Restricted Access Barrier System (RABS) enhances product control but reduces operator communication in aseptic manufacturing. The main aim of the RABS system in pharmaceutical products must be free of all contamination risks.
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During the start of1990s, two systems develop that have helped the sterile pharmaceutical preparation to assure contamination-free sterile products at a very high level. The isolator and the restricted access barrier system are commonly called RABS. First Isolator was launched for ensuring sterility. Isolator allowed for a whole part of the machinery from the environment. Such units help keep the processing of the product separate from human mediation.
In the starting phase, some problems came, like technical issues and discussions around sterilization validation or decontamination of the isolator. These problems are reduced after essential improvements. The isolator is the safest and best-verified process. However, it still consuming lengthy changeover time.
Hence, RABS can allow faster start-up time, ease of changeover, and reduced capital costs, particularly with backlit and improvements.
What is a RABS in Pharmaceutical?
RABS means “Restricted Access Barrier system.” In 2005, the FDA commissioned a study group to develop a definition and determine what components need to be included to ensure that a RABS system works well for the manufacturer. The International Society for Pharmaceutical Engineering (ISPE) study group dwell of experts from major manufacturers.
According to the group, RABS must include quality-designed equipment, and all operators must receive comprehensive training in critical practices such as proper gowning practice. Additionally, all RABS must also include the following:
- A barrier to avoid human enrollment directly into the critical area
- ISO 5 environmental for airflow, at least in the critical zone
- Different ports for glows are provided to avoid direct contamination
- High-level disinfection
- well-defined procedures and Highly automated processes for very few open-door interventions.
How RABS System works in Pharma:
Ensure the use of Gloves port barrier system During the change over of machines parts or products change parts.
The Dispensing material is passed inside the closed chamber through glows port provided at the opening. Materials shall be weight inside it on a calibrated instrument. After weight, the material is passed directly in stainless steel containers lined with polybags. The remaining materials (after weight) are tied inside the chamber with a cable tie and passed at another end.
The system shall be followed during other manufacturing activities as per requirement.
Best practices for Restricted access barrier system
RABS provides a gap between products and operating personal to ensure a high degree of product quality. However, to operate RABS well, some best practices must be followed:
Open-door interference is not allowed. During operation, the barriers may not be compromised; if not followed, it can lead to contamination and increased risk to the product. Therefore, when aseptic operations are carried out in a RABS, complete cleaning and line clearance must be carried out before the start of operation.
Ensure the use of Gloves port barrier system During the change over of machines parts or products change. The details study was done for the configuration of the machine and the barrier around it that allows the operator to handle all areas within the machine using the gloves.
The study was also done for operations and potential interference on the machine. Officers of different departments (e.g., engineering and quality assurance) join the study to ensure the overall function of the RABS system.
Disinfection activities shall be performed after the completion of products at each stage. After the filling process, the microbial activities shall be monitored. The barriers system shall be opened only during the cleaning procedure. Then disinfectants with (e.g., Dettol and Savlon).
All used gloves shall be checked at particular time intervals for their integrity and Microbial test. after checking of their airtight, they can be cleaned, steam-sterilized Using a pressure-decay test, the gloves are removed and tested for even the smallest hole. Fit all the gloves in the RABS system for the following product.
The material for products such as syringes and stoppers shall be sterilized in steam and dry heat. The outer packaging is sprayed with a sterilizing agent like IPA 70% before being transferred to the ISO 5 area through a lock, and the outer packaging is removed.
Use glove portal system for all steps. Packaging materials shall be placed in sterilized bad or special containers. The container’s content shall be exposed to ISO 5 conditions only.
Conclusion
A RABS process is secure, with both a cleanroom design and aseptic safety like an isolator, but with a better degree of flexibility. Automation of the system reduces variability thanks to operators and makes the whole process reproducible.
The RABS system may be a proven and practical approach to impact cleanliness within the finished product favorably. RABS is also one of the foremost effective and efficient responses to current and future challenges in manufacturing aseptic products.
