Isolators or rabs meaning Restricted Access Barrier Systems that play a very important role in Advanced Aseptic Processing. RABS for Drug Manufacturing is helpful in ensuring the necessary conditions and reducing microbial contamination brought on by direct human interventions in the critical zone of the pharmaceutical manufacturing units. The CCS should take into account how they are used. Any substitute methods for using RABS or isolators should be supported.
Rabs Technology:
These are physical barrier that protects the aseptic processing area (often grade A) by separating it from the surrounding area. These systems commonly use RABS or isolators, which are barriers, in part or in full.
A system that prevents product exposure to the environment. This can be accomplished by using bulk product holders (such as tanks or bags) that are connected to one another by pipes or tubes. When used for sterile items, the entire system is sterilized after the connections are formed. Large-scale reusable systems, like those used in the production of active substances, or disposable bag and manifold systems, like those used in the production of biological products, are just a few examples. After an operation is finished, closed systems are opened. The phrase “closed systems” as used in this Annex does not apply to systems like RABS.
To move and process materials or devices through small openings (referred to as “mouse holes”) designed to enter and exit such equipment, RABS and C-RABS attempt to provide a controlled environment with a high level of protection. The risk of microbiological or particle contamination inside the core working region is reduced by the use of overpressure, which preserves the integrity of the working area even when “mouse holes” are present.
Overview:
The common traits of a RABS system are described in the ISPE RABS definition1 of the term. This will ensure the ISO Class 5 environment, unidirectional ventilation, and glove port access. The enclosure’s interior is manually sanitized, and sterile components are added using aseptic techniques, which may include transfer systems. The system is often installed in an ISO Class 7 or superior environment because it is exposed to the room around it. 2 Before usage, all portions of a RABS that come into touch with the product or the process are sterilized or steamed-in-place (SIP). Although doors can be opened, this rarely happens, and when it does, the proper line clearance and cleaning must take place in accordance with standards.
Material of constructions:
Grade A environment should be separated from the environment of the surrounding room by means of isolators or RABS, which are different technologies, and the accompanying processes. The risks brought on by the entrance or removal of items during processing should be reduced, and high-capability transfer technologies or validated systems that effectively prevent contamination should be used.
- Internals Parts: A special stainless steel shell made of AISI 316L, measuring 3mm thick, with internal mirror brite finishing (0.03mm) and smooth angles with a minimum 20mm radius for better visibility and cleanability.
- Finishing on the outside: Scotch Brite ( 0,8 m)
- TIG-method welds are ground, flattened, and polished.
- Silicon inflatable seals that have received FDA approval
- doors that include inflated gaskets
- Aseptic view glass.
- system for unidirectional air flow (predisposed to be connected to a dedicated HVAC system).
- Filtering using pressure transmitters to prevent filter obstruction when using HEPA H14 filters.
Use of the RABS:
The use of isolators or restricted access barrier systems (RABS) is helpful in ensuring the necessary conditions and reducing microbial contamination by direct human interventions in the critical zone. The CCS should take into account how they are used. Any substitute methods for using RABS or isolators should be supported.
Background area of RABS/Isolators:
Airflow pattern studies should be carried out to show that there is no air intrusion during interventions, including door openings if appropriate, and the background environment for RABS employed for aseptic processing should correspond to at least grade B.
Gloves of RABS:
Before installation and before each manufacturing campaign, gloves used in the grade A area for RABS should be sterilized or effectively bio-decontaminated by a proven method. If exposed to the ambient environment while in use, disinfection should be carried out as soon as possible after each exposure. Each time they are used, gloves should be visually inspected, and integrity testing should be done periodically.
Cleaning and bio-decontamination procedures, as well as any necessary inactivation of biological materials, should be properly established and regulated. Prior to the bio-decontamination step, cleaning is crucial since any residues left behind could hinder the process efficiency. Also, there should be proof that the cleaning and bio-decontamination agents utilized do not have any negative effects.
Cleaning and Sanitization procedures:
The routine application of a sporicidal agent using a technique that has been verified and shown to thoroughly cover all interior surfaces and ensure a proper environment for aseptic processing should be a part of the sporicidal disinfection procedure.
Validation and tests of RABS area:
The total process of determining how well a piece of cleanroom or clean air equipment complies with its intended function is known as cleanroom and clean air equipment qualification. The qualification of cleanrooms and clean air equipment shall, where applicable to the design/operation of the installation, comprises the following as part of the requirements of Annex 15 for qualification:
- Leakage and integrity testing of the installed filter system.
- Tests of the volume and speed of airflow.
- Test for air pressure differences.
- Test and visualization of airflow direction.
- Swab test for microbes on surfaces and in the air.
- Test of temperature measurement.
- Test for relative humidity.
- Test for recovery.
- Test for containment leaks.
A system that uses a rigid-wall enclosure and integrated gloves to keep its interior separate from the surrounding cleanroom environment while providing an enclosed but not completely sealed environment fulfilling established air quality criteria (for aseptic processing grade A). A sporicidal chemical is used to clean and sanitize the interior surfaces of the RABS. To perform manipulations or transport materials into the inside of the RABS, operators employ gloves, partial suits, RTPs, and other integrated transfer ports. Depending on the design, doors are very occasionally opened and then only under very specific circumstances.
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FAQ:
What does Rabs stand for?
Answer: RABS stand for the Restricted Access Barriers System. Used to protect the critical A class area from contaminations from the surrounding area.
What are rabs in pharma?
Answer: A system that prevents product exposure to the environment of the lower class. These help the product prevent sterility without human direct interventions.
What is Rabs technology?
Answer: This technology is a physical barrier that protects the aseptic processing area (often grade A) by separating it from the surrounding area i.e. B class area.
What is Rabs in sterile compounding?
Answer: Many research investigations have estimated the aseptic processing operator’s contamination source strength. As a result of this knowledge, a number of technological developments have been made that aim to reduce the risk of contamination. These developments fall into the following general categories: Significantly less personnel contact with the sterile products, Each of these methods increases the level of separation between workers and the sterilized materials, components, and product touch surfaces necessary for the aseptic assembly of the sterile product from its constituent parts, adding an additional layer of security to the process.
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