Thermal processing validation of a canned vegetal protein product

Authors

  • Gladistone Carvalho Santos Filho Universidade de São Paulo; Faculdade de Ciências Farmacêuticas; Departamento de Tecnologia Bioquímico-Farmacêutica
  • Thereza Christina Vessoni Penna Universidade de São Paulo; Faculdade de Ciências Farmacêuticas; Departamento de Tecnologia Bioquímico-Farmacêutica

DOI:

https://doi.org/10.1590/S1516-93322003000400006

Keywords:

Validation, Bacillus stearothermophilus, Autoclave, Sterilization, Canned food

Abstract

Process validation in the Food and Pharmaceutics Industries is one of the most important tools meant to guarantee quality, making safe and trustworthy products. Physical and biological validations were performed in the terminal sterilization of a canned vegetal protein product. Physical validation of the autoclave has been proceeded in three empty chamber cycles and 12 temperature sensors. It has been confirmed to the geometrically distributed spots inside the autoclave that the maximum temperature difference between one and another spot has been 1.0 ºC concerning the average chamber temperature (122 ºC). Sterility Assurance Level (S.A.L.) of at least 10-12, in relation to biological indicator of B. stearothermophilus with D121ºC value of 3.68 minutes and average spore population of 1,00 x 10(6) per strip, was obtained. Despite the absence of a margin of safety for canned products sterilization, periodical validation of an autoclave has provided greater trust on the sterility evaluation than the simple incubation test of some samples, recommended by the Brazilian Ministry of Health.

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Published

2003-12-01

Issue

Section

Original Papers

How to Cite

Thermal processing validation of a canned vegetal protein product. (2003). Revista Brasileira De Ciências Farmacêuticas, 39(4), 391-401. https://doi.org/10.1590/S1516-93322003000400006