919-827-0933

Bulk Manufacturing Equipment Train Cleaning Validation

Duration- 8 months

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.