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KR-20260066151-A - Drainage actuator base for sterility testing

KR20260066151AKR 20260066151 AKR20260066151 AKR 20260066151AKR-20260066151-A

Abstract

Embodiments of the present invention relate to a drain actuator for a cassette used in sterility testing. A sterile cassette may include a spring-loaded drain that allows fluid to flow through a porous membrane. To actuate the drain, upward pressure is applied to the spring through the actuator base during the kit preparation process. When the cassette is inserted into the actuator base, the actuator base may automatically actuate the drain and may be separated from or integrally formed with the thermoformed drain tray. When the sterile cassette is removed from the tray, the base automatically closes the drain. The actuator base has the following functions: maintaining rotational alignment between the tray and the cassette, acting on the drain port at the bottom of the cassette, minimizing the flow rate outflowing into the drain, minimizing the collection of drain fluid, providing a rigid support across the entire surface of the drain tray, and maintaining a fixed state within the drain tray when the cassette is removed.

Inventors

  • 아이작스, 토비
  • 프랑코, 에단
  • 청, 빅터

Assignees

  • 래피드 마이크로 바이오시스템스, 인코퍼레이티드

Dates

Publication Date
20260512
Application Date
20240906
Priority Date
20230908

Claims (20)

  1. A drain actuator base having a drain outlet formed inside; and A drain actuator for a sterile cassette comprising a drain actuator configured to interface with a drain plunger base of a drain plunger provided at the drain outlet and provided in the sterile cassette, wherein the drain actuator is a drain actuator whose size and shape are adjusted so as to apply an opening pressure to the drain plunger when the drain actuator is coupled with the base of the drain plunger.
  2. In claim 1, the drain actuator is a drain actuator that is substantially triangular in shape.
  3. In claim 1, the drain actuator has a flat surface for coupling with a drain plunger base, said flat surface located between rounded sides, the drain actuator.
  4. A drain actuator according to claim 1, wherein the drain actuator further comprises one or more alignment features whose size and shape are adjusted to engage with corresponding features of a drain tray, thereby maintaining rotational alignment between the drain tray and the sterile cassette.
  5. A drain actuator according to claim 1, wherein the drain actuator base comprises one or more ridges extending radially across the surface of the drain actuator base.
  6. A drain actuator according to claim 1, wherein the drain actuator further comprises an inner circumferential ridge along the circumference of the drain outlet.
  7. The drain actuator according to claim 1, wherein the drain actuator further comprises an outer circumferential ridge formed on the outer circumferential surface of the drain actuator base.
  8. A drain actuator according to claim 1, wherein the drain actuator further comprises one or more fasteners configured to secure the drain actuator to a drain tray.
  9. In claim 1, the drain actuator is a drain actuator manufactured of thermoplastic resin.
  10. A sterile cassette including a drainage assembly; A sterility testing kit comprising a drainage actuator according to paragraph 1.
  11. In item 10, the drainage assembly is a sterile test kit including a spring.
  12. In paragraph 10, the drainage assembly is a sterile test kit comprising a drain plunger.
  13. In item 10, the drainage assembly further comprises a sealing member, a sterile test kit.
  14. In item 10, the above sterility test kit is a sterility test kit that additionally includes a drainage tray.
  15. A step of inserting a sterile cassette into an actuator base, wherein the drain of the sterile cassette is automatically opened by the insertion; A step of injecting a sample into a sterile cassette, wherein the sample is filtered through a membrane; and A method for assembling a sterile kit, comprising the step of removing a sterile cassette from an actuator base, wherein the drain portion within the sterile cassette is automatically closed upon removal.
  16. A method for assembling a sterile kit according to claim 15, wherein the above method further comprises the step of sterilizing a drainage actuator.
  17. A method for assembling a sterile kit according to claim 15, wherein the above method further comprises the step of assembling a drain portion to the base assembly of a sterile cassette.
  18. A method for assembling a sterile kit according to claim 15, wherein the actuator base is formed integrally with the drainage tray.
  19. A method for assembling a sterile kit according to claim 15, wherein the above method further comprises the step of attaching an actuator base to a drainage tray.
  20. A method for assembling a sterile kit according to claim 19, wherein when the sterile cassette is removed from the actuator base, the actuator base remains attached to the drainage tray.

