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Sterilization Techniques of Biomaterials (Implants and Medical Devices)

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Biomaterials and Biopolymers

Part of the book series: AAPS Introductions in the Pharmaceutical Sciences ((AAPSINSTR,volume 7))

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Abstract

Biomaterials comprise natural and synthetic components including polymers, tissues, living cells, metals, ceramics, etc. They are used to replace or repair the living tissues and organs that are malfunctioning. Hence, it is essential to ensure the biomaterials are safe and sterilized before being used in the body. Particularly, we learned that sterilization is crucial from the most recent pandemic caused by the COVID-19 virus. The most commonly used sterilization methods include steam-autoclaving, dry-heat, radiation processes (gamma, X-rays, electron beam, and ultraviolet), gas plasma, and ethylene oxide treatment. Supercritical carbon dioxide has been investigated extensively as an alternative to conventional sterilization methods in recent years. The sterilization techniques with their advantages and disadvantages will be detailed in this chapter.

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References

  1. Beh CC, Farah S, Langer R, Jaklenec A (2019) Chapter 12. Methods for sterilization of biopolymers for biomedical applications. In: Antimicrobial materials for biomedical applications. The Royal Society of Chemistry, London, pp 325–347

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Author information

Authors and Affiliations

  1. Western Australian School of Mines: Minerals, Energy & Chemical Engineering, Curtin University, Perth, WA, Australia

    Chau Chun Beh

Authors
  1. Chau Chun Beh
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Corresponding author

Correspondence to Chau Chun Beh .

Editor information

Editors and Affiliations

  1. School of Pharmacy-Faculty of Medicine, The Hebrew University of Jerusalem and Centre for Cannabis Research and the Institute of Drug Research The Alex Grass Centre for Drug Design and Synthesis, Jerusalem, Israel

    Avi Domb

  2. Laboratory for Bio-materials Faculty of Biotechnology and Food Engineering, Technion-Israel Institute of Technology, Haifa, Israel

    Boaz Mizrahi

  3. The Laboratory for Advanced Functional/Medicinal Polymers & Smart Drug Delivery Technologies, The Wolfson Faculty of Chemical Engineering Technion-Israel Institute of Technology, Haifa, Israel

    Shady Farah

Quiz

Quiz

  1. 1.

    Which of the following sterilization methods is suitable for all types of materials?

    1. (A)

      Steam-autoclaving

    2. (B)

      Ethylene oxide treatment

    3. (C)

      Radiation process

    4. (D)

      None of the above

    There is no single sterilization process that can fit all purposes. All processes lead to various adverse effects on biomaterials including changes in physical, mechanical, and biological properties.

  2. 2.

    What is the acceptable sterility assurance level?

    1. (A)

      10−4

    2. (B)

      10−5

    3. (C)

      10−6

    4. (D)

      None of the above

    A minimum sterility assurance level of 10−6 is important in good manufacturing practices and patient safety.

  3. 3.

    What is the operating temperature range of steam-autoclaving sterilization?

    1. (A)

      90–100 °C

    2. (B)

      100–110 °C

    3. (C)

      121–134 °C

    4. (D)

      151–164 °C

    The optimum temperature range has been investigated, i.e., 121–134 °C. An operating temperature lower than the above range will not achieve a sterility assurance level of 10−6 within the same time frame.

  4. 4.

    Which of the following is not suitable for steam-autoclaving sterilization?

    1. (A)

      Catheters

    2. (B)

      Vascular prostheses

    3. (C)

      Hematic circuits

    4. (D)

      Electric device components

    The moisture content from steam-autoclaving will damage the electric device components.

  5. 5.

    Gas plasma sterilization was introduced as an alternative to which of the following sterilization method?

    1. (A)

      Steam-autoclaving

    2. (B)

      Dry-heat

    3. (C)

      Ethylene oxide treatment

    4. (D)

      Supercritical fluid

    This is due to gas plasma using less toxic materials than ethylene oxide.

  6. 6.

    Chemical sterilization using ethylene oxide (EtO) may not be suitable for biopolymers due to EtO may affect their…?

    1. (A)

      Degradation rate

    2. (B)

      Molecular weight

    3. (C)

      Mechanical properties

    4. (D)

      All the above

    The biopolymer properties can be significantly affected, especially the polymers that contain COOH functional group and PEG. Significant degradation was observed on PEG-based bioresorbable biopolymers where EtO esterified the carboxylic acid groups in desaminotyrosol-tyrosine.

  7. 7.

    Which of the following procedure is applicable for reducing the toxic effects and flammability of EtO?

    1. (A)

      Mix EtO with water during the sterilization process

    2. (B)

      Mix EtO with inert gases such as fluorinated hydrocarbons and CO2 during the sterilization process

    3. (C)

      Heat the sterilization vessel up to 200 °C

    4. (D)

      None of the above

    It is important to remove all EtO toxic residues as they may lead to extreme skin irritation and medical complications if the biomaterials are incorporated into the body. In addition, the residual EtO contents including its secondary products such as ethylene chlorohydrin and ethylene glycol have mutagenic, carcinogenic, and allergenic effects. The procedure above (mixing with inert gases) will help in reducing the toxic effects of EtO.

  8. 8.

    Which of the following is non-ionizing radiation?

    1. (A)

      X-ray

    2. (B)

      Electron beam

    3. (C)

      Gamma radiation

    4. (D)

      Ultraviolet radiation

    UV is a non-ionizing radiation. It uses long-wavelength and low-energy radiation while the ionizing radiation (gamma, X-ray, and electron beam) uses high-intensity and short-wavelength radiation.

  9. 9.

    What is the standard dose of gamma irradiation for sterilization?

    1. (A)

      5 kGy

    2. (B)

      15 kGy

    3. (C)

      25 kGy

    4. (D)

      50 kGy

    A single standard dose of ϒ-irradiation for sterilization is 25,000 Gray (25 kGy). Gamma rays have a relatively high penetrating power of up to 50 cm. High doses of ϒ-rays are required for substances involving stubborn microorganisms including viruses, parasites, and helminths.

  10. 10.

    Which of the following sterilization method may contain toxic residues?

    1. (A)

      Ethylene oxide treatment

    2. (B)

      Steam-autoclaving

    3. (C)

      Dry-heat

    4. (D)

      Supercritical CO2

    The other three options do not involve chemicals. Hence, they will not have toxic residues.

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Beh, C.C. (2023). Sterilization Techniques of Biomaterials (Implants and Medical Devices). In: Domb, A., Mizrahi, B., Farah, S. (eds) Biomaterials and Biopolymers . AAPS Introductions in the Pharmaceutical Sciences, vol 7. Springer, Cham. https://doi.org/10.1007/978-3-031-36135-7_12

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