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Volume 13
Issue 9
10.3390/pr13092917
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Comparison of Statistical Process Control Models for Monitoring the Biological Burden of a Buffer Solution Used as Input to Produce an Attenuated Viral Vaccine

by
Josiane Machado Vieira Mattoso
1,2,
Greice Maria Silva da Conceição
1,
Ana Paula Roque da Silva
1,
Paulo Vinicius Pereira Miranda
1,
Letícia de Alencar Pereira Rodrigues
2,
Marcelo Luiz Lima Brandão
1,* and
Jeancarlo Pereira dos Anjos
3,4
1
Oswaldo Cruz Foundation FIOCRUZ, Brazil Avenida Brasil, 4365, Manguinhos, Rio de Janeiro 21040-900, Rio de Janeiro, Brazil
2
Industrial Management and Technology, SENAI CIMATEC University, Orlando Gomes Avenue, 1845, Piatã, Salvador 41650-010, Bahia, Brazil
3
Center for Natural and Human Sciences, Federal University of ABC, Avenida dos Estados 5001, Bangú, Santo André 09210-580, São Paulo, Brazil
4
National Institute of Science and Technology in Energy and Environment (INCT E & A), Federal University of Bahia, Ondina Campus, Salvador 40170-110, Bahia, Brazil
*
Author to whom correspondence should be addressed.
Processes 2025, 13(9), 2917; https://doi.org/10.3390/pr13092917
Submission received: 12 August 2025 / Revised: 5 September 2025 / Accepted: 10 September 2025 / Published: 12 September 2025
(This article belongs to the Special Issue Microbiological Environmental Monitoring in the Pharmaceutical Industry)
Versions Notes

Abstract

The pharmaceutical industry faces various production challenges. Bioburden control is essential, and appropriate strategies and procedures must be implemented at all stages of production to prevent microbial contamination and comply with regulatory standards. Quality tools can provide important information for data management in production processes. The objective of this study was to compare two types of statistical process control charts (Laney’s U-chart and Bell distribution) in monitoring the bioburden of a buffer solution used as an input to produce an attenuated viral vaccine. Bioburden data for the buffer solution were obtained over a two-year period. The results showed that the analyzed products met the regulatory specifications, as 99% of them presented ≤10 colony-forming units (CFU)/100 mL after filtration. Various microorganisms were identified in the buffer solution, including species from the genus Bacillus spp., Micrococcus spp., Kocuria spp., Staphylococcus spp., and Acinetobacter spp. The Bell distribution proved to be statistically more suitable for application in the management of bioburden data for the buffer solution since the limits were closer to the specified value and could more effectively assist in the investigation of process deviations in the production of an attenuated viral vaccine.
Keywords: bacteria; Bell distribution; contamination; Laney U control chart; microorganisms; statistical process control bacteria; Bell distribution; contamination; Laney U control chart; microorganisms; statistical process control

Share and Cite

MDPI and ACS Style

Mattoso, J.M.V.; Conceição, G.M.S.d.; Silva, A.P.R.d.; Miranda, P.V.P.; Rodrigues, L.d.A.P.; Brandão, M.L.L.; dos Anjos, J.P. Comparison of Statistical Process Control Models for Monitoring the Biological Burden of a Buffer Solution Used as Input to Produce an Attenuated Viral Vaccine. Processes 2025, 13, 2917. https://doi.org/10.3390/pr13092917

AMA Style

Mattoso JMV, Conceição GMSd, Silva APRd, Miranda PVP, Rodrigues LdAP, Brandão MLL, dos Anjos JP. Comparison of Statistical Process Control Models for Monitoring the Biological Burden of a Buffer Solution Used as Input to Produce an Attenuated Viral Vaccine. Processes. 2025; 13(9):2917. https://doi.org/10.3390/pr13092917

Chicago/Turabian Style

Mattoso, Josiane Machado Vieira, Greice Maria Silva da Conceição, Ana Paula Roque da Silva, Paulo Vinicius Pereira Miranda, Letícia de Alencar Pereira Rodrigues, Marcelo Luiz Lima Brandão, and Jeancarlo Pereira dos Anjos. 2025. "Comparison of Statistical Process Control Models for Monitoring the Biological Burden of a Buffer Solution Used as Input to Produce an Attenuated Viral Vaccine" Processes 13, no. 9: 2917. https://doi.org/10.3390/pr13092917

APA Style

Mattoso, J. M. V., Conceição, G. M. S. d., Silva, A. P. R. d., Miranda, P. V. P., Rodrigues, L. d. A. P., Brandão, M. L. L., & dos Anjos, J. P. (2025). Comparison of Statistical Process Control Models for Monitoring the Biological Burden of a Buffer Solution Used as Input to Produce an Attenuated Viral Vaccine. Processes, 13(9), 2917. https://doi.org/10.3390/pr13092917

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