PREVALIDATED, MODULAR GOOD MANUFACTURING PRACTICE-COMPLIANT FACILITY

摘要

The invention is directed to a ready-to-use modular clean room and facility, in particular for the production of drugs and biological substances, which is equipped with pre-approved manufacturing equipment cores (10). The modular clean room is implemented in the interior space of a container (20), such as a standard shipping container, and includes at least one bioreactor station. The modular facility can be installed on-site from pre- approved clean room modules (10) without further regulatory approval. The clean room and facility comply with FDA-approved good manufacturing practices (GMP) and good laboratory practices (GLP).