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Industrial Use Biological Indicators
Standard Biological Indicators (BIs) are easy to use and are
available for industrial or healthcare use. However, some
manufacturing situations require a modified or specialty Biological
Indicator to assist in validating the sterilization process.
Manufacturers and validation specialists require unique tools where
spore strips and ampoules are not suitable because of size,
packaging or carrier material.
Carriers
Discs have advantages over spore strips due to their size.
Different materials may be compatible only with specific modes of
sterilization. Discs can be used to monitor various sterilization
methods and can be inoculated with any organism we manufacture.
Several types and sizes of discs are available including: paper,
borosilicate paper, and stainless steel. The
user must determine the suitability of the indicator for their
particular use.
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Steel Discs
Steel discs are representative of materials found in an
isolator, and are compatible with vapor hydrogen peroxide.
We strongly recommend our polished stainless steel to
eliminate crevices in the carrier which can lead to
tailing.
The oblong disc is inoculated with G.
stearothermophilus1, catalog # 3A-6100ST
for use in H202 vapor.
Discs are packaged in a Tyvek/Tyvek® pouch and may be
exposed in the pouch or an off-center hole in the disc
allows them to be removed from their package and suspended
throughout the isolator to insure proper flow. See
Certificate of Analysis for resistance characteristics.
Paper discs have been used to validate sterilization of
contact lenses in steam where placement of a strip was
impossible due to its size. They are also suitable for EO,
Dry Heat (up to 180°C) and radiation sterilization.
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Woven Cotton Threads
Threads can be used to monitor various sterilization
methods and can be inoculated with any organism we
manufacture. Threads have been used at the interface of a
syringe and plunger to show sterilant penetration and
efficacy at that point. Other uses include placement in
tubing and small vials.
Bio-threads are 100% cotton,
3/4" long, and can be inoculated with B.
atrophaeus1, G.
stearothermophilus1 or
with another organism.
The device/lumen into which the thread is inserted affects
its resistance characteristics.
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Steel Wires
Wires can be inoculated with G.
stearothermophilus spores
and placed into very small lumens. Due to their rigid
nature, they are easy to retrieve even if there is
condensation within the lumen. Wires can also be made with
a closed loop at one end, so a small wire can be attached
to ease in retrieval.
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ProSpore DH
ProSpore DH is a biological
indicator (BI) specifically designed for Dry Heat
sterilization and is uniquely suited for extremely high
temperature processes. ProSpore DH won’t char or
introduce particulates as a paper strip might. |
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ProLine
Biological Indicator system designed for use in the
validation or monitoring of steam or EO sterilization
cycles of tubing ranging from 1/8" to 5/8" tubing ID. The
ProLine PCD (Process Challenge Device) contains a filter
paper disc inoculated with bacterial spores of Geobacillus
stearothermophilus (steam)
or Bacillus
atrophaeus (EO).
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Steel Coupons
Steel Coupons (same size as our standard paper strip) are
intended for use in dry heat ovens at depyrogenation
temperatures.
Inoculated with 106 B.
atrophaeus spores,
they are used to correlate spore death (sterilization) with
endotoxin reduction. Raven does not sell endotoxin or other
LAL reagents at this time.
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Paper strips
Paper spores strips are available in our standard one and
one-half inch length, half length, and 2mm x 10mm sizes and
can be used in any sterilization method compatible with
paper products.
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Steri-Chart
Steri-Chart is a set of strips with 5 different
populations, all made from the same spore batch for use in
cycle development. Expose the five test strips to determine
what level of sterility is being delivered by a particular
cycle (industrial use only).
A control strip is also included. Available with G.
stearothermophilus (log
3, 4, 5, 6, & 7 test strips and a log 5 control) or B.
atrophaeus (log
4, 5, 6, 7, & 8 test strips and a log 6 control).
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Spore Suspensions
Are diluted aliquots from our primary spore crop (batch).
They are used to directly inoculate (and therefore
challenge) a material or solution with a known
concentration of spores. US FDA requires pharmaceutical and
medical device manufacturers to challenge their products
directly with spores prior to approving them for sale. This
challenge is intended to determine if the device's carrier
material or pharmaceutical's properties (viscosity, salt
content, etc.) has any sporicidal or preservative effect
that will impact the manufacturer's ability to sterilize
the product and to determine instructions on how the user
can sterilize the device if reusable.
Suspensions offered in a 40% ethanol solution or 100%
deionized H2O.
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Species
Manufactures many species of non-pathogenic spore-forming bacteria.
Most are used for various types of sterilization, though some have
other uses. Following is a brief description of the most common
uses:
B. subtilis1
Used to test the growth promotion ability of bacteriological media
(specified in USP and other compendial monographs). We do not
certify this organism with any resistance characteristics.
