BEST PRACTICE  

Potent mix­ture

The Swiss pack­aging spe­cialist Neopac is devel­oping a glass-free pri­mary pack­aging con­cept for par­enter­ally used drugs. Harro Höfliger has been pro­viding assis­tance with the process devel­op­ment since the test phase.

T

he Fleximed ® tube is a trans­parent, flex­ible med­ical tube made of syn­thetic lam­i­nate offering sig­nif­i­cant advan tages in com­par­ison to con­ven­tional small glass bot­tles or ampoules. In addi­tion to break resis­tance, ease of use and safety are among the most impor­tant fea­tures. With Easymix, a product from the Fleximed ® product family, Neopac goes even one step fur­ther. This two-chamber tube enables simple and safe prepa­ra­tion of mix­tures for injec­tions or infu­sions. The two cham­bers are sep­a­rated from one another by a flex­ible bar­rier: A seam opens under pres­sure to the rear chamber, which enables mixing. With this method, two liq­uids as well as one liquid and one powder com­po­nent can be mixed.

At present, Neopac is in var­ious clin­ical trial phases with sev­eral poten­tial cus­tomers. For the aseptic filling and sealing of the tubes, Neopac relies on the know-how of Harro Höfliger. “In our search for a poten­tial partner, we were looking for tech­nology leaders in the industry,” says Ralf Künzi.

Ralf-Kuenzi

“Harro Höfliger is the clear leader in spe­cialty machine engi­neering for par­enteral pack­aging.“Ralf Künzi, Busi­ness Devel­op­ment Man­ager Med­ical, Neopac

Since 2011, Harro Höfliger has been a partner in the process devel­op­ment of the Fleximed ® product family. In the early phase of the col­lab­o­ra­tion, the com­pany sup­plied a semi-auto­matic lab­o­ra­tory machine, which can fill the tubes with liq­uids as well as pow­ders and is equipped with an inte­grated sealing tool.

More sta­bility

Liquid active ingre­di­ents which are used in the field of par­enteral med­i­cine often do not remain stable for long. This is why they are stored in powder form and mixed with a sol­vent prior to appli­ca­tion. The tube’s multi-layer struc­ture offers the nec­es­sary high bar­rier pro­tec­tion against water vapor and oxygen. At this year’s Inter­pack in Düs­sel­dorf, the first labeled Fleximed ® Easymix Tube was pre­sented to the trade pro­fes­sionals – another mile­stone on the road to market launch.

Clever labeling

Labeling the Easymix tube cre­ated an espe­cially major chal­lenge. Regarding the basic require­ments for label solu­tions, Ralf Künzi says: “You have to fit a lot of infor­ma­tion on the label, which is required for reg­u­la­tory pur­poses. Fur­ther­more, the infor­ma­tion must be per­ma­nently attached to the tube.” Simply adhering the label was not an option due to the com­plex tube geom­etry.  Here, the label experts from Schreiner MediPharm came into play. “Accord­ingly, we had to find a labeling solu­tion which does not limit the func­tion­ality of the Easymix tube. It is also imper­a­tive that the user has an unob­structed view of the con­tent,” Max­i­m­ilian Jaeger explains the cri­teria.  “This is why we devel­oped a new label with a front and back part that sur­rounds the tube like a bag. The experts from Harro Höfliger have also made it pos­sible to apply this tube bag with a machine. As machine man­u­fac­turers, they have been able to add a dif­ferent per­spec­tive with regard to processes,” con­tinues Jaeger.

Max­imil­lian Jäger

“We often seek new ways which break with estab­lished approaches.“Max­i­m­ilian Jaeger, Pro­dukt- und Process Man­ager, Schreiner MediPharm

In gen­eral, Ralf Künzi sees great market poten­tial for the Fleximed ® tubes: “We are cer­tain that in the next few years we can win sev­eral cus­tomer projects, each of which will have dif­ferent require­ments that demand cus­tomized devel­op­ments.” For Künzi it is impor­tant that he can rely on the part­ners who have already been involved in the devel­op­ment of the product, “because we have gone through common learning processes and now have shared knowl­edge.  Together with the two project part­ners, we have an extremely potent mix of inno­v­a­tive strength.”

About Neopac und Schreiner MediPharm

Neopac with head­quar­ters in Oberdiess­bach (Switzer­land) was founded in 1906 and has been pro­ducing syn­thetic tubes since 1954. Neopac is part of the Hoff­mann Neopac AG, an inde­pen­dent family-owned enter­prise based in Thun (Switzer­land), spe­cial­izing in the devel­op­ment and pro­duc­tion of tubes for the safe­guarding of health­care prod­ucts. The annual pro­duc­tion output is more than 600 mil­lion tubes.

Schreiner MediPharm with head­quar­ters in Ober­schleißheim near Munich is a leading devel­oper and man­u­fac­turer of inno­v­a­tive, multi-func­tional spe­cial labels and labeling solu­tions for the phar­ma­ceu­tical industry and med­ical tech­nology. Thanks to the enterprise’s spe­cial know-how, Schreiner MediPharm has made a name for itself as a pow­erful devel­op­ment partner and reli­able quality sup­plier for leading phar­ma­ceu­tical companies.

Down­load this article as PDF file

Photos: JK1991/iStockphoto.com, MediPharm, Neopac