Manufacturing and process development

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.