Body

- Properly managed equipment
- Management oversight
- A quality system in place
- Proper surrounding room design to maintain ISO 5 in critical zone
- Proper gowning practice
- Proper training
- Initial high level disinfection with sporicidal agent
- Proper SOPs for rare interventions
The FDA encouraged ISPE to develop a clearer definition of the elements that characterize RABS technology to assist the agency and industry professionals to understand it.
The International Society for Pharmaceutical Engineering provides pharmaceutical manufacturing professionals with opportunities to develop technical knowledge, exchange practical experience and collaborate with global regulatory agencies. It has affiliates and chapter in 19 countries.
For more information, visit www.ispe.org.
Add new comment