Avantti Medi Clear, is first company in Mexico that specializes in medical devices sterilization through E-Beam technology and provides the following services: outsourced electron beam sterilization product testing, dosimetry, dose mapping, and dose validation studies to manufacturers in Baja California and other regions of Mexico.
Avantti Medi Clear allows your company to reduce the need to ship to U.S. for sterilization processing by assisting with a local service that lowers your logistics costs. In addition, we have a state-of-the-art dosimetry laboratory that can facilitate testing and dose mapping requirements for new products.
We have the highest trained personnel with industry expertise to support clients validating and problem-solving on any issue relating to our services.
We recognize that compliance is a prerequisite for successful long-term operations in the medical device industry.
Avantti Medi Clear will provide your company with a transparent and timely service while complying with all regulatory requirements.
Range of Services
Our Business
E-Beam sterilization is the primary service offered to our clients by operating a state-of-the-art E-Beam sterilization
facility with an installed capacity margin, flexible scheduling capabilities and ancillary equipment, which enables a more profitable supply chain for clients by reducing transportation costs, client’s inventory levels and cost-efficient options for medical device companies to distribute final product.
We implement a “Just-in-Time” system with our customers, which decreases the financial burden on suppliers and device manufacturers, improving operating margins and the entire supply chain.
Our objective is to offer an integrated solution to our customers by combining all our services. As medical device
manufacturers undergo major cutback and downsizing, they require increasingly complex sterilization and distribution solutions.
The services Avantti Medi Clear provides include, but are not limited to:
Electron Beam Irradiation Service
Dosimetry
Dose Mapping
Dose Validation
Data Analysis
Cross-linking
Maximum / Minimum Dose Test
Dose Audits Sterilization
Our Facility
Our Business
The sterilization facility is located in Tijuana B.C. and is part of the region’s Medical Cluster, near the Otay/San Diego Border and a few miles from the Tijuana International Airport. This proximity gives clients the opportunity to take advantage of IMEX benefits via USMCA.
Our facilities have 31,071 square feet (2,900 m2) that allows for sizeable operations future growth and expansion. The accelerator and the conveyor system are automated and can be calibrated to deliver doses ranging from 2 kilo grays to 93 kilo grays. The facility operates under the guidelines of all the industry appropriate and regulatory.requirements. By satisfying international standards, we provide assurance criteria and contribute to new opportunities in international markets for our regional clients.
We are certified:
ISO 13485:2016
ISO 11137:2015
ISO 9001:2015
C-TPAT Compliant
Registered with:
FDA
COFEPRIS
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