MIBA MEDICAL COMPLETES MEDICAL CONTROLLED ENVIORNMENT ROOM FACILITY
San Jose, Calif. – July 25, 2012 - MIBA Medical Inc., a medical aesthetics company, today announced the completion of its Medical Controlled Environment Room (CER) with the following features:
It meets the requirements of a ISO Standard 14644 and FDA Airborne Particle Standard 209E for medical clean zones for viable and non-viable particle count testing
Specifically it meets the requirements of a ISO 6 Class 1,000 certified medical clean zone room (14644-1:1999 and 14644-2:2000)
Meets the requirements of a ISO 8 certified medical clean room (14644-1:1999 and 14644-2:2000)
Our product manufacture is protected from airborne particulates by industrial-grade HEPA filters, air-lock doors and a positive pressure system
Tested for HEPA leaks, velocities, air volume changes and particle count
“This CER clean room is a significant milestone for MIBA Medical as it enables us to design and fabricate medical grade products safely. The medical device CER and clean zones cleanroom protects our products from contamination and provides the temperature and humidity controls to assure the environment needed to build our product for good quality and reliability and consistently,” said Dr. Phi Nguyen, CEO.
About MIBA Medical Inc.
MIBA Medical Inc. is a medical aesthetics company focused on developing and commercializing products that are used by physicians to enhance a patient's appearance. For more information, please visit http://www.mibamedical.com.