Single Use System Validation
- Item No.:
- Single-Use-System-Validation
Choose your Confidence® Validation Services
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
- E&L testing
- Chemical compatibility test
- Integrity & microbial ingress test
- Shipping validation
- Freeze & thaw studies
- Connection & disconnection studies
- Pharmacopeia test
Brochure
Questions & Answers (5)
The different options for the extraction conditions include process conditions determined by the customer and scale-down laboratory conditions provided by Confidence®.
The protocol for a Chemical Compatibility test includes the following tests: visual inspection, drop test (integrity), tensile strength test, dimensional analysis, and infrared spectroscopy.
Yes, it is possible to validate a new tube type with Biowelder® if existing appropriate welding parameters are identified.
To determine if your solution X is compatible with the bag or component Y, you should contact your Application Specialist (AS), who has access to a chemical compatibility database.
It is relevant to perform a Chemical Compatibility test when aggressive solutions are used or when the contact conditions exceed the conditions validated and recommended in the validation guideline.