Helpful Links

• LS 13 320 XR Particle Size Analyzer
  • 21 CFR Part 11
  • LS 13 320 XR Capabilities
  • Features: LS 13 320 XR Particle Size Analyzer
  • LS 13 320 XR ADAPT Software
• Industry Standards
  • 21 CFR Part 11: Data Integrity and Compliance
    • Global Equivalents and Related Regulations
    • Improve the Integrity of your Electronic Records
    • 21 CFR Part 11: Scope and Application
    • 21 CFR Part 11: Related Terms and Acronyms
    • 21 CFR Part 11: Data Integrity and Compliance
  • FDA ALCOA Guidance
  • EP 2.2.44
  • ICH Q2
  • ISO 11171 Standard
    • Understanding ISO 11171: The NIST Traceable Particle Counter Calibration Standard
    • The Evolution of ISO 11171
    • ISO 11171 Standard: Guideline and Application
    • Products Designed for ISO 11171 Compliance
  • ISO 14644: Airborne Particulate Cleanliness in Cleanrooms and Clean Zones
    • 2015 Published Standards for ISO 14644
    • ISO 14644-1 Classification of Air Cleanliness by Particle Concentration
    • Dynamic Light Scatter
    • ISO 21501-4: Light Scattering Airborne Particle Counter for Clean Spaces
    • Particle Counters Designed to Support ISO 14644-1 and ISO 21501-4 Requirements
    • Particle Counting: Terms and Formulas
  • USP<643>
  • USP<645>
  • USP <787>
    • USP <787>: Application and Scope
    • Cleanroom Requirements for Liquid Particle Testing
    • USP <787>: Particulate Testing Solutions for Contamination Control
    • Light Obscuration: Optical Method for Particle Detection
    • USP <787>: Subvisible Particulate Matter in Therapeutic Protein Injections