non-sterile container and the sterile environment, eliminating the need for long transfer tubes while maintaining sterility.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The sterile drape is a flexible thin film that can be draped over the non-sterile container to create a sterile enclosure. This flexible barrier allows the container to be positioned within the sterile environment while preventing contamination, replacing the rigid and complex long transfer tube system.

Inventive Principle:

Principle #30Flexible shells and thin films

2Ease of operation

If a long transfer tube is used to deliver liquid from a non-sterile container, then the container can be positioned outside the sterile environment, but the time to deliver liquid increases

Engineering Contradiction:

Improvecontainer positioningVSAvoidliquid delivery time

Core Design Contradiction:

Ease of operationVSLoss of time

Solution Approach 1:

The sterile drape serves as a mediator that enables direct introduction of the container into the sterile environment, eliminating the time-consuming process of using long transfer tubes for liquid transfer. The barrier allows immediate access while maintaining sterility.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If a long transfer tube is used, then the non-sterile container can be used, but liquid remaining in the tubing is wasted

Engineering Contradiction:

Improvecontainer usageVSAvoidliquid wastage

Core Design Contradiction:

Ease of operationVSLoss of substance

Solution Approach 1:

The sterile drape acts as a mediator that allows the container to be introduced directly into the sterile environment, eliminating the need for intermediate tubing that would retain and waste liquid. This direct introduction method prevents liquid loss in the transfer path.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Reliability

If the exterior surfaces of the container are sterilized, then the container can be introduced into the sterile environment, but the sterilization process can harm the liquid product

Engineering Contradiction:

Improvesterility maintenanceVSAvoidliquid product damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system segments the container into two distinct zones: the interior contents remain non-sterile and protected from sterilization processes, while the exterior is enclosed by a sterile drape that provides the necessary sterility barrier. This segmentation allows sterility maintenance without exposing the liquid product to harmful sterilization agents.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The sterile drape serves as an intermediary barrier that provides sterility protection without requiring sterilization of the container exterior or exposure of the liquid product to harmful sterilization processes. The drape mediates between the non-sterile container and the sterile environment requirements.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS20190300247A1Device and draping method for facilitating introduction of a non-sterile container into a sterile environment

Publication Date: 2019.10.03 REPLIGEN CORP

AI summary

An improved device for enabling a non-sterile container of liquid, such as, for example, a bottle to be introduced into a sterile environment. In one embodiment, the device seals the non-sterile container within a drape so that the non-sterile container can be introduced into the sterile environment. The device may include a drape having an interior cavity for receiving the non-sterile container and a cap coupled to the enclosure for coupling to the non-sterile container so that the liquid product may flow through the sterile cap.