December 11, 2023
When performing the Bacterial Endotoxin test, we observe changes within a solution that occur as a reaction to the presence of endotoxin. As such, it is necessary that the test medium be a liquid. For pharmaceutical products, the sample is...
See BlogJune 13, 2023
Cleaning validation requirements for reusable medical devices according to AAMI TIR30 did not distinguish between non-critical devices on the one hand and semi-critical or critical devices on the other. Additionally, many validation testing requirements were formulated using generalities rather than...
See BlogMay 30, 2023
Cleaning validation requirements for reusable medical devices according to AAMI TIR30 did not distinguish between non-critical devices on the one hand and semi-critical or critical devices on the other. Only general recommendations were formulated, which resulted in one validation approach...
See BlogJune 7, 2022
With the update to ISO 10993-18, is an extractables study required for all medical devices regardless of contact type and duration of contact? In this article, Helin Räägel, Matthew R Jorgensen, and Thor Rollins from Nelson Labs share insights on...
See BlogFebruary 9, 2022
There is a critical piece of reprocessing validations that has been largely overlooked for a long time: the cleaning chemicals. The devices and instruments used for the validations tend to get most of the attention. Recently Alpa Patel, Principal Scientist...
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