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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- Single-Use-System-Validation
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Choose your Confidence® Validation Services
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
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Benefits
- 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
Applications
- Culture media preparation
- Buffer preparation
- Mixing
- Storage
- Final filling
- Freeze & thaw
Services
- Chemical compatibility test
- Integrity & microbial ingress test
- Shipping validation
- Storage validation
- Freeze & thaw studies
- Connection & disconnection studies
- Pharmacopeia test
- E&L testing