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Equipment and Processing Report
At INTERPHEX 2019, MG2/MG America stages a packaging/processing summit; exhibitors offer packaging equipment innovations for parenteral products.
In an INTERPHEX first, MG2/MG America will host an educational forum on the show floor, the MG America Processing & Packaging Summit at INTERPHEX 2019 (April 2–4, 2019, Javits Center, New York, NY). Packaging sessions are scheduled on Tuesday, April 2; processing sessions will be presented on Wednesday, April 3. Packaging topics include serialization, robotic handling of sterile-filled glass vials, and the advantages of integrated automation (1).
Attendees also will have the opportunity to learn about aseptic filling and closing machines and material handling for parenteral products. NJM, a ProMach product brand, plans to introduce its Dara NFL/2-RDL aseptic filling and closing machine for ready-to-use, nested vials using the RayDyLyo cap. The patented, pre-assembled plastic closure from ARaymond LIFE features a rubber stopper within the cap to minimize the “pop-off” effect and eliminate the risk of stoppers adhering to freeze-dryer plates. Available with central tear-off for injectable products and total tear-off for product reconstitution and mixing, RayDyLyo closures come in 13-mm and 20-mm diameters (2).
The Dara NFL/2-RDL machine fills solutions, suspensions, diagnostics, or vaccines in glass or plastic vials in sizes ranging from 2R to 50R with dose volumes from 0.1 to 50 mL. Changeover to a different vial size takes less than 15 minutes with no tools required. The dual-station machine handles up to 4500 vials/hour in a footprint that measures only two meters long by one meter wide (2).
Thomas Kessler, regional sales manager at NJM, said in a press release, “The highly efficient Dara NFL/2-RDL was developed for biotech companies and 503B pharmacies and can be used from scale-up through small batch commercial manufacturing. Utilizing ready-to-use vials massively simplifies small-scale production by eliminating the need for a washer and depyrogenation tunnel, and using the RayDyLyo cap further simplifies operations by eliminating crimping and the particulate generation that comes along with that process. After introducing the high-speed Dara SX and HSL series machines for RayDyLyo caps last year, we’re now offering this NFL system for customers with smaller capacity requirements, who will benefit from this innovative stopper/cap technology and a more compact system that has the added value of syringe and cartridge processing capabilities in the same machine” (2).
A robotic aseptic filling and closing machine, the GENiSYS R model from AST, also works with nested, ready-to-fill containers and can handle vials, syringes, or cartridges. Designed for small-batch sterile production common to cell, gene, and regenerative medicines, the machine features a peristaltic dispensing system integrated with an electronic balance to provide 100% fill weight inspection. Modular design enables easy integration with isolator-barrier systems, lyophilizers, and other process systems. “The GENiSYS R bridges the gap for late-stage clinical and commercial products by integrating advanced aseptic features, and process and container flexibility within a simple and compact system,” reported Josh Russell, vice-president of Business Development of AST, in a press release (3).
Another machine designed to handle lower volume aseptic requirements associated with biologics and vaccines, thecompact Asep-Tech LAB+ blow/fill/seal machine from Weiler Engineering is ideal for stability, clinical, and development batches. A small footprint, servo-driven motion controls and modular platform expedite changeover and maximize the range of products handled. Options include single-use technology or conventional clean-in-place and steam-in-place technologies, a patent-pending Grade A filling zone, and a particulate matter removal system (4).
The Integra machine from groninger is an aseptic filling machine with integrated isolator. Built from the ground up in conjunction with Skan as an integrated isolator-equipped filling system, the line processes toxic products while achieving shorter decontamination cycles. Its Skanfog decontamination system enables cleaning and decontamination in 30 minutes (5).
For freeze-drying processes, Telstar is introducing the Lyogistics Zero automatic vial loading/unloading system, which can be cleaned and sterilized inside the lyophilization chamber. The unit eliminates concealed parts and features a steam-sterilizable slider, which is moved by a contact-free magnetic drive mechanism. This design allows the slider to remain inside in the chamber for cleaning and sterilization (6).
1. INTERPHEX, “MG2/MG America to Offer Processing & Packaging Summit at INTERPHEX 2019,” Press Release, Feb. 25, 2019.
2. NJM, “NJM Introduces Dara NFL/2-RDL Aseptic Filling and Closing Machine for Ready-to-Use Vials with RayDyLyo Caps,” Press Release, Jan. 15, 2019.
3. AST, “AST Unveils GENiSYS R Robotic Aseptic Filling and Closing Machine at INTERPHEX 2019,” Press Release, www.interphex.com/__novadocuments/559103?v=636863866954500000, accessed Feb. 27, 2019.
4. Weiler Engineering, “LAB+ Blow/Fill/Seal Machine,” Press Release, www.interphex.com/__novadocuments/558030?v=636861997071400000, accessed Feb 27, 2019.
5. INTERPHEX, “Revolutionary Technology and Innovation to Debut at INTERPHEX 2019,” Press Release, Feb. 20, 2019.
6. Telstar, “Telstar Promotes a New Generation of Automatic Vial Loading & Unloading Systems for Freeze-Drying Processes,” Press Release, www.interphex.com/en/Show-Info/Exhibitor-List/Company-Content1/?coId=498456, accessed March 1, 2019.