Sanal salt granted GMP certification
Sanal is the active pharmaceutical ingredient (API) in parenteral and peritoneal solutions and is also a base material for haemodyalisis, haemodiafiltration and haemofiltration.
The certification from the European Union follows the US Food and Drug Administration’s (FDA) approval of the site in March 2006.
Jörg Bockstede, business manager at Akzo Nobel Salt, said: “Highly pure sodium chloride free from additives and bacterial endotoxins plays an essential role in the pharmaceutical industry and in the manufacture of medical and pharmaceutical products.
“We are always committed to exceed the stringent requirements of the pharmaceutical industry and are therefore delighted to achieve this recognition for our Sanal products.”
The Mariager facility is dedicated to the production of Sanal, with two quality grades produced on site. Sanal P NaCl pharmaceutical quality is manufactured for use in drug production and is free from bacterial endotoxins and is compliant with GMP-ICH Q7A.
Both of these traits are also applicable to the other quality grade, Sanal SQ, which also meets the American Chemical Society’s (ACS) requirements for highly pure fine chemicals.
Sanal SQ has a NaCl content of over 99.99 per cent as opposed to 99.96 per cent for the pharmaceutical grade. Both quality grades are available in 25kg bags and a 1000kg Euro pallet sizes, with Sanal P also available loose in silo trucks.
Akzo Nobel Salt is the only company manufacturing salt in Scandinavia, with its Mariager plant producing 600,000 tonnes of salt a year for use by consumers, industry and on roads. The company has a workforce of 68,000 based in more than 80 countries.
In addition to sodium chloride the company produces a range of organometallic reagents, peroxides and initiators with applications in the synthesis of pharmaceuticals.
These are produced at facilities across the Americas, Asia and Europe and are available to customers in quantities ranging from grams to tonnes.
