Manual Inspection Booth
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 Appearance with the following details:
- Purpose / Rationale: Confirms basic product characteristics and absence of visible contaminants.
- Typical Acceptance Criteria: Clear to slightly opalescent, essentially free of visible particulates
From: Typical mRNA (Drug Substance) Specifications
This instrument is used in the context of measuring the Quality Attribute Appearance with the following details:
- Purpose / Rationale: Confirms absence of visible contaminants or precipitation; ensures bulk DS is suitable for downstream formulation.
- Typical Acceptance Criteria: Clear, colorless solution, essentially free of visible particulates.