Micro-Sphere SA was founded in 1998 and started its activity in 2000 in the factory in Madonna del Piano. Micro-Sphere SA has obtained the ISO 9001:2000 certification in February 2004. Development and pilot activities are operated under cGMP conditions. The company is regularly inspected by the Swiss Authorities (last inspection 7th April 2005).

Micro-Sphere's clean-rooms are operating in class D (100'000). To avoid powder cross-contamination of the production rooms the air-conditioning system uses 100% fresh air. Water for solutions is prepared by reverse osmosis and subsequently treated by electro-deionization. The quality of water is according to USP purified water (aqua purificata) specifications. On request water can be supplied as "highly purified water" according to the European Pharmacopoeia. Compressed air and nitrogen are also of pharmaceutical grade.