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Validation of the Sealing Machine Process for Surgical Packs: A Methodological Approach

Validation of the Sealing Machine Process for Surgical Packs: A Methodological Approach

Karina Cecilia Arredondo-Soto, Maria Marcela Solís-Quinteros, Marco Augusto Miranda-Ackerman, Julio Blanco-Fernàndez
Copyright: © 2022 |Pages: 31
ISBN13: 9781799896135|ISBN10: 1799896137|ISBN13 Softcover: 9781799896142|EISBN13: 9781799896159
DOI: 10.4018/978-1-7998-9613-5.ch010
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MLA

Arredondo-Soto, Karina Cecilia, et al. "Validation of the Sealing Machine Process for Surgical Packs: A Methodological Approach." Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry, edited by Eugenia Gabriela Carrillo-Cedillo, et al., IGI Global, 2022, pp. 179-209. https://doi.org/10.4018/978-1-7998-9613-5.ch010

APA

Arredondo-Soto, K. C., Solís-Quinteros, M. M., Miranda-Ackerman, M. A., & Blanco-Fernàndez, J. (2022). Validation of the Sealing Machine Process for Surgical Packs: A Methodological Approach. In E. Carrillo-Cedillo, K. Arredondo-Soto, K. Palomino-Vizcaino, & H. Magaña-Badilla (Eds.), Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry (pp. 179-209). IGI Global. https://doi.org/10.4018/978-1-7998-9613-5.ch010

Chicago

Arredondo-Soto, Karina Cecilia, et al. "Validation of the Sealing Machine Process for Surgical Packs: A Methodological Approach." In Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry, edited by Eugenia Gabriela Carrillo-Cedillo, et al., 179-209. Hershey, PA: IGI Global, 2022. https://doi.org/10.4018/978-1-7998-9613-5.ch010

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Abstract

A manufacturing plant in Tijuana focused on providing medical device solutions to improve the quality of life of patients. The company has developed thanks to its innovative products in the market considerably. As a business strategy at the corporate level, opportunities were detected and involved the transfer of the manufacturing of products to different facilities in Mexico. In order to manufacture a product that complies with standards to ensure the sterile barrier standards to ensure sterilization barrier of the product, this project consists of validating the Max Tray Sealer machine of the kit kat two production lines. The validations process covers all the quality system requirements governed under the ISO-13485 standards, which define the validation stages. The stages of the validation include the installation qualification, the operational qualification, and the performance qualification.

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