sirton pharmaceuticals

The production site

Total area:10.800 sm
Covered surface: 5.400 sm
Warehouse: 2.400 sm
Injectable forms:dedicated area 
free area  
650 sm
600 sm
Packaging area: 900 sm

Free space available for expansion. Current utilities can easily be expanded to cover additional requirements.



Injectable department  

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.

Main characteristics:

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



Packaging department 

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.


sirton pharmaceuticals