Air-Water Binary Gas Integrity Test for Sterilizing and Virus Filters
Abstract
Reliability of retention performance is of paramount importance for membrane filters designed for sterile and virus filtration. To achieve dependable retention, an integrity test can be applied to ensure the absence of oversize pores or defects that can compromise the retention capability of the filter. Probably the most commonly applied nondestructive integrity test for membrane filters is the gas-liquid diffusion test, with air and water often used as the gas-liquid pair. However, the sensitivity of the air-water diffusion test is limited by the fact that the diffusive flow rate for an integral membrane can span a range that is large compared to the flow contributed by a defect. A novel nondestructive air-water integrity test for microporous and nanoporous membranes is introduced here that provides improved test sensitivity by measuring the gas composition in addition to gas flow rate. Oxygen permeates through water faster than does nitrogen, so with air as the challenge gas and water as the wetting fluid, the permeate stream will be enriched in oxygen. The permeate oxygen concentration is predictable, accurately measurable, and within a narrow and repeatable range for an integral membrane. A leak through the membrane will result in a deviation from the integral permeate concentration, signaling a defect. Compared to the conventional air-water diffusion test, this air binary gas (i.e., O 2 and N 2 ) test in which the permeate gas composition is measured (in addition to the…
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Laser-drilled holes are considered to be the most practical and controllable among various methods for creating artificial leaks in thin films and membranes and have often been used for this purpose.
“While “real-world” defects can encompass a variety of forms, laser-drilled holes are considered to be the most practical and controllable among various methods for creating artificial leaks in thin films and membranes and have often been used for this purpose [11,16,17,20,30,31].”
From Defect Detection Sensitivity of Bubble-Point-Type Tests for Sterilizing-Grade Membrane Cartridge Filters (2023) · cites this paper as [11]
For the air-water diffusion test, the minimum detectable single defect size in a sterilizing-grade 10-inch (25.4 cm) cartridge filter has previously been estimated to be in the range of 5-20 μm, depending on the filter area, accuracy of the diffusive flow measurement, and variability in filter properties.
“For the air–water diffusion test, the minimum detectable single defect size in a sterilizing-grade 10-inch (25.4 cm) cartridge filter has previously been estimated to be in the range of 5–20 µm, depending on the filter area, accuracy of the diffusive flow measurement, and variability in filter properties [11,18,19].”
From Defect Detection Sensitivity of Bubble-Point-Type Tests for Sterilizing-Grade Membrane Cartridge Filters (2023) · cites this paper as [11]
Cited by
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Giglia, S., Alembath, A., & Hersey, J. (2023) · Membranes · doi:10.3390/membranes13010088 · Cited by 3 · see citing works
Self-citation
- Authors
- Giglia, S., Caulmare, J., Nhiem, D., & Porreca, D.
- Venue
- PDA Journal of Pharmaceutical Science and Technology
- Publisher
- Parenteral Drug Association, Inc.
- Published
- 2016-10-27
- Volume
- 70
- Issue
- 6
- Pages
- 577-590
- ISSN
- 1079-7440
- Cited by
- 2
- References
- 0
- Language
- en
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