Example Projects
Bulk Manufacturing Equipment Train Cleaning Validation
- Cleaning Validation
Overview
Developed and performed cleaning validation of a new manufacturing process implemented at a international pharmaceutical site to improve process yields. A full evaluation of their cleaning process on the existing equipment was required.
Scope of Work
The cleaning validation scope included:
- Bioreactors
- Various Vessels
- Buffer Distribution/supply skids
- Parts Washer for new equipment train parts
In addition, the Mangan team collaborated with onsite SME’s to determine worst case residues and sites, then utilized a family approach to perform cleaning validation on all the manufacturing equipment used during the process.
Outcome
Project was completed successfully on time.
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