Application of Statistical Process Control in Bioburden Monitoring in a Biopharmaceutical Industry: a Case Study
Year: 2024
Type: conference-paper
Abstract: "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."
Authors: Josiane Machado Vieira Mattoso, Greice Maria Silva da Conceição, Ana Paula Roque da Silva, Paulo Vinicius Pereira Miranda, Leticia de Alencar Pereira Rodrigues, Marcelo Luiz Lima Brandão, Jeancarlo Pereira dos Anjos
Language: English
Subfield: Statistics, Probability and Uncertainty
Field: Decision Sciences
Domain: Social Sciences
Open Access status: gold
OpenAlex ID: W4406752974