Scale-up to a new level

Whereas it was previously possible for air inclusions or insufficient homogenisation to impair the tests, the new Mini offers the full range of possibilities of a production mixer. This means that reliable data is already at a new level during development for later scale-up.

This puts FRIKE in a position to support new development projects even more competently, as the new Mini is a mixer of the latest generation. It has a high-shear homogeniser with a circuit that reflects all the dosing applications of a large-scale plant. In addition, the mixer has a memory that continuously logs the parameters travelled. This enables exact comparisons of the tests carried out.

Ultimately, the fact that the new Becolab Mini is the first qualified system of its kind at FRIKE is a decisive factor for us. It can be used to prepare small quantities under GMP production conditions, which can be used in clinical trials, for example. It has already passed its baptism of fire with the first test batches, and the first projects under GMP conditions are under discussion.

What is the role of the person with technical responsibility?

«Medicines are regulated by the authorities, so they are subject to high quality requirements and must be safe for patients. The person with technical responsibility has a bridging function between the regulatory requirements in the manufacture of medicinal products and the internal implementation of these regulations. This ensures that regulatory requirements are also applied in the company and that all products meet the high quality requirements. In this context, the person with technical responsibility also acts as an interface between the authorities and the company.»

What tasks does this person typically perform?

The most important requirement – ensuring high product quality – is set out in the GMP guideline. People often assume that these letters must relate to large tomes of information or the endless quantities of documents out there. In fact, the letters stand for Good Manufacturing Practice and describe what this means for medicinal products. GMP is mandatory for the pharmaceutical industry worldwide and must therefore also be integrated into our own processes.

Success with teamwork

A typical task for a person with technical responsibility is to monitor the implementation of this quality standard in the company. Of course, this can only be achieved with the support of a highly qualified and motivated team that actively evaluates, implements and finally archives the large quantities of paper. Another typical task relates to the release of medicinal products. Since the responsibility for correct production lies with the person with technical responsibility, they are in charge of releasing products and thus confirming that production has been carried out according to GMP.

Why did you choose the FRIKE GROUP as your new employer?

«With around 300 employees, the FRIKE GROUP is one of the largest contract manufacturers in Switzerland. I appreciate being part of the set-up of a large manufacturer with a broad product range and lots of interesting products, as it means exciting projects and challenging tasks. At the same time, I like the informal working environment of FRIKE PHARMA AG, as a small company. Thanks to the manageable size of the company, my tasks are very varied and range from team management to the implementation of the GMP guidelines and the release of medicinal products as the person with technical responsibility. That won me over, and I’m looking forward to taking on many new challenges.»

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