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Multi-stage process challenge device, indicator system and process challenge device system

An indicator, a series of technologies, applied in water supply devices, biochemical equipment and methods, sanitary equipment for toilets, etc., can solve problems such as invalid test results

Inactive Publication Date: 2021-03-09
GKE德国有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Undetected faults can lead to invalid test results

Method used

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  • Multi-stage process challenge device, indicator system and process challenge device system
  • Multi-stage process challenge device, indicator system and process challenge device system
  • Multi-stage process challenge device, indicator system and process challenge device system

Examples

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Embodiment Construction

[0107] exist figure 1 In , a process challenge device 2 in a preferred embodiment is shown. figure 1 The illustrated process challenge device 2 shows a configuration designed for testing the penetration properties of sterilants. The knowledge gained during the use of the test device 2 can in particular be used to validate or test steam during the sterilization process. With this steam sterilization process, the instruments or materials to be sterilized are placed in an undesignated sterilization chamber. First, remove air from the sterilization chamber. The degassing process can be performed by a downward gravitational displacement process, a super-atmospheric or sub-atmospheric degassing cycle, or a combination thereof. The Process Challenge Apparatus 2 is specially designed to test the sterilization properties of sterilization procedures. The process challenge device 2 comprises a first part or housing part 6 providing an outer housing or housing 10 . Partially and / or f...

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Abstract

The disclosure relates to a process challenge device (2), especially for simulating the worst-case penetration conditions of a load inside a sterilization chamber, comprising a detector volume (90) for housing a biological, chemical or physical indicator (140), whereby the detector volume (90) is arranged at a dead end of a series of gas volumes (110, 14, 118), whereby the process challenge device(2) comprises two parts (6, 14), namely a housing part (6) and an insertion part (14), whereby the insertion part (14) is at least partially insertable into the housing part (6) in such a way that the detector volume (90) is arranged without any seal inside the both parts (6, 14).

Description

technical field [0001] The present invention relates to a process challenge device that specifically simulates the worst case osmotic conditions of a load in a sterile chamber containing a biological, chemical or physical indicator disposed in a detector volume agent, the detector volume is arranged at the end of a series of volumes in which the gas flows in both directions. The invention also relates to an indicator system and process challenge device combination. [0002] According to EN ISO 11140-1, an indicator system is defined as a combination of a process challenge device and a detector, inside which may be a biological, chemical or physical indicator, which acts as a detector to monitor the presence of a sterilant. It is used as a surrogate model to represent worst case percolation conditions inside the sterilization load including packaging. Since it is not possible to place biological or chemical indicators at worst-case penetration sites inside complex instruments...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/28C12Q1/22
CPCA61L2/28C12Q1/22
Inventor 乌利希·凯撒
Owner GKE德国有限责任公司
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