“So much for powder is powder”

In the Swiss munic­i­pality Mon­teggio, located between lakes Lago di Lugano and Lago Mag­giore, is the devel­op­ment and pro­duc­tion center of Micro-Sphere S.A. In August 2017, the enter­prise tripled its pro­duc­tion capac­i­ties for spray drying and cap­sule filling, relying, among others, on tech­nology from Harro Höfliger.

Stefano Con­sole, Man­aging Director of Micro-Sphere S.A., is sit­ting in the con­fer­ence room of the bright admin­is­tra­tion building of a former fur­ni­ture fac­tory. On a screen, he shows the com­pany pre­sen­ta­tion and gives a sense of what their experts have been working on. Since 1998 the focus has been on over­coming com­plex for­mu­la­tion chal­lenges and the part­ner­ship-based sup­port of his cus­tomers from devel­op­ment to the com­mer­cial pro­duc­tion of pharmaceuticals.

The studied organometallic chemist Ste­fano Con­sole has spe­cial­ized in the busi­ness ­devel­op­ment of small and medium-sized enter­prises in the phar­ma­ceu­tical industry and has been a member of the company’s man­age­ment since 2012. He pays par­tic­ular atten­tion to focus on a market niche. This applies espe­cially to com­pa­nies with the size of ­Micro-Sphere. “Anyone who believes they can offer every­thing on their own, will not be suc­cessful in the long run,” empha­sizes the native Venetian Console.

For the dosing of highly cohe­sive and com­press­ible pow­ders, Micro-Sphere relies on the Modu‑C with drum filling.

With the pro­duc­tion and cap­sule fill­ing of highly potent pow­ders for inhala­tion, Micro-Sphere occu­pies a par­tic­u­larly inter­esting niche. Since com­ple­tion of the building exten­sion in August 2017, 16 clean­rooms are now avail­able, all of which comply with the require­ments of global GMP-stan­dards. Micro-Sphere has been inspected and cer­ti­fied by SwissMedic, the FDA and the Japanese PMDA, among others. The high quality stan­dard is evi­dent when looking at the cor­po­rate struc­ture. More than one third of the employees work in the Quality Unit, which includes Quality Assur­ance and Quality Control.

Part­ner­ship-based cooperation

Ste­fano Con­sole regards a coop­er­a­tive and trusting rela­tion­ship with his cus­tomers, which the Man­aging Director delib­er­ately calls “busi­ness part­ners”, as an indis­pens­able suc­cess factor. This is not the only thing in common with Harro Höfliger, which is some­thing he dis­cov­ered during his coop­er­a­tion with the machine man­u­fac­turer and highly appre­ci­ates. What makes both com­pa­nies stand out is the approach of always lis­tening care­fully in order to be able to offer their project part­ners a suit­able solu­tion package right from the start.

“We have pro­duced more than
100 var­ious pow­ders. One thing ist cer­tain: Every powder is dif­ferent.“Ste­fano Con­sole, Man­aging Director of Micro-Sphere S.A.

Ste­fano Con­sole was also lis­tening care­fully when, in search for an appro­priate dosing solu­tion for highly cohe­sive and com­press­ible pow­ders, a busi­ness partner told him about Harro Höfliger’s drum filling tech­nology. “I then con­tacted Marco Laack­mann, Harro Höfliger’s inhala­tion expert. A short time later we made an appoint­ment at the trade show CPhI and soon there­after met at Harro Höfliger in Allmers­bach. It quickly became obvious that we needed a Modu‑C with drum filling tech­nology for our field of application.”

Micro-Sphere’s 16 clean­rooms comply with all the require­ments of global GMP-standards.

Ever since, the two com­pa­nies have enjoyed a strong and coop­er­a­tive rela­tion­ship. While Micro-Sphere’s employees are con­sid­ered the leading experts in spray drying phar­ma­ceu­tical pow­ders, he credits Harro Höfliger with remark­able exper­tise in the field of cap­sule filling tech­nology. If the Swiss com­pany is unable to address cus­tomer ques­tions about filling methods, “Harro Höfliger is always ready to pro­vide answers,” says Console.

The Italian con­siders the model of the strategic alliance within Excel­lence United as exem­plary. In order to be able to offer your project part­ners the ideal solu­tion, strong coop­er­a­tion part­ners are needed to develop a holistic solu­tion approach. “We also see such a part­ner­ship with Harro Höfliger. What makes it so valu­able is that we can learn a lot from each other and share the knowl­edge and expe­ri­ence with the market.“

About Micro-Sphere S.A.

Micro-Sphere S.A., with head­quarters in Mon­teggio in the Canton of Ticino, is a con­tract man­u­fac­turer spe­cial­izing in GMP spray drying and cap­sule filling. They are con­sid­ered a leader in the pro­cessing of APIs and HPAPIs. With a team of 37 experts, Micro-Sphere sup­ports cus­tomers around the world in the devel­op­ment and man­u­fac­ture of phar­ma­ceu­tical prod­ucts with a spe­cial focus on spray dried powder and inhala­tion powder.

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Photos: Roberto Mar­che­t/Micro-Sphere