INSIGHTS ON LIQUID DOSE MANUFACTURING
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Jaw Crimping vs. Rotary Crimping: Enhancing Aseptic Assurance
Beyond a simple mechanical step, crimping is a critical control point. We examine how advanced rotary technology provides superior seal quality, particulate control, and data-driven compliance assurance.
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Bulk Filling Of Drug Substance | Accurate Aliquoting
Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to adjust pump controls to achieve accurate filling. This method, spanning multiple shifts, increases process risk through errors that can compromise accuracy.
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Key Topics And Trends In Aseptic Filling
Aseptic filling is vital yet often guided by outdated practices. Discover expert insights on modern technologies, evolving regulations, and data-driven strategies to improve compliance and reduce risk in this critical manufacturing step.
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EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging
Leveraging a pre-sterilized containment solution that meets the requirements of Annex 1 and outsources non-core activities can help prevent contamination and reduce the effort and liability of the CCS.
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Rethinking Liquid Handling Automation10/1/2025
Labs today require more than precision—they need systems built for flexibility, reproducibility, and trust. Explore how automation is evolving to meet the real-world needs of modern scientific teams
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5 Common Bowie-Dick Test Failures And How To Prevent Them11/26/2025
Bowie-Dick test failures indicate serious sterilization issues. Learn the five most common causes and proven strategies to prevent downtime, compliance risks, and compromised product integrity.
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Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators4/28/2025
Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
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Re-Engineering A Complex Process For FDA Compliance8/21/2024
Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.
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Navigating Sterile Injectable CMO Selection: A Technical And Quality Assessment6/11/2025
Learn how to carry out an effective technical and quality assessment and what specific criteria to prioritize when selecting a sterile injectable CMO partner.
LIQUID DOSE MANUFACTURING SOLUTIONS
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Maintain sample integrity whether processing ten or a thousand vials. This automated solution provides scalable, compliant cryovial filling and handling for demanding cell therapy applications.
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AST aseptic filling products address the unique processing requirements of biologics manufacturing to gently care for biologic products during the fill-finish process. Their highly accurate peristaltic dosing system uses single-use pharmaceutical grade tubing that has been optimized to keep shear stress to an absolute minimum. When exiting the fluid path through the filling needle, the motion control system maintains the fill needle within the container and slowly rises as the product is being dispensed to minimize splashing and foaming that could introduce stress to the product. Temperature controlled filling is also possible with the ASEPTiCell® and GENiSYS® systems. AST has experience dosing products at temperatures as low as 3°C.
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ASEPTiCell is integrated with isolator-barrier technologies to fully enclose and tightly control the aseptic environment for ideal conditions for processing sterile drug products. The system can be configured with a Restricted Access Barrier System (RABS) or an aseptic isolator to provide uninterrupted aseptic conditions during production. With isolator integrated systems, the ASEPTiCell is completely compatible with repeated in-situ bio-decontamination using hydrogen peroxide to further enhance the sterility assurance of the system.
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AST’s Container Filling System (CFS) is a bench-top, semi-automatic machine used for the filling of pre-filled syringes and cartridges, and the filling and stoppering of vials and bottles. The system is designed to meet the demanding requirements for small batch processing of sterile injectable products.
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BoMa systems allow transferring and dosing products with a complex rheology, in particular products of high viscosity. The absence of rotating seals is ideal for its use for aggressive or flammable products.