Human operators pose the greatest risk to product contamination during “conventional cleanroom” aseptic processing. Many different barriers of varying capabilities have been used to separate operators from critical sites during aseptic processing with the objective of reducing the probability of a contaminated unit. These range from simple flexible curtains used on many traditional aseptic processing lines to advanced aseptic processing in isolators.
A Restricted Access Barrier System (RABS) is an advanced aseptic processing system that can be utilized in many applications in a fill-finish area. RABS provides an enclosed environment to reduce the risk of contamination to product, containers, closures, and product contact surfaces compared to the risks associated with conventional cleanroom operations. RABS can operate as “doors closed” for processing with very low risk of contamination similar to isolators, or permit rare “open door interventions” provided appropriate measures are taken.
RAB’s Key features:
- Rigid wall enclosure that provides full physical separation of the aseptic processing operations from operators.
- A physical aerodynamic barrier maintaining the separation of the process and the support operators at defined stages in the support operator at defined stages in the aseptic process.
- Use of gloveports and/or automation to access all areas of the enclosure which need to be reached by an operator during filling operations.
- Gloves and gauntlets attached to glove ports are required to be sterile when installed and thereafter. Gloves should be sanitized or changed as appropriate to minimize the risk of contamination.
- Access control to prevent non-validated interventions includes restricting the access of personnel through open barrier doors, at air barrier overspill vents, at transfer device, barriers, at settle plate loading and at all open barrier access ports.
- The presence of monitoring and alarm systems for specified parameters and access events.
- Unidirectional airflow systems providing an EU Grade A (ISO 4.8 in operation) environment to the critical area.
- The Surrounding environment designed to meet EU Grade B (ISO 7 in operation) as a minimum.
- “High-level disinfection” of all non product contact surfaces within the RABS with an appropriate sporicidal agent before batch manufacture.
- Some processes may include rare open door interventions. In these cases, because of the inherently increased risk to product, the following are required to maintain the RABS protection concept:
- Provision for disinfection of non product contact surfaces using appropriate decontaminating agents following a door open intervention.
- Locked door access or interlocked door access with recorded intervention alarms (and/or other satisfactory means of documentation) and mandated appropriate line clearance.
- Positive airflow from the enclosure to the exterior environment while the door is opened.
- Appropriate ISO 5 classification areas may be necessary immediately adjacent to outside of enclosure to always assure ISO 5 conditions inside the RABS. Examples of such situations are: 1. Setup of oversized sterile equipment that requires unwrapping of autoclave packaging outside of the RABS. 2. Any machine sections that require open door interventions (such as certain powder filling applications). 3. After any open door intervention, operations cannot re-start until ISO 5 conditions are re-established in the critical zone.