RABS & C-RABS: restricted access barrier systems for aseptic processing of pharmaceutical products

RABS or C-RABS (Closed RABS) are a type of restricted access barrier systems for aseptic processing of pharmaceutical products that reduces or eliminates interventions into the critical zone providing:

• rigid wall enclosure (for physical separation of aseptic processing operations from operators) with interlocked doors;
• unidirectional air flow systems (to reach a class A environment to the critical area);
• use of glove ports to access all areas of the enclosure during operations;
• high level of asepsis (through unidirectional air flow with High Efficiency Filters) and / or monitoring of the internal particle contamination (through particles counting equipment).

Concept

RABS and C-RABS aim is to provide a controlled environment with high level of protection to transfer and process materials or devices through small openings (called “mouse holes”) designed to enter and exit such equipments. The use of overpressure ensures the integrity of the working area even with the presence of the “mouse holes”, therefore minimizing the risk of microbial or particulate contamination inside the core working area.

Examples & applications of RABS & C-RABS technology

C-RABS for Cap Sealing Machine

This C-RABS unit is designed to provide containment for a Cap Sealing machine

Features

• Crimping Cabinet, engineered to provide Class A (100) aseptic area to protect freeze-dried vials during the capping phase, ensuring compliance GMP Annex 1 provisions.
• Exit Mouse Hole Chamber: provided as a buffer to separate the Crimping Cabinet from the surrounding Class C environment of the laboratory
• Cap Loading Container: to introduce the caps and flange to be connected to the crimping cabinet (capacity: ca. 3000 aluminium caps).

C-RABS for Bottles Filling Machine

Features

• Negative pressure with respect to the laboratory environment
• Top-Down air flow
• Bag in Bag out filters replacing method
• Fully PLC controlled
• Fully Washable

RABS for Bulk filling station

• Positive pressure with respect to the laboratory environment
• Unidirectional airflow (LAF 0,45 m/s)
• Control: electro-mechanical
• Single chamber

OPEN ISOLATOR for Aseptic Bag Filling Station

Features

• Positive pressure with respect to the laboratory enviromnent
• Unidirectional airflow (LAF 0,45 m/s)
• Designed for the filling of aseptic bags (5-20 litres)
• 3 chambers: conditioning area, sterilizing area (by VPHP), aseptic filling area.
• Fully washable
• VPHP Sterilizable
• Fully PLC controlled

Construction Material

• Internals: Unique stainless steel shell AISI 316L (3mm thick) with internal finishing in mirror brite (<0,3μm) and smooth angles of min. 20 mm radius for improved visibility and cleanability.
• External Finishing: Scotch Brite (< 0,8μm)
• Welds: ground, smoothed and polished using TIG method
• Inflatable seals made of FDA approved silicon
• Doors: equipped with inflatable gaskets,
• View panels: made of 12mm tempered glass.
• Unidirectional Air Flow system (predisposed to be connected to a dedicated HVAC system). Filtration through HEPA H14 filters with Pressure Transmitters to control filter obstruction.