gke Clean-Record® Cleaning Process Monitoring Indicators with Hollow Flow-PCD and Holder
Application
The gke Clean-Record® cleaning test system is used for validation and routine monitoring of cleaning processes. The indicators can be used in washer disinfectors (WD) and also in ultra sonic baths for the manual cleaning for all kinds of instruments. To test hollow instruments, a special hollow flow process challenge device (PCD) can be connected to the hose connection of minimal invasive surgical (MIS) instrument and endoscope carts. Cleaning process monitoring indicators can also be used on containers and transport carts and adhered directly on metal surfaces.
Surgical instruments are contaminated with various soils. Depending on the pre-treatment of instruments the adhesion may be different. Body fluids consist 75-85% of water soluble proteins and can be washed off with cold water.
Instruments should be cleaned with cold water directly after use before the soils can adhere and before disinfectants are used which are fixing soils.
The use of cleaning detergents is very important for the efficacy of cleaning processes if non water-soluble soils are contaminants. Only watersoluble soils can be washed off with water.
Fats and other non water soluble soils, e.g. lipids can only be washed off, if a cleaning detergent is used. Some cleaning detergents are alkaline and hydrolyse the non water soluble substances by using a high pH-value making them water soluble. Other cleaning agents have a neutral pHvalue containing enzymes. Both mechanisms can be combined in one cleaning detergent.
Cleaning detergents are optimized depending on the contaminations on the instruments. Therefore, the optimal cleaning agent has to be chosen accordingly. Instruments made of aluminiummagnesium corrode at high pH-values. The water quality (hardness, salt content) highly influences the effectiveness of cleaning detergents.
gke offers different cleaning process monitoring indicators for washer disinfectors which represent different challenge levels as proof of the cleaning efficacy. It is recommended to test all indicators at the same time together with the most difficult instrument sets as a preliminary test. For this evaluation an introduction pack is available which contains different indicators and three holders. Alternatively an introduction pack with multi-level indicators is also available which contains the three mostly used indicators in one indicator (see order information).
The indicator which has just been washed off completely in the WD-program and is also more difficult to clean than the most critical soil should be used for routine monitoring later on. For validation the results of the cleaning performance need to be compared with the results of the indicators to prove the “worst-case” scenario.
Within the WD chamber there are completely different spray conditions caused by different reasons:
Lower spray conditions can be found in the corners and at the centre of the spray arm axles
Loads create spray shadows
Instruments have areas that are difficult to reach, e.g. splits
Channels which have to be flushed have different flow through characteristics because of their dimensions
Lower spray conditions can be found in the corners and at the centre of the spray arm axles.
Loads create spray shadows.
Instruments have areas that are difficult to reach, e.g. splits.
Channels which have to be flushed have different flow through characteristics because of their dimensions.
These situations must be considered during testing by positioning the indicator holder and/or using a hollow flow PCD in the WD. Testing shall be carried out in different locations and the most difficult location should be selected for routine monitoring. Alternatively the indicators can be directly adhered on metal surfaces.
In addition gke offers four different test sheets to check ultra sonic baths. The indicators should be immerged in fluids vertically or horizontally to check the different intensity in mechanical force inside the volume of the liquid. It is recommended to use these indicators at least once a day in every program used to ensure that there are no changes of the process parameters.
For bedpan washers gke has developed a special cleaning indicator to check the efficacy of those processes. Other indicators are available to monitor laundry processes. Please see separate data sheets
Product Description
Cleaning process monitoring indicators for WD
gke produces four different self-adhesive indicators using temperature stable plastic carriers. All indicator substances have different adhesion characteristics. Therefore, they require different strong mechanical spray force and different detergents to be washed off. The three mostly used indicators are also available as Multi-LevelIndicators (MLC) for test purposes. Different PCDs creating spray shadows to protect the indicator are not required since different cleaning properties are provided already by the different indicators without using a PCD.
The indicators are put in a holder (art. no. 800100 or 800-102) which can be fixed on a tray/ basket. To monitor the cleaning efficacy of hollow instruments the folded indicator may be placed in a gke Clean-Record® Hollow Flow PCD which is supplied with 2 adapters of 2 and 4 mm split width.
Small splits at the same flow rate create a higher internal flow through speed and therefore better cleaning efficacy as larger splits will create lower flow through speed and create worse cleaning conditions.
At the end of the process the indicators can be adhered for documentation.
Test sheets for ultrasonic baths
There are four cleaning indicators of a size of 56×125 mm with different wash-off characteristics available to monitor the cleaning efficiency inside the liquid volume in ultrasonic baths.
gke offers three different holders of different height to fix the indicator inside the ultrasonic bath at different locations in the volume. This test method offers the possibility to check the cleaning efficacy over time in the same liquid.
