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The last step in the production of a drug is fi ll/ fi nish. But while that term may evoke simple images of pills being decanted into containers, the reality can be much more complex, with
certain products needing a different approach to sterilisation before they can be sealed in packaging. David Callaghan speaks to Dalip Sethi, scientifi c affairs director at Terumo Blood and Cell Technologies, and Tom Heathman, vice president of commercial operations at Ori Biotech, to learn about the risks inherent in this fi nal step before drugs can be shipped.
Living
he fill/ finish stage of safe drug production often presents a unique set of challenges. In order to ensure each drug is proofed against any contamination, there are some essential questions the CDMO must answer: is a first stage terminal sterilisation procedure adequate? Or is an aseptic regime needed? And, if so, can the increased risk be contained? For drugs that are administered parenterally and through the ophthalmic route, as well as those that are inhaled or inserted into the ear, intense sterilisation is always a must. Terminal sterilisation techniques are usually enough for IV solutions such as saline, but aseptic methods are required for antibiotics, vaccines and biologics. If the drugs cannot cope with heat treatment at the conclusion of the process to secure a sterile outcome, then aseptic processing starts to become necessary.
T 20 World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net orld Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
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Corona Borealis Studio/
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