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Self-contained Biological Indicators

DESCRIPTION

The gke SCBI’s comprise a plastic vial containing a biological indicator spore disc and a glass ampoule with growth medium and pH indicator inside.

The SCBI has a Type 1 chemical indicator label (according to EN ISO 11140-1) to indicate whether the SCBI has been through a sterilisation process. Additionally our Instant SCBI’s contain a Type 5 chemical indicator allowing for instant evaluation of the load.

All of the gke biological indicators comply with the EN ISO 11138 Series of Standards and meet the performance characteristics published in the United States Pharmacopeia (USP) and the European Pharmacopeia (EP).

The incubation time of all the gke SCBI’s has been optimised so that steam SCBI’s can be interpreted within 24 hours and ethylene oxide, hydrogen peroxide and formaldehyde SCBI’s within 48 hours. The gke SCBI’s do not require fluorescent light for evaluation.

After sterilisation the SCBI’s are activated by crushing the glass ampoule. After correct incubation, the colour of the liquid will indicate a pass or fail of the sterilisation process. If the colour has not changed, this indicates a pass and a colour change indicates a fail.

Application

The gke Steri-Record® Mini-Bio-Plus self-contained biological indicators (SCBI) are used inside packs, containers or the gke Bio-Compact Process Challenge Device (Bio-PCD) for validation and routine monitoring of steam, ethylene oxide, formaldehyde and hydrogen peroxide sterilisation processes.

The gke SCBI’s are optimized for use in the gke Bio-PCD to allow users to challenge their BI to a hollow level, simulating complex instruments with internal lumens such as MIS instruments.

Order Details

Instant Mini-Bio-Plus SCBI

The Instant Mini-Bio-Plus SCBI allows for immediate release of the load in steam sterilisation processes without having to wait for an incubation result. The Type 5 indicator provides a much higher probability of sterility compared to the result of a BI alone. gke guarantee that if the Type 5 chemical indicator has passed, the BI will always provide a pass result as well after incubation.

Sterilisation Process Product Code Description Quantity
Steam B324-555  Instant SCBI – Geo. stearothermophilus 105 (50 pack) 50
Steam B324-550  Instant SCBI – Geo. stearothermophilus 105 (100 pack) 100
Steam B324-655  Instant SCBI – Geo. stearothermophilus 106 (50 pack) 50
Steam B324-650  Instant SCBI – Geo. stearothermophilus 106 (100 pack) 100

Standard Mini-Bio-Plus SCBI

The Standard Mini-Bio-Plus SCBI’s are available for Steam, Hydrogen Peroxide, Ethylene Oxide and Formaldehyde sterilisation processes.

Sterilisation Process Product Code Description Quantity
Steam B324-505 Standard SCBI – Geo. stearothermophilus 105 (50 pack) 50
Steam B324-510 Standard SCBI – Geo. stearothermophilus 105 (100 pack) 100
Steam B324-605 Standard SCBI – Geo. stearothermophilus 106 (50 pack) 50
Steam B324-610 Standard SCBI – Geo. stearothermophilus 106 (100 pack) 100
Hydrogen Peroxide B327-605 Standard SCBI – Geo. stearothermophilus 106 (50 pack) 50
Hydrogen Peroxide B327-610 Standard SCBI – Geo. stearothermophilus 106  Glass Carrier (100 pack) 100
Hydrogen Peroxide B337-605 Standard SCBI – Geo. stearothermophilus 106  Tyvek Carrier (50 pack) 50
Hydrogen Peroxide B347-605 Standard SCBI – Geo. stearothermophilus 106  Stainless Steel Carrier (50 pack) 50
Hydrogen Peroxide B357-605 Standard SCBI – Geo. stearothermophilus 106  Stainless PET Carrier (50 pack) 50
Ethylene Oxide B326-605 Standard SCBI – B. Atropheus 106 (50 pack) 50
Ethylene Oxide B326-610  Standard SCBI – B. Atropheus 106 (100 pack) 100
Formaldehyde B325-605  Standard SCBI – Geo. stearothermophilus 106 (50 pack) 50

Bio-Compact Process Challenge Device

The patented design of the gke Bio-PCD consists of an external highly durable case containing an internal stainless-steel tube/helix connected to a capsule that holds the gke biological indicator.

The Bio-PCD together with a gke SCBI can simulate porous loads and hollow devices simultaneously. Our Bio-PCD is in accordance with requirements of Standard EN 867-5.
As BI’s cannot be placed inside the most difficult position inside a surgical instrument, use of the Bio-PCD allows the user to simulate the death of the spore inside complex instruments.


Which device is right for me?

The Bio-PCD’s are available in two designs:

  • Round version with a stainless-steel bracket –suitable for use in large steam sterilisers. The PCD can be hung vertically on a rack or placed horizontally on the bracket.
  • Oval version – suitable for use in benchtop sterilisers. The PCD can be placed horizontally on the flat side of the device.
Product Code Description Quantity
B300-039 Bio-PCD – Lime Green – Oval 1
B300-040 Bio-PCD – Lime Green – Round 1

Dry Bath Incubator

The gke incubator is temperature and time programmable. The incubation temperature is visible on the LCD display.

Product Code Description Quantity
B610-122 Electronic Dry Bath Incubator (temp and time programmable) 1

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Product Matrix - Detergents

Note: Please check Product Data Sheet and always check item compatibility before product use.

neodisher® MediClean forte
neodisher® MediKlar
neodisher® MediZym
neodisher® MultiZym
neodisher® FA
neodisher® MA
neodisher® N
neodisher® Z
neodisher® IR
Neoblank®
neodisher® IP Spray
neodisher® PreStop
neodisher® LaboClean A8
neodisher® LaboClean FLA
neodisher® LaboClean FT
neodisher® LaboClean GK
neodisher® 30
neodisher® Alka 220
Type of Process
Manual
Automated
Machine Type
Immersion Bath
Ultrasonic Bath
Washer Disinfector
Dishwasher
pH
Acidic 
Neutral
Mildly Alkaline
Alkaline
Hazard Rating
Non-hazardous
Hazardous
Additions
Enzymes
Surfactants
Phosphates
Type of Product
Liquid Detergent
Powder Detergent
Neutraliser
Rinse aid
Instrument Pre-Treatment
Instrument Lubricant
Stainless steel care
Tarnish and Stain Remover
Application
Surgical Instruments
Anaesthetic Equipment
Theatre Shoes
Flexible Endoscopes
Laboratory Glassware
Other Laboratory Utensils
Animal cages
Stainless steel surfaces
Dishwashers