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Fill & Finish

Increasing requirements regarding GMP guidelines for aseptic production (Annex 1, revision), smaller batch sizes (personalized medicine) and innovative forms of application (pumps, auto-injectors etc.) bring new challenges for the Fill & Finish area.

Typically, filling lines either bring a high degree of flexibility to efficiently and profitably process different products and different formats (vials, syringes, ampules, etc.), or they are designed to allow a high throughput of products that are always the same. In all cases, it is important to balance the quality of the filling and the unit price for the desired product. We can advise you with our experience.

Our range of services extends from the preparation of a concept study through practical development and implementation to commissioning with qualification and validation on site. We can draw on experience in sterile, aseptic, and safety-based filling. Our expertise lies particularly in the area of liquid filling, freeze-drying as well as in the area of solids.

Pharmaceutical products are becoming more and more potent and sensitive and so the demand for safety requirements more and more complex. The value of a single product also increases. Therefore, rejection rates should be kept as low as possible and continuous monitoring of the installations is essential. The increasing monitoring requirements for particles and microbes also call for barrier technologies such as RABS (Restricted Air Barrier System) or isolators. These can be made with traditional or flexible (single-use) design. Which technology is optimal varies greatly from customer to customer. We can help you select and implement a solution that is right for you.

We offer conceptual, detailed, or front-end studies of new or existing plants. These are based on current GMP guidelines and balanced between investment and operating costs and appropriate risk.

In order to guarantee a smooth process, we also support you in setting up quality systems, process validation, mappings and production planning.

Reference projects – (Only available in German)