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Media-fill kits for USP 797 testing, 5/13:88

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Hardy Diagnostics’ Val media-fill challenge kits are for USP 797 compliance testing for compounding-sterile preparations (CSPs).

The ready-to-use media-fill challenge kits are for use in validating pharmacy compounding personnel in accordance with USP 797 guidelines. Aseptic media-fill testing is part of an effective quality assurance program to ensure pharmaceutical processes and personnel produce sterile products that are free of microbial contaminants.

Hardy Val CSP kits are recommended as part of an industry QA program to identify potential areas for process improvement. Regular use can provide competitive customer quality confidence as well as a standard of best practice to ensure regulatory compliance. Kits are available in low-risk (HVL1), medium-risk comprehensive (HVM1), medium-risk basic (HVM2), and high-risk (HVH1) formats. Each kit is ready to use and certifies one technician. A log sheet is included to record results for record retention.

Hardy Diagnostics, 800-266-2222

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