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Industrial Use Biological Indicators
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Standard 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. Raven offers a
full line of Industrial Use BIs to address the unique requirements of the medical device and pharmaceutical
industries.
Carrier | Species | Packaging | Lab Services
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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Peroxi-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®/poly 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. Additional information on Peroxi-Disc
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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 are available for placement into small openings or lumens. 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-thread are 100% cotton, ½" 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.
Steel Wires are intended for use in steam sterilization.
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.
ProLine ProLine is a 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).
The spore disc is packaged
in a glassine envelope and is located in the center of the ProLine housing. If adequate steam
penetration occurs, the spores on the disc will be deactivated and verify an adequate sterilization
cycle. more info
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.
Paper 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.
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).
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 medical device and pharmaceutical 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.
Some hydrophobic materials would cause a drop (0.1ml) to bead on its
surface. As this bead dries, the spores would be clumped on top of each
other. For these types of materials it would be to your advantage to use the
ethanol solution so the spores spread more evenly over the surface. The
same is also true when inoculating into a solution, where a water inoculum
may not be miscible.
Raven 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. stearothermophilus would 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 usedto validate 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 H2O2 D-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
to B. 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 to B. subtilis designate 5230
(lower temperature steam sterilization at 106° to 115°C). B. cereus is also used as a surrogate for B.
anthracis and 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 or if the purchased volume is high enough.
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 Raven’s spore strips and blue glassine packaging cannot be used with this type of sterilization.
Tyvek packaging and steel carriers are recommended.
Depyrogenation temperatures (180°C 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 of completion of the sterilization cycle, aseptically transfer the spore carrier from the
test unit into sterile Trypticase Soy Broth. An acid indicator may be used to facilitate detection of
growth. Incubate at 55°-60°C for G. stearothermophilus, 30°-35°C for B. atrophaeus, for seven days. Check
daily for growth and record growth as a failed sterilization cycle.
Certification
Raven certifies the species and population of each lot. 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.
Raven performs Steam, EO and Dry Heat resistance studies, organism ID, and
population verification on our BIs, your coupon or competitor's products.
Call for specific details.
Steam, Dry Heat, and EO D-value testing according to USP recommended procedures in
one of our four AAMI compliant BIER vessels. Raven can inoculate a coupon,
inoculate and fill 1 to 20 ml 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 106 G. stearothermophilus or B. atrophaeus
Culturing of Biological Indicators
Custom filled ampoules
Custom BI development
Organism Identification (Biolog)
Note:
- Derived from recognized reference strains as specified within USP, ISO or
EN guidelines. These products are not certified as being representative of
the reference strain and they should therefore not be used where a reference
culture is specified.
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