High-pre­ci­sion coating of wafer-thin web materials

The man­u­fac­ture of phar­ma­ceu­tical prod­ucts requires the highest accu­racy. The need for pre­ci­sion is clearly reflected in the coating process, the pre­cise appli­ca­tion of an active ingre­dient con­taining matrix onto a car­rier mate­rial. Together with spe­cial­ized tech­nology part­ners, Harro Höfliger man­ages to inte­grate inno­v­a­tive coating processes into the pro­duc­tion sequence – always with a focus on product properties.

The basic prin­ciple of coating is simple – applying active sub­stances to web mate­rial. This process step is impor­tant, for example, in the man­u­fac­ture of patch prod­ucts such as TTS/TDS (Trans­dermal Ther­a­peutic Sys­tems), which enable the gentle absorp­tion of active ingre­di­ents through the patient’s skin.

Coating is also used in the pro­duc­tion of orally ingested films with a polymer matrix con­taining active ingre­di­ents. This applies to the wafer-thin, rapidly dis­in­te­grating ODF (Orally Disintegrating/Dissolvable Film) as well as to the slower sol­uble MBF (Mucoad­he­sive Buccal Films).

Supe­rior quality

It is pre­cisely this exper­tise that Harro Höfliger pro­vides to its cus­tomers together with the nec­es­sary process sup­port. This is mainly based on decades of expe­ri­ence in the pro­cessing of web mate­rial; but the pre­ci­sion needed is also achieved by fine-tuning the process to the customer’s indi­vidual product requirements.

For example, dif­ferent coating processes are avail­able depending on vis­cosity prop­er­ties. This makes it pos­sible to apply layers ranging from rel­a­tively thick to wafer-thin, or to process very cohe­sive masses. The ideal drying method required after coat­ing can also be selected. Of course, quality assur­ance must always be a top pri­ority when man­u­fac­turing phar­ma­ceu­tical products.

The coating processes there­fore comply with GMP and GAMP5 stan­dards. In addi­tion, it is pos­sible to inte­grate optical ­sys­tems and sen­sors for quality con­trol throughout the entire process. For example, a mea­suring device can move along the web and con­tin­u­ously deter­mine the thick­ness of the coating layer. In other process areas, con­sid­er­a­tion is also given to the spe­cial require­ments and doc­u­men­ta­tion reg­u­la­tions of the phar­ma­ceu­tical industry. All rel­e­vant data can be recorded automatically.

Flex­i­bility through modularity

The pro­duc­tion of the matrix pre­cedes the coating process. Even at this early stage, Harro Höfliger pro­vides cus­tomers with the nec­es­sary resources. To begin, the indi­vidual com­po­nents can be weighed and mixed. The entire post-coating processes are also cov­ered – from cut­ting and pack­aging to car­toning. System exten­sions are pos­sible at any time due to the mod­ular design concept.

“On request, we can offer our cus­tomers a turnkey system where all com­po­nents har­mo­nize,” says Hartmut Thier, Director Web Con­verting Tech­nology at Harro Höfliger. “But regard­less of whether the goal is the pro­duc­tion of small batches or large quan­ti­ties, we sup­port our cus­tomers throughout all process steps, right from the ini­tial idea.”

The recently expanded clean­rooms at the Allmers­bach site play an impor­tant role in terms of process reli­a­bility. “Even the smallest quan­ti­ties of a new product can be tested there for their process capa­bility – so that sub­se­quent coating and all other steps can be pre­cisely adapted,” explains Hartmut Thier. “Nat­u­rally, exten­sion and scale-up options are a given at Harro Höfliger.”

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Photo: Janine Kyofsky