APW Active Ingredient Processing Workstation from SOTAX

Description

The APW Active Ingredient Processing Workstation fully automates the sample preparation and analysis process for APIs and low dose products. Traditional manual sample preparation for these applications requires time consuming and labor intensive processes such as shaking, sonication, diluting, and filtering. The APW automates this entire process, gravimetrically confirming all liquid-handling operations for enhanced method reproducibility. It also uses a sonication probe and mixing station to disperse samples in a test tube containing up to 10 ml of solvent, making the APW ideal for:

  • API assay
  • API stability and other impurities
  • Low Dose Products such as Oral Contraceptives
  • Residual components
  • Cleaning validation
  • Creams and semi-solid dosage forms
  • Drug loaded medical devices
  • Other extractions for assay

The APW workstation supports both on-line and off-line sample analysis. Vial filling options are available to support off-line analyses such as UPLC. The APW can also act as an auto-sampler for both UV and HPLC on-line analysis. The optional APW barcode reader coupled with online-HPLC and an optional Waters Empower™ interface provide seemless “LIMS to LIMS” automation solutions for HPLC analysis.

All APW sample processing and method change control processes are comprehensively documented in a secure, compliant database. The APW client server configuration option supports a central database, facilitating method sharing across multiple systems as well as efficient electronic method and data review. Electronic signature capabilities enable a compliant method and data approval process. Implementing the APW provides the following benefits

Superior Analysis Quality
  • Gravimetric confirmation of liquid handling operations ensures accuracy and precision of the sample dilution process.
  • Technique dependent steps such as sample dispersion and extraction are consistently executed and controlled to be highly reproducible.
  • Reproducibility of procedure execution eliminates analyst technique as a source of variability, greatly reducing the frequency of laboratory investigations.
Increased Productivity
  • Alleviate bottlenecks to increase result throughput through unattended analyses.
  • Free-up highly skilled resources from routine and mundane laboratory work to increase laboratory resource capabilities.
  • Reduce cycle times to do more with the existing resources.
Improved Safety
  • Eliminate repetitive tasks (filtering, pipetting, etc) that can cause repetitive stress injury.
  • Reduce exposure to hazardous materials such as solvents and potent or toxic compounds.
  • Streamline glassware and washing needs.
  • Minimize environmental impacts and waste disposal costs by reducing the amount of solvents used.
Enhanced Security and Compliance
  • Comprehensive and secure documentation enables 21 CFR Part 11 compliance
  • Electronic signatures serve to record the approval status of methods and test results