Double-Envelope Bag Integrity Testing via Segmentation
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Solution Overview
Problem
Current methods for verifying the integrity of biopharmaceutical fluid bags are inadequate for detecting small leaks, risk contamination during testing, and cannot be performed when the bag is filled with fluid, leading to unreliable results and potential microbial contamination.
Innovation Solution
A flexible, double-envelope bag design with a spacer element between the envelopes to prevent hole obstruction, allowing for reliable integrity testing before, during, or after use, and using a system with pressurized gas or bacteriological methods to verify fluidtightness without compromising sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If physical test methods are used to verify bag integrity, then detection capability is improved, but small leaks smaller than 2 micrometers cannot be detected due to obstruction by residual drops
Solution Approach 1:
The invention divides the bag into two separate envelopes (first envelope containing the biopharmaceutical fluid and second envelope providing an outer barrier). This segmentation allows the outer envelope to be tested for integrity without the interference of residual fluid drops that would obstruct detection in a single-envelope design, thereby enabling reliable detection of small leaks while maintaining protection against microbial contamination.
2Ease of operation
If integrity verification is performed after bag use, then testing can be conducted, but holes smaller than 2 micrometers cannot be detected as leaks are too small to distinguish from background leakage
Solution Approach 1:
By segmenting the bag into two envelopes with an intermediate space between them, the system enables integrity testing of the outer envelope independent of the inner envelope's fluid contents. This allows testing at any time (before, during, or after use) while maintaining the ability to detect small leaks, as the test measures pressure changes in the intermediate space without interference from residual drops or background leakage of the biopharmaceutical fluid.
3Ease of operation
If gas or fluid is introduced into the bag for integrity verification, then testing can be performed, but sterility is compromised and contamination risk increases
Solution Approach 1:
The invention introduces an intermediate space between the first and second envelopes as a mediator for integrity testing. Gas or fluid is introduced into this intermediate space rather than directly into the biopharmaceutical fluid container. This intermediary approach allows integrity verification to be performed while maintaining the sterility of the biopharmaceutical fluid, as any contamination would be confined to the intermediate space and not the inner envelope containing the product.
4Device complexity
If a single-envelope design is used, then device complexity is reduced, but the ability to prevent microbial entry through small holes is insufficient
Solution Approach 1:
The invention employs segmentation by creating a double-envelope structure where the first envelope contains the biopharmaceutical fluid and the second envelope provides an outer barrier. This segmentation creates multiple layers of protection, significantly reducing the probability that microbial contamination can penetrate through small holes in both envelopes. The intermediate space between envelopes further enhances this protection by allowing integrity monitoring without compromising the inner envelope's sterility.
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
Enhances the reliability of integrity verification and prevents microbial contamination by ensuring accurate testing of the bag's fluidtightness, even when filled with biopharmaceutical fluid, reducing the risk of contamination and improving the structural protection of the fluid.
Implementation Method 1
a spacer element interposed between the first envelope and the second envelope, in the intermediate space, suitable for preventing a possible hole in the wall of the first envelope or in the wall of the second envelope from being covered
Implementation Method 2
a source of pressurized gas intended to be introduced into the intermediate space
Implementation Method 3
a member for measuring the pressure of the gas in the intermediate space in order to compare the pressure drop in the intermediate space once inflated, relative to a predefined pressure drop threshold
Implementation Method 4
a gas detection member
Implementation Method 5
two fixed expansion-limiting plates, spaced apart from and facing one another, suitable for not obstructing any leak in the wall of the second envelope placed against them
Data Source
AI summary
Disclosed is a bag including: a first envelope having at least one fill and/or discharge orifice for a biopharmaceutical fluid and a fill and/or discharge tube associated in a fluidtight manner with the fill and/or discharge orifice, a second envelope within which the first envelope is located, and a spacer element. The first envelope, the second envelope, and the spacer element form a coherent whole, in particular during use of the bag, and the fill and/or discharge tube traverses the second envelope by a fluidtight connection, the fill and/or discharge inlet being located outside the second envelope.