Cleaning, Sterilization and Process Validation

Our consultants have experience in validating a majority of the systems found in the Pharmaceutical, Biotech and Medical Device Industry. PCI has the expertise to develop validation strategies, master plans, protocols, and final reports.

We have hands-on experience to validate utilities, process equipment and computers/automation systems. We can also help you in supporting the validation of your process. Based on specific needs, PCI is able to customize a value added approach which may entail strategic expertise, project execution, third party auditing services or/and staff augmentation.

  • Validation Strategies and Development of Validation Programs
  • Process Validation Master Plans, PPQ Protocols and Summary Reports write-up/review
  • Cleaning Validation protocol development and execution
  • Steam Sterilization protocol development and execution