초록 ▼

An apparatus and method for an aseptic fluidic interface between bioprocess systems is provided. The apparatus includes an inlet valve, adapted for automatic control, that is coupled to a biofluid source site. A sampling conduit extends from the inlet valve to an outlet valve. The outlet valve is ad

An apparatus and method for an aseptic fluidic interface between bioprocess systems is provided. The apparatus includes an inlet valve, adapted for automatic control, that is coupled to a biofluid source site. A sampling conduit extends from the inlet valve to an outlet valve. The outlet valve is adapted for automatic control and is coupled to a biofluid process site. A trap is at the sampling conduit. A waste valve, adapted for automatic control, is located at a waste conduit extending from the sampling conduit to a waste site. Also included is a wash fluid source that is coupled to at least one of the inlet or outlet valves. In the method, the sample is automatically directed to the biofluid process site by opening the outlet valve, and closing the waste valve Also included is isolating the biofluid sites by closing the inlet and outlet valves, and opening the waste valve to drain biofluid from the trap to the waste site. Another step is cleaning the sampling conduit before sample collection by directing the wash fluid through at least one valve selected from the inlet and outlet valves, and subsequently through the waste valve to the waste site.

대표청구항 ▼

What is claimed is: 1. A method of aseptically sampling a biofluid, comprising automatically: collecting a biofluid sample by opening an inlet valve at a biofluid source site; directing the sample through a trap to a biofluid process site by opening an outlet valve coupled to the process site, and

What is claimed is: 1. A method of aseptically sampling a biofluid, comprising automatically: collecting a biofluid sample by opening an inlet valve at a biofluid source site; directing the sample through a trap to a biofluid process site by opening an outlet valve coupled to the process site, and closing a waste valve that couples the trap and a waste site, the trap being a portion of a sampling conduit extending from the inlet valve to the outlet valve, the trap having a low region that is lower than the inlet valve and the outlet valve, and the waste valve being coupled to the low region of the trap; isolating the biofluid sites by: closing the inlet and outlet valves; and opening the waste valve to drain biofluid from the trap to the waste site; and cleaning the sampling conduit before sample collection by directing a wash fluid through at least one valve selected from the inlet and outlet valves, and subsequently through the waste valve to the waste site. 2. The method of claim 1, further comprising cleaning before collecting each sample. 3. The method of claim 2, further comprising cleaning to reduce the number of bacterial colony forming units per milliliter of rinse water to less than about 100. 4. The method of claim 2, further comprising cleaning to reduce macromolecule contamination in rinse water to less than about 1 part per million. 5. The method of claim 2, further comprising cleaning by directing wash fluid through the outlet valve into the sampling conduit. 6. The method of claim 5, further comprising employing a wash fluid selected from steam, compressed air, an organic solvent, supercritical CO2, and an aqueous cleaning solution. 7. The method of claim 6, further comprising directing the wash fluid through the inlet valve at the biofluid source site. 8. The method of claim 1, further comprising directing the wash fluid through a double isolated gate valve to the waste site, wherein at least one of the inlet and outlet valves is the double isolated gate valve, a waste output of each double isolated gate valve being coupled to the waste site. 9. The method of claim 8, wherein the inlet valve is a double isolated gate valve. 10. The method of claim 8, wherein the outlet valve is a double isolated gate valve. 11. The method of claim 1, further comprising monitoring for a backflow condition while the biofluid sites are isolated by sensing fluid flow. 12. The method of claim 11, further comprising sensing for fluid flow in the sampling conduit. 13. The method of claim 11, further comprising sensing for fluid flow through the waste valve. 14. The method of claim 11, further comprising isolating the biofluid sites by closing the waste valve and opening a relief valve that is located at a relief conduit, wherein the relief conduit has a proximal end coupled to the trap and a distal end coupled to the external environment. 15. The method of claim 14, further comprising sensing for fluid flow in the relief conduit. 16. The method of claim 15, further comprising excluding particulate contaminants from entering the relief conduit by employing a filter selected to remove particulates having a diameter of at least about 0.2 μm. 17. The method of claim 16, further comprising collecting overflowing biofluid in an overflow reservoir at the relief conduit. 18. The method of claim 1, further comprising locating the inlet and outlet valves at the same height. 19. The method of claim 18, further comprising draining biofluid from the trap at a location that is lower than the inlet and the outlet valves by a least about 3 times the inside diameter of the conduit. 20. The method of claim 19, further comprising draining biofluid from the lowest point of the trap. 21. A method of aseptically sampling a biofluid, comprising automatically: collecting a biofluid sample by opening an inlet valve at a biofluid source site; directing the sample to a biofluid process site by: opening an outlet valve, coupled to to process site, that is located at the same height as the inlet valve; closing a waste valve that couples a trap and a waste site, the trap being a portion of a sampling conduit extending front the inlet valve to the outlet valve, the trap having a low region that is lower than the inlet and outlet valve, and the waste valve being coupled to the low region of to trap; isolating the biofluid sites by: closing the inlet and outlet valves; opening the waste valve to drain biofluid from the trap to the waste site; closing the waste valve and opening a relief valve located at a relief conduit, the relief conduit having a proximal end coupled to the trap and a distal end coupled to a filter selected to exclude particulate contaminants having a diameter of at least about 0.2 μm; and monitoring for backflow by sensing fluid flow in the relief conduit; and cleaning the sampling conduit before collecting each sample, including: directing a wash fluid through the outlet valve, into to sampling conduit, and through the waste valve to the waste site; and reducing macromolecule contamination in the sampling conduit to less than about 1 part per million. 22. A method of aseptically sampling a biofluid, comprising automatically: collecting a biofluid sample by opening an inlet valve at a biofluid source site; directing the sample to a biofluid process site by opening an outlet valve coupled to to process site, and closing a waste valve that couples a trap and a waste site, wherein the trap is located at a sampling conduit extending from the inlet valve to the outlet valve; isolating the biofluid sites by: closing the inlet and outlet valves; and opening the waste valve to drain biofluid from the trap to the waste site; and cleaning the sampling conduit before sample collection by directing a wash fluid through a double isolated gate valve to the waste site, at least one of the inlet and outlet valves being the double isolated gate valve, an output of each double isolated gate valve being coupled to the waste site, through at least one valve selected from the inlet and outlet valves, and subsequently through the waste valve to the waste site, the wash fluid selected from steam, compressed air, an organic solvent, supercritical CO2, and an aqueous cleaning solution. 23. The method of claim 22, wherein the inlet valve is a double isolated gate valve. 24. The method of claim 22, wherein the outlet valve is a double isolated gate valve.