Morten Munk from the Parenteral Drug Association has said the pharmaceutical industry faces a challenge in making ageing facilities compatible with single-use systems. The benefits of single-use to industry and patients were numerous, Mr Munk told delegates at the Disposable Solutions for Biomanufacturing Conference in Munich, Germany. But “ageing” facilities needed rebuilding to stay apace of the growth in single-use systems. Mr Munk was presenting details of the PDA’s Technical Report 66: Application of Single-Use Systems in Pharmaceutical Manufacturing. The research, he said, supported the further integration of single-use systems but had also cast light on a number of key challenges. In addition to modifying the design and operations of bioprocess plants, industry needed to:
Ensure fully closed systems
Work towards a standardisation of quality requirements and testing procedures
Collaborate with industry, suppliers and regulators
TAGS:
Biomanufacturing, Biopharmaceutical, Parenteral Drug Association, Single-use,
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