BIOLOGICAL INDICATORS - BioNovus Life Sciences

BIOLOGICAL INDICATORS
Spore Coupons: Vaporized Hydrogen Peroxide
Technical Data Sheet | NAMSA Order Code: CPS-06
Physical Properties
Organism Geobacillus stearothermophilus cell line 7953
Description
Dimensions
Packaging
Sterilized 316 steel coupon inoculated with Geobacillus stearothermophilus spores
at a specified population level with known resistance to vaporized hydrogen peroxide
sterilization processes.
L x W x H: 34 mm x 7 mm x 0.9 mm
Each coupon has a hang hole at one end to allow for suspension in the sterilizer when
removed from packaging.
Individually in Tyvek ® /Mylar pouches, each pouch is 2.25” (57mm) x 2.75” (70mm)
Guidelines for Use
Application
Shelf Life
Post Exposure
Incubation
Storage Conditions
Clean Up/Disposal
Ideal for use in monitoring vaporized hydrogen peroxide sterilization processes.
Place spore coupons into most difficult area of the sterilizer. In general, a minimum of 10
spore coupons are utilized in each cycle.
Spore coupons may be utilized in or out of Tyvek ® /Mylar pouches.
12 months from the Date of Manufacture
The DOM is based on the day the spore suspension is inoculated onto the coupon.
Subsequent testing is required after the DOM, thus the shelf life will be less than 12
months at the point of purchase.
Following exposure, remove BI from sterilizer and aseptically transfer from packaging
materials placing bare strip into individual tubes of growth medium such as Soybean
Casein Digest Broth (SCDB).
For population verification, incubate at 55-65°C for a minimum of 16 hours. For sterilization
monitoring or efficacy studies, incubate at 55-65°C for a minimum of 7 days.
Room temperature 15 – 30°C. Protect from exposure to sterilizing agents, direct sunlight
and high temperatures.
Autoclave for not less than 30 minutes at 121°C or per validated disposal cycle prior to
discard.
Performance Characteristics
Population
VH2O2 D-value (50°C, 59%)
1.0 to 5.0 x 10 6 spores per carrier
Other population levels are available, please inquire for availability and lead time.
≥0.1 minutes
North American Science Associates, Inc. © 2011
USA Corporate Headquarters | 6750 Wales Road | Northwood, Ohio 43619 | T 866.666.9455 (toll free) | F 419.662.4386

BIOLOGICAL INDICATORS
Spore Coupons: Vaporized Hydrogen Peroxide
Technical Data Sheet | NAMSA Order Code: CPS-06
Resistance
Compliance
The certified d-value(s) are typically determined based on the stock suspension on filter
paper strips packaged individually in glassine envelopes.
Placement of the Spore coupon into a device or container will impact the resistance of
spores based on the influence of the device/container on the penetration rate of the
hydrogen peroxide vapors.
The certified d-value(s) serve as a guide and are only reproducible when performed under
the exact conditions (exposure parameters, culture and incubation conditions) the initial
d-value was determined.
ANSI/AAMI/ISO 11138-1:2006, USP, EP and JP (where applicable)
NAMSA offers a variety of sterilization monitoring products and the full
range of pre-clinical safety testing and consulting services to medical
device, pharmaceutical and biotech companies throughout the world.
For additional product information:
Please visit us at www.namsa.com
Email us at productorders@namsa.com
Call us at 800-860-1888 (toll free)
North American Science Associates, Inc. © 2011
USA Corporate Headquarters | 6750 Wales Road | Northwood, Ohio 43619 | T 866.666.9455 (toll free) | F 419.662.4386