Performance Characteristics
The technical specification ISO/TS 15883-5 describes 19 test soils with completely different cleaning properties without making any recommendation, as to which test soil to use. Currently none of the test soils are offered as a reference, because there is no test method defined to compare the soil properties.
The gke research centre has developed a test equipment (spray rig test) to be able to compare real soils, test soils of the standard and the different gke Clean-Record® cleaning process monitoring indicators. Comparative tests with a normative standard are not possible since currently no standard is available. Still gke has already carried out several tests under different cleaning conditions (flow rate, detergents, dosage, temperature etc.) in order to compare the cleaning characteristics of the above-mentioned materials and gke indicators. For the first time it is possible to describe the properties of cleaning process monitoring indicators. Test results are available on request.
The indicator colour is non-toxic and is dissolved with most of the cleaning agents and flushed away with the washing fluid.
Performance Characteristics
The technical specification ISO/TS 15883-5 describes 19 test soils with completely different cleaning properties without making any recommendation, as to which test soil to use. Currently none of the test soils are offered as a reference, because there is no test method defined to compare the soil properties.
The gke research centre has developed a test equipment (spray rig test) to be able to compare real soils, test soils of the standard and the different gke Clean-Record® cleaning process monitoring indicators. Comparative tests with a normative standard are not possible since currently no standard is available. Still gke has already carried out several tests under different cleaning conditions (flow rate, detergents, dosage, temperature etc.) in order to compare the cleaning characteristics of the above-mentioned materials and gke indicators. For the first time it is possible to describe the properties of cleaning process monitoring indicators. Test results are available on request.
The indicator colour is non-toxic and is dissolved with most of the cleaning agents and flushed away with the washing fluid.
Benefits of the gke Clean-Record® indicators
Additional benefits
For WDs and washing machines
For ultrasonic baths
For bedpan washers
Order Information
Cleaning process monitoring indicators to monitor WDs and endoscope WDs
| Art.-No.* | Product code | Quantity | Indicator version | Application | |
|---|---|---|---|---|---|
| N/A | W-WA-L1-4-KIT | YELLOW, GREEN, BLUE and RED | Introduction pack to test and select the correct indicator | ||
| N/A | W-WA-MLC-KIT | Multi-Level Indicator GREEN, BLUE and RED |
|||
| N/A | W-WA-L1 | YELLOW | Different wash-off characteristics | Cleaning process monitoring indicators for validation and monitoring in WD | |
| 810-201 | W-WA-L2 | 160 | GREEN | ||
| 810-301 | W-WA-L3 | 160 | BLUE | ||
| N/A | W-WA-L4 | RED | |||
| N/A | W-WA-MLC | Multi-Level Indicator GREEN, BLUE and RED |
|||
Test sheets for ultra sonic cleaning baths
| Art.-No.* | Product code | Quantity | Indicator version | Application | |
|---|---|---|---|---|---|
| N/A | W-U-L1-4 | YELLOW, GREEN, BLUE and RED | Introduction pack to test and select the right indicator | ||
| N/A | W-U-L1 | YELLOW | Different wash-off characteristics | Test sheets for routine monitoring to test the cleaning efficiency in ultrasonic cleaning baths with 4 different indicators | |
| 810-211 | W-U-L2 | 40 | GREEN | ||
| 810-311 | W-WA-L3 | 40 | BLUE | ||
| N/A | W-WA-L4 | RED | |||
Holders and PCDs
Holder for ultrasonic cleaning indicators, consisting of a bottom plate and a stainless steel bar with height adjustable holder
| Art.-No.* | Product code | Content | Application |
|---|---|---|---|
| Holder for cleaning indicators for WDs | |||
| 800-100 | W-HO | 1 stainless steel holder | For reproducible location of the cleaning indicator on a tray/basket in the WD |
| 800 -102 | W-PHO | 10 plastic holders, colour: orange | |
| Hollow Flow-PCD for cleaning indicators for WDs and endoscope WDs | |||
| 800-111 | W-HF-PCD | 1 Hollow Flow PCD with 2 adapters (split 2 and 4 mm), 2 LL connectors and 2 silicone tubes of 0,3 m | Hollow Flow PCD to be connected in endoscope WD machines to simulate hollow devices |
| Holder for ultrasonic cleaning indicators, consisting of a bottom plate and a stainless steel bar with height adjustable holder | |||
| 800-115 | WW-U-HO-7 | Holder with 7 cm stainless steel bar | To fix the indicator horizontally or vertically inside the basin volume |
| 800-116 | W-U-HO-20 | Holder with 20 cm stainless steel bar | |
| 800-117 | W-U-HO-40 | Holder with 40 cm stainless steel bar | |
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