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:

  1. Lower spray conditions can be found in the corners and at the centre of the spray arm axles.
  2. Loads create spray shadows.
  3. Instruments have areas that are difficult to reach, e.g. splits.
  4. 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.

Benefits of the gke Clean-Record® indicators

  • Use of synthetic test soils on plastic carrier instead of using natural test soils with blood prevent transfer of pathogenic germs and offers long-term stability and long expiry dates.
  • Permanent economical batch monitoring is possible for the first time due to cost-effective production of the indicators.
  • Easy documentation because of self-adhesive indicators.
  • Easy to use.
  • Cost-effective due to the use of plastic carriers and printed test soils.
  • The five indicator levels require different mechanical force to be washed off and therefore, the use of PCDs is not required.
  • All accessory parts of the holder, PCD and Laundry-Check ball are made of durable materials and are maintenance free. They can be used for an unlimited number of cycles.
  • Monitoring of laundry/washing processes is also possible.

Additional benefits

For WDs and washing machines

  • The gke cleaning process monitoring indicators provide constant cleaning characteristics in comparison to natural test soil which may change their cleaning properties during storage time.
  • The indicator colour chemistry is a non-reversible chemical reaction. The indicator strip can be documented proof for several years without changing back to its original colour.

For ultrasonic baths

  • Special test sheets to monitor ultrasonic baths.
  • The cleaning efficacy can be tested in all three dimensions of the volume using special holders
  • Test of mechanical cleaning conditions of ultrasonic baths with four different indicators.
  • The cleaning efficacy of the bath can be controlled over time.

For bedpan washers

  • A special adopted indicator for this application is available.
  • Easy documentation of the results.
  • The adhesive property allows easy fixation.
Cleaning Process Monitoring Indicators with Hollow Flow-PCD and Holder

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

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

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

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