Key Manufacturers: MilliporeSigma, BD (Becton, Dickinson and Company)
Category: Rapid Microbiology & Environmental Monitoring Systems
Automated Autofluorescence / Flow Cytometry
Automated autofluorescence and flow cytometry based rapid microbial detection systems are used to rapidly detect and enumerate microorganisms in pharmaceutical products, water systems, and in-process materials. These technologies provide same-day or next-day detection—far faster than traditional culture-based bioburden or environmental monitoring methods.
They are especially valuable where fast microbial decision-making is required (e.g., aseptic processing, in-process controls, and short-shelf-life products such as viral vectors).
Official Websites & Resources
- Milliflex® Quantum system. (www.sigmaaldrich.com)
- BD BACTEC™ MGIT™ automated mycobacterial detection system (www.bd.com)
Associated Analytical Procedures
Context in Practice: Example Specifications
From: Typical AAV Drug Product Specifications
This instrument is used in the context of measuring the Quality Attribute Bioburden: Pre-Sterilization Microbial Control (IPC) with the following details:
- Purpose / Rationale: Ensures microbial load is acceptably low as a critical IPC prior to final sterile filtration, providing sterility assurance for the drug product.
- Typical Acceptance Criteria: Meets process-defined IPC limit (e.g., ≤ 10 CFU/100 mL), justified by process capability and with action/alert levels established by risk assessment.
From: Typical mRNA (Drug Substance) Specifications
This instrument is used in the context of measuring the Quality Attribute Bioburden: Pre-Sterilization Microbial Control (IPC) with the following details:
- Purpose / Rationale: Ensures microbial load in the bulk drug substance is acceptably low to support aseptic formulation and prevent downstream contamination.
- Typical Acceptance Criteria: Meets product-defined limit (e.g., ≤ 10 CFU/mL), justified by process capability and risk assessment.