A customer active in the hormone production recently searched an appropriate solution for grinding material and clean packaging after the filtering and drying process.
The following requirements had to be met:
• To provide a safe barrier between the operator and the active drug substance to provide both operator and product protection
• System designed for multi product use for OEB5 category potent compounds
• Isolator designed for the automated discharge and manual heel removal, milling and dispensing of product discharge from filter drier.
• The system is to enable manual sampling to be achieved via the filter dryer sampling port which is integral to the discharge hatch
• The system is designed also to mill and pack other products introduced to the isolator via a RTP Rapid Transfer Port.
• System to operate in an inert atmosphere during product discharge.
• To enable the process plant to be Cleaned In Place
