HIAC 9703+ Pharmaceutical Particle Counter
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 Sub-Visible Particles (SVP) with the following details:
- Purpose / Rationale: To ensure safety by controlling particles that can increase the risk of immunogenicity.
- Typical Acceptance Criteria: Meets USP limits for small-volume injections (e.g., NMT 6000 ≥10 µm; NMT 600 ≥25 µm per container).