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Sterilisation Indicators
Sterilisation Monitoring Products
Comply with the industry's regulations and maintain the highest standards with the latest technology in sterilisation monitoring products. Our range of chemical process indicators, biological indicators and self-contained biological indicators allows you to validate your sterilisation method, ensure adequate sterilisation is achieved and monitor load processing. All our indicators comply with AAMI, ISO 11138, USP and EN 886 standards.
Products available:
- Biological Indicators - spore strips and suspensions for process and batch validation.
- Self-contained Biological IndicatorSelf-contained Biological Indicators - results in 24 and 48 hours.
- Chemical Process Indicators - batch processing control.
Biological Indicators
Our biological indicators offer consistent resistance between lots, consistent purity and certified population levels. They meet the requirements of ISO 11138 and EN 866. They may be used for sterility tests during release testing procedures. Organisms include Geobacillus Stearothermophilus (steam/autoclave), Bacillus Pumilus (radiation) and Bacillus Atrophaeus (EO/dry heat), available in the following formats:
Spore Strips
- Highly controllable D-values
- Most species available in population from 104 to 108
- Certificated population and resistance
- Easy peel-open glassine envelopes
- Packs of 100 standard. Some available in boxes of 500 and 1,000
- Room temperature storage
- Dual species spore strips available
Spore Suspensions
The FDA requires medical device and pharmaceutical manufacturers to challenge their products by directly inoculating the device with spores to validate sterility assurance. Our spore suspensions are developed specifically for direct inoculation and for the preparation of biological indicators.
- Suspended in 20% or 40% ethanol
- Most species available in population 105 to 108 per 1ml or per 0.1ml
- Supplied in 10ml vials
- Certificated population and resistance
- 18 months shelf life
SporView® Culture Set
SporView® is an in-office BI system providing clear and easy to interpret results, for use with steam, EO and chemical vapour. Each box contains spore strips and culture media to be aseptically transferred for final spore test after 7 days incubation. Available in boxes of 20 and 100.
Self-contained Biological Indicators
Self-contained biological indicators allow simple verification of steam or EO sterilisation. They require only simple incubation and provide a clear indication or performance. Solid block incubators are also available.
SporView® Self-Contained BIs
SporView® are convenient self-contained Bis for use with saturated steam or EO sterilisation. They include a CPI line on the label to indicate that the vial has been through the sterilisation cycle. They provide final results in 24 hours for use in gravity, dynamic air removal, and flash cycles to comply with standards for routine sterilizer efficacy monitoring.
- Simply process along with normal load
- Read-out: colour change indicates steriliser failure
- Organisms: - B. Stearothermophilus, pop 2.2 x 105 (specials on request), B. Atrophaeus (ex subtilis var niger), pop 2.3 x 106 (specials on request)
- Boxes of 25 or 100
- Storage in a cool and dry location
- 18 months shelf life
SporAmpule® Self-Contained Bis
SporAmpule® are convenient error-free hermetically sealed self-contained Bis for use with saturated steam sterilisation processes, including liquids.
- Organism: B. Stearothermophilus in own culture medium
- Population: 1.0 x 105 (106 as special on request) - CFU / 1.9ml ampoule
- No activation or crushing required
- Only 48 hours incubation at 55-60° C
- Read-out: colour change from purple to yellow + visible turbidity indicate sterilizer failure
- Boxes of 20 or 100
- 18 months shelf life
Chemical Process Indicators
Our CPIs are convenient adhesive labels that change colour to help you monitor sterilisation and establish which product loads have been processed. Labels are available plain or pre-printed in several formats for steam, EO and gamma radiation sterilisation including low-dose radiation.
- Rolls of 1,500 and 5,000 labels
- 24 months shelf life
