Event Date/Time: Sep 07, 2007
End Date/Time: Sep 07, 2007
The information in this course is paramount for continual successful of high quality medical devices and pharmaceutical manufacturing. The day starts off by explaining the types of cleaning, passivation and their use in the medical device and pharmaceutical industries. Different types of aqueous cleaning, their advantages and disadvantages will be discussed along with different types of surfactants. Then non-aqueous solvents will be reviewed including their advantages, disadvantages and applications. Passivation will be covered including different passivation formulations. The second half of the course will go over cleaning validations in the pharmaceutical and medical device industry. Since pharmaceutical cleaning validations are more clearly defined by FDA (Food and Drug Administration) as well as the ICH (International Conference on Harmonization), those details will be reviewed and discussed. The limit determination for each compound of interest will be discussed including how to do the calculations.