Exela Pharma Sciences owns and operates a 20,000 sqft cGMP sterile products research and manufacturing facility in Lenoir, NC. Lenoir is about an hour and a half north of Charlotte, NC, in the picturesque foothills of the Blue Ridge Mountains.
The facility contains two class 1,000 clean rooms and 2 class 10,000 clean rooms that are equipped with state-of-the-art automated particle measuring systems that continuously monitor viable and non-viable particles. The clean rooms currently house a Chase-Logeman vial filler/crimper/capper and a Chase-Logeman ophthalmic filler. The class 10,000 clean rooms contain a Cozzoli vial washer, a Gruenburg depyrogenation oven, and a Getinge air-over-pressure sterilizer.
Exela Pharma Sciences is developing lyophilization capabilities incorporating a 24 sqft lyophilizer in a class 1,000 clean room.
Exela Pharma Sciences produces its own Water for Injection (WFI). The facility is equipped with a high purity high capacity (up to 1,000 gallons per hour) WFI system with hot loop that is fully validated.
Exela Pharma Sciences is capable of developing and manufacturing highly potent an cytotoxic products by using its Flanders double isolator system. We use state-of-the-art compounding processes with disposable bag mixing systems to further reduce exposure and expedite the whole manufacturing process.
Fully validated analytical and microbiology laboratories are to support our manufacturing activities on site. All the product stability is conducted in-house.
The facility has a walk-in cooler to accommodate handling of cold-storage products that require storage temperatures 2 - 8°C. The building is climate controlled, fully sprinklered, and swipe-card access controlled for added security.