We set ideas in motion

Harro Höfliger has expanded its ser­vice port­folio with Device Ser­vices, which com­plete the new Process Ser­vices divi­sion. From now on, in their own product devel­op­ment efforts, cus­tomers will also ben­efit from our exten­sive know-how in machine manufacturing.

Harro Höfliger attaches great impor­tance to sup­porting cus­tomers throughout the entire life cycle of prod­ucts and machines. As with all other com­pany divi­sions, the ser­vice offer­ings are reg­u­larly put to the test. What do cus­tomers need and which ser­vices can we pro­vide to better sup­port them? CEO Thomas Weller explains: “In order to be able to respond even more directly to our cus­tomers’ wishes, we have cre­ated the Process Ser­vices divi­sion headed by Stefan Mayer. Under this umbrella we bring together all ser­vices which we can pro­vide to assist cus­tomers in the devel­op­ment of a product from con­cept to market readi­ness.” What was missing for a long time was a ser­vice com­po­nent that specif­i­cally sup­ports cus­tomers in the devel­op­ment or opti­miza­tion of existing devices and med­ical prod­ucts. Starting last summer, the so-called Device Ser­vices, which are also man­aged by Stefan Mayer, now per­fectly com­ple­ment our ser­vice offerings.

(Illus­tra­tion: Bernd Schifferdecker)

Every­thing has to fit

With the cre­ation of the new ser­vice divi­sion, Harro Höfliger also responded to the increasing number of cus­tomers who are seeking sup­port for their own product devel­op­ment. “Of course, first and fore­most we are machine engi­neers,” explains Stefan Mayer. “But careful con­sid­er­a­tion of what is filled and processed on our machines is essen­tial for their design. An opti­mally designed device is just as impor­tant for the suc­cessful overall process as per­fect product devel­op­ment processes, which we have been ensuring for many years with our Pharma Ser­vices.” Thomas Weller adds: “Our cus­tomers rightly rely on us to develop processes that can be imple­mented one-to-one from the lab­o­ra­tory machine to inter­me­diate sizes to high-speed machines. It is only log­ical that we con­tribute to the com­mer­cially optimal pro­duc­tion of a device with this new ser­vice com­po­nent. This exper­tise allows us to offer a com­plete solu­tion package.”

An opti­mally designed device is just as impor­tant for the suc­cessful overall process as per­fect product devel­op­ment processes.“Stefan Mayer, Leader Process and Device Services

Cus­tomers ben­efit from the fact that the four depart­ments within Process Ser­vices are closely inter­linked. The Device Ser­vices experts work hand in hand with their coun­ter­parts at Pharma Ser­vices, who pro­vide sup­port in process selec­tion, devel­op­ment and opti­miza­tion at an early stage of product devel­op­ment. The spe­cial­ists in the Engi­neering & Inno­va­tion Ser­vices divi­sion, in turn, assist with inno­va­tion projects, design test and trial setups, con­duct fea­si­bility studies and build pro­to­types. The focus is always on product safety and the devel­op­ment of proven, robust machines and processes which can be qual­i­fied or val­i­dated by our Val­i­da­tion Ser­vices employees.

An eye on details

Cus­tomers can ben­efit greatly from the sup­port ren­dered by Device Ser­vices. For example, the FDA (US Food and Drug Admin­is­tra­tion) reg­u­la­tions regarding device opti­miza­tion have become more strict. In the future it will no longer be so easy to change indi­vidual pro­duc­tion steps after an approval, even if they do not fun­da­men­tally inter­fere with the func­tion of the device. Every sub­se­quent change inevitably means a great deal of effort, in the most serious case even a new approval, resulting in lost time and high costs. It there­fore pays to design an inhaler or injector right from the start so that it is suit­able for all pro­duc­tion stages up to series pro­duc­tion on a high-end machine without later adjustments.

“This com­ple­men­tary exper­tise of our Device Ser­vices spe­cial­ists allows us to offer our cus­tomers a com­plete solu­tion package.“ Thomas Weller, CEO 

The often com­plex joining processes of devices, that often con­sist of small com­po­nents, can be reli­ably tested in trial appli­ca­tions at Harro Höfliger. And in the case of pre-devel­oped devices, our spe­cial­ists have a keen eye for detail. For example, an infeed angle that per­fects a good device. “In addi­tion to our knowl­edge in mold making and mate­rial sci­ence, our many years of expe­ri­ence come into play,” explains Mayer. “We have worked with count­less devices from cus­tomers and have also devel­oped our own with the XTray®. This gives us a sense of what a product should look like and where there is still room for improvement.”

Our Device Ser­vices spe­cial­ists also take care of the exten­sive, quite com­plex devel­op­ment of proper doc­u­men­ta­tion, which is very demanding. We need to be familiar with Inter­na­tional stan­dards in order to ensure com­pli­ance. For example, spec­i­fi­ca­tions on how to struc­ture device his­tory doc­u­men­ta­tion according to 21CFR820 and which risk analyses and tests are manda­tory according to the ICH Q9 Guideline.

(Illus­tra­tion: Bernd Schifferdecker)

Ideal con­di­tions

Harro Höfliger invested heavily in the new Process Ser­vices divi­sion. This began with addi­tional man­power and training, such as for the new doc­u­men­ta­tion depart­ment. But it also entailed an invest­ment in equip­ment and new clean­rooms. In addi­tion to the four newly installed clean­rooms equipped with humidity and tem­per­a­ture con­trol, six more will go into oper­a­tion in the fourth quarter of 2018. In two of them even highly potent sub­stances up to level OEB 5 (per­mis­sible expo­sure limit of less than 1 µg / m3 breathing air) can be tested. A spe­cial air­lock tech­nology makes sure that no sub­stances spread to the outside.

New lab­o­ra­tory equip­ment such as a New Gen­er­a­tion Impactor – a device that makes it pos­sible to better map the aero­dy­namic behavior of inhaled drugs – will allow even more pre­cise pre­lim­i­nary studies by both Pharma Ser­vices and Device Ser­vices. Stefan Mayer: “Our cus­tomers are demanding more and more trials with their own active ingre­di­ents and prod­ucts on our machines. After all, such a system is a big invest­ment and cus­tomers want to be sure that ulti­mately every­thing works just as it should. Our goal is to pro­vide this assurance.”

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Graphic: Bernd Schif­fer­decker, Photos: Janine Kyofsky