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The Good Manufacturing Practices (GMP) guide and EU GMP Annex 1 – Manufacture of Sterile Medicinal Products states sterile products are subject to special requirements and details the use of appropriate technologies, referencing RABS and isolators, as manufacturing necessities to ensure the protection of the product from probable particulate, pyrogen, and microbial contamination sourced from personnel, materials, and or the surrounding environment. Unfortunately, the documents fail to differentiate the limitations between the two types of equipment. The RABS design renders it impossible to eliminate human interaction during processing. Consequently, its capacity to mitigate contamination sourced from the human element is less effective than isolators. While RABS can approach isolator like capability in their most advanced iteration, human intervention remains a necessity in its manufacturing processes despite the configuration. RABS environmental control processing range from less evolved design, cleanroom capabilities, and expand to state of the art designs that meet sterility manufacturing specifications. However, the most advanced RABS configuration is still inferior to the isolator because the isolator provides absolute separation between the human element, sterile materials, and correlating processing events.
EU GMP Annex 2 – Manufacture of Biological Active Substances and Medical Products for Human Use introduces additional bioburden level requirements for sterile processing materials. The constant evolution of sterile processing requirements is an example of the ever evolving GMP requirements as technology advances. The limitations of the RABS design has put an expiration date on its usability as the equipment has exhausted its adaptability potential, and will not be able to meet the ever increasing aseptic processing regulatory expectations. In the near future companies will be forced to obsolesce their legacy RABS capital and upgrade their facilities to meet the new sterile processing compliance and regulatory mandates. Sterile processing equipment needs to be pliable and or advanced enough to be able to adapt to the ever evolving aseptic processing cGMP environment in order to placate the large capital expenditure. Subsequently, it is imperative facilities transition all their sterile processing to the isolator closed system design, ensuring their equipment to be fit for use for many years to come.
References
EU guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Volume 4; Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use
Proceedings of the council for Pharmaceutical Excellence volume 1 June 2020; copyright 2020 James Agalloco and Russell Madsen
Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice – September 2004 Pharmaceutical cGMPs
