Featured Products & Services
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A User-Friendly Solution For Fill-Finish Professionals
1/31/2024
When AST came to the table on the design for our new fill-finish isolator, one of the first areas AST engineers wanted to address was the usability and accessibility of the isolator and corresponding operations. With our customers’ point of view in mind, we wanted to address specific points of friction routinely encountered by operators and closely examine whether those friction points were necessary.
Does an isolator need to be ergonomically unfriendly to clean?
Should simple mechanisms like isolator doors be challenging to engage? (As much as one can appreciate exercise, no one wants to do “arm day” in cleanroom coveralls).
Does routine maintenance have to be time-consuming and laborious?
Many of these factors are accepted as par for the course in aseptic fill-finish manufacturing. Our question was, why?
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cGMP Aseptic Manufacturing And Sterile Fill-Finish
1/28/2022
Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.
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Automatic
2/2/2022
We offer a comprehensive range of automatic inspection machines for injectable pharmaceutical products contained in ampoules, vials, cartridges, syringes and bottles. Designed and manufactured to meet the most demanding technical requirements, our solutions feature different production speeds and advanced vision standards for an optimum performance.
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Pharmaceutical Vial Filling Equipment: VFM
4/28/2021
VFM automatic filling and stoppering machines are designed for injectable solutions in vials.
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GENiSYS® C Multi-Format Filling and Closing Machine
12/27/2019
AST’s GENiSYS® C is an advanced, yet compact, filling and closing system for automated processing of nested, custom and ready-to-use vials, syringes, and cartridges. With many features typically found in large scale filling machines, the GENiSYS C’s compact footprint makes this system ideal for use in small scale filling applications, including R&D, process development, engineering runs, niche product manufacturing, and even cGMP clinical and small-batch commercial manufacturing.
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Rapid Development Through Phase I CTM
1/28/2022
Ascendia works with discovery-stage pharmaceutical companies to provide lab-scale formulations suitable for pre-clinical testing. We conduct pre-formulation assessments, bioavailability modeling, and formulation approach comparisons. We provide trial formulations suitable for animal studies, toxicology studies, and cGMP clinical trial materials for Phase I studies.
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Injection Molding
8/24/2020
Capabilities that improve efficiency and accelerate development.
B. Braun's OEM Division offers a variety of in-house molding capabilities including injection molding, insert molding and over molding. They own a primary 400,000-square-foot U.S. plant that includes a 16,500-square-foot ISO Class 8 molding facility housing some of B. Braun’s 80 injection molding presses, which range from 55-330 tons.
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Fluid Administration Systems
3/22/2017
B. Braun OEM Division has designed and produced a broad range of standard and customized fluid administration products to meet a variety of application requirements. Hundreds of standard components are readily available to be incorporated into a set, saving clients both time and money.
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Sterile Formulation Development
7/1/2022
With over 20 years of experience, PCI’s strength lies in our ability to manage products with unique challenges ranging from small molecules presenting with solubility issues or a labile molecule that is only stable as a liquid presentation for a short time.
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ASEPTiCell® - Robotic Multi-Format Filling & Closing System
1/2/2020
AST’s ASEPTiCell® is a flexible fill/finish system that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.