Post drying and more
Alongside spray drying and capsule filling, the two core technologies of Microsphere, we have developed additional services, both upstream and downstream, to offer our customers a ‘one-stop-shop’ partner with a wide range of pharmaceutical and particle engineering services, such as:
Post drying
We carefully design all our spray drying processes to achieve the residual solvent specifications defined by the Pharmacopoeia (USP or EU Ph.), or more stringent thresholds required by the customer. When this is not possible through spray atomization, secondary drying (or post drying) is performed.
Microsphere is equipped with 3 secondary drying lines to accommodate a wide range of batch sizes:
- Static vacuum tray dryer for small batches and pilot batches (approximately 0.5 liters to 6 liters of equivalent powder)
- Static vacuum tray dryer for medium-sized batches (approximately 6 liters to 80 liters of equivalent powder)
- Dynamic vacuum dryer (Planex® System Italvacuum), an innovative horizontal dryer
with an eccentric agitator and two independent movements, allowing it to rotate simultaneously around its own axis and also tangentially to the drying chamber.
This equipment allows us to obtain a very gentle drying and simultaneous homogenization, making it the right machine for large batch sizes (100 to 500 L of equivalent powder) and for highly sensitive Drug Products (DP) and Drug Substances (DS).
High-Pressure Homogenization (HPH)
This technology, available both in GMP and R&D environment, is essential to prepare some feedstock for spray drying, such as emulsions, liposome emulsions, dispersions, oily and water mixtures, as well as for cell lysis.
Our High-Pressure homogenizers can apply to a liquid solution a pressure of more than 1400 barg; this high shear, applied through a special valve or membrane with very narrow slits, creates a large pressure drop, and cavitation, acting as homogenizer of insoluble components.
Our HPH equipment in Microsphere is produced by premium manufacturers like GEA Niro Soavi and IKA. They are also equipped with high-efficiency cooling systems to preserve thermal-sensitive products.
Nano-suspension and ball milling
Microsphere produces nano-emulsion and mill liquid suspension to shape the right feedstock for spray drying.
We are equipped with a DYNO®-MILL WAB ‘bead mill’, that allows for products from a low to a high viscosity to be ground reproducibly or manufactured as ultrafine dispersions in the micron- to nano-range.
Our bead mill is equipped with high-efficiency cooling systems to preserve thermally-sensitive products, and with ceramic design (made of zirconium oxide/silicon carbide) to assure a metal-free process.
Bottle-filling for clinical studies
We offer an accurate bottle or vial filling service, with 100% weight check, through manual filling or semi-automatic machines. Cap sealing can be automatically performed, with torque check of filled bottles.
Third party service for stability studies
Thanks to the availability of four stability chambers and a skilled group of analysts, we offer
qualified and accurate stability studies on finished products, including pharmaceutical forms
manufactured by other companies.
