Method and device for injection of a sterile and antipyrogenic fluid
AssigneeHospal Industrie
InventorLaurent Simard
Life of this patent
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Abstract
A device and method for injecting a sterile pyrogen free fluid uses a main filter having first and second compartments separated by a porous membrane. The first compartment has an inlet connected to a source of fluid to be filtered, and the second compartment has an outlet connected to an injection line. A pump is provided for circulating the fluid through the main filter and into the injection line. A secondary filter is provided downstream of the main filter and, in combination with pressure sensors, is used to determine if a rupture exists in the main filter.
Claims17
A device for injection of a sterile and pyrogen free fluid, comprising:
- at least one main filter having a first compartment and a second compartment separated by a porous membrane, the membrane having a filtration surface, the first compartment having an inlet for connection to a source of fluid to be filtered, and the second compartment having an outlet connected to an injection line;
- means for circulating the fluid through the at least one main filter and into the injection line;
- and
- means for checking the integrity of the at least one main filter, the checking means including a secondary filter which is able to hold back bacteria and pyrogens and is arranged in the injection line so that all the fluid filtered through the at least one main filter passes through the secondary filter, the secondary filter having a filtration surface which is substantially smaller than the filtration surface of the at least one main filter, and the checking means further including means for detecting a clogging of the secondary filter during an injection of fluid via the injector line to determine if a rupture exists in the at least one main filter.
A device according to claim 16 further including means for stopping the circulating means in response to detection of clogging in the secondary filter by the detecting means.
A device according to claim 16 further including means for notifying an operator in response to detection of clogging of the secondary filter by the detecting means.
A method for checking the integrity of a main filter used to render sterile and pyrogen free a fluid intended for continuous injection, the main filter having a first compartment and a second compartment separated from the first compartment by a porous membrane, the first compartment having an inlet connectable to a source of fluid to be filtered, and the second compartment having an outlet connected to an injection line, the method comprising the steps of:
- flowing all fluid filtered by the main filter through the secondary filter, the secondary filter being able to hold back bacteria and pyrogens and having a membrane with a filtration surface which is substantially smaller than the filtration surface of the membrane of the main filter;
- measuring in the injection line during fluid injection, a value of a parameter susceptible to being influenced by a clogging of the secondary filter;
- and
- determining the integrity of the main filter based on the measured value.
Dependencies are inferred from the claim text.