It’s 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 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.
This is where a modular, compact system like AST’s GENiSYS C 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.
The latest generation GENiSYS C epitomises over 10 years of continuous improvement, a conviction that’s 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, and automation.
Design: 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’s design is balancing simplicity with flexibility. AST accomplishes this through multiple strategies including a modular configuration that minimises the use of change parts. Our engineering approach across all our systems is that if it’s 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’re well-constructed, autoclavable and can be installed with a knob fastener aseptically. Additionally, AST utilises 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 prioritise flexibility; a trained operator can complete machine changeover in 15 minutes.
Operation: 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 centring 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.
Automation: 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.
The GENiSYS C is ideal for
- Research and Development
- Process Development
- Engineering Runs
- Clinical Trials
The Isolated GENiSYS C with Enhanced Automation: A Compact, Patient-Centred Solution
The GENiSYS C now features optional enhanced automation with robotic nest transfer functionality for improved process efficiency and risk reduction, eliminating a common point of human intervention. When combined with AST’s new fill-finish isolator, this turn-key solution offers a new dimension of processing flexibility, ideal for the commercial production of high-value liquid pharmaceuticals, compounding hospitals and pharmacies, highly targeted patient-centred medicines, and other distributed manufacturing needs.
The AST Isolator matches the spirit of the design behind the GENiSYS C with a clean, simple design combined with robust functionality. Designed to fit in rooms with ceilings as low as ten feet and featuring adaptable ducting in case of space restrictions, the AST isolator is a user-friendly solution that improves some of the common pain points faced in day-to-day aseptic processing operations, including routine cleaning, maintenance, and decontamination protocols. With features like an end-to-end ergonomic design, cutting-edge automation for HEPA filter changeout and filter integrity testing, and groundbreaking new bio-decontamination technology that completes a full cycle (including aeration) in 60 minutes, this isolator solution is the next step in efficient, integrated barrier technology.
The GENiSYS C and the AST isolator offer parenteral drug manufacturers the ultimate compact combination for aseptic processing. Curious about walk through demonstration our isolated GENiSYS C system? Watch the video below for an in-depth presentation from Josh Russell, AST’s VP of Sales & Marketing.