Meridian Biologics' 3,500 sq. ft. facility is designed to meet FDA requirements for production under current Good Manufacturing Practices (cGMP). This facility offers flexibility for each project, and Meridian Biologics will make every effort to provide the most technically correct and cost effective solution possible.
Designed to maintain the identity, purity, and strength of the product through proper air flow, materials flow, and personnel flow.
• Each person involved in manufacturing is trained and the training is documented.
• Assays appropriate for each manufacturing phase can be validated for each new process.
Memphis, TN 3,500 sq/ft facility containing:
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Class 10,000 Support Areas |
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Class 10,000 Purification Area with Downdraft Hood |
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Dedicated Cleanroom Equipment |
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Dedicated HVAC Systems |
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WFI System |
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Prokaryotic Suite |
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Eukaryotic Suite |
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Dedicated Storage at -70°C, -20°C, 4°C and Uncontrolled Room Temperature |
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Dedicated cGMP Facilities