The production site
|Total area:||10.800 sm|
|Covered surface:||5.400 sm|
|Injectable forms:||dedicated area |
|Packaging area:||900 sm|
Free space available for expansion. Current utilities can easily be expanded to cover additional requirements.
The Injectable Manufacturing Department was established in 2002 and obtained its first manufacturing authorisation in December 2003.
Processes rely on an aseptic working environment. It is possible also to terminally sterilise thermal resistant products.
• Continuous particle monitoring with visual alarms for operators and with remote registration of data and alarms
• Continuous microbiological monitoring with fixed plates with active aspiration
• Microbiological environmental and personnel monitoring is conducted by the internal Quality Control
• Continuous HVAC monitoring with remote registration of data and alarms
• Water for injection generated through tap water softening and inverse osmosis treatment
• Clean steam generation starting from purified water
• Oil-free compressed air
• Nitrogen distributed via a dedicated line and filtered with 0.22μm filters
The packaging department includes 4 packaging lines:
• ampoules in PVC blister
• single vial, multiple vials, vial and ampoule in carton box
• pre-filled syringes in PVC blister
• semi-manual packaging in PVC blister or in carton box
A dedicated area in the packaging department is located for the manual clinical trials packaging.
Liquid (vials, ampoules, pre-filled syringes)
Freeze dried (vials)