By: Paul F. Valerio, Elizabeth Dorn, and Jessica J. Frantz
For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its key results, which were first shared at the 2020 ISPE Aseptic Conference in North Bethesda, Maryland, in March 2020.
Unit operations involving aseptic processing are critical to product integrity and safety in the drug manufacturing process. The cleanliness of the environment surrounding these processes and adherence to associated standard operating procedures ensure that the drug delivered to the patient is sterile and essentially free of particulates. Aseptic processes include the filling of injectable products into final containers (in the form of vials, syringes, cartridges, ampules, and others) and aseptic formulation of suspensions or live virus vaccines that do not undergo subsequent sterile filtration. Given the current increase in other small-scale aseptic applications, including cell and gene therapy processes and 503A and 503B compounding pharmacies, aseptic barrier technology is needed now more than ever before.
ORIGINS OF ASEPTIC BARRIER TECHNOLOGY
Those new to the world of aseptic processing may take the now mature solutions of today’s robust barrier isolators and restricted access barrier systems (RABS) for granted. However, it is important to note the challenges the industry faced before arriving at the current state of barrier technology.