Description

Drainage actuator base for sterility testing Cross-reference regarding related applications This application claims priority to U.S. Application No. 18/464,066 filed on September 8, 2023, the entire contents of which are incorporated herein by reference. Sterility testing is an important process used to determine whether viable microorganisms are present in a product or sample. It is commonly performed to ensure the safety and efficacy of pharmaceuticals, medical devices, and other sterile products. Generally, sterility testing is conducted in the following procedure. First, a representative sample of the product or material under test is collected. Then, a test method is selected. In general, membrane filtration is a widely used test method because it offers several advantages in terms of sensitivity, versatility, quantification, compatibility, sample recovery rate, validation, automation capabilities, and time efficiency. In membrane filtration, the sample is filtered through a membrane filter with a fixed pore size (typically 0.45 μm). The filter removes microorganisms present in the sample, enabling subsequent analysis. The membrane filter may be provided in a suitable analytical vessel, such as a sterile cassette provided by Rapid Micro Biosystems, Inc. (Lowell, Massachusetts, USA). As the sample passes through the membrane filter and is filtered, any remaining sample liquid after passing through the membrane filter can be discharged through a drain port on the base of the cassette. After filtration, the membrane filter is aseptically transferred to a suitable culture medium that supports the growth of various microorganisms. The culture medium may be a liquid medium or an agar medium depending on the test method used. The inoculated culture medium is then cultured under suitable conditions, generally at a temperature of 20°C to 40°C, for a specified period (usually 2 to 14 days). This allows viable microorganisms to multiply and form colonies visible to the naked eye. After the incubation period, the presence of microbial growth in the culture medium is observed. If colonies are observed visually, it is a positive result, indicating the presence of viable microorganisms and a failure of the sterility test. Conversely, if no visible growth is observed, it is a negative result, indicating the absence of viable microorganisms and a success of the sterility test. In the event of a positive result, additional tests, including molecular biological techniques such as Gram staining, biochemical tests, or polymerase chain reaction (PCR), may be performed to identify the present microorganisms. The results of a sterility test, including the test method, sample information, culture conditions, and results, are documented as part of the test record. To easily identify discussions regarding specific elements or actions, the top digit of the reference number indicates the drawing number where the element first appears. FIG. 1 is a drawing illustrating an exemplary configuration of a cassette assembly according to one embodiment of the present invention. FIG. 2 is an enlarged view of a portion of a cross-sectional view of a cassette assembly according to one embodiment of the present invention. FIG. 3 is a drawing illustrating an exemplary configuration of a base assembly for a sterile cassette including a drainage assembly according to one embodiment of the present invention. FIG. 4 is an enlarged view of a portion of a cross-sectional view of a base assembly according to one embodiment of the present invention. FIG. 5a is a cross-sectional view in which an actuator base that is coupled to a base assembly and a drainage unit according to one embodiment of the present invention is in an open position. FIG. 5b is a perspective view of a base assembly according to one embodiment of the present invention. FIG. 5c is a cross-sectional view in which an actuator base combined with a base assembly and a drainage unit according to one embodiment of the present invention is in a closed position. FIG. 6 is a perspective view of an alternative base assembly design according to one embodiment of the present invention. FIG. 7 is a drawing illustrating an exemplary base assembly attached to a drainage tray according to one embodiment of the present invention. FIG. 8 is a drawing showing an assembled cassette attached to the base assembly and drainage tray of FIG. 7 according to one embodiment of the present invention. FIG. 9 is a flowchart illustrating an exemplary procedure for using a drainage actuator with a sterile test kit according to one embodiment of the present invention. As mentioned above, the sample liquid remaining during the filtration process can be discharged through the drain port of the cassette base. Conventional systems typically use manual drain ports, such as plugs or flip-out drains. Since these drains must be operated manually, they increase the labor required for sterility testing, hinder automation possi