Aseptic Sampling Device With Confined Chamber Decontamination
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Solution Overview
Problem
Current methods for aseptic sampling and transfer of raw materials in the pharmaceutical and biotechnology industries are prone to contamination, leading to delays, additional costs, and health risks due to manual handling and the limitations of laminar flow enclosures.
Innovation Solution
An aseptic sampling device with a confinable receiving chamber and sampling means that allows aseptic collection and transfer of raw materials, featuring a closable opening, orientable receiving means, and flexible guide systems to minimize contamination risks, suitable for use as a single-use, portable device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual sampling with syringe in laminar flow enclosure is used, then sampling can be performed, but contamination risk increases and aseptic reliability decreases
Solution Approach 1:
The device divides the sampling system into distinct functional compartments: a first chamber for receiving the container, a second chamber for sampling operations, and a third chamber for transfer. Each chamber can be independently sealed and processed, allowing aseptic barriers to be implemented at each stage and preventing contamination between different operational zones.
Solution Approach 2:
The patent introduces an intermediary sealed chamber system between the external environment and the sampling/transfer process. This intermediate confined space acts as a protective barrier, allowing all critical operations to occur within a controlled aseptic environment rather than directly exposing the raw material to the external milieu.
2Productivity
If manual handling and laminar flow enclosure are used, then sampling can be performed, but time consumption increases and productivity decreases
Solution Approach 1:
The device merges multiple sequential operations into a single integrated apparatus: the receiving chamber, sampling chamber, and transfer chamber are combined in one device, allowing continuous operation without removing the container between steps. This eliminates transfer time and maintains aseptic conditions throughout the entire process.
Solution Approach 2:
The device is pre-assembled with all necessary components (chambers, seals, sampling means, transfer means) ready for immediate use. The container is received in a pre-prepared first chamber, and the sampling and transfer operations can be performed sequentially without disassembly or reconfiguration, significantly reducing setup time.
3Reliability
If manual disinfection and opening of glass container is performed, then sampling can be performed, but contamination risk increases and reliability decreases
Solution Approach 1:
The device enables self-contained aseptic processing where the container is received in a sealed first chamber, disinfectant can be applied within the sealed chamber, and the container can be opened and sampled in a controlled second chamber without manual handling of the raw material outside the sealed environment. The system performs the aseptic functions automatically without requiring skilled manual operations.
4Reliability
If laminar flow enclosure is used, then sampling can be performed, but cost increases and device complexity increases
Solution Approach 1:
Instead of using a complex full-enclosure laminar flow system, the patent segments the aseptic function into discrete sealed chambers within a simpler housing. Each chamber (receiving, sampling, transfer) is independently sealable, providing aseptic protection without requiring the complex airflow control systems of traditional laminar flow enclosures.
Solution Approach 2:
The invention extracts the essential aseptic protection function from the complex laminar flow enclosure system, retaining only the critical sealed chamber structures while eliminating the complex airflow generation, filtration, and control systems. This provides sufficient aseptic reliability through physical containment rather than controlled airflow.
Data Source
AI summary
The invention relates to an aseptic sampling device comprising:A sampling means (1) being configured to aseptically collect a raw material (2) which is contained in a first container (3) of a predetermined volume, andA receiving chamber (4) which has a confinable space (5) and being arranged to allow decontamination thereof via the passage of at least one fluid in said confinable space (5), said receiving chamber (4) being provided with a closable opening (6), a receiving means (7) which can be oriented in the confinable space (5).


