Apex Discs – NA5-152 - Biological Indicators

BIOLOGICAL INDICATOR INSTRUCTIONS -- NAS-152
Certifi cate of Analysis
PROCESS EVALUATION
'Place biological indicators in Iocations pleviously deterrnined to be the most diffrcult to sterilize.
Aleas experiencing rninimal gas flow or poor gas distribution include enclosure comers, areas in and
atouud equiptnent, and locations among disposable rnate¡ials to be used in the enclosure. Note that
the inoculated side ofthe carrier faces the prìnted label on the Tyvek pouch, therefore the printed
side should face outward during a process cycle.
Apex Biological Indicator (Reorder # NAS-I52)
for Gaseous Hydrogen Peroxide
Lot #: N0975
02
Manufacfure: 2015 APRIL
Expiration: 2016 JANUARY 31
Indicator: Geobacillus stearothermophilus 7953 (t)
Mean population: àlij x 106 CFU per stainless steel carrier (2)
Storage conditions: 2-8"C; less than 50% RH; move to ambient conditions > t hr
before use.
Shipping conditions: Ambient temperatures; cold pack and desiccant may be used
to moderate conditions during shipping.
Resistance Characteristics
D-value(3):
.Conduct the sterilization and aemtion cycle.
'Retnove the indicatols and deliver thern, plus one ol morc unexposed control indicators, to the
labomtoly fol sterility testing. Culturing of exposed indicators should be conducted as soon as
possible following rerroval from the enclosure being tested.
CULTURING PROCEDURES
'Culture in a laminar flow hood. Observe shict aseptic technique at all times. Minirnally, sterile
gloves should be wom. Include donning hoods, masks, and gowns as appropriate for the facility and
:
circumstances.
0.7r¡inutesin2rnglLgaseousHzOz
'Aseptically open the Tyvek pouch by cutting with sterile scissors or peeling apart at the end with the
package offset.
units are manufactured in cornpliance with Mesa Laboratory, Bozeman Manufacturing
Facility's quality standards and ISo 1 I 138-1 guidelines and all appropriate subsections.
'l]sing sterile forceps, withdmw the canier and place in a tube containing sterile Soybean Casein
Digest Mediurn (SCDM) / Tryptic Soy Broth (TSB).
.Aseptically cultu¡e the control carrie(s) last.
Purity: No evidence of contaminants using standard plate count techniques.
Incubate at 55-60"C for 7 days. The recommended growth medium is Soybean
Casein Digest Medium (SCDM) / Tryptic Soy Broth (TSB).
.Select one or mole tubes ofthe sarne lot ofculture lnediurn to sewe as negative controls.
.lncubate test and control tubes for 7 days at 55-60'C. Observe daily for evidence of growth
(tuÌbidity).
INTERPRETATION
This product is for Industrial Use Only.
Disposal: Treat
'Validation and napping processes generally lequire rnultiple indicators at numerous sites in an
enclosure.
.Turbidity:
as non-pathogenic
material and sterilize (steam, EtO, etc) or
For test indicatom, tuúidity suggests that the stedlization was incomplete and that at least one
incinerate before discarding.
spore suwived the process.
(r)Culture is
traceable to a recognized culture collection identified in USP and ISO I I I 38.
(2)
Heat shock population detennined at 95-l 00"C for I 5 rninutes
(3)
Resistance was calculated using Fraction Negative rnethod. The D-value is leproducible only when
exposed and cultured under the exact conditions used to obtain results reported here.
Fol positive contrcl indicators, turbidity indicates that viable spores were present and capable
of^outgrowth in the culture mediurn used.
hr negative contlol tubes, turbidity indicates that viable organisrns rnay have been present in
.
the growth rnedium. Contact youl supplier.
.No turbidity:
_ Fol test indicators, lack ofturbidity indicates sterjlization was complete and no spores survived
the process.
hr negali.ve contlol tubes, Iack
_
oftutbidity indicates no other viable organisms were present in
.
the culture medium.
For positive control indicator, no turbidity suggests no viable organisrns were present on the
canier or that the media tnay be inhibiting the outgrcwth of the test olganism. Contaòt your supplier.
Certified By:
ffi MesaLmhs
Bozeman Mânufacturing Facility
I 0 Evergreen Drive
Bozeman, MT 59715
T: 303/987-8000 ¡ F: 406/585-9219
www.mesalabs.com
Rev. I
23MAR201 5
Part #: 36.7008-1 0
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