Vessel useful for monitoring plasma sterilizing processes

• US 5,482,684 A
• Filed: 05/03/1994
• Issued: 01/09/1996
• Est. Priority Date: 05/03/1994
• Status: Expired due to Term

• Current Assignee: Abtox, Inc.
• Original Assignee: Abtox, Inc.
• Inventors: Caputo, Ross A., Martens, Phillip A.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): Kim, Christopher Y.
• Application Number:
  US08/237,268
• Time in Patent Office: 616 Days
• Field of Search: 422/21, 422/23, 422/28, 422/119, 422/121, 422/906, 435/31, 435/33, 435/291, 435/296, 315/111.21
• US Class Current: 422/119
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: C12Q 1/22 Testing for sterility conditions
• CPC Class Codes: G01N 31/226 for investigating the degree of sterilisation
• CPC Class Codes: Y10S 422/906 Plasma or ion generation means

Abstract

A system for testing sterilization processes is provided by a vessel having a chamber, a plasma generator adapted to generate a plasma upstream of the chamber, a monitor associated with the chamber, and a biological or chemical indicator disposable within the chamber. The plasma generator generates upstream plasma that contains a plurality of atomic and/or molecular species, and the monitor is capable of determining a concentration of selected species in the plasma when flowing through the chamber.

Claims

1. A vessel, useful for evaluating the performance of an indicator under sterilization conditions, comprising:

a chamber defining a volume, the volume adapted to receive a biological and/or chemical indicator, the chamber of sufficient construction uniformly to distribute a cycle of a sterilizing species in the volume within a predetermined time;

a plasma generator adapted to generate a plasma upstream of the chamber and in communication with the chamber, the plasma containing a plurality of atomic and/or molecular species;

pumping means for continuously flowing plasma through the chamber during a plasma sterilizing cycle while maintaining a reduced pressure in the chamber; and

a monitor operatively associated with the vessel and capable of determining a concentration of selected species in the plasma when a plasma sterilizing cycle constituted entirely or in part by the plasma is flowing through the volume.

2. The vessel as in claim 1 wherein the monitor is downstream of the chamber and includes a mass spectrometer, a photometer, or a filter.

3. The vessel as in claim 1 further comprising an emission spectrometer operatively associated with the chamber or the plasma generator and of a construction sufficient to determine plasma consistency in the plasma generator.

4. The vessel as in claim 1 further comprising:

a source of antimicrobial fluid in fluid communication with the chamber.

5. The vessel as in claim 1 further comprising:

a source of a plasma forming gas mixture in fluid communication with the plasma generator.

6. The vessel as in claim 1 wherein the cycle of sterilizing species has a plurality of determinable characteristics that affect sterilization, and further comprises:

means for monitoring one or more of the characteristics affecting sterilization of the biological indicator being evaluated.

7. The vessel as in claim 6 wherein the vessel is adapted to evaluate resistance performance of biological indicators, and the characteristics affecting sterilization of the biological indicator include temperature and pressure within the volume.

8. A system for testing sterilization processes, comprising:

a chamber defining a volume, the chamber of sufficient construction uniformly to distribute a cycle of a sterilizing species in the volume within a predetermined time;

a plasma generator adapted to generate a plasma upstream of the chamber and in communication with the chamber, the plasma containing a plurality of atomic and/or molecular species;

a monitor operatively associated with the vessel and capable of determining a concentration of selected species in the plasma when a sterilizing cycle constituted entirely or in part by the plasma is flowing through the volume; and

a biological and/or chemical indicator adapted to be disposed within the chamber volume.

9. The system as in claim 8 wherein the indicator is a biological indicator using Bacillus circulans spores.

10. The system as in claim 8 wherein the indicator is a chemical indicator adapted to indicate sterilization cycle exposure when the sterilization cycles includes use of peracetic acid.

11. A BIER vessel, useful for evaluating the performance of an indicator under sterilization conditions including use of a plasma, comprising:

a chamber defining a volume;

a plasma generator adapted to generate a plasma upstream of the chamber and being in communication with the chamber, the plasma including an oxygen species and a hydrogen species;

distribution means for uniformly distributing plasma entering the chamber within the volume within a predetermined time;

pumping means for continuously flowing plasma through the chamber during a plasma sterilizing cycle while maintaining a reduced pressure in the chamber; and

means for monitoring the plasma within the chamber or the plasma generator, the monitoring means including an emission spectrometer and a mass spectrometer.

12. The BIER vessel as in claim 11 wherein the emission spectrometer is adapted to determine plasma consistency via spectra of at least the oxygen species and the hydrogen species.

13. The BIER vessel as in claim 11 wherein the monitoring means is adapted to monitor electromagnetic radiation emitted by short-lived excited states of plasma species, long-lived excited states of plasma species or both.

14. The BIER vessel as in claim 11 further comprising a source of peracetic acid in fluid communication with the chamber.

15. A BIER vessel, comprising:

a chamber defining an evacuatable volume in which an indicator can be disposed;

a plasma generator in communication and upstream with respect to the chamber, the plasma generator capable of generating a plasma from at least one gaseous species upstream of the chamber;

at least one baffle, the at least one baffle being interposed between the plasma generator and an indicator when disposed in the chamber volume, the at least one baffle being of a construction sufficient to distribute plasma entering the chamber within the volume adjacent to the indicator; and

,

a mass spectrometer operably associated with the vessel to determine a concentration of a selected species in the plasma when the volume is evacuated and the plasma is flowed into the volume.

16. The BIER vessel as in claim 15 wherein the mass spectrometer is downstream of the chamber.

17. The BIER vessel as in claim 15 or 16 further comprising a source of antimicrobial fluid in fluid communication with the chamber.

18. The BIER vessel as in claim 17 wherein the antimicrobial fluid is an oxidizing fluid.

19. The BIER vessel as in claim 18 wherein the oxidizing fluid includes peracetic acid.

20. The BIER vessel as in claim 15 further comprising an emission spectrometer operably associated with the chamber or the plasma generator to determine plasma consistency in or flowed from the plasma generator.