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Technology
Linking the pharmacist with the manufacturer
A close co-operation between the pharmacist and the equipment manufacturer in the early project stages is of extreme importance, especially in the production of pharmaceutical inhalation products. Here the cost saving is determined by avoiding “misguided development”.
Focus on powder
It is well known that dosing behavior is primarily determined by the powder’s physical characteristics. This is determined by parameters such as particle size distribution, particle shape, particle density, melting point, hygroscopicity and the tendency to electrostatic charging. Therefore at the beginning of a powder project, Höfliger offers to its customers an analysis of the material in order to determine the optimal dosing system for the filling process. The analysis also supplies valuable data for the optimization of site conditions such as relative humidity and temperature.
The adhesive behavior of various materials is also examined at this stage. This influences the design of the parts of the machine that come into contact with the product.
Support during the galenic development, the clinical test phases II and III as well as the production of stability samples:
Apart from these services, Höfliger’s Pharma Service Team has the possibility of supporting customers with the following technical line components:
- Omnidose TT laboratory hand-dosing equipment
- Omnidose laboratory filling machine with various filling techniques (scaleable to large industrial line solutions)
- Capsule filling machine Modu-C
- Proof-of-Principle test rigs
- Dosing modules for many different products
- Customer-specific system developments.
The GMP test area insures process quality:
The final proof of perfect machine function by the FAT and the final qualification can only be provided under actual production conditions. The test areas installed at the Höfliger plant allows us to provide the following conditions:
- constant climatic site conditions.
- processing the original product (verum).
- highly effective equipment protect both the product and the operator.
More services that optimizes your process:
Höfliger offers different protection concepts for contamination-free processing of highly active materials under the product line “Advanced Protection Modules”. Active materials can be fed into the machine and Verum products sluiced out of the machine.
A further module from our service package contains the GMP approved, FMEA based qualification of the production line using the original product.
