Single Use System Validation

Confidence® single-use system validation is available for a wide range of products used in applications such as final filling, freezing, and thawing, mixing, storage or shipping.

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*Custom/bulk order quotes are provided within 72 hours of request.

Our validation experts support you to identify validation needs and the appropriate testing scope for single-use systems considering budget, timeframe, and regulatory acceptance. We offer microbiological and physicochemical studies for a wide range of single-use consumables



  • Customized Study Design: We perform a process risk-based approach to address your individual needs
  • Cost Efficiency: Our risk-based approach enables up to 50% cost savings
  • Customer Orientation: Our Confidence® experts guide through the entire validation process, from the first meeting to the successful completion of the project
  • One Single Point of Contact: Our project managers facilitate a more efficient validation project workflow by managing internal and external stakeholders


  • Culture media preparation
  • Buffer preparation
  • Mixing
  • Storage
  • Final filling
  • Freeze & thaw


  • Chemical compatibility test
  • Integrity & microbial ingress test
  • Shipping validation
  • Storage validation
  • Freeze & thaw studies
  • Connection & disconnection studies
  • Pharmacopeia test
  • E&L testing