B. subtilis1(called
“ Designate 5230”) is used in steam sterilization procedures below
121C. Some pharmaceutical products are sterilized at 106° to 115°C
for longer times because they are heat labile and would be damaged
at 121°C or higher temperatures. This species has been used as a
challenge to the lower temperatures in steam, where G.
stearothermophiluswould be too great a challenge. In using a
lesser challenge (C. sporogenes species and environmental isolates
are also used) it is necessary to have an extremely high level of
control over the manufacturing process, environment, and bioburden
of components. This organism is certified with a Steam D and
z-value so its resistance at the lower temperatures can be
determined.
G. stearothermophilus1 has
been used for steam and other types of sterilization by several BI
manufacturers. In particular, it has been used to validate Vapor
Hydrogen Peroxide (VHP) sterilization of barrier isolators and
clean areas in pharmaceutical production. To be able to provide a
comparable product we also offer G.
stearothermophilus1 and
test it in H2O2 vapor.
This product is typically inoculated onto steel carriers so it is
compatible with the H2O2 process.
This organism is certified with an H2O2D-value.
G. stearothermophilus1 – is
used to detect residual antibiotics in dairy products. We do not
certify this organism with any resistance characteristics.
B. thuringiensis1 –
This species has a protein crystal on the spore coat that makes the
spores toxic to various insect larvae. In Canada, some trees are
sprayed with a spore suspension to protect them from certain
larvae. Geneticists have engineered this protein to be expressed in
some varieties of corn (referred to as Bt-corn). B.
thuringiensis has
also been used as a surrogate toB. anthracis or
other more hazardous organisms in testing decontamination
processes. We do not certify this organism with any resistance
characteristics.
B. cereus and B.megaterium would
be used in a similar manner toB.
subtilis designate
5230 (lower temperature steam sterilization at 106° to 115°C).B.
cereusis also used
as a surrogate forB.
anthracisand other
more dangerous organisms in testing decontamination processes. We
do not certify this organism with any resistance characteristics,
but one can be provided upon request for a fee.
Packaging
Carriers can be packaged individually in glassine paper, a Tyvek®
pouch, or in bulk plastic bags (no primary packaging). Carriers
(individually wrapped) are sold in quantities of 100. Bulk packaged
items are sold in quantities of 1,000. Steel Discs are only
packaged individually in Tyvek® pouches.
Sterilization/Carrier compatibility:
Hydrogen
peroxide (vapor or plasma) is not compatible with cellulosics
(paper, wood pulp products), so the spore strips and blue glassine
packaging cannot be used with this type of sterilization. Tyvek
packaging and steel carriers are recommended.
Depyrogenation temperatures (180° to 250°C) char or incinerate
paper, so we recommend our steel strip carrier. This product is
packaged in a Tyvek® pouch so the user can handle it without
contaminating the lab with spores. Raven does not offer a foil
package for our steel strips, but recommends that the user wrap the
strip in foil or place it inside a glass container prior to
exposure in the depyrogenation tunnel/oven. This will assist
aseptic transfer to media after the exposure.
Procedure for use (general)
Spore carrier may
be removed or left in primary packaging. Place carrier into test
environment. Within 4 hours (per USP) of completion of the
sterilization cycle, aseptically transfer the spore carrier from
the test unit into sterileTrypticase
Soy Broth. An acid indicator may be used to facilitate
detection of growth. Incubate at 55-60°C forG.
stearothermophilus, 30-35°C forB.
atrophaeus, for seven days. Check daily for growth and record
growth as a failed sterilization cycle.
Certification
Some carriers may have D-value
determined on the carrier in a particular packaging. Call for
specific availability of resistance information. We can also
provide resistance characteristics of the spores from the same
batch on a paper strip packaged in glassine envelopes (Steam, Dry
Heat, and EO) as a reference. Since the carrier will likely be
removed from its package and placed inside a lumen or other
environment, which may increase/decrease the resistance. The user
must determine the suitability of the unit for their particular
use. Actual D-value is dependent upon placement of the carrier and
the accessibility of sterilant to that placement.
Storage
Store away from sterilants, out of
direct sunlight, and in cool dry place (15°C-27°C, 30-70%RH).
Samples
Raven is happy to provide samples so
the user can determine the indicator’s suitability for their
particular use.
Lab Services
Steam, Dry Heat, and EO D-value testing according to USP
recommended procedures in our AAMI compliant BIER vessels. Raven
can inoculate a coupon, inoculate and fill 1 to 20ml ampoules with
your product, or verify a competitor's claim for population and
D-value/z-value. Testing performed includes:
- Steam D-value on a commercially prepared BI
- EO D-value on a commercially prepared BI
- Population analysis of a commercially prepared BI
- Inoculation of client provided coupon with 106G. stearothermophilusorB. atrophaeus
- Custom filled ampoules
- Culturing of Biological Indicators
- Custom BI development
- Organism Identification (Biolog)
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