METHOD FOR AUTOMATIC AND STERILE-CONTAINER-SPECIFIC DETECTION OF STERILISATION CYCLES CARRIED OUT BY A STERILE CONTAINER

Abstract

A method for automatic and sterile-container-specific detection of sterilization cycles carried out by a sterile container, and a system for carrying out the method. A temperature acting on the sterile container is detected using a temperature measurement device associated with the sterile container. A temperature measurement device detects the temperature at fixed first time intervals. Detected temperature values are stored in a memory once a predetermined first limit temperature has been exceeded. Storage of detected temperature values is suspended once a predetermined second limit temperature has been undershot or after a predetermined duration has elapsed after the first limit temperature has been exceeded. The stored temperature values are compared with reference temperature values. A deviation between the temperature values and the reference temperature values is determined. A counter and/or a display device are/is actuated when a deviation is determined within a predetermined tolerance range.

Claims

1.-13. (canceled)

14. A method for automatic and sterile-container-specific detection of sterilization cycles carried out by a sterile container, the method comprising the steps of: A. detecting a temperature acting on the sterile container with a temperature measurement device at predetermined first time intervals; B. storing temperature values detected after a predetermined first limit temperature has been exceeded in a memory; C. suspending step B after the temperature falls below a predetermined second limit temperature or after a predetermined period of time has elapsed after the predetermined first limit temperature has been exceeded; D. comparing said temperature values with reference temperature values with a control unit; E. determining a deviation between said temperature values and the reference temperature values with the control unit; F. determining whether the sterilization cycle was carried out, based on whether the deviation is within a predetermined tolerance range, with the control unit; and F. actuating a counter and/or a display device after the control unit determines that the sterilization cycle was carried out.

15. The method according to claim 14, wherein the counter is not actuated and/or an error message is output and/or stored when the deviation is determined outside of the predetermined tolerance range.

16. The method according to claim 14, wherein the predetermined first time intervals are four to six minutes.

17. The method according to claim 14, wherein the temperature measurement device detects the temperature at predetermined second time intervals after the predetermined first limit temperature has been exceeded.

18. The method according to claim 17, wherein the predetermined second time intervals are 40 to 90 seconds.

19. The method according to claim 14, wherein the temperature measurement device detects the temperature again at the predetermined first time intervals after the temperature has fallen below the predetermined second limit temperature or after the predetermined period of time has elapsed.

20. The method according to claim 14, wherein the predetermined first limit temperature and/or the predetermined second limit temperature are adjustable.

21. The method according to claim 14, wherein after the predetermined first limit temperature has been exceeded, temperature-specific holding time durations are detected and stored in a memory.

22. The method according to claim 21, wherein the temperature-specific holding time durations are compared with reference holding time durations to determine when the temperature-specific holding time durations deviate from the reference holding time durations.

23. A system for automatic and sterile-container-specific detection of sterilization cycles carried out by a sterile container, the system comprising: a temperature measurement device configured to detect a temperature acting on the sterile container; a memory; a control unit configured to determine when a sterilization cycle is carried out; and a counter and/or a display device, wherein the system is configured to: detect the temperature at predetermined first time intervals with the temperature measurement device, store temperature values detected after a predetermined first limit temperature has been exceeded in the memory, suspend storage of said temperature values after the temperature has fallen below a predetermined second limit temperature or after a predetermined period of time has elapsed after the predetermined first limit temperature is exceeded, compare said temperature values with reference temperature values, determine when said temperature values deviate from the reference temperature values, and actuate the counter and/or the display device when said temperature values deviate from the reference temperature values within a predetermined tolerance range.

24. The system according to claim 23, wherein the temperature measurement device is a temperature logger.

25. The system according to claim 24, wherein the temperature logger is associated with the sterile container.

26. The system according to claim 23, wherein the counter and/or the display device comprises a counter that is an incrementable cycle counter that counts a number of sterilization cycles.

27. A machine-readable data memory storing the steps according to claim 14.

Description

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0040] Further features and advantages of the present disclosure will be apparent from the following exemplary and non-limiting description of the drawings. These drawings are merely schematic in nature and are provided only for the purpose of understanding the invention. In these drawings:

[0041] FIG. 1 shows a schematic flow chart of an exemplary embodiment of the disclosure; and

[0042] FIG. 2 shows a schematic diagram of a system according to the disclosure.

DETAILED DESCRIPTION

[0043] At the beginning of the exemplary embodiment of the method illustrated in FIG. 1, a temperature measurement device 1 in the form of a communicative temperature logger is used to detect temperatures to which a sterile container 2 is exposed at intervals/first intervals/first time intervals of five minutes (300 seconds). This monitoring is a kind of rough monitoring. Here, both the temperature of an atmosphere surrounding the sterile container 2 and the temperature of an atmosphere inside the sterile container 2 may be concerned. The temperature can be detected with one or more temperature sensors.

[0044] The detected temperatures are analyzed on the basis of the method and, in this context, compared with a first limit temperature value stored in a memory unit 4. This value can be adjusted as required. As long as the temperature values measured in the first time intervals do not exceed the first limit value temperature, the method and the system remain in rough monitoring by means of the first intervals. As soon as a sterilization is carried out with the sterile container 2, the temperature to which the sterile container 2 is exposed increases. If a temperature measured during this phase exceeds this defined first limit value, the logger 1 automatically switches to a sterilization mode. The latter represents a kind of fine monitoring of the sterile container 2 and the sterilization process. The system now initially assumes that the now detected temperature values are sterilization temperatures and that a sterilization process is being carried out with the sterilization container 2.

[0045] After the first limit temperature has been exceeded, i.e. in sterilization mode or fine monitoring, the interval time is reduced from the first interval duration to a second interval duration of one minute (60 seconds). Due to the then more frequent temperature measurements, holding times and temperature changes can be detected as accurately as possible during this entire phase. Furthermore, the detected temperature values or time values/holding times are stored in an internal memory 4 so that they can be evaluated later.

[0046] On falling below a second limit temperature or a certain period of time, the fine monitoring is finished. In some embodiments, the temperature measurement can also be terminated. The temperature values detected and stored during fine monitoring, as well as any time values/holding times that may be present, are compared with reference values stored in the system/memory 4, for example a sterilization temperature curve and/or a time curve. As a result, the times/holding times and temperatures/temperature curves/temperature changes that run during the process can be detected and checked (by means of a computer 6) so that an analysis and check of the conducted sterilization process on the basis of intended values/sequences (also by means of the computer) is made possible in a simple manner and, compared with a simple limit value observation according to the prior art, considerably safer.

[0047] If the measured/stored temperature values/time values are within a defined tolerance range, i.e. match the specification, the sterilization is classified as successful. In this case, either a computer-internal counter is incremented as a counter or an indicator is set as a display device 8 to make the successful sterilization visible to the outside. If the values do not comply with the specifications, i.e. if they are outside the tolerance range, this can either be made visible in a similar manner. Alternatively, the system can be set back to the original mode, i.e. to temperature monitoring with the first interval time duration. After detection and evaluation, the internal memory 4 is reset and the measurement interval for the ambient temperature is five minutes again.