ANTICOAGULANT SOLUTIONS FOR APHAERESIS COLLECTION
Suitable with all aphaeresis devices
ACD Formula A
C H A R AC T E R I S T IC S
ANTICOAGULANT SOLUTION FOR AUTOMATED APHERESIS, CONTAINED IN A FLEXIBLE PVC / DEHP BAG, STERILISED IN ITS INDIVIDUAL OVERWRAP.
1 Description
Solution
Composition:
- • Trisodium Citrate 2H2O.....................................................22, 0 g
- • Citric Acid 1H2O.................................................................8, 0 g
- • Glucose 1H2O..................................................................24, 5 g
- • PPI Water: 1000 ml.
PH: 4, 5-5, 5; Osmolality: 400-440 mOsm/kg. Sodium content: 214-234 mol/l.
2 Sterilization method
- • Steam sterilization in overwrap (121°C / 15 minutes).
- • Sterile and non-pyrogenic solution
Compliance
- • Sterile class IIb device (compliant with EC labelling dossier).
- • Directive 93/42/CEE.
- • Good Manufacturing Practices (GMP’s).
- • Bonnes Pratiques de Fabrication (BPF).
- • Norme ISO 594-2:1998 (Luer-lock connexion, ABS references).
Storage conditions and shelf life
Do not store above +35°C in original overwrap. Protect from light during storage. Do not freeze.
2 years shelf-life in original overwrap.
