Key Manufacturers: Charles River Laboratories, MilliporeSigma
Category: Rapid Microbiology & Environmental Monitoring Systems
ATP Bioluminescence Systems (Celsis, Milliflex)
ATP Bioluminescence is a rapid microbial method (RMM) used for the detection of microbial contamination in pharmaceutical products, water, and raw materials.
Principle of Operation The technology relies on the reaction between ATP (adenosine triphosphate), found in all living cells and the enzyme luciferase / substrate luciferin. In the presence of microbial ATP, this reaction produces light (bioluminescence). The intensity of the light, measured in Relative Light Units (RLU), is directly proportional to the amount of microbial ATP present, indicating contamination.
Key Applications
Alternative / Rapid Sterility Testing:
When validated under USP <1223> and Ph. Eur. 5.1.6, ATP bioluminescence can serve as an alternative sterility test, reducing time-to-result from 14 days to ~3–7 days.
In-Process Bioburden: Real-time monitoring of intermediates and buffers.
Environmental Monitoring & Water Testing: Rapid detection of contamination in WFI loops.
System Benefits
Speed: Delivers results in 18–48 hours compared to 3–14 days for traditional culture methods.
Sensitivity: Capable of detecting very low levels of contamination (down to 1 CFU).
Supply Chain Efficiency: Drastically reduces inventory holding times and storage costs.
Official Websites & Resources
- Charles River Laboratories (www.criver.com)
- Millipore Milliflex (www.sigmaaldrich.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.