Phar­ma­ceu­tical com­pa­nies who want to launch an injec­tion pen or an autoin­jector are faced with sev­eral chal­lenges. Once the active ingre­dient has been devel­oped and is under­going trials, the appro­priate injec­tion device has to be iden­ti­fied and market approval obtained. On the way to the fin­ished product, phar­ma­ceu­tical com­pa­nies not only have to deal with approval author­i­ties but also with var­ious com­pa­nies: the device man­u­fac­turer, the man­u­fac­turer of the filling machine as well as one or more man­u­fac­turers of assembly and pack­aging machines.

This involves a great deal of coor­di­na­tion. Harro Höfliger rec­og­nized this chal­lenge at an early stage and has con­tin­u­ously expanded its ser­vice and con­sulting offerings.

 

Close part­ner­ship

A few years ago, the Swiss device man­u­fac­turer Ypsomed also responded to the need for com­pre­hen­sive cus­tomer sup­port by estab­lishing a joint pro­duc­tion net­work with Harro Höfliger. In the devel­op­ment of injec­tion pens and auto-injec­tors, the device and machine man­u­fac­turer work hand in hand with phar­ma­ceu­tical com­pa­nies in order to address indi­vidual wishes and at the same time ensure rapid market launch.“

For both the phar­ma­ceu­tical cus­tomer and Ypsomed, reli­able and timely coop­er­a­tion with the machine sup­plier is essen­tial in order to adhere to strict sched­ules,” says Orfeo Nie­der­mann, Busi­ness Devel­op­ment Director at Ypsomed. While dosage, shape and color of the device can be adjusted at the customer’s option, the func­tional com­po­nents are based on stan­dard­ized plat­forms – both in the layout of the Ypsomed device and in the design of the assembly machines.

A strong partner who under­stands the device and the processes is extremely impor­tant. With their com­pe­tence and expe­ri­ence in the field of semi-auto­matic pen assembly, we felt com­fort­able that the required quality would be met.“ Kristen D’Urso, Project Man­ager, Ambio, Inc.

Exper­tise

With their con­sulting ser­vices, Ypsomed and Harro Höfliger facil­i­tate the entry into pen and autoin­jector pro­duc­tion and sup­port com­pa­nies in the expan­sion of their port­fo­lios. Harro Höfliger’s Process ­Ser­vices, such as Engi­neering & Inno­va­tion Ser­vices, also play a helpful role. The experts in this spe­cial devel­op­ment depart­ment focus on careful and pre­cise han­dling. They test mate­rial prop­er­ties and opti­mize man­u­fac­turing processes with the aim of meeting the required quality stan­dards even at high pro­duc­tion speeds.

Allotted tasks

The com­plex pre-assembly of the injec­tion devices takes place directly at Ypsomed. The device man­u­fac­turer can guar­antee its con­sis­tently high quality through high-pre­ci­sion assembly and con­trol processes. The pre-assem­bled devices are assem­bled with the syringes or car­tridges and pack­aged at the phar­ma­ceu­tical com­pany or con­tract man­u­fac­turer. Filling of the active ingre­dient takes place at the phar­ma­ceu­tical com­pany or con­tract man­u­fac­turer on a spe­cial filling machine.

This is where a spe­cialist for the filling of ­l­iquids such as Bausch+Ströbel comes into play. Due to the long-standing coop­er­a­tion within the Excel­lence United net­work, the pro­duc­tion lines of Bausch+Ströbel can be easily inte­grated into the lines of Harro Höfliger. The ben­e­fits of this close coop­er­a­tion are also ­reflected in the project flow, thanks to reduced ­inter­faces and col­lec­tive exper­tise. Harro Höfliger offers tailor-made machine plat­forms from labora­tory to full-scale pro­duc­tion for both the final assembly and the sub­se­quent pack­aging tasks of the devices.

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Photos: Helmar Lünig, Janine Kyofsky, Ypsomed AG