Improper cleaning of pharmaceutical manufacturing equipment has caused many FDA Form 483's and warning letters over the years. Many of the regulatory and manufacturing issues may be avoided by understanding one's process well, including the cleaning of process equipment. This understanding includes knowing why a particular cleaning process was chosen, how it is implemented, and how the validation was or will be done.
This presentation will specifically cover the selection of detergents and how the chemistry of residual material, the material of construction of the manufacturing equipment, as well as the mode of cleaning affect the detergent choice.
A discussion of process optimization will cover the aspects of cleaning that need to be understood in order to design the best possible cleaning process. These aspects are represented by the acronym BATH-O-CARD.
A review of cleaning validation in the pharmaceutical industry will cover limit determination/MACO (maximum allowable carryover) calculations and all the information needed to have a successful cleaning validation.
- Learn how to choose an appropriate detergent for critical cleaning applications.
- Learn how to optimize a critical cleaning process.
- Understand how to do a cleaning validation in the pharmaceutical industry.