USP 797 Compliance

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• QuadraCare’s sterile compounding operation was built in accordance with USP 797 and is therefore compliant with the design, procurement, and installation of appropriate clean room facilities as well as established policies and procedures.

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• QuadraCare compounds its low, medium, and high risk level sterile preparations with better than ISO Class 5 flow hoods and an ISO Class 7 sterile compounding room, exceeding USP 797 guidelines.

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• In addition, environmental monitoring equipment, cleaning, and gowning supplies are enforced to follow our stringent policies and procedures, environmental monitoring protocols, aseptic technique challenges, calibration methods, and all related documentation requirements.

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• Furthermore, QuadraCare’s extensive technician training and evaluation process ensures compounding personnel are properly trained in the preparation of compounded sterile products (CSPs).

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USP 800 Compliance

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• QuadraCare embraces the quality standards for handling hazardous drugs within its facility to help promote patient safety, worker safety, and environmental protection.

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• Proactive with USP 800, QuadraCare is prepared to properly compound antineoplastic and other hazardous drugs in their certified negative pressure clean room.