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Chemical Surface Bio- Decontamination Applied to Material Transfer into Sterile Enclosures

Presentation outline Material transfer to sterile suite issue and available technologies; Surface bio-decontamination drivers; QbD and risk assessment and mitigation overview; Surface chemical bio-decontamination cycle; Cycle validation approach; The material transfer issue… It is critical to adequately control material (e.g., in-processsupplies, equipment, utensils) as it transfers from lesser to higher classified clean areas to prevent […]
  • author: Mauri Sergio
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Lowering the risk of personnel induced contamination: The use of robotics in aseptic processing

Abstract One of the most problematic issues of aseptic manufacturing is the involvement of personnel. Human presence generates millions of particles every minute. Some of these particles are biologically active and can generate product contamination. Now, technology can create a revolution by removing human intervention from the aseptic manufacturing process to reduce its impact on […]
  • author: Mauri Sergio
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Emerging Gloveless Robotic Technologies in Aseptic Manufacturing for Personalized Cytotoxic Drugs

Abstract This article discusses trends for the pharmaceutical manufacturing industry in the following years. A robotic solution for the next generation of drugs is introduced and its main advantages are presented. The concepts integrated into this innovative solution are explained and technical details are provided. Pharmaceutical manufacturing of the future The blockbuster-model that was driving […]
  • author: Mauri Sergio
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Flexibility and cost-effectiveness for advanced aseptic production

Abstarct The use of robotics and automation in the industry is not new. For several decades now, many assembly lines have utilized production robots in different functions to increase productivity. Although human operators result in a potentially risky activity in sterile areas, pharma manufacturing remains heavily human. This article discusses how to apply current isolation […]
  • author: Mauri Sergio
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Recent articles
  • A History of Isolator and Containment Technology, Part 5: Development and use of sterilising agents with associated devices
  • A history of isolator and containment technology Part 4: Transfer devices
  • A history of isolator and containment technology Part 3: Non-flexible film isolators including RABS
  • A history of isolator and containment technology Part 2: Flexible film isolators
  • Importance of risk assessment for aseptic transfer in pharmaceutical compounding
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