Laboratory Services

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Steritec, Inc. is a contract provider of 100% ethylene oxide sterilization, steam sterilization, and laboratory services in accordance with ISO 13485:2016, ISO 11135, and ISO 17665.

Download and submit a Test Request Form .

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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.