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Bulk Manufacturing Equipment Train Cleaning Validation

Duration- 8 months


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.



Project was completed successfully on time.