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.

Item No.: 
Single-Use-System-Validation
Availability: 
*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

.

<h3>Benefits</h3>

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

<h3>Applications</h3>

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

<h3>Services</h3>

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

´