Over the past decade, aseptic filling isolators have improved patient safety by use of barriers to isolate the point of filling from personnel. This industry-wide movement creates opportunities to further increase patient safety by minimizing viable and nonviable risks to the aseptic fill.
The Food and Drug Administration strongly supports the use of restricted access barrier systems (RABS) and isolators for any aseptic filling operation. The FDA’s comments at the 2017 ISPE Aseptic Conference included a statement that implementation of a restricted access barrier system or isolator would decrease regulatory scrutiny.
RABS and isolators segregate the largest source of contamination to the aseptic area and personnel. The Grade A (ISO 5) space is partitioned and provides high-efficiency particulate air with laminar-flow characteristics at the point of fill. The implementation of these barrier systems reduces the Grade A area and provides a defined physical barrier. Having a physical barrier not only removes the operator from the aseptic zone, but it also creates an opportunity for more controlled introduction of materials to the aseptic zone.
The use of RABS or isolators does not reduce the need for good aseptic technique. To have good aseptic technique, knowledge of the process is critical. Introducing, handling and moving material through the Grade A space while minimizing disruption of first air, or laminar flow, is possible with good planning during the equipment and barrier design phase. Part of knowing the process is identifying the materials to be transferred and the frequency of transfer. This will help determine the best method of transfer across the barrier. Successful implementation of a barrier system is dependent upon an evaluation of the process and careful planning.
Below are common materials that are transferred across the aseptic barrier and methods to decontaminate these materials to minimize the potential for bioburden transfer into the Grade A space.