Disposable Particle Impactor for Cleanroom Sampling
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Solution Overview
Problem
Current particle collection systems in cleanroom and manufacturing environments face challenges in achieving high collection efficiencies while maintaining biological particle viability and reducing false positive detection events, which can lead to costly product recalls and safety risks.
Innovation Solution
A particle impactor device with an integrated sampler and enclosed impact surface, designed for single-use or disposable applications, minimizes user handling risks and allows for effective sampling and growth of biological particles, featuring an integrated sampler and impact surface that can be sterilized in a fully assembled configuration, and is optically transparent for in situ analysis without physical access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional particle collection systems are used, then collection efficiency can be improved, but biological particle viability is compromised and false positive detection increases
Solution Approach 1:
The patent employs a disposable impactor system where the entire sampling device including the impact surface is discarded after single use. This eliminates the need for complex sterilization procedures and handling operations that compromise biological particle viability, while maintaining high collection efficiency through optimized impactor design. The disposable nature ensures each sampling event starts with a completely sterile, pre-packaged unit.
Solution Approach 2:
The impactor system is segmented into separable components: a reusable housing and a disposable cartridge containing the impact surface. This segmentation allows the critical sampling interface to be replaced frequently with fresh sterile units, maintaining biological particle viability, while the housing provides stable mechanical support and airflow control for consistent collection efficiency.
2Reliability
If sterilization and handling procedures are implemented, then contamination risks are reduced, but operational complexity and false positive events increase
Solution Approach 1:
The impactor is pre-sterilized and pre-packaged in a sterile container before delivery to the user. All critical sterilization steps are performed in advance during manufacturing, eliminating the need for complex on-site sterilization procedures. The user simply opens the pre-sterile package and inserts the impactor, dramatically reducing handling complexity while maintaining contamination control.
Solution Approach 2:
The disposable impactor is designed as a self-contained, self-sterilizing unit that requires no external sterilization equipment or procedures. The sterile barrier is integrated into the product design itself, allowing the system to maintain contamination control autonomously without adding operational complexity for the user.
3Reliability
If integrated sampler and impact surface design is used, then handling risks are minimized, but device complexity increases
Solution Approach 1:
The sampler and impact surface are merged into a single integrated disposable cartridge. This combination eliminates the need for separate handling of multiple components, reducing handling risks and potential contamination points. The integrated design maintains manageable complexity by combining functions into one replaceable unit rather than creating a complex multi-component system requiring coordinated assembly.
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 solution enhances collection efficiency, reduces false positives, eliminates sterilization and handling-related contamination risks, and supports safe and efficient monitoring of biological particles in cleanroom and aseptic environments, ensuring compliance with cleanliness standards.
Implementation Method 1
Each stage of an inertial impactor operates on the principle that particles suspended in air can be collected by forcing a dramatic change in the direction of the particle-containing airflow, where the inertia of the particle will separate the particle from the airflow streamlines and allow it to impact on the surface.
Implementation Method 2
Once the colonies reach a large enough size, they can be identified and characterized, for example using microscopic imaging, fluorescence, staining or other techniques, or simply counted visually by eye or by image analysis techniques.
Data Source
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AI summary
The invention generally provides devices and methods for sampling, detecting and/or characterizing particles, for example, via collection, growth and analysis of viable biological particles such as microorganisms. Devices and methods of the invention include particle samplers and impactors for collecting and/or analyzing biological particles in manufacturing environments requiring low levels of particles, such as cleanroom environments for electronics manufacturing and aseptic environments for manufacturing pharmaceutical and biological products, such as sterile medicinal products. Devices and methods of the invention incorporate an integrated sampler and impact surface, such as the receiving surface of a growth media, in a manner to minimize, or entirely eliminate, risks associated with user handling, such as the occurrence of false positive determinations due to contamination of the impact surface during particle sampling, growth or analysis processes.