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Catalog item

STERILIZATION TEST PACK,BIOLOGIC

6530FSC

01NCB code

580-9432Item number

NIIN 01-580-9432

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DEMIL code: A

Identification

Item name code: 46808
PINC: 0046808
Criticality code: X
II: 0
DEMIL code: A
DEMIL integrity code: 1
NIIN assigned: 30-DEC-09
Precious metals indicator: A
ADP equipment code: 0
Hazardous material indicator: N
ESD/EMI code: A

Part numbers

Part number: EZH/5
CAGE: 6XX00
SGM BIOTECH, INC.
CAGE status: A
RNCC: 3
RNVC: 2
Document availability code: 4
RNAAC: 9Z
RNFC: 4
RNSC: A

Characteristics

FURNISHED ITEMS	100 UNITS;SPORE-G.STEAROTHERMOPHILUS;THERMOPLASTIC CULTURE TUBE HOUSING GLASS AMPULE AND FILTER-PAPER CARRIER
END ITEM IDENTIFICATION	TEST EQUIPMENT FOR STERILIZATION
PROTECTIVE STORAGE FEATURE	CONTROLLED ROOM TEMPERATURE
PACKAGE MODEL NUMBER	EZTEST H2O2 (FOR HYDROGEN PEROXIDE)
USAGE DESIGN	STERILIZATION BIOLOGICAL INDICATOR
APPROXIMATE SHELF LIFE	MONTHS 24.0
PART NAME ASSIGNED BY CONTROLLING AGENCY	EZTEST H2O2 (FOR HYDROGEN PEROXIDE;SELF-CONTAINED BIOLOGICAL INDICATOR
SPECIAL FEATURES	BACTERIAL SPORES ON A FILTER-PAPER CARRIER PACKAGED IN A SMALL,THRMOPLASTIC CULTURE TUBE;INSIDE THE TUBE IS A SEALED-GLASS AMPOULE OF SPECIALLY-FORMULATED SOYBEAN CASEIN DIGEST CULTURE MEDIUM CONTAINING A COLOR INDICATOR-TURNS YELLOW WHEN SPORES GROW
FUNCTIONAL DESCRIPTION	TEN UNITS PER CYCLE IS COMMONLY USED;EXPOSE LOAD TO STERILIZATION CYCLE;WITH ONE NON-STERILIZED UNIT MARK POSITIVE CONTROL AND THE ONE EXPOSED, CRUSH GLASS CULTURE AMPOULE TO ACTIVE;PLACE IN INCUBATOR 55-60 DEG C 24 HOURS;IF ALL SPORES ARE KILLED THE CULTURE MEDIUM WILL REMAIN RED;IF SPORES SURVIVED MEDIUM WILL TURN YELLOW (POSITIVE)
SPECIAL TEST FEATURES	FOR HYDROGEN PEROXIDE-RESULTS IN 24 HOURS WITHOUT LABORATORY TRANSFERS
SUPPLEMENTARY FEATURES	EXPIRATION IS 24 MONTHS FROM DATE OF MANUFACTURE;READ RESULTS EVERY 12 TO 24 HOURS;ALL POSITIVE (YELLOW) SAMPLES SHOULD BE RECORDED AND DISCARDED IMMEDIATELY. ALL YELLOW SAMPLES SHOULD BE AUTOCLAVED PRIOR TO DISPOSAL

MOE rules

MOE rule: ZW01
MOE CD: ZW
Date assigned: 01-DEC-09
PICA: ZW
PICA LOA: 81
Auth collab: ZW

Freight

ACTY CD: ZW

Related items

Standardization

Item standardization code: 5
Orig stdzn dec: 97
Dt stdzn dec: 30-DEC-2009
NIIN status code: 0

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