Q: How can I ensure there are no residues left behind in the artificial heart we manufacture? A: Swabbing for detergent and manufacturing residues (machining oils, particulate, etc.) is a validation standby. If you cannot swab the interior of the artificial heart, then we recommend to do a final sampling rinse with high purity water, after you have completed all your … [Read more...] about Removing Residues from Artificial Heart
Validation
Cleaning Validation Virtual Summit, 2021
February 10th and 11th....Come join Michael Moussourakis, Senior Director, Alconox Inc. and several other industry experts at the PharmaEd Resources Inc. Cleaning Validation Virtual Summit, 2021. Get 20% off registration when you mention "Alconox Inc." sent you!! Just email khubbard@pharmaedresources.com for the discount. Download the program To request any Alconox … [Read more...] about Cleaning Validation Virtual Summit, 2021
Differences between Alconox and Liquinox
Q. Currently using Alconox, but are considering a switch to Liquinox. What are the recommendations and concerns with switching from Alconox to Liquinox? What are the difference in ingredients between Alconox and Liquinox? Do we need to do a validation? A. Alconox® Powdered Precision Cleaner and Liquinox® Critical Cleaning Liquid Detergent, are functionally equivalent … [Read more...] about Differences between Alconox and Liquinox
Cleaning Visual Inspection
Q: I work for a medical device company where we make machined parts. I’m interested in finding a supplemental visual inspection tool that will aid in inspecting the surface of a part after being cleaned. Perhaps additional fluorescent light or a different tool that can support in detecting visual surface contaminants on medical device components? A: Visual inspection is a … [Read more...] about Cleaning Visual Inspection
Clean in place (CIP) with Citrajet Detergent
Q. Our pharmaceutical company is transferring product manufacture to a different one of our facilities. We used a CIP cleaning process with Citrajet detergent and are going to have to perform validation and verification tests again. What information do we need for our testing? Chemical properties might be helpful as well as the science on how this chemical works. We would also … [Read more...] about Clean in place (CIP) with Citrajet Detergent