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Process Validation Apparatus and Methods

A technology for verifying equipment and equipment, applied in biochemical equipment and methods, sanitation equipment for toilets, microbiological determination/inspection, etc.

Inactive Publication Date: 2011-12-07
3M INNOVATIVE PROPERTIES CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

While such devices are already available, they are not always convenient to use and / or they do not always provide a close correlation between an indication of complete sterilization of a product or article and actual complete sterilization

Method used

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  • Process Validation Apparatus and Methods
  • Process Validation Apparatus and Methods
  • Process Validation Apparatus and Methods

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0264] Sterilant inlet pipe

[0265] Attest TM Rapid 5 Test Pack Plus #41382 contains Attest TM 1292 Rapid Biological Indicators (Attest BIs) (Attest TM 1292 Rapid Biological Indicator) and Comply TM SteriGage TM 1243 Steam Chemical Integrator (SteriGage) (Comply TM SteriGage TM 1243 Vapor Chemical Integrator), both available from 3M Company (St. Paul, MN), provided in a heat-sealable polyfoil pouch to increase the amount of time required for the inactivation of the biological and chemical indicators inside the test pack. time. in US 4,636,472 figure 2 The structure of the Attest Test Pack is shown in . Attest Rapid 5 Test Packs are designed to monitor a 4-minute 132°C (270°F) 4-pulse pre-vacuum sterilizer, so the indicator is deactivated within 4 minutes. CadPak N sachets were obtained from TechniPac Inc. (Le Sueur, Minnesota). The pouch is a multilayer pouch constructed of layers of nylon, polyethylene, foil, and polyethylene. Sachets have tubing at one ...

example 2

[0275] Sterilant inlet multi-layer piping

[0276] In this example the same configuration as described in Example 1 was used except that the tubing was altered to reduce the time to deactivate the biological and chemical indicators. In this example, the tubing is a multi-ply construction using two 10 mil indexed sheets with a tissue sheet sandwiched between the indexed sheets to enlarge the discharge opening, as in Figure 4 shown. The tubing is held together with the tape around the exterior creating an opening between the two index paginated sheets and the tissue. The length of the pipe is approximately 14 cm, and the estimated surface area is 9 cm for widths of 0.64 cm and 0.95 cm, respectively 2 and 13.3cm 2 .

[0277] Table 2 shows the results. The data shows that the multi-layer drain construction can reduce the time to deactivate the biological and chemical indicators inside the test pack. This configuration should be useful for monitoring a 10 minute sterilizat...

example 3

[0282] Sachets with small diameter openings

[0283] In this example, the Attest Rapid 5 Test Pack was heat sealed to the inside of a clear polyester and polypropylene laminate film commercially available under the tradename Material 123 from Alcan Packaging. The pouch is discharged by punching a hole in the membrane with an 18 gauge needle. Three different configurations are compared. The package tested has a hole on the top of the package, as in Image 6 shown; with two holes, one on the top and one on the bottom of the bag; and one hole on the top with a membrane channel below the hole, as Figure 7A with Figure 7B shown. Exposure conditions and BIs and CIs were tested as described in Example 1. The packages were exposed for 5 minutes, 10 minutes, 15 minutes and 20 minutes in a 132°C pre-vacuum sterilizer.

[0284] The results in Table 3 show that sachets with pinhole openings in the membrane significantly increased the exposure time required to inactivate the biol...

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Abstract

A sterilization process challenge device comprising a first container comprising walls which define a first space within the first container; a process indicator within the first space; at least one sterilant access for a sterilant to enter the first space within the first container; wherein at least one of the walls which defines the first space is a flexible wall; and wherein the walls are impervious to the sterilant; a method of using the device and a kit including the device are disclosed.

Description

[0001] Cross references to related patent applications [0002] This application claims priority to the following applications: U.S. Provisional Application No. 61 / 112,041, filed November 6, 2008; U.S. Provisional Application No. 61 / 112,149, filed November 6, 2008; and U.S. Provisional Application No. 61 / 112,071, filed November 6, 2008. Each of these applications is hereby incorporated by reference in its entirety. Background technique [0003] Various products and articles, including medical devices, must be sterilized prior to use to inhibit biological contamination of samples, organisms, wound sites, and the like. A variety of sterilization processes have been employed that involve contacting a product or article with a fluid sterilant, such as a gaseous sterilant. Examples of such sterilizing agents include, for example, steam, ethylene oxide, hydrogen peroxide, and the like. [0004] In general, products and articles are packaged such that the sterilant can pass thro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/28C12Q1/22
CPCA61L2/28
Inventor 威廉·E·福尔茨查德·M·赫莱恩乔舒亚·M·施米茨巴里·W·罗博莱凯尔文·J·威彻保罗·N·霍尔特
Owner 3M INNOVATIVE PROPERTIES CO
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