Sterile Fluid Path System for On-Site Pharmaceutical QC

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Solution Overview

Problem

There is a need for an apparatus that enables accurate and efficient quality control analysis of pharmaceutical products that are prepared on-site or at the point-of-use, particularly for products with short shelf lives like hyperpolarized imaging agents, which require immediate QC to ensure safety and sterility, and must allow for both contact and non-contact measurements.

Innovation Solution

A quality control system comprising a receiver vessel, a sample tube with a one-way valve, and an appendage with chambers to receive and measure pharmaceutical products, along with a sterile fluid path system that includes a vial, dissolution medium, and a tubing system for transferring the product, ensuring sterility and allowing for multiple parameter measurements.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If QC analysis is performed on-site for hyperpolarized imaging agents, then safety and sterility are ensured, but time is lost due to the short shelf life of the product

Engineering Contradiction:

Improvesafety and sterilityVSAvoidQC analysis time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary QC measurements of multiple parameters (pH, temperature, concentration, sterility) before the hyperpolarized imaging agent is administered to the patient. This preliminary action ensures that all necessary quality checks are completed while the product is still viable, preventing time loss during administration.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent replaces traditional contact-based QC measurement methods with non-contact optical measurement techniques. This substitution eliminates contamination risks and reduces measurement time, allowing rapid QC analysis without compromising safety or sterility.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If non-contact QC measurement is used, then sterility is maintained, but measurement capability is limited

Engineering Contradiction:

ImprovesterilityVSAvoidmeasurement capability

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The QC system is designed with multi-functionality to perform both contact and non-contact measurements. It includes optical sensors for non-contact measurements of pH, temperature, and concentration, as well as interfaces for contact-based sterility testing, making it universally applicable to various measurement needs while maintaining sterility.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system uses an intermediary optical measurement approach that allows QC analysis without direct contact between the measurement device and the pharmaceutical product. Optical sensors detect parameters through the container walls, serving as an intermediary that maintains sterility while enabling comprehensive measurements.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Measurement precision

If contact QC measurement is performed, then comprehensive parameter measurement is possible, but contamination risk increases

Engineering Contradiction:

Improveparameter measurement accuracyVSAvoidcontamination risk

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The system replaces contact-based mechanical measurement methods with non-contact optical measurement techniques. This substitution maintains measurement precision for parameters like pH, temperature, and concentration while eliminating the contamination risk associated with introducing measurement devices into the pharmaceutical product.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Reliability

If multiple QC parameters are measured, then product quality is thoroughly assessed, but system complexity increases

Engineering Contradiction:

Improveproduct quality assuranceVSAvoidsystem complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The system merges multiple QC measurement functions (pH measurement, temperature monitoring, concentration analysis, sterility testing) into a single integrated platform. This consolidation allows thorough product quality assessment while managing system complexity through unified hardware and software architecture.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS7803320B2Apparatus for quality control analysis of an on-site prepared pharmaceutical product

Publication Date: 2010.09.28 GE PRECISION HEALTHCARE LLC

AI summary

A quality control system for measuring parameters in a pharmaceutical product includes a receiver vessel to receive a pharmaceutical product therein. The quality control system also includes a sample tube having a first end attached to the receiver vessel to remove pharmaceutical product from the receiver vessel and an appendage connected to a second end of the sample tube. The appendage includes at least one chamber therein to receive a quantity of pharmaceutical product from the receiver vessel. A valve positioned within the sample tube controls flow of the pharmaceutical product to the appendage and prevents flow of the pharmaceutical product from the appendage back into the receiver vessel. The system also includes a quality control device configured to measure at least one parameter of the pharmaceutical product in at least one of the receiver vessel and the appendage.