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Sterilization and Validation

Sterilization and Validation
The sterilization process is the applications made in areas where hygiene requirements are important, especially in medicine, medicine and health processes. Although there are many different sterilization methods, a validation process is required after the sterilization process in each technique. These applications, called sterilization validation, are necessary to ensure the accuracy and reliability of the processes and to show compliance with the conditions of the published standards on this subject.

The important issues for a sterilization application to be validated are as follows:

• Cleaning and disinfection
• Working mechanism and functional control of the sterilization process
• Properties of the substance to be used as a sterilizer
• Product category to be sterilized (medicine, food, etc.)
• The packaging technique of the products and the materials used in the packaging
• Storage time and procedure of sterilized products
• Delivery of products to end users
• A quality management system developed for all these steps

Three different steps are basically followed for sterilization validation:

1. Establishment of quality (IQ - Installation qualification)
2. Operational qualification (OQ)
3. Performance qualification (PQ - Performance qualification)


An enterprise that performs sterilization validation should act according to quality principles in steps such as the installation, operation and maintenance of machinery and equipment that it will use as a sterilizer. For this, the published standards should be followed in all aspects. EN 285 and EN 1360 are some of these standards. Different standards are taken as reference according to the place where sterilization validation will be performed (hospital, production facility, etc.) and the scale of sterilization.

The working conditions of this technique also affect the OQ step, with which technique the sterilization validation will be performed. In this context, it should be ensured that the elements such as water, light, steam, electricity etc. required for the operation of the sterilizer are provided correctly, adequately and effectively. For example, steam quality, temperature, flow rate etc. are very important parameters in steam sterilization. Likewise, in ethyleneoxide sterilization validation, the temperature, humidity and pressure values ??of the ethylene oxide used are among the most important operating parameters.


Performance evaluation step in validation processes is only possible with accurate and reliable tests. Although the devices, machines and systems that perform the sterilization process operate within the desired values, this situation cannot provide a complete guarantee in terms of sterilization of the products. The sterilization program followed, the use of correct equipment, the packaging, transportation and loading procedures of the products are of great importance for sterilization. Therefore, within the scope of sterilization validation studies, it is necessary to perform some tests based on the referenced standards.

Sterilization Validation Tests

The tests to be carried out in order to ensure validation in sterilization studies are detailed in the referenced standards. We can list the most important and most frequently used standards as follows:
• TS EN ISO 11135: Sterilization of healthcare equipment - Ethylene oxide - Requirements for the development, validation and routine control of the sterilization process of medical devices
• TS EN ISO 11137-1: Sterilization of healthcare equipment - Radiation - Part 1: Requirements for the development, validation and routine control of the sterilization process for medical devices (including ISO 11137-1:2006, Amd 1:2013)
• TS EN ISO 14937: Sterilization of health care products - General rules for the properties of the sterilizing agent and the development, validity and routine control of the sterilization process for medical devices
• TS EN ISO 17665-1: Sterilization of healthcare products - Humid heat - Part 1: Specifications for the development, validation and routine control of the sterilization process for medical devices
• TS EN ISO 10993-7: Biological evaluation of medical devices-Part 7: Sterilization residues with ethylene oxide

The most frequently required tests within the scope of sterilization validation are:

• Sterilization test of biological indicators
• Half and full cycle tests
• Sterilization test
• Crop grafting
• Bioburden test
• Dosing reporting
• Visual inspection tests
• Paint, bubble and strength tests related to packaging

The Solution Partner You Are Looking For In Sterilization Validation: Aşan Danışmanlık

Aşan Danışmanlık can offer you all kinds of support for the execution, monitoring, verification and development of your sterilization studies. You can learn all the information you need from Aşan Danışmanlık, from the beginning to the end of your validation process, and receive initial and advanced training at necessary points. Aşan Consulting´s sterilization valid can be designed to be completed.

• A bio service package that includes micrological method development, validation and final sterility testing.
• In addition to microbiological tests, a special product will be produced for processing devices and hardware.
• Providing sterilization validation for complex or individual products.
• Sterilization test documentation suitable for completed sterilization validation.
• Ensuring that sterilization dose control tests are kept throughout the product / device life.
• Test times in accordance with product timelines.
• Continuous support, guidance and updating of sterile validation.