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RABS and isolator cleanroom technology combined in V-CRT®

RABS and isolator cleanroom technology combined in V-CRT®

Significant innovation in disease treatment, including the increased focus on complex biologic therapies1, has resulted in important industry trends that have had an impact on many aspects of aseptic processing.

For example:

  • Pharmaceutical portfolios are shifting as companies meet the demand for more specialized treatments (including orphan drugs) and prefilled delivery systems.  
  • The desire for flexibility is growing to help anticipate future format, packaging and filling needs
  • Quality assurance regulations, such as visual inspection requirements and germ load standards, are becoming increasingly stringent

CDMOs today need to advance their aseptic processes and technology to meet the competing demands for the highest levels of quality and flexibility.

RABS or isolators, or both?

At their core, aseptic processes and technologies are designed to minimize any contact between a drug product and the outside environment, therefore minimizing any chance for contamination. Historically, two distinct cleanroom technologies have been employed to this end: isolators and restricted access barrier systems (RABS). Isolators are often considered the best solution for a high level of sterility, whereas RABS permit greater flexibility and higher capacity of filling lines when running multiple products.