
Aidan Harrington discusses current trends in aseptic fill finish of pre-filled syringes at the PDA Europe Conference
The conference was held from 26 -27 April in Lindau/Bodensee (Lake Constance) in Germany and presented a broad overview of current best practices in aseptic processing, with a focus on fill & finish for pre-filled syringes, including the current technical and regulatory trends. In addition, the challenge of environmental monitoring using gloveless isolator technology was presented.
Dr. Aidan Harrington, Principal CQV & Regulatory Consultant with DPS, presented on the topic of; Introducing an Innovative, Advanced Aseptic Filling Technology to a New Manufacturing Facility.
Aidan has worked in the pharmaceutical industry since 1992, working in QA, Validation and Engineering roles in both manufacturing and capital project environments for the pharmaceutical industry and is an expert in US FDA and EU cGMP regulations.
Aidan has extensive regulatory inspection exposure experience, both FDA and HPRA (ex.IMB) and has played significant roles on the planning and implementation of Commissioning and Qualification programs for large capital projects including implementation of Quality Risk Management principles from concept design phases to product Process Validation for aseptic manufacturing facilities.
Aidan offers consultancy to a range of clients in areas such as concept design for cGMP compliance, risk reviews, technology transfers and contamination investigations.
Click here to download a copy of the presentation: Introducing an Innovative Advanced Aseptic Filling Technology to a New Manufacturing Facility.pdf