Steritec Automation Sterilizer Control System - The Paradigm of Next Gen Sterilization
Steritec Automation

Laboratory Services



Steritec, Inc. is a contract provider of 100% ethylene oxide sterilization, steam sterilization, and laboratory services in accordance with ISO 13485:2003, ISO 11135, and ISO 17665.


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MICROBIOLOGY


PRE-STERILITY TESTS

BACTERIOSTASIS / FUNGISTASIS


TYPE QTY CODE
Bacteriostasis / Fungistasis USP, per organism BF001


BIOBURDEN (100-800 ml wash):

STANDARD PLATE COUNT


TYPE QTY CODE
Total Aerobic 1 Sample BB01-100
Total Aerobic 2-9 Samples BB01-110
Total Aerobic 10+ Samples BB01-120
Total Aerobic Plus Spores 1 Sample BB01-200
Total Aerobic Plus Spores 2-9 Samples BB01-210
Total Aerobic Plus Spores 10+ Samples BB01-220
Total Anerobic Per Sample BB01-500
Total Fungi Per Sample BB01-700


BIOBURDEN (100-800 ml wash):

FILTRATION METHOD


TYPE QTY CODE
Total Aerobic 1 Sample BB01-300
Total Aerobic 2-9 Samples BB01-310
Total Aerobic 10+ Samples BB01-320
Total Aerobic Plus Spores 1 Sample BB01-400
Total Aerobic Plus Spores 2-9 Samples BB01-410
Total Aerobic Plus Spores 10+ Samples BB01-420
Total Anerobic Per Sample BB01-600
Total Fungi Per Sample BB01-800


STERILITY TESTS

MEDIA VOLUME 100-800 ml


TYPE QTY CODE
Custom Testing Available - ST001-CUST
40 Products, Immersion 14 days innoculation ST001
20 Products + 10 Spore Strips, Immersion 10 days innoculation ST002
20 Products + 10 Spore Strips, in situ 10 days innoculation ST003
10 Products, Immersion 7 days innoculation ST004
10 Products, in situ 7 days innoculation ST005
10 Products + 10 Spore Strips, Immersion 7 days innoculation ST008
Membrane Filtration 7 days innoculation ST006
Spore Strips, Immersion 7 days innoculation ST007


SUPPLEMENTAL SAMPLE TESTING

MEDIA VOLUME 100-800 ml


TYPE QTY CODE
Extra Product Sterility Samples 100 ml or less Media SST01-101
Extra Product Sterility Samples 101-400 ml Media SST01-102
Extra Product Sterility Samples 401-600 ml Media SST01-103
Extra Spore Strips Samples - SST01-104
Positive Control - SST01-105
Gram Stains - SST01-106
Product Innoculation - SST01-108
Contact Plates 10 + report SST01-109
Settling Plates 10 + report SST01-110
Device Particulate Analysis - PA001


SPORE STRIP POPULATION


TYPE QTY CODE
Verification Count (Heat Shocked) - PV001-101


LAL PYROGEN ANALYSIS (GEL CLOT METHOD)


TYPE QTY CODE
Extract of Device - Test, Positive, Negative, and Inhibition Controls - PL001-101
Medical Device Validation Program (USP) - LAL-VAL
Ethylene Oxide Residual Analysis (EO, ECH) - EO001-101


PHYSICAL TESTS

PULL TEST, PEEL STRENGTH, ETC.



STERICHECK

STERILIZER MONITORING SERVICE



Steritec Inc.

For more information or to schedule an appointment, call

903.677.3950