Powder Systems Ltd (PSL) recently delivered a high containment installation and will start the manufacturing of a range of isolators, both projects for Spain.
The first project consists of a large-scale pressure agitated nutsche filter dryer (ANFD) and a discharging isolator achieving a design occupational exposure limit (DOEL) of less than 1 µm during the sampling period.
This multipurpose isolator allows full recovery of the dried product obtained from the 0.6 m2 filtration vessel plate, sampling without process disruption, powder dispensing, weighing and packing off within a safe and contained environment for the protection of both the operator and the product.
One of the leading Spanish pharmaceutical groups will install these advanced contained filtration and drying facilities in 2013 in their synthesis plant for production of innovative medicines.
PSL is also working on a second project for a Spanish world leader in developing and manufacturing advanced pharmaceutical intermediates and APIs/HAPIs for the pharmaceutical industry.
This high containment project includes two dispensing isolators, two SlurryBoxes (charging isolators for highly potent slurry into reactors through pressured vessels), one reactor charging isolator and one vacuum drying isolator, including PSL CakeStand tray dryer.
The whole 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 factory acceptance tests (FATs) will be carried out over the next few months, prior to their installation at the end user’s manufacturing site in Spain by the end of this year.
The partnership between the two companies has only just begun, with future projects being discussed to complement the installation later on in 2013.
PSL has been exporting to Spain for more than 10 years and is expecting more business to come from this growing pharmaceutical and chemical market. The appointment of agent José Roldán Pázos in July 2013 allows PSL to now cover both Spain and Portugal with a direct presence.