Sanal® P – Requirements

  • Active pharmaceutical ingredients quality
  • Certificate of Suitability (CEP 2008-105) - available for authorisation
  • Free from bacterial endotoxins
  • Highly pure sodium chloride without any additives, NaCl content >99.96%
  • Manufacture, quality management and analysis pursuant to the guidelines for the manufacture of pharmaceutical agents (GMP-ICH Q7A)
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    Sanal® P – Application

  • Suitable for the manufacture of parenterals
  • Also suitable for the manufacture of haemodialysis, haemofiltration, haemodiafiltration and peritoneal dialysis solutions
  • Sanal® P – Packing

    Sanal® P is available in 25 kg LD-PE bags (40 x 25 kg), in 1000 kg formstable FIBC’s with EURO pallet size and loose in silo trucks. Other filling quantities and forms of delivery will be evaluated on request.

     

     

     

    Sanal® P - 25 kg LD-PE bag

    sanalQ

    1 on heat-treated EURO wooden pallets, comply with IPPC/ISPM 15
    2 each wrapped with flex net for stacking stability and covered with a corrugated cardboard cover