Micro Bioburden Testing and Microbial Limit

Many vaccines, including those for influenza, are produced using viruses grown in embryonated chicken eggs. There are many stages throughout the manufacturing process where it is imperative to evaluate microbial bioburden. The Micro PRO™ is used for determining bioburden in in-process vaccine intermediates, such as allantoic fluids, concentrated and inactivated virus bulks.

Key Benefits:

• The Micro PRO™ provides a rapid bioburden result in 4 minutes, eliminating the need to quarantine in-process bulks
• The Micro PRO™ accurately detects contaminated in-process vaccine intermediates/bulks
• Kits containing specialized reagents are available for enumerating total bioburden in in-process bulk vaccines
• The Micro PRO™ is fully automated and performs reagent additions, mixing, and sample injection.
• The system holds a maximum of 42 samples, but also allows for continuous operation utilizing a batch process.
• Technical and validation support services are available.

Figure 1. Summary of Micro PRO™ and agar plate bioburden results of 63 in-process bulk influenza vaccine samples harvested from allantoic fluid.

Source: Bhusari, P, Galinski, M., Steger, A. 2008. Application for a Rapid Flow Cytometry Method for Process Control Bioburden Testing in Live Attenuated Influenza Vaccine Intermediates. American Society of Microbiology Annual Meeting. Poster Presentation.

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