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Our knowledge
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Knowledge of the industry. Adapting the design to medical requirements and integrating specific processes. |
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Clean-room compatibility. Comprehensive knowledge of class 10,000 to 100,000 for clean room production and a wealth of experience in using automated systems in aseptic environments. |
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Guidelines and standards. A quality system satisfying the requirements of the 21 CFR 820 standard (GMP), expert assessment (DQ, IQ, OQ, PQ) for FDA qualification, and comprehensive experience in working to 21 CFR Part 11. |