RABS for Cap Sealing Dedicated Equipment From Comecer Preserves Isolation When Vials Are Filled

| Editor: Dr. Jörg Kempf

Restricted access barrier systems (RABS) use combinations of physical and aerodynamic barriers to minimize contamination risk in aseptic facilities. A development of the RABS known as closed RABS (C-RABS, or “open isolator”) creates a controlled environment with a high level of protection. A typical application for C-RABS is in the filling of vials — a task for which Italian pharmaceutical equipment specialist Comecer offers a dedicated solution.

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The International Society for Pharmaceutical Engineering (ISPE) defines a RABS as an “advanced aseptic processing system that can be utilized in many applications in a fill-finish area. RABS provides an enclosed environment to reduce risk of contamination to product, containers, closures and product contact surfaces compared to risks associated with conventional clean room operations”.

A C-RABS builds on this concept, using a combination of rigid walls, interlocked doors, glove ports, and unidirectional air flow backed up by high-efficiency filters or continuous particulate monitors to maintain a high level of asepsis and reduce or eliminate interventions into the critical zone.

For more than 30 years Comecer has manufactured isolators for the pharmaceutical, nuclear, electronics, food and beverage industries. The company makes C-RABS for vial filling, as described below, and other pharmaceutical applications, for both new machinery and retrofits. Comecer’s Isolation Team delivers standard and customized solutions with an emphasis on performance, process integration, ergonomics and durability.

Comecer’s dedicated C-RABS unit for cap sealing comprises a crimping cabinet, an exit mouse hole chamber, and a cap loading container. The operator works standing up, using a control panel to minimize the need for human intervention.

The crimping cabinet is engineered to provide Class A (100) aseptic protection for an automatic cap sealing machine handling vials of freeze-dried material, ensuring compliance with GMP Annex 1 and especially paragraphs 116–124, “Finishing of sterile products”.

The cabinet is made from 316L stainless steel, 3 mm thick, with all TIG welds ground and polished. The inside is mirror polished, with edges and corners radiused to a minimum of 20 mm for easy cleaning. The external finish is Scotch-Brite.