Dezembro 2024 vol. 11 num. 2 - X Simpósio Internacional de Inovação e Tecnologia

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APPLICATION OF STATISTICAL PROCESS CONTROL IN BIOBURDEN MONITORING IN A BIOPHARMACEUTICAL INDUSTRY: A CASE STUDY

APPLICATION OF STATISTICAL PROCESS CONTROL IN BIOBURDEN MONITORING IN A BIOPHARMACEUTICAL INDUSTRY: A CASE STUDY

Mattoso, Josiane Machado Vieira ; Conceição, Greice Maria Silva da ; Silva, Ana Paula Roque da ; Miranda, Paulo Vinicius Pereira ; Rodrigues, Leticia de Alencar Pereira ; Brandão, Marcelo Luiz Lima ; Anjos, Jeancarlo Pereira dos ;

Completo:

"Quality control in a biopharmaceutical industry and quality tools provide important information for managing production processes. The objective of this study was to apply statistical process control to the bioburden of a viral vaccine buffer solution. The method consisted of constructing statistical control charts based on data from a 3-year period. Statistical process control helped to analyze the variation of data in the process and indicated that the variations in bioburden were within the limits acceptable under the legislation. However, the data obtained was out of statistical control and the capability indices could not be calculated in this work."

Completo:

"Quality control in a biopharmaceutical industry and quality tools provide important information for managing production processes. The objective of this study was to apply statistical process control to the bioburden of a viral vaccine buffer solution. The method consisted of constructing statistical control charts based on data from a 3-year period. Statistical process control helped to analyze the variation of data in the process and indicated that the variations in bioburden were within the limits acceptable under the legislation. However, the data obtained was out of statistical control and the capability indices could not be calculated in this work."

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Palavras-chave: Bioburden, Biopharmaceutical industry, Control chart, Quality tools, Vaccine,

Palavras-chave: Bioburden, Biopharmaceutical industry, Control chart, Quality tools, Vaccine,

DOI: 10.5151/siintec2024-390072

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Como citar:

Mattoso, Josiane Machado Vieira; Conceição, Greice Maria Silva da; Silva, Ana Paula Roque da; Miranda, Paulo Vinicius Pereira; Rodrigues, Leticia de Alencar Pereira; Brandão, Marcelo Luiz Lima; Anjos, Jeancarlo Pereira dos; "APPLICATION OF STATISTICAL PROCESS CONTROL IN BIOBURDEN MONITORING IN A BIOPHARMACEUTICAL INDUSTRY: A CASE STUDY", p. 67-73 . In: . São Paulo: Blucher, 2024.
ISSN 2357-7592, DOI 10.5151/siintec2024-390072

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