It has become one of the largest health issues in the world: According to a WHO report, about half of all patients with chronic dis­eases do not take their med­ica­tion as pre­scribed. This lack of ther­a­peutic adher­ence or “com­pli­ance” not only neg­a­tively affects patients. It is esti­mated that in the US alone the sub­se­quent cost amounts to at least 100 bil­lion dol­lars a year – a heavy burden on the health­care system.

Tiny rods with great potential

Sub­cu­ta­neous implants promise to poten­tially improve this sit­u­a­tion. These are active sub­stance-con­taining rods of polymer com­pounds that are placed under the patient’s skin with a device. Depending on the field of appli­ca­tion, they release their active ingre­dient evenly over a period of up to sev­eral months. This can replace the daily intake of tablets or recur­rent injec­tions. More­over, in many cases the implants are biodegrad­able, i. e. they dis­solve com­pletely in the body. The range of appli­ca­tions is broad: Cur­rently, the rods are already used in oncology, in the treat­ment of opiate depen­dence, or as contraceptives.

Every­thing from a single source

As with all implants, it is imper­a­tive that the rods con­taining the active ingre­dient are sterile in order to avoid risks for ­patients. Coop­er­ating with spe­cial­ized tech­nology part­ners enables Harro ­Höfliger to offer cus­tomers a com­pre­hen­sive solu­tion and supply implants, device com­po­nents and machines for aseptic assembly from a single source.

The com­pany pro­vides sup­port from the ini­tial product idea. “We con­sider all com­po­nents and make sure that aseptic pro­cessing is fea­sible. For con­ducting ster­il­iza­tion tests we can estab­lish ­con­tacts with spe­cial­ized partner com­pa­nies,” says Ulrich Stahl, Director New Tech­nolo­gies at Harro Höfliger.

If inter­ested, cus­tomers can also receive ­sup­port in the devel­op­ment of trays for feeding the indi­vidual parts during assembly: “For past projects, our spe­cial­ists have pro­vided spe­cific advice on the design and func­tion­ality of the ther­mo­formed work­piece car­riers. Aseptic pro­ce­dures have very par­tic­ular require­ments. And when it comes to suc­cessful process ­devel­op­ment, cus­tomers can always count on the sup­port of our Engi­neering & Inno­va­tion Ser­vice Team,” explains Stahl.

Even while the device is assem­bled and fitted with the implant, var­ious mea­sures ensure that a sterile envi­ron­ment is main­tained. For example, opti­mized motion sequences of the gripper sys­tems min­i­mize the dis­per­sion of air­borne par­ti­cles. In addi­tion, lam­inar air flow sys­tems with sterile fil­ters are used. Last but not least, “mock-ups” – true-to-scale wooden models of the entire machine – offer addi­tional safety and reli­a­bility since they can be used to sim­u­late and opti­mize all inser­tion processes and manual oper­a­tion pro­ce­dures on the machine prior to design approval.

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“An admin­is­tra­tion form with a future”

One of Harro Höfliger’s tech­nology part­ners cov­ering the pro­duc­tion of sterile implants is Thermo Fisher Sci­en­tific. Marc Hofrichter reports on the product’s poten­tial and the ­man­u­fac­turing challenges.

Mr. Hofrichter, in which areas are sub­cu­ta­neous implants used?

The fields of appli­ca­tion are almost unlim­ited: Whether in oph­thal­mology, the treat­ment of schiz­o­phrenia and cancer, con­tra­cep­tion or the delivery of opi­ates, hor­mones and antibi­otics – sub­cu­ta­neous implants are used in all these areas. Mean­while, even in vet­eri­nary med­i­cine there is a strong interest in this admin­is­tra­tion form.

Are there any spe­cial chal­lenges during production?

Not only is it impor­tant to process these highly potent and sen­si­tive mate­rials safely and care­fully, but also to ensure high-pre­ci­sion length and diam­eter tol­er­ances as well as excel­lent sur­face quality. Another major chal­lenge is to guar­antee the pre­cise dis­tri­b­u­tion of active ingre­di­ents with the tightest tol­er­ance limits in a fully auto­mated man­u­fac­turing process – which includes mea­suring, trim­ming and sorting. With the Thermo Sci­en­tific^TM Pharma mini Implant Line, we are well equipped to meet these challenges.

How do you see the future of the market?

In recent years we have noticed an increasing interest in implants as drug depots and in our implant line. There­fore, I am con­vinced that this is an admin­is­tra­tion form with a promising future.

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Illus­tra­tion: Thomas Heller, Photo: Helmar Lünig