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gke Steri-Record® Incubator SCBI with Process Challenge Device
gke Steri-Record® Incubator - Self-Contained Biological Indicators
gke Steri-Record® Incubator SCBI with Process Challenge Device
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 |
