Featured Products & Services
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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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Aseptic Filling Systems For Biopharmaceutical Manufacturing
3/28/2023
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® - 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.
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Blow-Fill-Seal Packaging Systems For Large Volume Nebulizers And Humidifiers
7/9/2020
Large volume humidifiers and nebulizers – typically in sizes from 250 – 1000mL – can be specifically designed to fit existing delivery devices. Custom designs to facilitate the control of humidification in oxygen delivery can be developed.
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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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Single Dose Blow/Fill/Seal Pharmaceutical Vials
5/26/2017
Unit dose blow/fill/seal vials for one-time ophthalmic use have become an accepted international standard for pharmaceutical manufacturing and packaging. The ASEP-TECH Advantage is reflected in the development of formulations that no longer contain preservatives, minimizing the risk of allergic reactions for patients.
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Aseptic Filling System For Pharmaceuticals: BI-MI
2/16/2021
Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.
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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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Oral Dosage Form Development
10/23/2024
Oral administration remains the most widely used route for the successful delivery of active pharmaceuticals to patients.
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Bionanoparticle Technology
4/24/2023
Nanoform’s proprietary bionanoparticle technology can deliver large-molecule drug particles as small as 50 nm while retaining biological activity. This can not only enable more patient-friendly approaches to drug delivery, but also potentially higher loads of active ingredients.