Medibrane carries out small-batch manufacturing intended for clinical trials. Product design specifications are transferred to production, and the production processes are established to support volume manufacturing. Following process validation, the manufacturing of commercial product can commence in our cleanroom facility, scaling up to meet commercial volume requirements.
The transfer to production activities include:
- Establishment of manufacturing and inspection specifications and procedures
- Establishment of routing and bill of materials
- Risk analysis
- Validation planning
- Process validation execution
- Sterilization validation
- Product microbial monitoring schedule
- Operator training and certification
