Medibrane provides the following:
- Transferring product design specifications to production, including:
- Formulating manufacturing and inspection specifications and procedures.
- Establishment of rout card
- Process risk analysis (FMEA)
- Process validation planning (MVP)
- Process validation execution (IQ/OQ/PQ)
- Before and after sterilization validation
- Establishing production processes to accommodate volume manufacturing.
- Commercial product manufacturing in our controlled ISO Class 7/Class 10,000 cleanroom facility, scaling up to meet commercial volume requirements.