Applying quality risk management to develop an isolator filling line
Following the patent of the innovative “Espresso” intravenous delivery device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a filling line to meet the unique requirements of the solution. Particle Measuring Systems’ advisory team leveraged their industry and regulatory expertise to oversee the development of the aseptic filling process and the environmental monitoring system by applying proven risk management techniques. Using this case study, we provide practical insights for Quality by Design principles with input from IBI and Comecer.
Maurizio Della Pietra, Global Data Management Specialist and Process Advisor, Particle Measuring Systems
He earned his Master’s Degree in Physics.
Anna Campanella, Global Sterility Assurance Advisor, Particle Measuring Systems
Anna has a diverse background in the Pharmaceutical field including a PhD in Molecular Medicine, expertise in QA&QC processes, validation of chemical and microbiological methods, validation of sterile production processes and experience in microbiological aspects of aseptic production processes.
Key learning points
- Challenges of difficult-to-recover compounds in cleaning validation applications
- Examples of TOC recovery studies and best practices
- Comparison of acidified and non-acidified vials for recovery studies
- How to make dilutions, test and evaluate resultant data for recovery and linearity
- Other considerations using TOC for CV.
Biopharmaceuticals, Bioprocessing, Downstream, Environmental Monitoring, Manufacturing, Microbiology, Outsourcing, Packaging, Process Analytical Technologies (PAT), QA/QC, Quality by Design (QbD), Rapid Microbiological Methods (RMMs), Single Use