APPLICATION OF STATISTICAL PROCESS CONTROL IN BIOBURDEN MONITORING IN A BIOPHARMACEUTICAL INDUSTRY: A CASE STUDY
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
- Paulo Miranda (ORCID: https://orcid.org/0000-0001-8901-2056)
- Letícia de Alencar Pereira Rodrigues (ORCID: https://orcid.org/0000-0002-6061-3189)
- Jeancarlo Pereira dos Anjos (ORCID: https://orcid.org/0000-0001-8353-1066)
- Greice Maria Silva da Conceição (ORCID: https://orcid.org/0000-0001-9840-4860)
- Josiane Machado Vieira Mattoso (ORCID: https://orcid.org/0000-0003-1692-0955)
- Marcelo Luiz Lima Brandão (ORCID: https://orcid.org/0000-0003-1121-7312)
- Ana Paula Roque da Silva (ORCID: https://orcid.org/0000-0002-9076-0091)
Publication Details
- Published
- 2024-12-01
- DOI
- https://doi.org/10.5151/siintec2024-390072
- Primary Topic
- Fault Detection and Control Systems
- Type
- article
- Field-Weighted Citation Impact
- 0.00