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Industrial equipment in a cGMP environment

Concentration and isolation equipment

Kyrapharm has access to all of Orgapharm’s industrial concentration and isolation equipment (distillator, reactors, filters, dryers) in a cGMP environment.

About thirty industrial reactors and twelve others in the pilot plant can allow solvent concentrations at atmospheric pressure or under vacuum. Purified products can be crystallized and isolated into agitated filter dryers, in order to prevent any contamination. These equipment allows the direct drying or the product without any transfer.
When centrifuges or monoplate filters are required, Orgapharm can also dry products in ventilated ovens.
For any operation of treatment of eluting solvents or isolated products, Orgapharm HSE and QA policies are applied; Orgapharm being a FDA certified site.

Equipement de concentration et d'isolement
cGMP pilot plant - Multipurpose reactors ranging from 20 to 600 L

The Axyntis Group, an intermediate-sized company with estimated turnover of €100 M in 2014 and more than 420 employees, is a leading speciality chemicals company in France thanks to its GMP capabilities (700 m3). The group owns six sites (All’Chem in Montluçon, Centipharm in Grasse, Orgapharm in Pithiviers, Steiner in Saint Marcel and Synthexim in Calais, withtwo sites) and three R&D centres, all located in France. Its activities revolve around the life sciences (pharmacy, animal health, agrochemicals), dyes and speciality fine chemicals (electronics, photography, cosmetics, flavourings and perfumes, etc.)
www.axyntis.com

Orgapharm, located in Pithiviers, is a subsidiary of the Axyntis Group. The site employs 95 people and has a total reactor volume of 90 m3. It has been inspected by the Food and Drug Administration (last inspection in 2014), the French National Agency for Drug and Health Product Safety (ANSM) and is also ISO 14001 certified. Main Axyntis Research & Development centre is located at Orgapharm, together with a GMP pilot plant as well as multipurpose synthesis plants and an automated GMP crystallisation/finishing unit. The entire production cycle is covered, from the laboratory to industrial production, thereby enabling support for a project in its entirety.