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Chapter 6 : Chemical Sterilization

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Chemical Sterilization, Page 1 of 2

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Abstract:

Theoretically, any chemical that demonstrates broad-spectrum antimicrobial activity, in particular, those with sporicidal activity, could be developed for use in a sterilization process. Although this may be true depending on the types of microorganisms that are known to be present in certain situations, it is important to remember that because a given process is sporicidal does not necessarily mean that sterilization can be achieved (see discussion in chapter 1, section 1.4.3). Sterilization is a validated process that ensures that a surface or product is free from viable microorganisms, and evidence should be provided to support such a designation of a process. Examples of the requirements for validating such processes are given in the international standard on sterilization of health care products (ISO 14937, “Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices”). Although this standard has been designed for use specifically for health care applications, it does specify the minimum requirements for any sterilization process to include the following:

  • Characterization of the biocidal agent(s) to include safety, antimicrobial efficacy, and effects of materials
  • Characterization of the sterilization process and any delivery equipment
  • Definition of the sterilization process for a given application
  • Definition of the product to be sterilized within the process
  • Validation of the sterilization process for its intended use

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Figures

Image of FIGURE 6.1
FIGURE 6.1

EO sterilizers. Small, front-loading EO sterilizer chamber (left) into which the load is placed (load not shown) and the insertion of an EO canister which is used to deliver the gas during the sterilization process. Large, industrial-scale EO sterilizer (right). Images courtesy of STERIS, with permission.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.2
FIGURE 6.2

A typical EO sterilizer.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.3
FIGURE 6.3

Typical EO sterilization processes. Vacuum processes (top), in which sterilization is conducted at pressures below atmospheric pressure conditions (i.e., below 101.35 kPa), are generally applied with 100% EO, while pressurized cycles (bottom), in which sterilization is conducted above atmospheric pressure, have traditionally used EO mixtures.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.4
FIGURE 6.4

The sporicidal () effect of EO concentration at 60% relative humidity and 54°C.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.5
FIGURE 6.5

A typical LTSF sterilization system.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.6
FIGURE 6.6

A typical LTSF sterilization cycle.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.7
FIGURE 6.7

An LTSF sterilizer. The sterilizer (with open door) is shown on the left, with the liquid formalin delivery system on the right.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.8
FIGURE 6.8

An example of the effect of hydrogen peroxide gas concentration on sporicidal activity. Various gas concentrations were tested under atmospheric pressure with spores.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.9
FIGURE 6.9

Typical gas hydrogen peroxide sterilizer.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.10
FIGURE 6.10

Examples of hydrogen peroxide gas sterilizers. The examples on the left are the STERRAD hydrogen peroxide gas plasma sterilizers (far left image: STERRAD® Systems with ALLClear™ Technology and second from left STERRAD VELOCITY™ Biological Indicator System). Examples on the right are the STERIS V-Pro Low Temperature Sterilization Systems (smaller V-PRO 60 and larger V-PRO maX). Images courtesy of STERIS Corporation and Advanced Sterilization Products, with permission. ASP and the ASP logo are trademarks of Advanced Sterilization Products Division of Ethicon, Inc.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.11
FIGURE 6.11

Typical hydrogen peroxide gas sterilization processes. In the cycle on the right, only single conditioning, sterilization, and aeration pulses, which can vary in number () depending on the application, are shown. Similarly, the gas-plasma cycles can have multiple-stage pulses (only a single pulse is shown); for example, the most widely used health care application (the STERRAD 100S) consists of two ( = 2) peroxide injections.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.12
FIGURE 6.12

SYSTEM 1E Liquid Chemical Sterilant Processing Systems with S40 Sterilant Concentrate. Images courtesy of STERIS, with permission.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.13
FIGURE 6.13

Electrolyzed water system. (Left) A representation of a typical electrolyzed water generator. (Right) Generation of electrolyzed water, with a simple depiction of the active species formed.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.14
FIGURE 6.14

Examples of electrolyzed-water generators. ©2016 Mar Cor Purification, Inc.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.15
FIGURE 6.15

Examples of PAA gas sterilizers. (Left) Image courtesy of Johnson & Johnson, with permission. (Right) ©2016 Mar Cor Purification, Inc.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.16
FIGURE 6.16

An ozone sterilizer. Image courtesy of TSO3, with permission.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.17
FIGURE 6.17

A representation of a nitrogen dioxide gas sterilizer.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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Image of FIGURE 6.18
FIGURE 6.18

Typical nitrogen dioxide gas sterilization process.

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
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References

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Tables

Generic image for table
TABLE 6.1

Typical EO sterilization process conditions, based on FDA -approved cycles for health care sterilizer applications

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
Generic image for table
TABLE 6.2

Examples of standards and guidelines for EO sterilization applications

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
Generic image for table
TABLE 6.3

Examples of standards and guidelines for LTSF sterilization applications

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6
Generic image for table
TABLE 6.4

A comparison of hydrogen peroxide gas sterilization systems used in health care and industrial applications. Chamber sizes are shown in parentheses for each sterilizer type but may not indicate the actual total load capacity

Citation: McDonnell G. 2017. Chemical Sterilization, p 215-245. In McDonnell G, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819682.ch6

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