Our core competencies in fill and finish:
- Proteins as formulated pharmaceutical medicines
- Automatic and manual aseptic filling of up to 6000 vials/h or 95,000 vials/batch
- Aseptic filling of vials with/without lyophilization or terminal sterilisation
- Aseptic filling of pre-filled syringes for immediate use
- Production of up to 20,000 syringes/batch
- Labeling, packaging, and shipping of clinical samples
- All methods reach FDA and EMEA standards
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Galenic development
Our galenic group has years of experience in the development and optimization of galenic formulations and, in this context, can offer the formulation of proteins for parenteral applications. Through the cooperation with different European corporations, we can guarantee the success of your project even in the case that capacities are overextended.
Aseptic filling and lyophilization
In the area of fill and finish, Rentschler offers formulation, automatic and manual aseptic filling as well as freeze-drying or terminal sterilization in accordance with FDA and EMEA standards.
Our fill and finish services cover:
- filling of up to 6,000 vials/h
- Batches from 1,000 to 95,000 vials
- Filling, vial sizes from DIN 2R to 20R
For lyophilization, there are two automatic freeze driers with 10 m2 and 24 m2 available. As an example, it is possible to process up to 40,000 or 95,000 DIN 2R vials respectively.
Non sealed vials are stored in a class B clean room. The visual inspection functions semi-automatically through expertly trained personnel.
Pre-filled syringes
We can also produce charges of up to 20,000 pre-filled syringes from 0.5 to 20 ml. All methods reach FDA and EMEA standards.
Packaging
For products destined for clinical trials, we offer the packaging of clinical samples as well as shipping and logistic services to clinics throughout Europe. Rentschler also provides the documentation needed for approval/registration (pharmaceutical development and production).
