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.

© 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