Aseptically Transferring Fluid Using Piercing Member and Air Pump

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Solution Overview

Problem

The biopharmaceutical industry faces challenges in aseptically transferring liquid substances from glass vials to processing systems, which requires stringent sterility controls and increases manufacturing costs.

Innovation Solution

A system comprising a sterilized vial with a septum, a fluidic assembly with a piercing member and air pump, and a sterilized pouch that allows the piercing member to puncture the septum without breaching the pouch, enabling aseptic fluid transfer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If aseptic transfer is performed in a cleanroom with stringent sterility controls, then contamination risk is reduced, but manufacturing cost increases

Engineering Contradiction:

Improvesterility assuranceVSAvoidmanufacturing cost

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The system divides the aseptic transfer process into two distinct phases: (1) pre-assembly and sealing of the vial-piercing member assembly in a controlled environment, and (2) deployment and actuation in a non-sterile setting. This segmentation allows the critical sterility assurance to occur only where needed (during assembly) while eliminating expensive cleanroom requirements for the actual fluid transfer operation.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The piercing member is pre-assembled with the vial and sealed within the pouch before use. All critical components are sterilized and positioned in advance during manufacturing under controlled conditions. During actual use, the pre-assembled unit is activated by simply pushing the piercing member against the septum, eliminating the need for complex real-time sterilization procedures and expensive cleanroom infrastructure.

Inventive Principle:

Principle #10Preliminary action

2Productivity

If a piercing member is used to puncture the septum, then fluid transfer efficiency is improved, but risk of pouch breaching increases

Engineering Contradiction:

Improvefluid transfer rateVSAvoidpouch integrity

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The pouch is designed as a flexible barrier that can accommodate the piercing action. The flexible material allows the piercing member to penetrate the septum while the pouch itself remains intact, absorbing the mechanical stress of puncture without breaching. This flexible shell design enables efficient fluid transfer through the piercing member while maintaining pouch integrity to preserve sterility.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The pouch is designed with sufficient thickness and structural integrity to cushion and absorb the impact of the piercing member during puncture. This beforehand cushioning prevents the piercing action from transmitting forces that would breach the pouch, thereby protecting the sterile barrier while allowing efficient fluid transfer through the created pathway.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Device complexity

If manual air pump is used to propel liquid, then device complexity is reduced, but transfer speed may be limited

Engineering Contradiction:

Improvepumping mechanismVSAvoidfluid transfer speed

Core Design Contradiction:

Device complexityVSProductivity

Solution Approach 1:

The manual air pump is designed to be self-actuating through user manipulation. The pump utilizes human hand power to generate the necessary pressure differential for fluid transfer, eliminating the need for external power sources, motors, or complex automated pumping systems. This self-service approach maintains simplicity while providing sufficient transfer speed for most applications through direct manual operation.

Inventive Principle:

Principle #25Self-service

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

This solution allows for aseptic transfer of liquid substances in a non-sterile environment, reducing the risk of contamination and lowering manufacturing costs by eliminating the need for stringent cleanroom conditions.

Implementation Method 1

a manual air pump filled with sufficient air to propel all of the liquid substance out of the sterilized vial

Methodology Applied

Scientific EffectPressure: Pressure Increase

Implementation Method 2

expelling air from the manual air pump into the sterilized vial disposed in an inverted orientation to propel the liquid substance

Methodology Applied

Scientific EffectGas compression: Compression

Data Source

PatentUS12329721B1System and method for aseptically transferring fluid

Publication Date: 2025.06.17 APPL CELLS INC

AI summary

A system for aseptically transferring a liquid substance comprises a sterilized vial filled with the liquid substance and sealed with a sterilized septum; a sterilized fluidic assembly including a piercing member including therein first and second channels and having a tip end that operably punctures the sterilized septum, the first and second channels having first and second channel openings at the tip end; a manual air pump; an inlet line fluidically connects the manual air pump to the first channel of the piercing member; and an outlet line fluidically connected to the second channel of the piercing member at one end and hermetically sealed at the other end; and a sterilized pouch enclosing and hermetically sealing the sterilized vial and the piercing member and operably allowing the piercing member to puncture the sterilized septum when the piercing member is manually pushed from the exterior of the sterilized pouch.