[email protected]
+(506) 7005-5497
+(506) 7005-5498

About Us

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.

 

Since we do know your needs regarding supplier quality, we are totally able and open to receive your requests on matter of supplier surveys/questionnaires, providing all the documents you need, and receiving your on-site audits in order to have MCI qualified as your microbiological testing service provider. If you need to schedule an audit or to request documents for this process, please contact Mauren Monge or Roberto Avila through This email address is being protected from spambots. You need JavaScript enabled to view it. and This email address is being protected from spambots. You need JavaScript enabled to view it..

News

Air Quality and Cleanrooms

The performance of a cleanroom is defined by a set of complex interactions between the airflow, sources of contamination and heat, position of vents, exhausts and any objects occupying the space. Consequently changes to any of these elements will potentially affect the operation of the cleanroom and could invalidate aspects of the room design.

Read more ...