Producing sterile dosage forms at pilot scale, through all stages of the process chain
Pharmaceuticals must be produced in cleanrooms to ensure that they contain no impurities, especially if administered as infusions or injections.
In the Process Technology Centre (PTC)'s cleanrooms, the entire process chain for various sterile dosage forms can be reproduced on a pilot scale. This includes all critical steps from compounding, filling, lyophilization and terminal sterilization to the visual inspection of the product.
This wide scope make the PTC cleanrooms particularly suitable for developing processes with scale-up/scale-down potential, filling reference samples, manufacturing drug product for preclinical studies or process development for sterile pharmaceutical production on a pilot scale under non-GMP conditions.
The PTC is equipped with class C and D cleanrooms for processing chemical and biological drugs and for production of sterile solutions, emulsions and suspensions. Up to 10 litres of product solution can be filled automatically or manually into prefilled syringes (1mL long, staked needle) or vials (6R). Subsequently, up to 3000 vials per batch can be lyophilized.
Practical training in the PTC cleanroom allows students to learn about and experience sterile pharmaceutical production processes and cleanroom qualification and operation. Specialists will also be able to use the cleanroom for further training in the future: A PDA/FHNW course "Aseptic Processing" is planned.
A look inside the facility
Infrastructure
- Class C and D cleanrooms (EU GMP guideline)
- Formulation compounding in temperature-controlled glass or stainless steel containers (0.5-10 L)
- Cleanroom washing machine, capacity 500 L
- Steam sterilization, capacity 305 L
- Freeze dryer 2.02 m2 floor space
- Automatic filling line, peristaltic pump, nested packaging, up to 1000 units/hour
- Heat sterilization/de-pyrogenisation up to 260°C, capacity 450 L
- Safety workbench class 2, ISO 5
- Mobile cleanroom monitoring for particles, air velocity, temperature, and relative humidity
- Climate cabinets for stability studies including photostability according to ICH
- Controlled storage of active ingredients and products at -60 °C, -20 °C and 2-8 °C
Contact
Prof. Dr. Oliver Germershaus
- Phone
- +41 61 228 55 26