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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

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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.

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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

This work was supported by CNPq (Brazil).

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Authors and Affiliations

  1. Departamento de Ciências Farmacêuticas, Instituto de Ciências Ambientais, Químicas e Farmacêuticas, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil

    Débora Cristina de Oliveira & Leandro Augusto Calixto

  2. Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo (USP), São Paulo, Brazil

    Isa Martins Fukuda, Alessandro Morais Saviano, Terezinha de Jesus Andreoli Pinto & Felipe Rebello Lourenço

  3. Laboratório de Sistemas Integráveis, Escola Politécnica, Universidade de São Paulo (USP), São Paulo, Brazil

    Adir José Moreira & Ronaldo Domingues Mansano

  4. Departamento de Química Fundamental, Instituto de Química, Universidade de São Paulo (USP), São Paulo, Brazil

    Yoshio Kawano

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  1. Débora Cristina de Oliveira
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  2. Leandro Augusto Calixto
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  3. Isa Martins Fukuda
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  4. Alessandro Morais Saviano
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  5. Adir José Moreira
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  6. Yoshio Kawano
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  7. Ronaldo Domingues Mansano
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  8. Terezinha de Jesus Andreoli Pinto
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  9. Felipe Rebello Lourenço
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Correspondence to Débora Cristina de Oliveira or Leandro Augusto Calixto.

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de Oliveira, D.C., Calixto, L.A., Fukuda, I.M. et al. 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. J Pharm Innov 13, 110–120 (2018). https://doi.org/10.1007/s12247-018-9309-1

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