Project: Cleaning Validation Program Development Primary Packaging

 Duration- 4 months

Overview:

Developed the cleaning validation program and performed cleaning validation at a multi-product drug product repacker with over 90 different active ingredients.  A full revamp of their cleaning validation program was required including the development of a product cleaning risk matrix that evaluated each product on toxicity, solubility, and cleanliness.  From this matrix, representative compounds were selected as the most challenging products to clean and used to demonstrate the equipment cleaning process was both effective and reproducible. 

In addition, the product contact equipment was assessed for the worst case locations from a cleaning perspective and sample site diagrams were created to ensure a consistent approach to cleaning validation/verification sampling would be applied for future activities.  

 Scope of Work:

The cleaning validation scope included: 

• Identification of the worst case product from a cleaning and risk standpoint
• Development of a Cleaning Validation Master Plan
• Development of a product cleaning risk matrix
• Evaluation of the worst case locations for swabbing
• Development of Swab Sampling diagrams
• Cleaning Validation protocol development, execution, and summation 

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.