Aseptic filling and release of liquid dosage forms of IMPs

Final processing of biopharmaceutical investigational drug substances to investigational medicinal products (IMPs) at Fraunhofer ITEM is performed in a GMP grade-B clean-room suite equipped with a class-A laminar flow bench for manual filling operations and a restricted-access barrier system (RABS) equipped with an automated filling machine for vials and ampoules. The RABS and the laminar flow bench fulfill both clean-room grade-A (EU) and class-100 (US) ambient requirements for aseptic processing with open primary containments of final dosage forms. All aseptic filling operations are performed in compliance with Annex 1 of the EU GMP Guide. US requirements are met as well.

Aseptic filling and release of liquid dosage forms of IMPs
© Fraunhofer ITEM

Services

  • Manual and automated filling liquid dosage forms (up to 3000 containers) for
  • Manufacture of investigational medicinal products
  • Formulation development/stability studies
  • Evaluation of primary containment type
  • Execution of ICH Q1A/Q5C stability programs

 

Methods and hardware

  • Automated Bosch ARF 1010 filling machine for ampoules and vials
  • Class-A laminar flow bench for manual filling operations
  • Applicable dosage forms: ampoules and vials (1 to 20 ml), infusion bags and bottles

Contact

Holger Ziehr

Contact Press / Media

Prof. Dr. Holger Ziehr

Division Director of Pharmaceutical Biotechnology

Phone +49 531 6181-6000

Nico Langer

Contact Press / Media

Dr. Nico Langer

Manager of the Working Group on Quality Control

Phone +49 531 6181-6502