El Paso I, Texas

Continuous Gamma Process Components:

• Uses a Cobalt-60 continuous irradiator with a source overlap configuration (for high-volume applications)
• Moves product throught the gamma irradiation process using a monorail system and an automatic conveyor system
• Uses hydraulic elevators to facilitate product loading and unloading
• Employs barriers to prevent contamination and mixing of processed and unprocessed products
• All gamma and ethylene oxide (EO) facilities are in compliance with FDA 21 CFR part 820 requirements, ISO 13485 registered, and AAMI/ANSI/ISO 11135-1:2007, AAMI/ANSI/ISO 11137-1:2006, and EN 550 compliant for product acceptance in U.S. and international markets.

GammaExpress^® Expedited Processing Service

Our GammaExpress expedited processing option uses dosimetric release, which enables products to be shipped immediately after processing. Our two expedited options ensure your product will go from receipt to outbound shipping in either 24 or 48 hours, or less.

Ethylene Oxide (EO) Sterilization Process Components:

• Uses 100% ethylene oxide (EO), a fully automated conveyor system, and a highly flexible computerized vessel control system
• 60,000 cfm PCR recirculation system ensures highly efficient temperature and RH distribution
• Full height chambers eliminate the need to re-stack products between trailer and carrier
• Full load temperature and RH monitoring is available
• Facility meets all Clean Air Requirements and the proposed EO Standards for Sterilization Facilities (CFR-40, part 63, Sub-part O)
• Preconditioning rooms and Degas Cells are individually controlled

STERIS Isomedix El Paso, TX ISO Certificate
PAL Registration Number: BG30400295