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  6. Containment of high-activity materials Flexible enclosure

Containment of high-activity materials Flexible enclosure

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ILC Dover

last updated:Sep 03, 2024

ILC Dover
ILC Dover
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Are you clinging to processes that cannot be changed? Please consider single-use enclosures that enable simple and safe pharmaceutical manufacturing.

ILC Dover's flexible enclosures elevate traditional concepts to a new level. They utilize reliable manufacturing technologies and proven containment design features used in the DoverPack family. Specifically, they offer a product lineup of flexible enclosures that can be adapted to a wide range of existing equipment, using the same proven containment design and processing techniques found in DoverPack family products. By using these enclosures, customization to fit existing manufacturing equipment is possible, saving customers time and costs while achieving containment of high-active materials at the nanogram level. All materials meet FDA standards and are designed to accommodate operator ergonomics for cGMP manufacturing. This means that operators can work in an environment as comfortable as putting on a dress shirt, leading to improved efficiency.

    isolator
isolator

Containment of high-activity materials Flexible enclosure

isolator with jet vent.jpg
isolator with jet vent.jpg

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【Specifications】 - Containment at the nanogram level has been demonstrated through SMEPAC testing by a 3rd party. - High economic efficiency. - Simple installation and replacement. - Compatible with a wide range of existing manufacturing equipment. - Bag-out using crimping is possible, similar to containment with existing DOVER packs. - Increased range of motion for operators based on ergonomic design. - Possible to enclose part or all of the equipment. - Containment control is possible with connection to a negative pressure control unit.

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Applications/Examples of results

The following containment achievements: - Tablet press - Granulator/mixer - Weighing/dosing machine - Coating equipment - Dryer - Reactor

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Containment of high-activity materials Flexible enclosure

Containment of high-activity materials Flexible enclosure

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ILC

ILC Dover

Pharmaceuticals and Biotechnology

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ILC Dover began its activities as the Primary Supplier of NASA's spacesuits and was established in the United States in 1947. As part of the company's mission, aptly named "Protecting People and Process," it is essential to "protect" astronauts due to the extremely hazardous space environment. At the same time, it is necessary to provide a comfortable working environment, and to achieve the seemingly contradictory goals of being durable yet easy to move in, the company has developed flexible and robust materials that are "soft yet strong." Based on this technology, approximately 25 years ago, ILC Dover collaborated with Eli Lilly to develop ArmorFlex film for contamination prevention in pharmaceutical active ingredient manufacturing, successfully applying it to single-use flexible enclosures. This film stretches over five times its original size, has high chemical resistance, and features static electricity suppression, making it a high-value product. In addition to enclosures, it has also been applied to powder-specific bags and is compliant with FDA regulations, leading to its adoption by many pharmaceutical manufacturing companies globally.

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