Minneapolis, Minnesota, USA

Kontaktdetails

Adresse:

Isomedix Operations, Inc.
a STERIS Company
380 90th Avenue NW
Minneapolis, Minnesota 55433
United States of America

+1 (763) 786-2929

ast_info@steris.com

SITE DETAILS

Our Minneapolis, Minnesota, USA site has the following characteristics:

Ethylene Oxide:

Number of Chambers:

12 chambers of various sizes

Pallet Dimensions:

48 x 40 x 76 (in) 1219 x 1016 x 1930 (mm) or 48 x 40 x 72 (in) 1219 x 1016 x 1828 (mm)

Chamber Sizes:

11 pallets 9 pallets 7 pallets 4 pallets 3 pallets 2 pallets

Process Components:

Ethylene Oxide (EO) Sterilization Process Components:

Uses 100% EO and a highly flexible computerized vessel control system.
24,000 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 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 Minneapolis, MN ISO Certificate FDA Device Registration Number: 2183744 PAL Registration Number: BG30400163 EO Engineering Run Request Form