Active pharmaceutical ingredients (API)
The particle size is an important parameter in the development and manufacture of pharmaceutical products. Micronisation serves to significantly improve the dissolution rate of active pharmaceutical ingredients (API). In the case of inhalers (DPI – dry powder inhalers), the particle size of the active ingredients and carriers is a decisive, quality-determining property in the formulation of the dry powder. The optimal particle size ensures the transport of the medicine into the lungs and also its effectiveness.
Flexibility is required with respect to the different fineness values and products. Furthermore, varying batch sizes often call for different handling concepts.
The process transfer is a special challenge: whether it be from development to production scale regardless of the location, or to a toll manufacturer.
The quality is always paramount in the manufacture of pharmaceuticals, achieved through reliable, reproducible and well-documented processes.
Whether continuous production or batch mode, the construction materials, surfaces, the automation and documentation of production systems for pharmaceuticals are all prepared according to cGMP design criteria.
A solution for manifold challenges
Quality begins as early as the planning and project phase. An individual system concept is prepared to match the user requirement specification (URS). A wide range of different technologies from preliminary crushing to fine grinding and micronisation can be chosen from.
The aim is to achieve an optimum grinding process.
Typical quality-determining features are:
Product- and process-gas-contact parts in AISI 316L
Surface roughness standard Ra < 0.8 µm (dependent on the product Ra < 0.4 or Ra < 0.25 with/without eletropolishing)
Seals and filter materials are food- and drug-grade quality as defined in FDA 21CFR177.2600
The pharma bearing concept includes a clear separation between drive and process, thus the end product contains neither particles nor oil
Encapsulated, permanently lubricated bearing or the use of USDA-H1 grease
Fully CIP/SIP-capable machines thanks to the patented Pharmaplex® bearing concept
Largely monobloc components with a minimum of welds and seals
Design free from dead spaces
Drainage and venting points for complete emptying with CIP/SIP-capable systems
Controls as defined in GAMP 5 and 21 CFR Part 11
Increasingly important is to ensure the flexibility and thus to make the systems obsolescence-proof. The multi-mill system concept is a tried-and-tested approach in order to produce different products, fineness values and batch sizes.
Design free from dead spaces
Easy to dismantle and clean
High production quality
Modern automation concepts
Manufacture in monobloc design
Validation documents
Production management standards
Hosokawa Micron provides various types of drying and mixing equipment for the production and processing of active pharmaceutical ingredients. Undoubtedly, each type of equipment fully complies with industry standards such as cGMP (Current Good Manufacturing Practice), FDA (Food and Drug Administration), and GAMP (Good Automated Manufacturing Practice).
The dynamic Good Manufacturing Practice (cGMP) production of sterile and non-sterile active pharmaceutical ingredients (APIs) imposes stringent requirements on process equipment in their respective fields. Hosokawa Micron is capable of meeting the rigorous current good manufacturing practice standards, making us a favored choice. Our Nauta vacuum dryer is often selected as an efficient secondary drying device, for instance, to reduce the moisture content of materials in the production process of antibiotics.
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