Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.
In-line UV Spectrometry Monitoring in Cleaning Validation
The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.
Considerations for Cleaning Lipid Nanoparticles
This article explores the concerns with cleaning pharmaceutical products utilizing LNP delivery vehicles and provides a general cleaning recommendation based on laboratory and field testing.
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.
Preventive and Corrective Maintenance for Rouge in Stainless-Steel Equipment
Process conditions can corrode stainless-steel surfaces, necessitating corrective and preventive maintenance.
A Risk-Based Approach to Stainless Steel Equipment Maintenance
Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.
Cleaning Validation in Continuous Manufacturing
A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.