Whitepaper
4 Jul 2019

RABS & Isolators Track-and-trace trends

PDF 2.8 MB

Sola dosis facit venenum: “Only the dose makesthe poison”. The quote from Paracelsus, the Swissphysician, alchemist, and astrologer born in 1493-considered by many as the father of toxicologypositsthat any substance can become a poisonat certain doses. The problem arises when a drug,which is formulated to cure, becomes preciselythe opposite: a poison. Shockingly, data fromthe FDA show that the main causes of injectabledrugs product recall are the presence of particles,lack of sterility and bacteria contamination. Both professionals and companies involved indrug manufacturing are therefore part of thesolution and have the responsibility of improvingthe situation, either by designing safer facilities,investing in safer equipment, or manufacturing ina safer way. This article compares two key technologies formitigating contamination risks in the manufactureof sterile medicines through aseptic process(isolators and RABS), identifying main differencesand uses depending on the product and type ofapplication, and give a glimpse of the trends inthe field of track-and-trace system integration intoaseptic and sterile processes.

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  • 2016
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