STERIS Technical Expert Presenting at the Cleaning Validation Conference

Tuesday, August 20, 2013 1:30 PM

Paul Lopolito, Technical Services Manager at STERIS, will be presenting on “Design of a Cleaning and Passivation Program for Buffer Preparation Tanks.”

When: Tuesday, August 20, 2013 from 1:30 – 3:00 pm
Where: At the Cleaning Validation Conference, Philadelphia, PA, Session 6 

“Design of a Cleaning and Passivation Program for Buffer Preparation Tanks”

A large biotech manufacturer observed rouge in their 316L stainless steel buffer preparation and storage tanks. Based on solubility profiles of the buffer components, purified water should have effectively removed the residue. However, persistent rouge impacted the use of equipment for buffer preparation and production. This biotech manufacturer wanted to further investigate loss of passivation prior to adjusting their cleaning, maintenance, and/equipment programs to resolve the issue.

Case Study Objectives:
• Confirm deionized water cleans the buffer residue, or determine whether a formulated cleaner is required
• Verify the buffer storage condition that could result in a loss of the passive layer
• Confirm parameters of acid cleaner needed to restore the passive layer
• Confirm condition of buffer exposure that resulted in loss of passive layer after passivation
• Confirm treatment of acid passivation that protects against loss of passivation from buffer exposure

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