Automated Eluent Preparation for GMP / 21 CFR Part 11 Environments

SWING SP Eluent Preparation for GMP

Pharmaceutical and fine chemicals QC labs face an increasing challenge providing and assuring data integrity.

Chemspeed’s SWING SP allows fully automated, standardized and digitalized eluent preparation with full regulatory compliance.

  • Data integrity
  • Increase productivity, accuracy and reproducibility
  • Full regulatory compliance

Key advantages

  • Electronic records
  • Electronic signatures
  • Gravimetric dispensing of buffer salts
  • The balance moves to the destination, increasing speed and efficiency
  • Balance resolution of 0.1 mg (optional 0.01 mg)
  • 4-Needle Head for volumetric liquid handling and pH adjustment

Regulatory aspects

Regulatory Compliance

  • Electronic Records / Electronic Signatures
  • Data Integrity
  • Audit Trail

Software features - Regulatory compliance by design
Validation / Qualification

  • User Requirements & Specifications, Functional Specifications, Hardware Design Specifications, Software Design Specifications
  • Installation Qualification, Operational Qualification

Exemplary workflow HPLC eluent production