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Journal of Pharmaceutical Innovation

, Volume 13, Issue 2, pp 110–120 | Cite as

Compatibility of Polyvinyl Chloride (PVC) Medical Devices and Other Polymeric Materials with Reactive Ion Etching (RIE) and Inductively Couple Plasma (ICP) Sterilization Using a Quality by Design (QbD) Approach

  • Débora Cristina de OliveiraEmail author
  • Leandro Augusto CalixtoEmail author
  • Isa Martins Fukuda
  • Alessandro Morais Saviano
  • Adir José Moreira
  • Yoshio Kawano
  • Ronaldo Domingues Mansano
  • Terezinha de Jesus Andreoli Pinto
  • Felipe Rebello Lourenço
Original Article
  • 165 Downloads

Abstract

Purpose

The sterilization process for medical devices is an important step due to microbiological quality requirements of polymeric products. Irradiation and ethylene oxide sterilizations, traditional techniques, may compromise safety and efficacy of medical devices due to oxidation/alkylation or due to the presence of residues in polymeric materials. Alternatively, reactive Ion etching (RIE) and inductively coupled plasma (ICP) may be used for this purpose; however, the compatibility of polymeric materials with these processes and their lethality must be addressed.

Methods

We assessed herein chemical and biological modifications in polymeric materials after an RIE and ICP sterilization process, using photoacoustic Fourier transform infrared spectroscopy (FTIR-PAS), scanning electron microscopy with energy dispersive X-ray spectroscopy (SEM/EDS), surface profilometry analysis (SPA), and in vitro agar diffusion cytotoxicity. In addition, a factorial design was adopted to study lethality in PVC catheters, evaluating the influence of sterilization mode (RIE or ICP), radio frequency power (from 100 to 300 W), hydrogen peroxide concentration (from 0 to 20%), and internal lumen diameter of PVC catheters (from 1 to 7 mm) in D-values.

Results

RIE and ICP sterilization using a mixture of O2 and H2O2 (80 and 20%, respectively) have caused chemical modifications in all polymers, however, without increasing in vitro cytotoxicity. Based on factorial design results, we proposed mathematical models to predict the D-values (time to kill 90%––or 1 log reduction––of microbial load) as a function of H2O2 concentration and internal lumen diameter of catheters.

Conclusions

Quality by design approach allow one to develop a rational sterilization process considering the required time for sterilization, concentration of H2O2, and the internal lumen diameter of catheters.

Keywords

Reactive ion etching (RIE) Inductively coupled plasma (ICP) Sterilization process Polymeric medical devices Quality by design (QbD) 

Notes

Acknowledgements

We thank Nelson Ordonez, Alexandre Camponucci, José Antônio R Porto, Elisio José de Lima, Áurea Silveira da Cruz, Fernanda de Sá Teixeira, Cleide Amaral, Aline Morais de Oliveira, and Fernando Adas Pereira Vitalli. Jim Hesson of AcademicEnglishSolutions.com revised the English.

Funding Information

This work was supported by CNPq (Brazil).

Compliance with Ethical Standards

Conflict of Interest

The authors declared that they have no conflict of interest.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Débora Cristina de Oliveira
    • 1
    Email author
  • Leandro Augusto Calixto
    • 1
    Email author
  • Isa Martins Fukuda
    • 2
  • Alessandro Morais Saviano
    • 2
  • Adir José Moreira
    • 3
  • Yoshio Kawano
    • 4
  • Ronaldo Domingues Mansano
    • 3
  • Terezinha de Jesus Andreoli Pinto
    • 2
  • Felipe Rebello Lourenço
    • 2
  1. 1.Departamento de Ciências Farmacêuticas, Instituto de Ciências Ambientais, Químicas e FarmacêuticasUniversidade Federal de São Paulo (UNIFESP)São PauloBrazil
  2. 2.Departamento de Farmácia, Faculdade de Ciências FarmacêuticasUniversidade de São Paulo (USP)São PauloBrazil
  3. 3.Laboratório de Sistemas Integráveis, Escola PolitécnicaUniversidade de São Paulo (USP)São PauloBrazil
  4. 4.Departamento de Química Fundamental, Instituto de QuímicaUniversidade de São Paulo (USP)São PauloBrazil

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