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Robotic Aseptic Filling Could Help Production, But Faces Regulatory Inconsistency

 
• By Shannon Brown

Use of robotic aseptic manufacturing techniques is increasing, but regulatory agencies are giving conflicting feedback, according to an industry executive. The dilemma points to the need for more development of and consistency in regulation for advanced manufacturing.

Industry receives mixed messages about new technology • Source: Alamy

As manufacturers increasingly use closed, gloveless isolators for aseptic processing of new sterile injectable drug products, they are dealing with contradictory feedback from regulatory authorities.

Michael Schneider, the global head of technical innovation drug product at Roche Holding AG/Genentech, described the benefits of robotic aseptic filling using closed gloveless isolators at an International Forum...

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