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

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.