Blucher Engineering Proceedings

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

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

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

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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 23577592, DOI 10.5151/siintec2024-390072

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