Temecula, California, USA

SITE DETAILS

Our Temecula, California, USA site has the following characteristics:

Ethylene Oxide:

Number of Chambers:

6 chambers

Pallet Dimensions:

2, 4, & 6: 1016 x 1219 x 2438 (mm) 40 x 48 x 96 (in) *Maximum product height is 96" with pallet” (2438 mm)

10 Pallet chambers: 1016 x 1219 x 1879 (mm) 40 x 48 x 74 (in) *Maximum product height is 72" with pallet

Chamber Sizes:

2 pallets 4 pallets 6 pallets 10 pallets

Process Components:

Ethylene Oxide (EO) Sterilization Process Components:

• Uses 100% EO, a fully automated conveyor system, and a highly flexible computerized vessel control system.
• 15,000 cfm PCR recirculation system ensures highly efficient temperature and RH distribution.
• Full load temperature and RH monitoring is available.
• Facility meets all Clean Air Requirements, including Ethylene Oxide Standards for Sterilization Facilities (CFR-40, part 63, Sub-part O).
• STERIS ASToperates under a quality system that is in compliance with 21 CFR Part 820 and applicable sections of 21 CFR Part 211. In addition, STERIS AST is registered to the ISO 13485:2003 Quality Standard, and adheres to the requirements of ISO 11137-1:2006 (Gamma) and ISO 11135-1:2007 (EO).

STERIS AST Temecula, CA ISO Certificate FDA Device Registration Number: 2030624 PAL Registration Number: BG30400453