Location: San Diego, California

PharmaEd Cleaning Validation Summit
October 9 - 10, 2019

Join us in sunny San Diego for the Cleaning Validation Summit that covers cleaning standards and best practices for drugs, medical devices and biologics.  This two-day comprehensive summit is meant to illuminate cleaning validation best practices while bringing industry leaders together. See STERIS at the summit during the following presentations: 

Wednesday, October 9

3:45PM | Common Issues with Cleaning and Maintaining Stainless Steel Equipment 

Presented by: Beth Kroeger, 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 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. The presentation will also include laboratory studies that investigate cleaning, passive layer monitoring, and preventative maintenance approaches to prevent surface non-uniformities and costly un-scheduled equipment downtime of process equipment, vessels, and piping.

4:25PM | Swab Sampling
Presented by: Beth Kroeger, Technical Services Manager

Swab sampling is designed to maximize recovery of surface residues, especially on difficult to clean areas and is used, in conjunction with rinse sampling to verify that the surface of the equipment is in fact, clean. This would account for residues that might adhere to the surface post-cleaning process, thus not detected in the rinse water. Swab sampling involves the removal of residue from a target surface after the final rinse with a fibrous material (swab tip). The residue is then extracted from the swab tip with an appropriate solvent and the extract analyzed for residue content. It is advantageous in that it allows for physical removal of your target residue, however, swabbing can be extremely technique dependent. This demonstration is intended to discuss best practices in swab qualification.