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.

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  • 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
Complete software solution: design, execute, analyze, report

Chemspeed’s AUTOSUITE User Interface & Executor software packages execute and control all modules of the entire product development cycle. They control all Chemspeed robotic platforms and any other integrated 3rd party software and hardware.
AUTOSUITE suite SWING is a software with a user friendly interface which allows easy workflow orienteted programming. Many features such as gravimetric dispensing are automatically calibrated, eliminating tedious optimization steps.

  • The AutoTeaching tool simplifies dispensing applications without manual trials and is applicable to e.g. solids eliminating the need for manual optimization before the dispenses are done.
  • Easy programming: drag-and-drop workflow steps or just execute standard workflow protocols.
  • Barcode tracking.
  • ARKSUITE Workflow Studio and Internet of the Lab Tools (e.g. DoE, data mgt, substance parameter database, inventory mgt, product mgt, run mgt) includes a full document management system (electronic labjournal) and is 21 CFR Part 11 compliant. The software scales from a single PC to large network / cloud installations with multiple hardware and clients.

Compliance requirements

Sources:

  • Regulatory requirements
  • Company guidelines and SOPs
  • Good manufacturing practices

Goals:

  • Stable process
  • Focus on quality
  • Evidence driven

Validation deliverables

(GAMP 5 - Source: ISPE)