Creating a Grade A environment, implementing quick setup and shutdown, and achieving maximum efficiency with the sterile isolator soloPURE.
The soloPURE sterile manufacturing closed system isolator system provides a Grade A sterile environment for filling operations in formulations, along with processes that require sterile treatment. Equipped with an H14 HEPA filter for intake airflow and dual H14 HEPA filters for exhaust airflow, soloPURE enables the handling of very delicate products in a positive pressure environment and allows for the handling of highly active sterile powders in a negative pressure environment. The system, featuring a flexible disposable chamber, eliminates the need for costly cleaning and validation work when concerns about cross-contamination arise.
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basic information
【Specifications】 - Integrity testing of HEPA filters can be performed for each campaign - Double HEPA filter - Sleeves installed on both sides for easy access to the chamber - Control of both positive and negative pressure is possible - Pressure drop test function is standard - Fully disposable chamber - Compatible with VHP generation devices and freeze dryers - Equipped with a fully automated control system - User-friendly interface
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Applications/Examples of results
- Inoculation of cells used in bioreactors - ADC formulation process - Formulation process for highly active pharmaceuticals requiring aseptic manufacturing - QA/QC - Flow from connection to freeze dryer to formulation - Manual filling - Filling using a dispenser
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Company information
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.