Disposable Membrane Chamber Isolation for Sterile Sample Handling
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Solution Overview
Problem
Existing apparatuses for sterilization, depyrogenation, and freeze-drying require complex and costly procedures to maintain sterility when handling samples, especially in pharmaceutical and chemical industries, as operators must frequently disinfect and sterilize equipment and risk cross-contamination.
Innovation Solution
A disposable membrane or film-based apparatus with a sealing mechanism that isolates the treatment chamber from the outside atmosphere, allowing for sterile conditions to be maintained even when the door is open, using a polymer material that withstands operating conditions like freeze-drying.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If isolators are used to maintain sterile atmosphere during sample handling, then sterility is maintained, but operator complexity and cost increase due to isolator suits and complex procedures
Solution Approach 1:
The apparatus is divided into two distinct zones: a sterile treatment chamber and a non-sterile external environment. The membrane creates a physical segmentation that allows the sterile chamber to be maintained independently, eliminating the need for complex isolators while preserving sterility through spatial separation.
Solution Approach 2:
A disposable membrane acts as an intermediary barrier between the sterile treatment chamber and the non-sterile external environment. This membrane enables controlled interaction (sample transfer) while maintaining sterility, replacing complex isolator systems with a simple barrier mechanism.
2Reliability
If conveyors and laminar flow systems are used to introduce samples, then sterility is maintained, but device complexity and operational difficulty increase
Solution Approach 1:
The complex sterility maintenance functions (laminar flow, conveyor systems) are extracted from the apparatus. Instead, a simple membrane barrier is used that passively maintains sterility while allowing straightforward manual sample introduction, removing unnecessary complexity.
Solution Approach 2:
A disposable membrane is used instead of expensive, complex, and difficult-to-sterilize mechanical systems. The membrane is simple, inexpensive, and can be easily replaced, making sample introduction both sterile and operationally simple.
3Ease of operation
If mechanical parts (jacks, screws, handles) are used on the door, then operation is enabled, but sterilization becomes difficult or impossible
Solution Approach 1:
Mechanical parts on the door are replaced with a membrane-based sealing system. The membrane can be easily sterilized by standard methods (autoclaving, chemical sterilization) unlike complex mechanical assemblies, while still allowing the door to function for sample introduction.
Solution Approach 2:
The door system transitions from mechanical components with complex sterilization requirements to a membrane system that can withstand and be sterilized by extreme temperatures and chemicals. This parameter change in material properties enables complete sterilization while maintaining operational functionality.
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
Enables easy and cost-effective maintenance of sterile conditions during sample handling and processing, reducing the risk of contamination and simplifying operations in pharmaceutical and chemical industries by allowing sterile samples to be introduced and processed without direct contact with external atmospheres.
Implementation Method 1
The film or membrane advantageously separates the apparatus chamber from the apparatus outside when the door is open, so that when said apparatus chamber is sterile, disinfected, or freed from pyrogen, said chamber remains sterile, disinfected, or freed from pyrogen when the door is open.
Implementation Method 2
the membrane or film comprises a joint or seal for sealing the membrane or film along the apparatus inside periphery
Data Source
AI summary
The invention relates mainly to an apparatus comprising a chamber for physically and/or chemically treating one or more samples or products, said apparatus comprising a door for introducing samples inside the apparatus chamber or bringing samples outside the apparatus, said apparatus comprising a membrane or film defining a chamber wall inside said apparatus when the door is closed.