Validation Service
Validation Service – our Service
In the pharmaceutical, biotechnology and blood fractionation sectors, it is particularly important to be able to provide products for all filtration and separation solutions with a final validation service. Together with our validation partner, it is possible to offer these product-related validations as a vipur service for our customers:
- Completion of standard studies within 12 weeks, optional could be reduced to 6 or 8 weeks, using a project schedule by a defined project manager
- Control and documentation of the individual processes
- Preparation of a final report approval
Below is an excerpt of the possibilities offered by our Validation Partner:
Material Qualification
Filter Validation
Material Qualification
Material Qualification Assessment
- Basic qualification data: plastics/glass/elastomers in-process materials and primary packaging
- Process validation for intended use: plastics/glass/elastomers in-process materials and primary packaging
Materials and Tests
- Materials: In-process materials (filters, tubes and pipes, Single-Use-System,…) and primary packaging
- Tests: Compatibility assessment (adsorption studies, extractables and leachable studies with toxicological evaluation) and durability of the inner surface (delamination) for glass containers and materials
Filter Validation
Product and Process Validation
- Filterability studies
- Compatibility testing, validation of the life cycle (API)
- Extractables and leachable studies (E&L)
- Adsorption studies
- Bacterial challenge test with B. diminuta
- Product-wetted integrity test values (bubble point and/or forward flow)
