Single-Use Implementation Services
Helping with Single-Use Validation and Implementation Strategies
The Biotechnology and Pharmaceutical Industries have shown an increasing demand for Single-Use equipment and components used in a wide array of process and unit operations. Single-Use technologies are becoming available for an increasing number and range of applications. These Single-Use assemblies include standalone devices as well as multi-component systems used to support many different processes applications with varying validation requirements. Our objective is to provide our clients with single use implementation and validation strategies to satisfy current US and EU regulatory requirements while ensuring the Single-Use equipment or components do not alter the drug products Safety, Identity, Strength, Quality or Purity (SISPQ).
Our Single-Use Solutions Include
- Subject Matter Expertise
- Implementation Strategies
- Change Control and Change Management
- Disposable Component Flow Diagrams (P&ID’s, PFD’s)
- User Requirements
- Standard Operating Procedures
- Engineering Test Planning
- Component Development
- Component Material Evaluation
- Component Testing and Design of Experiments
- Mixing Studies
- Temperature Mapping
- Destructive Testing
- Media Challenge
- Process Optimization
- Return on Investment Analysis
- Chemical Compatibility Assessment
- Leachable and Extractable Assessment
- Adsorption and Shedding Assessment
- IQ, OQ, PQ
- Vendor Audit and Inspection
- Vendor Coordination
- Vendor Documentation
Our Disposable Experience Includes:
- Disposable Bioreactors
- Mixing Systems
- Filtration
- Aseptic Connectors and Disconnection
- Tube Sets
- 2D pillow and 3D bags
- Peristaltic Pumps
- Transfer Assessemblies
- Sample Systems
- Silicon Molding and Extrusion
- Totes and bio shells
- Flexware
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