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