Our San Diego, California, USA site has the following characteristics:
|Number of Chambers:||9 chambers|
|Pallet Dimensions:||1219 x 1016 x 2642 (mm) 48 x 40 x 104 (in)|
|Chamber Sizes:||28 pallets|
Ethylene Oxide (EO) Sterilization Process Components:
- Parametric Release: All sterilizers are equipped to meet the strict requirements of ANSI/AAMI/ISO 11135.
- Facility meets all Clean Air Requirements, including Ethylene Oxide Standards for Sterilization Facilities (CFR-40, part 63, Sub-part O).
- STERIS AST operates 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 San Diego, CA ISO Certificate FDA Device Registration Number: 2032112 PAL Registration Number: BG30400181
We hold the following Site Certificates:
- San Diego, California (EO), USA ISO 13485 RvA Certificate
- San Diego, California, USA E-beam JPAL QMS
- San Diego, California, USA (EO), Japanese FMA Certificate
- San Diego, California (EO), USA ISO 13485 UKAS Certificate
- San Diego, CA, USA E-beam Japanese FMA Certificate
- San Diego, CA, USA E-beam ISO 13485 UKAS Certificate