Traditional aseptic production lines are a thing of the past. Isolators are being integrated with traceability system to watch over safety of the product and the staff.
Sola dosis facit venenum: “Only the dose makes the poison”. The quote from Paracelsus, the Swiss physician, alchemist, and astrologer born in 1493 -considered by many as the father of toxicologyposits that any substance can become a poison at certain doses. The problem arises when a drug, which is formulated to cure, becomes precisely the opposite: a poison. Shockingly, data from the FDA show that the main causes of injectable drugs product recall are the presence of particles, lack of sterility and bacteria contamination.
Both professionals and companies involved in drug manufacturing are therefore part of the solution and have the responsibility of improving the situation, either by designing safer facilities,
investing in safer equipment, or manufacturing in a safer way.
This article compares two key technologies for mitigating contamination risks in the manufacture of sterile medicines through aseptic process (isolators and RABS), identifying main differences and uses depending on the product and type of application, and give a glimpse of the trends in the field of track-and-trace system integration into aseptic and sterile processes.