{"id":6672,"date":"2024-06-12T11:43:31","date_gmt":"2024-06-12T15:43:31","guid":{"rendered":"https:\/\/www.ast-inc.com\/?p=6243"},"modified":"2025-04-21T12:13:28","modified_gmt":"2025-04-21T16:13:28","slug":"how-genisys-c-provides-precision-automation-and-intuitive-simplicity-for-pharmaceutical-manufacturers","status":"publish","type":"post","link":"https:\/\/www.ast-inc.com\/blogs\/how-genisys-c-provides-precision-automation-and-intuitive-simplicity-for-pharmaceutical-manufacturers\/","title":{"rendered":"The GENiSYS\u00ae C: Precision Automation, Intuitive Simplicity"},"content":{"rendered":"\n
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For pharmaceutical manufacturers, every endeavor into drug development<\/a> comes with a measure of uncertainty and unpredictability. It\u2019s important to have a plan in place for when the need for adaptability arises, and that leaves many looking into proven ways to incorporate flexibility into their operational strategy. Additionally, trends in aseptic fill-finish manufacturing show customers are looking for compact solutions with a lighter operational footprint as the market continues to grow towards patient-centered applications.<\/p>\n\n\n\n

This is where a modular, compact system like AST\u2019s GENiSYS C<\/a> line excels. The GENiSYS C is an advanced and compact filling and closing system for automated processing of nested, custom, and ready-to-use vials, syringes, and cartridges. One of the key difference makers of this system is its configurability to the scope of the operation while offering robust, simplified automation. For those looking for an intuitive, economical solution that features advanced automation without more sophisticated robotics, this system is designed to be an ultra-compact, flexible aseptic processing system. Robotic nest transfer is also available for additional efficiency and risk reduction.<\/p>\n\n\n\n

The latest generation GENiSYS C epitomizes over 10 years of continuous improvement<\/a>, a conviction that\u2019s at the heart of what we do at AST, where our team continually works to improve the effectiveness and efficiency of our products. The simplicity and intuitiveness of this solution is demonstrated in three distinct areas: design, operation, <\/em>and automation.<\/em><\/p>\n\n\n\n

Design<\/strong>: This fill-finish line is designed to have a light operational footprint, so making critical processes as efficient as possible is crucial. A key consideration in the system\u2019s design is balancing simplicity with flexibility. AST accomplishes this through multiple strategies including a modular configuration that minimizes the use of change parts. Our engineering approach across all our systems is that if it\u2019s possible to efficiently eliminate a change part, it should be done. Furthermore, the change parts that are necessary for the GENiSYS C can all be installed without the use of tools; They\u2019re well-constructed, autoclavable and can be installed with a knob fastener aseptically.  Additionally, AST utilizes single-use technology for direct product-contacting components, eliminating the risk of product crossover and reducing or eliminating the need for clean-in-place procedures. Combined, these design considerations prioritize flexibility; a trained operator can complete machine changeover in 15 minutes.<\/strong><\/p>\n\n\n\n

Operation<\/strong>: All operator-led processes have been designed with ergonomics, ease of process and safety in mind. In the Semi-automatic Bag Opener (SABO), bag cutting is initiated and completed by maintaining contact with two touch sensors for safe opening. No-touch transfer can then be initiated into the Manual Tub Opener (MTO) module where touch button-activated vacuum systems assist the operator in de-lidding the tub as well as transferring the nest into the centering plate to begin filling operations. All actions, including routine interventions like installing a fluid path on a pump and changing EM plates, can be executed through the glove ports.<\/p>\n\n\n\n

Automation: <\/strong>Automation on the GENiSYS C is intuitive and recipe-driven through a fully integrated HMI program. Container filling and closing are fully automated. Recipes can be inputted for a variety of formats, including custom formats like cryovials. Critical data, including process and IPC data, are recorded on batch records. Additionally, ASTView integrates fully with isolator-barrier technology and offers comprehensive data recording for batch records that are 21 CFR Part 11 compliant.<\/p>\n\n\n\n

 The GENiSYS C is ideal for<\/p>\n\n\n\n