Testing & Release, Stabilities
In-house testing is key to a timely release to the market.
At Aspen, we have invested in large quality control labs for physico-chemical, biochemical and microbiological testing with redundancy of all main equipment.
In line with the Thrombosis family of products (heparin and fondaparinux), we have developed a high level expertise in biologicals testing.
TESTING
Physico-chemical
- HPLC
Sites:
- Aspen Notre Dame de Bondeville S.A.S. (France),
- Aspen Bad Oldesloe GmbH (Germany),
- Aspen SA Operations (Pty) Ltd (South Africa),
- Alphamed Formulations Private Limited (India)
- GC
Sites:
- Aspen Notre Dame de Bondeville S.A.S. (France),
- Aspen Bad Oldesloe GmbH (Germany),
- Aspen SA Operations (Pty) Ltd (South Africa),
- Alphamed Formulations Private Limited (India)
- AAS
Sites:
- Aspen Notre Dame de Bondeville S.A.S. (France)
Release
In-house testing, release of all incoming materials and all finished products.
More than 20 Qualified Persons over four sites are duly certified for the release of products.
Stability programs
Stability chambers for on-going and registration stabilities.
All climatic conditions for zones I, II, III, IV and semi-permeable (low humidity)
Thermocycling/Freeze Thaw -25°C to 110°C
Photostability Chamber