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US 12,584,843 B2Granted
Method and system for testing the integrity of filters
AssigneeSartorius Stedim Biotech GmbH
InventorKirit Chatterjee
Life of this patent
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Abstract
A method for testing integrity of a filter can include pressurizing an upstream side of the filter to a test pressure and performing a check step that includes determining a flow rate of fluid from the upstream side to a downstream side of the filter, comparing the determined flow rate with a flow range including a flow threshold, and setting stop criteria based on the comparison.
Claims13
A method for testing integrity of a filter, the method comprising:
- pressurizing an upstream side of the filter to a test pressure;
- and
- performing a check step comprising:
- determining a flow rate of fluid from the upstream side to a downstream side of the filter;
- comparing the determined flow rate with a flow range including a flow threshold;
- setting stop criteria based on the comparison, wherein the stop criteria comprise at least one quantitative constraint indicative of a reliability of the determined flow rate and wherein:
- if the determined flow rate is within the flow range, the stop criteria are set to first stop criteria;
- and
- if the determined flow rate is outside the flow range, the stop criteria are set to second stop criteria;
- determining whether the stop criteria are satisfied;
- if the stop criteria are not satisfied, repeating the check step until the stop criteria are satisfied;
- if the stop criteria are satisfied, comparing the determined flow rate with the flow threshold;
- if the determined flow rate is greater than or equal to the flow threshold, determining that the filter is non-integral;
- and
- if the determined flow rate is less than the flow threshold, determining that the filter is integral,
- wherein the stop criteria comprise a stability range and a pressure drop threshold, and determining whether the stop criteria are satisfied comprises:
- determining a stability indicator of the determined flow rate, the stability indicator being a parameter that quantifies the stability of the determined flow rate;
- measuring an instantaneous pressure at the upstream side of the filter to obtain a measured pressure drop as a difference between the test pressure and the instantaneous pressure;
- comparing the stability indicator with the stability range and comparing the measured pressure drop with the pressure drop threshold;
- and
- determining that the stop criteria are not satisfied when the stability indicator is outside the stability range and the measured pressure drop is greater than or equal to the pressure drop threshold.
18 more elements
A system for testing integrity of a filter, the system comprising:
- at least one processor;
- a memory;
- a communication channel configured to be connected to the filter;
- wherein the at least one processor is configured to:
- pressurize an upstream side of the filter to a test pressure;
- and
- perform a check step comprising:
- determining a flow rate of fluid from the upstream side to a downstream side of the filter;
- comparing the determined flow rate with a flow range including a flow threshold;
- setting stop criteria based on the comparison, wherein the stop criteria comprise at least one quantitative constraint indicative of a reliability of the determined flow rate and wherein
- if the determined flow rate is within the flow range, the stop criteria are set to first stop criteria, and if the determined flow rate is outside the flow range, the stop criteria are set to second stop criteria;
- determining whether the stop criteria are satisfied;
- if the stop criteria are not satisfied, repeat the check step until the stop criteria are satisfied;
- if the stop criteria are satisfied, compare the determined flow rate with the flow threshold;
- if the determined flow rate is greater than or equal to the flow threshold, determine that the filter is non-integral;
- and
- if the determined flow rate is less than the flow threshold, determine that the filter is integral,
- wherein the stop criteria comprise a stability range and a pressure drop threshold, and the at least one processor is further configured to:
- determine a stability indicator of the determined flow rate, the stability indicator being a parameter that quantifies how stable the determined flow rate is;
- measure an instantaneous pressure at the upstream side of the filter to obtain a measured pressure drop as a difference between the test pressure and the instantaneous pressure;
- compare the stability indicator with the stability range and comparing the measured pressure drop with the pressure drop threshold;
- and
- determine the stop criteria are not satisfied when the stability indicator is outside the stability range and/or the measured pressure drop is less than the pressure drop threshold;
- and
- determine the stop criteria are satisfied when the stability indicator is within the stability range and the measured pressure drop is greater than or equal to the pressure drop threshold.
22 more elements
Dependencies are inferred from the claim text.