Steriles

Our injectables are filled with the latest top level isolator technology and high throughput equipment.

We perform compounding, filling, autoclaving (option), visual inspection, packaging, serialisation, and aggregation, testing and release.

Read more about our Centre of Excellence for Products and Strategy.

INJECTABLES

Pre-filled syringes

Pre-filled Syringes with luer-Lock or needle tip (8,15 or 10,85 outside diameter)

Fill volume: 0,3 to 2 ml

Mixing, compounding, sterilisation, visual inspection and packaging:

Solutions or ready-to-fill bulk
Aseptic filtration and/or autoclaving
Fully automated 100% visual inspection
Device assembly
In-line fully automated blister-packing, cartonning, leaflet, serialisation, shipper, aggregation palletisation

Site: Aspen Notre Dame de Bondeville S.A.S (France)

Capacity per year: 280 million

Vials

Vials (freeze-dried)

Fill volume: B3, B5, B12, 2R
Mixing, compounding, sterilisation, visual inspection and packaging:

Stainless steel compounding with integrated containment isolator for dispensing of High-Potent API
Stainless steel and single use compounding capability (Capacity shared between liquid and lyophilized vials)
Aseptic filtration and/or autoclaving (terminal sterilisation)
Manual, semi-automated and fully automated visual inspection
In-line fully automated cartonning, leaflet, serialisation and/or aggregation

Site: Aspen SA Operations (Pty) Ltd (South Africa)
Capacity per year: 16 million

Vials filled with liquid

Fill volume : 1, 2, 5, 10, 20, 30 ml
Mixing, compounding, sterilisation, visual inspection and packaging:

Solutions, suspensions or ready-to-fill bulk
Aseptic filtration and/or autoclaving (terminal sterilisation) Capacity shared between liquid and lyophilized vials
Crimp seal 30m F200, 50m ALICE
In-line fully automated cartonning, leaflet, serialisation and/or aggregation

Site: Aspen SA Operations (Pty) Ltd (South Africa)
Capacity per year: 80 million

Glass ampoules and cartridges

Glass ampoules

Fill volume: 1, 2, 3, 5, 10, 20 ml
Mixing, compounding, sterilisation, visual inspection and packaging:

Stainless steel and single use compounding capability
Aseptic filtration and/or autoclaving (terminal sterilisation) 25m B&S, 30m ALF
Manual, semi-automated and fully automated visual inspection
In-line fully automated cartonning, leaflet, serialisation and/or aggregation

Site: Aspen SA Operations (Pty) Ltd (South Africa)
Capacity per year: 55 million

Cartridges (carpules)

Fill volume: 50 to 100 ml
Mixing, compounding, sterilisation, visual inspection and packaging:

Compounding
Aseptic filtration and/or autoclaving (terminal sterilisation)
Manual, semi-automated and fully automated visual inspection
In-line fully automated cartonning, leaflet, serialisation and/or aggregation

Site: Aspen SA Operations (Pty) Ltd (South Africa)
Capacity per year: 10 million

Blow Fill and Seal (BFS)

Blow Fill and Seal plastic ampoules PE (PolyEthylene)

Fill volume: 2, 5, 10 ml
Mixing, compounding, sterilisation, visual inspection and packaging:

Solutions
Aseptic filtration
Fully automated and in-line 100% leak detection and visual inspection
In-line fully automated cartonning, leaflet, serialisation and/or aggregation

Site: Aspen Notre Dame de Bondeville S.A.S (France)
Capacity per year: 40 million

Blow Fill and Seal plastic ampoules PP (PolyPropylene)

Fill volume: 10, 20ml
Mixing, compounding, sterilisation, visual inspection and packaging:

Solutions
Aseptic filtration and autoclaving in blister-packs
Fully automated and in-line 100% leak detection and visual inspection
In-line fully automated cartonning, leaflet, serialisation and/or aggregation

Site: Aspen Notre Dame de Bondeville S.A.S (France)
Capacity per year: 25 million

Form Fill and Seal (infusion bags)

Form Fill and Seal Semi-rigid infusion bags

Fill volume: 100 to 200 ml (smaller or larger size upon request)
Mixing, compounding, sterilisation, visual inspection and packaging:

Solutions
Aseptic filtration and autoclaving in blister-packs
Fully automated and in-line 100% leak detection and visual inspection
In-line fully automated cartonning, leaflet, serialisation and/or aggregation

Site: Aspen Notre Dame de Bondeville S.A.S (France)
Capacity per year: 4 million

NON-INJECTABLES

Blow Fill and Seal (nebules)

BFS nebules for inhalation PE (PolyEthylene)

Fill volume: 2.5 ml

Mixing, compounding, sterilisation, visual inspection and packaging:

Solution
Fully automated in-line 100% leak detection
Aluminum pouching
In-line fully automated cartonning, leaflet, serialisation

Site: Aspen Bad Oldesloe GmbH (Germany)

Capacity per year: 11 million

Gels (topical) Eye-drops

Gels (sterilisation by autoclaving)

Fill volume: 30 g

Mixing, compounding, sterilisation, visual inspection and packaging:

Emulsions, oily preparations
Tube filling, Option: autoclaving
In-line fully automated cartonning, leaflet, serialisation

Site: Aspen Bad Oldesloe GmbH (Germany)

Capacity per year: 8 million

Eye-drops with preservatives

Fill volume: 6, 10, 15 and 30 ml (0,2 oz, 0,3 oz, 0,5 and 1)

Mixing, compounding, sterilisation, visual inspection and packaging:

Solutions
Aspetic filtration
In-line fully automated cartonning, leaflet, serialisation

Site: Aspen SA Operations (Pty) Ltd (South Africa)

Capacity per year: 42 million