{"id":6891,"date":"2025-03-12T12:32:01","date_gmt":"2025-03-12T16:32:01","guid":{"rendered":"https:\/\/www.ast-inc.com\/?page_id=6891"},"modified":"2025-06-06T11:57:12","modified_gmt":"2025-06-06T15:57:12","slug":"key-technologies","status":"publish","type":"page","link":"https:\/\/www.ast-inc.com\/key-technologies\/","title":{"rendered":"Key Technologies"},"content":{"rendered":"\t\t
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PRODUCTS<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Key Technologies<\/strong><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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AST\u2019s aseptic processing solutions are outfitted with the latest in intuitive cGMP technology designed to optimize the fill-finish process for the highest standards of quality and regulatory compliance.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Pioneering Flexibility in RTU Processing <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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AST has led the flexible aseptic manufacturing movement since the design and launch of our first ASEPTICELL, which was the industry\u2019s first multi-format system designed to process ready-to-use nested vials, cartridges, and syringes. Now an industry standard, multi-modal pharmaceutical manufacturing stakeholders are looking for ways to grow pipeline agility through proven cGMP technology. AST\u2019s integrated lines offer fill-finish processing for the full range of commercial and custom RTU formats and product applications.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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The RTU Advantage:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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  • Enhanced sterility assurance<\/li>\n \t
  • Faster qualification and process validation<\/li>\n \t
  • Significant savings on equipment, facility, & operations<\/li>\n \t
  • Increased speed to market.<\/li>\n \t
  • Flexible closing and sealing options for syringes, cartridges, and vials.<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Formats<\/strong> | AST systems are compatible with:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    • Ompi EZ-fill\u2122<\/li>
    • Schott adaptiQ\u2122<\/li>
    • BD Hypak\u2122<\/li>
    • West CZ\u2122 (trayed and nested formats)<\/li>
    • SiO2\u2122<\/li>
    • And many more, including custom formats<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Technology Highlights<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      In-Process Weight Checks<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Non-destructive in-process weight checks verify that every container is filled to specification and ensure that product yield is maximized. Features of this innovative system include:<\/p>

      • Batch start-up mode that allows priming the fluid path without wasting any product by filling the first few containers on an analytical scale.<\/li>
      • Batch end mode that places the last few containers on an analytical scale to ensure that every possible drop of product is used.<\/li>
      • Pump calibration performed using feedback gained during statistical IPC checks<\/li>
      • Recipe-programmable weight checks to allow for statistical or 100% IPC<\/li><\/ul>

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        Augmented IPC<\/strong> is an available option that adds new capability to In-process weigh checks. AST\u2019s <\/em>approach, Augmented IPC, leverages a flow-based system programmed to work in concert with an analytical balance to ensure the quality threshold of 100 percent IPC is met while a machine remains in a high-speed, statistical IPC mode. \u00a0<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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        Environmental Monitoring<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Environmental monitoring is a critical consideration when designing and implementing your aseptic operation. With the growing development of highly targeted liquid pharmaceuticals, there are increased expectations around quality as reflected in regulatory emphases like the revised Annex 1. AST provides expertise and guidance for the proper EM placement and strategy for your environmental monitoring program.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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        Total particulate, active viable, and passive viable environmental monitoring stations placed strategically throughout processing stations ensure ideal environmental conditions and provide a record of environmental data to your batch record system.\u00a0<\/p>

        Auto<\/strong>EM<\/em><\/strong> \u2013 AST\u2019s automatic plate changer for active and passive viable monitoring <\/strong><\/p>

        Automatic environmental monitoring is available to automate and de-risk environmental monitoring process interventions. The EM plate-changing tool utilizes pre-sterilized settling plates that are aseptically introduced into the fill line and loaded into an inline cassette dispenser. Plate changes are automated through the HMI, saving process time on typically manual, ergonomically unfriendly gloved interventions.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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        AutoEM<\/i> Highlights Include:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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