Isolation Technology: Case Study

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