Stop waiting for plate counts
Types of Traditional Bioburden Testing Methods
- Membrane filtration
- Pour plate method (plate count method)
- Culture-based methods
How Does Bioburden Testing Work?
Bioburden testing is performed as routine testing to ensure safety, quality, and regulatory compliance during manufacturing. Traditionally, testing for microbial or bioburden contamination at different stages of production requires days to obtain results. This is because samples are incubated for days before the resulting culture can be enumerated.
- Personnel collect samples from the manufacturing process or plant
- Samples get submitted to Quality Control for bioburden testing
- QC Analysts gather samples for testing
- A biological safety cabinet (BSC) or laminar flow hood (LFH) is utilized for bioburden testing. The BSC or LFH will be cleaned prior to testing to minimize any contamination risk
- Samples and testing materials are introduced into the BSC/LFH for testing
- Membrane filtration - The analyst will place a membrane filter cup onto a manifold (vacuum), put the sample into the cup, and filter the sample through.
- Once the sample is filtered, the sample is rinsed with a buffer or diluent
- The analyst will transfer the membrane filter to the surface of an agar plate
- Upon completion of all samples using this method, the agar plates will be incubated for a specific amount of time to determine if any microbial growth is observed.
- Rapid Microbiological Methods (RMMs) or rapid bioburden testing now drastically reduces the time requirements of the above steps, providing a simplified process and faster time to results.
Where is Bioburden Testing Used?
- Quality control of pharmaceutical manufacturing water
- Process water testing (water for injection/WFI)
- Raw material testing
- In-process testing for pharmaceutical products (upstream, downstream, formulation, fill/finish)
- Environmental monitoring of process areas (surface, air, etc.)
- Food and Beverage industry
- Medical Devices
Due to the nature of traditional bioburden testing methods (i.e., culture-based methods/ agar plate counts), obtaining results for bacterial contamination found in water loops or production sites can take days. Rapid Microbiological Methods (RMMs) were developed to obtain microbiology results faster, finally giving you the ability to determine whether you have a contamination event in near real time. With ultra-sensitive, high throughput testing that has a strong correlation to culture-based methods, you can feel confident in your ability to quickly detect microbial contamination and take action to ensure safety, quality, and compliance.
Stop waiting for plate counts. Get fast detection of microbial contamination and improve your microbiological control.