Sterile Single-Use Sampling Device for Process Conduits

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Existing methods for obtaining sterile fluid samples from process conductions often introduce contamination, leading to misleading results in decontamination process verification, as they require flushing to maintain sterility.

Innovation Solution

A device comprising a tubular core and sleeve assembly with a syringe attachment, allowing for sterile sampling without contaminating the conduit, featuring a Luer-Lok fitting for secure attachment and o-rings for a fluid-tight seal, ensuring sterility and ease of use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional sampling methods with valves are used to obtain sterile samples, then samples can be withdrawn and conduit can be resealed, but flushing is required to maintain sterility which may introduce contamination

Engineering Contradiction:

Improvesterility maintenanceVSAvoidcontamination risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device divides the sampling system into separate sterile and non-sterile zones. The tubular core with passageway remains isolated from the conduit fluid stream, while the tubular sleeve interfaces with the external environment. This segmentation allows sample extraction without compromising conduit sterility or requiring flushing operations that could introduce contamination.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The tubular core acts as an intermediary barrier between the sterile conduit fluid and the non-sterile sampling apparatus. The core's passageway allows fluid communication while its sealed construction prevents contamination. The needle punctures the core to access the fluid stream without introducing contaminants from the external sampling system.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If flushing is performed to maintain sterility in conventional systems, then sterility can be maintained, but biological activity may be introduced into the sample

Engineering Contradiction:

Improvesterile condition maintenanceVSAvoidsample accuracy

Core Design Contradiction:

ReliabilityVSLoss of information

Solution Approach 1:

The tubular core is pre-sterilized and sealed before installation in the conduit. The sampling system is prepared in advance with sterile components (core, sleeve, needle) that maintain sterility without requiring flushing during operation. This preliminary preparation eliminates the need for flushing that could introduce biological activity into the sample.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The device extracts only the necessary fluid sample through the needle puncture without requiring extraction of fluid for flushing purposes. The sampling action is direct and targeted, removing only the sample volume needed for analysis while leaving the conduit fluid stream intact and sterile, thereby avoiding introduction of external biological contaminants.

Inventive Principle:

Principle #2Taking out (Extraction)

3Adaptability or versatility

If a removable sampling device is installed in the conduit, then sampling can be performed without permanent modification, but ensuring fluid-tight sealing and sterility becomes more difficult

Engineering Contradiction:

Improveremovable installationVSAvoidsealing and sterility assurance

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The device employs flexible sealing elements including O-rings and grommets that conform to the conduit interior surface and connection interfaces. These thin film seals create fluid-tight barriers while allowing the device to be installed and removed without permanent conduit modification. The flexible seals maintain sterility assurance through their ability to conform perfectly to mating surfaces.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The tubular core and sleeve assembly can be designed as a disposable unit that is replaced periodically. This approach ensures consistent sealing performance and sterility without relying on long-term durability of removable components. Each new installation provides fresh sealing surfaces and sterile barriers, guaranteeing reliable sealing and sterility for each sampling campaign.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Data Source

PatentUS7437958B2Sterile single use sampling device

Publication Date: 2008.10.21 AMERICAN STERILIZER CO

AI summary

The present invention provides a device for obtaining a sample of fluid from a process conduit. The device includes a tubular core that has a passageway extending therethrough. The tubular core has ends that are attachable to spaced-apart portions of a conduit. A tubular sleeve surrounds the tubular core such that the tubular core extends lengthwise through the tubular sleeve. The tubular sleeve has a boss formed thereon that has a bore extending therethrough. The bore fluidly communicates with the tubular core. A syringe is mountable to the boss and the syringe has a needle. The needle is dimensioned to extend through the bore to puncture the core and to project into the passageway inside the core.