Microbiología y Calidad Industrial MCI S.A. is a company dedicated to offer laboratory testing and consulting services for industry. Our goal is to satisfy requirements and needs of medical devices and pharmaceuticals manufacturing industries, which are commonly subjected to constant review and inspection of their processes and systems under international quality standards.
In order to achieve this goal, MCI executes all laboratory tasks, from customer service through sampling/testing, to final reporting, in compliance with an implemented quality system based on ISO17025 requirements.
Tests are focused on microbiological quality of products, as well as the controlled environment and supporting systems used for manufacturing. For the execution of all tests, MCI based its methods on international standards:
- US Pharmacopeia (USP)
- ISO14644-1, Cleanroom and associated controlled environments
- ANSI/AAMI/ISO 11737, Sterilization of health care products-Microbiologial methods
- ISO14698-1, Cleanrooms and associated controlled environments-Biocontamination control-Part 1: General principles and methods
- ISO14698-2, Cleanrooms and associated controlled environments-Biocontamination control-Part 2: Evaluation and interpretation of biocontamination data
- ISO8573, Compressed air
- ANSI/AAMI ST72, Bacterial Endotoxins-Test methodologies, routine monitoring, and alternatives to batch testing.
- Standard Methods for the examination of water and wastewater. APHA, AWWA, and WEF.