ANTICOAGULANT SOLUTION ACD-A

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.

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