Featured Products & Services

  1. Isolator Barrier Pharmaceutical Aseptic Filling Systems 11/12/2020

    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.

  2. 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.

  3. Pharmaceutical Aseptic Filling Systems For Sterile Injectables 5/25/2021

    The injectables market is a very demanding market, with high standard requirements. i-Dositecno is offering a very high standard solution for medium and low-speed solutions with very high requirements. Our speed range covers till 9.000u/h. In this product range, we can offer maximum benefits like Isolators for high containment solutions, oRAB’s and cRAB's, IPC control with check weighing of 100% of the production, CFR 21 part 11 compliance, and smooth and accurate production.

  4. Pharmaceutical Aseptic Filling Equipment 6/29/2022

    AST’s ASEPTiCell® and GENiSYS® systems combine industry-proven technologies such as robotics and isolator-barrier systems to provide flexible pharmaceutical aseptic filling and closing of ready-to-use vials, syringes, and cartridges with a single machine. These innovative platforms use a modular design approach to provide a truly adaptive system with the capabilities and features necessary for cGMP production of clinical and commercial sterile injectable products.

  5. Pharmaceutical Filling System For Non-Injectable Products: Ophthalmic, Nasal Sprays, Syrups: OFM 4/27/2021

    OFM automatic filling and closing machines are designed for pharmaceutical formulations, such as syrups, ophthalmic products, and nasal sprays either in glass or plastic containers.

  6. Pharmaceutical Vial Filling Equipment: VFM 4/28/2021

    VFM automatic filling and stoppering machines are designed for injectable solutions in vials.

  7. Analytical And Testing Services 2/2/2022

    As part of Stevanato Group’s commitment to R&D, our analytical testing facilities focus on investigating physico-chemical properties of primary packaging materials and components and studying the interactions between container closure system and drugs. Stevanato Group relies on a multi-disciplinary team of highly skilled professionals, including, scientists, engineers, pharmaceutical chemists and biotechnologists. Their knowledge and experience covers a range of specialized areas including container closure systems and drug-delivery devices.

  8. Cartridges For Use In Drug Delivery Applications

    Predictable, Reliable, Versatile. West offers Daikyo Crystal Zenith® cartridges used in drug delivery applications. These cartridges are manufactured with the highest dimensional tolerances ensuring this cartridge technology is predictable and safe. Daikyo Crystal Zenith offers superior performance by using a polymer with proven functionality, safety, and compatibility for a variety of devices making it suitable for high-viscosity drugs and long-term storage.

  9. 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?

  10. 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.