Growth-Based RMM
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.