Cleaning, Sterilization and Process Validation
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 that may entail strategic expertise, project execution, third party auditing services or/and staff augmentation.
Including
- 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