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.
- Manufacture, quality management and analysis pursuant to the guidelines for the manufacture of pharmaceutical agents (GMP-ICH Q7)
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)1,2, in 1000 kg formstable FIBC’s with EURO pallet size1 and loose in silo trucks. Other filling quantities and forms of delivery will be evaluated on request.
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