Process reliability plays an important role in the production of medicinal products in order to satisfy the effectiveness and health-safety requirements. So, at Harro Höfliger you receive the support of our interdisciplinary Pharma Services team 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 devices. Finally, you can process original formulations in a controlled environment in our cleanrooms (including three High Potency rooms) – the chosen processes are confirmed in this manner in terms of the “Quality by Design” concept.
- Product characterization and support in the selection of recipe variants
- Feasibility studies to choose optimal processing variants
- Statistic trial planning (DoE) and evaluation of trial series
- Compiling of test logs and reports for development documentation
- Manufacturing of samples for analyses and stability tests
- Support in the upscaling of processes
- FAT of the machine under production conditions
High process reliability
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).
High product reliability
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.
Appropriate pharmaceutical processes
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. This is because only those trials can be conclusive that are done 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 lab. Based on the results and our customer’s requirement profile, we can define a series of possible dosing methods. Using the relevant systems, we then conduct initial feasibility studies, generally on manual devices.
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 reference substances. This allows us to arrive more quickly to the optimal dosing principle, including process parameters. Based on the lab standard, we can then reliably scale the processes up to production level.
ALL YOU NEED
More than just engineering: We focus on the entire lifecycle of your product. Harro Höfliger Verpackungsmaschinen GmbH has the experience and expertise to support you in realizing your entire product idea and will accompany you as a partner from the laboratory stage to production and packaging lines. As your supplier of technology and all-around problem solver, our work does not stop until your production is running perfectly. Across the board, all-encompassing and only the very best quality. Simply put – ALL YOU NEED.
Key word laboratory: How do customers benefit from the expansion?
New, state-of-the-art devices have changed our analysis methods. New possibilities are now available in addition to physical measurement techniques. This allows us, for example, to perform assays and provide not only our customers but also our developers and designers with even more process-relevant information.
In what project phase can you provide support to customers?
We accompany our customers very early on in the project, for example by providing support in galenic development, filling process development or format design. Our services are also in demand during FAT in our cleanrooms or on site at the customer’s location. And of course, we are also “troubleshooters” for safely transferring the process.
What is Pharma Services’ winning formula?
Most of Pharma Services’ employees come from the pharmaceutical industry and thus understand what our customers need. We aren’t just aware of the regulatory requirements, like documentation, but we also have extensive experience with a wide range of products.
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.