Sterile Aseptic Processing – Stepping into the Future
Purpose: Demonstrate the advantage isolator sterile processing manufacturing has over restricted access barrier systems (RABS), and the need for biopharmaceutical sterile manufacturing facilities to obsolete their existing RABS equipment and replace with isolator units to have the capability to meet future heightened current good manufacturing practices (cGMP) aseptic processing standards. Results: EU GMP Annex 2: Manufacture of […]
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