08.14.13
Powder Systems Limited (PSL), an international manufacturer of high containment isolators and glove boxes for the pharma and biopharma industries, recently delivered a high containment installation and will start the manufacture of a range of isolators in Spain.
The first project consists of a large scale pressure agitated nutsche filter dryer (ANFD) and a discharging isolator achieving a DOEL (Design Occupational Exposure Limit) of less than 1 microgram during sampling period. According to the company, this multipurpose isolator allows full recovery of the dried product obtained from the 0.6m² filtration vessel plate, sampling without process disruption, powder dispensing, weighing and packing off within a safe and contained environment. One of the Spanish pharmaceutical groups will install these contained filtration and drying facilities in its synthesis plant for production of innovative medicines.
The second project is for a Spanish company developing and manufacturing APIs / HAPIs for the pharma industry. This high containment project includes two dispensing isolators, two SlurryBoxes (charging isolators for high potent slurry into reactors through pressured vessels), one reactor charging isolator and one vacuum drying isolator including PSL CakeStand Tray Dryer. The high containment suite is designed for an OEB5 environment achieving a DOEL of less than 100 nanogram/m³ during eight hours Time Weighted Average (TWA). The six rigid isolators in stainless steel will be pre-tested and FAT (Factory Acceptance Tests) in the next few months and installed in the manufacturing site by the end of the year.
The first project consists of a large scale pressure agitated nutsche filter dryer (ANFD) and a discharging isolator achieving a DOEL (Design Occupational Exposure Limit) of less than 1 microgram during sampling period. According to the company, this multipurpose isolator allows full recovery of the dried product obtained from the 0.6m² filtration vessel plate, sampling without process disruption, powder dispensing, weighing and packing off within a safe and contained environment. One of the Spanish pharmaceutical groups will install these contained filtration and drying facilities in its synthesis plant for production of innovative medicines.
The second project is for a Spanish company developing and manufacturing APIs / HAPIs for the pharma industry. This high containment project includes two dispensing isolators, two SlurryBoxes (charging isolators for high potent slurry into reactors through pressured vessels), one reactor charging isolator and one vacuum drying isolator including PSL CakeStand Tray Dryer. The high containment suite is designed for an OEB5 environment achieving a DOEL of less than 100 nanogram/m³ during eight hours Time Weighted Average (TWA). The six rigid isolators in stainless steel will be pre-tested and FAT (Factory Acceptance Tests) in the next few months and installed in the manufacturing site by the end of the year.