The World Health Orga­ni­za­tion (WHO) cur­rently esti­mates that up to 600 mil­lion people are affected by asthma and COPD world­wide. Many patients use inhal­able drugs for therapy pur­poses. How­ever, in many cases they do not use the inhalers cor­rectly which reduces the therapy suc­cess or can poten­tially lead to a health dete­ri­o­ra­tion. The phar­ma­ceu­tical com­pany Chiesi with head­quar­ters in Parma has rec­og­nized this problem and has devel­oped the NEX­Thaler^®, a powder inhaler which is both easy to handle and safe to use. Its intu­itive oper­a­tion ensures that the intended dose reli­ably reaches the lungs.

Closing the inhaler trig­gers the counting mechanism.

Fur­ther­more, a highly effec­tive com­bi­na­tion of proven active ingre­di­ents assures a well-­tol­er­ated treat­ment in case of dif­fi­culty breathing and dys­pnea. After every suc­cessful inhala­tion process, a counter indi­cates to the user the number of med­ica­tion doses remaining. When plan­ning to expand their pro­duc­tion capacity in 2013, the Italian enter­prise banked on the assembly and filling exper­tise of Harro Höfliger. The turnkey system which was put into oper­a­tion in the French Blois in 2015, fills and assem­bles up to 70 units per minute.

Filled with high precision

At the start of the filling process, the empty inhaler hous­ings are taken from trays and con­veyed to the inter­mit­tent oval turret on a puck belt. Gripper units push the hous­ings into the pro­duc­tion machine. This is fol­lowed by a per­for­mance test: After opening the inhaler, a com­pressed air impulse opens a small flap in the air intake shaft, called the Breath Actu­a­tion Mech­a­nism (BAM). This mech­a­nism ensures that the patient inhales deeply enough and, at the same time, serves to acti­vate the counting unit when the inhaler is closed.

“The wealth of ideas and inno­v­a­tive solu­tions which the Harro Höfliger team showed during the var­ious project phases really impressed us.“Roberto Bugarin, Engi­neering Director at Chiesi

Next the empty weight of the inhaler is deter­mined as the basis for the sub­se­quent fill quan­tity con­trol. A high-pre­ci­sion auger doser fills the powder reser­voir of the NEX­Thaler^®, which is then weighed again. The system imme­di­ately detects devi­a­tions from the defined fill quan­tity and sorts out inhalers exceeding or falling below the fill weight limit. The appro­priate adjust­ment of the fill system is per­formed by means of a trend con­trol. The active ven­ti­la­tion of the con­tain­ment system for oper­ator pro­tec­tion con­sti­tutes a major chal­lenge during weighing. It must not com­pro­mise the machine’s very sen­si­tive weighing units.

The powder reser­voir of the NEX­Thaler® is filled by means of a high-pre­ci­sion auger doser.

Tray­han­dling of the powder reservoirs.

Per­fect closure

In the next step the caps of the powder reser­voirs are fed to the line from a con­veyor unit. A high-speed robot arm picks up the indi­vidual caps with the cor­rect ori­en­ta­tion and places them prop­erly posi­tioned into a trans­port system for assembly. In order to avoid down­times of the assembly line at this posi­tion, the robot arm works over ten per­cent faster than required. The sub­se­quent product accu­mu­la­tion con­trols the buffer quan­tity. A mea­suring system detects any improp­erly mounted caps and rejects the respec­tive devices.

Fol­lowing the detec­tion process, the mouth­pieces, which are fed trans­versely in order to save space, are brought into the length­wise posi­tion for assembly. The mouth­pieces are mounted and checked for cor­rect fas­tening in an assembly sta­tion. Closing the NEX­Thaler^® trig­gers the counting mech­a­nism and a camera checks the counter for cor­rect func­tion­ality based on the dis­played counter posi­tion. An addi­tional con­trol sta­tion ensures that only the good prod­ucts advance and, ulti­mately, reach the hands of the patients.

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Photos: shutterstock.com/Denis Tabler, Helmar Lünig