Join our experts at the upcoming virtual Cleaning Validation Summit hosted by PharmaEd Resources Inc. Senior Technical Services Manager’s Beth Kroeger and Walid El Azab will be speaking about common issues with cleaning and maintaining stainless steel equipment and visual inspection practices for cleaning validation. With two days of virtual presentations on the best practices to cleaning validation, this is a must-attend event! 

February 10 | 9:45AM
Common Issues with Cleaning and Maintaining Stainless Steel Equipment

STERIS Expert: Beth Kroeger, Senior Technical Services Manager

Stainless steel equipment is ubiquitous in the Pharmaceutical manufacturing environment. How well it is maintained or not can impact the manufacturing schedule, the product, or the piece of equipment itself. Stainless steel has the unique ability to maintain a chemically resistant, chromium enriched, passive layer when exposed to oxygen. Acids such as nitric, phosphoric, citric as well as proprietary acid blends are commonly used to enhance the rate of formation of this passive layer. When the passive layer is exposed to adverse conditions there can be damage to the passive layer resulting in surface non-uniformities. This presentation will review standard recipes to enhance the passive layer formation as well as common test methods to evaluate the passive layer for predictive maintenance rather than reactive. 

February 11 | 1:00PM

Cleaning Validation: Visual Inspection Practices 

STERIS Expert: Walid El Azab, Senior Technical Services Manager

This presentation will compare the current practices for visual inspection amongst several pharmaceutical manufacturers. The presentation discussions the manufacturer practices against the current regulatory requirements for cleaning validation (EU Annex 15, ISCH Q7, US FDA guideline on cleaning validation, EMA HBEL guidelines, etc.) In this regard, a survey performed on various manufacturers around the world will be shared and discussed comparing practices and minimum requirements for visual inspection procedure. 

Key Takeaways: 

  • Understand the current benchmark regarding visual inspection of clean process equipment

  • Understand the regulatory requirements for cleaning inspections

  • Share lessons learned and understand the minimum requirements for visual inspection training