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Manufacturing of sterile injectables

Sopharma has capacity and experience to meet a range of sterile injectables contract manufacturing needs.
Sopharma is specialized in manufacturing of sterile dosage forms:

• terminally sterilized injectables
• aseptically prepared injectables

At any stage of the production, from the filling to the packaging, we can offer pharmaceutical contract manufacturing services for the following pharmaceutical forms: glass ampoule of 1, 2, 5 and 10 ml, 100, 250, 500 and 1000 ml PP bags and 0.7÷ 500 ml BFS (blow fill seal manufacturing technology).

Ampoule plant

Main manufacturing equipment includes:

• PW installation with capacity up to 6 t/h
• WFI installation (used jointly with the lyophilized products plant) with capacity up to 1.5 t/ h
• Lines for visual control AIM277SD12 & AIM296EISAI
• High voltage inspection (leak detection, pinhole and crack detection) line NIKKA DENSOK HDB 7080
• Labeling lines Newman 6VA and Newman VAL 550
• Metronic UDA 150S
• Secondary packaging lines Soteco FP-300, ZKBS

Main manufacturing equipment with terminal sterilization includes:

• Washing-dosing-sealing line #1, Bosch, capacity 1&2 ml glass ampoules - 6 ÷ 18 000 units / h
• Washing-dosing-sealing line #2, Bosch, capacity 2 ml glass ampoules 6 ÷ 16 000 units / h; 5 ml - up to 12 000 units / h; 10 ml - up to 9 000 units / h
• Autoclaves for steam sterilization, Getinge, 3000 l
• Vessel, Schrader, capacity 20 l, 50 l, 100 l, 250 l

Main manufacturing equipment with aseptic preparation includes:

• Washing-depyrogenization-dosing-sealing line #3,Bosch ALF, capacity 1&2ml glass ampoules - up to 24 000 units/ h, 5 ml – up to 15 000 units/ h, 10 ml- up to 9 000 units/ h
• Autoclaves for steam sterilization, Getinge, 500 l
• Vessels, Schrader, capacity 100 l, 300 l

Lyophilized products Plant

Main manufacturing equipment includes:

• Shared PW and WFI lines with Ampoule plant
• Vessel Buchi - 15 l, equipped with dosing device, cryostat, pH-meter, thermocouple
• Vessel, Steridose, capacity 50 l
• Lyophilizer, Leybold
• Autoclaves – Tuttnauer

For additional information, please contact us:

Ana Lichkova
Manager Contract Manufacturing and New Products
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