When producing medication with active ingredients, process reliability plays a crucial role in order to satisfy the need for safety and efficacy. At Harro Höfliger, you therefore receive the support of our Pharma Services experts in the selection, development and optimization of processes, especially for the core process of dosing. Critical steps are clarified in advance using test assemblies, manual, semi-automatic or fully automatic equipment. Finally, you can process original formulations in a controlled environment in our clean rooms. The chosen processes are confirmed in line with the "Quality by Design" principle.
Having accurate knowledge about a product makes it easier to choose a suitable method for the filling process, especially with regard to the reliable upscaling of lab and production standards. The design space is defined based on statistic trial planning (DoE).
In our internal labs and clean rooms, based on a risk assessment of the product, even highly potent active ingredients can be processed reliably. The possibility to produce stability samples on the qualified machine, which is time-saving, accelerates introduction into the market.
The implementation and documentation of all tests are geared towards strict GMP quality guidelines. Defined specifications are also used for product characterization. Our clean rooms allow tests under the required controlled conditions.
Why was the Pharma Services department established?
Pharma Services, managed by a pharmacist, has existed since 2003. We wanted to give our customers the opportunity to perform risk management in the strictest sense. Only those trials can be conclusive using the original product, not a placebo, under future ambient conditions. This allows process risks to be recognized early and solutions to be found.
Can you illustrate this based on a specific example?
Let's take the filling of inhalation powder: We start by conducting extensive product characterization in our labs. Based on the results and our customer's requirements profile, we can define a series of possible dosing methods. Using the relevant systems, we then conduct initial feasibility studies, commonly on manual equipment.
What are the next steps?
We have built up a database of products, as a scientific addition, to be able to define or pinpoint the machine process parameters by comparing to reference substances. This allows us to arrive more quickly to the optimal dosing principle, including process parameters. From laboratory level, we can then reliably scale the processes up to production level.
In what project phase can you provide support to customers?
We accompany our customers very early on in the project and during the development and assembly of their systems. Our services are even in demand during FAT in our clean rooms or on site at the customer's location. And of course, we are also "troubleshooters" for safely transferring the process.
Accelerating processes, minimizing project costs and risks – this is what the Harro Höfliger Pharma Services experts specialize in. The basis for their product consulting is a comprehensive database.
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