Application

The gke Clean-Record® cleaning test system is

used for validation and routine monitoring of clean-

ing processes. The indicators can be used in washer

disinfectors (WD) as well as cleaning of bedpans

(Level 0 indicator) and also in ultra sonic baths for

the manual cleaning for all kinds of instruments. To

test hollow instruments, a special hollow flow proc-

ess challenge device (PCD) can be connected to the

hose connection of minimal invasive surgical (MIS)

instrument and endoscope carts.

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 di-

rectly 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 water-soluble

soils can be washed off with water.

gke Clean-Record®

Cleaning Indicators

with hollow flow PCD and holder

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 hydrolize

the non water soluble substances by using a high pH-

value making them water soluble. Other cleaning

agents have a neutral pH-value containing enzymes.

Both mechanisms can be combined in one cleaning

detergent.

Cleaning detergents are optimized depending on the

contaminations on the instruments. Therefore, the opti-

mal cleaning agent has to be chosen accordingly. In-

struments made of aluminium-magnesium corrode at

high pH-values. The water quality (hardness, salt con-

tent) highly influences the effectiveness of cleaning

detergents.

gke offers different cleaning 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 Level 1 to Level 4 indicators and three hold-

ers. Alternatively multi-level indicator which contains

the three most difficult indicators in one indicator is

also available (see order information).

gke Clean-Record® Cleaning indicators, Holder and Hollow Flow-PCD

At the end of the process the indicators can be adhered

for documentation.

2. Test sheets for ultrasonic cleaning baths

There are 4 different difficult to wash off indicators to

prove ultrasonic cleaning baths of a size of

125 x 56 mm to monitor the cleaning efficiency inside

the liquid volume.

gke offers two different holders 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 liq-

uid.

The indicator which has just been washed off com-

pletely 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 or bedpan washer. Testing shall

be carried out in different locations and the most diffi-

cult location should be selected for routine monitoring.

In addition gke offers 4 different test sheets to check

ultra sonic baths. The indicators should be immerged

in fluids vertically or horizontally to check the differ-

ent 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. It is

also recommended to monitor each batch where loads

are difficult to clean.

For bedpan washers gke has developed a special

cleaning indicator to check the efficacy of those proc-

esses.

Product Description

1. Cleaning indicators for WDs

gke produces 5 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 most difficult indicators are also available as

Multi-Level-Indicators (MLC) for test purposes. Dif-

ferent PCDs creating spray shadows to protect the in-

dicator are not required since different cleaning prop-

erties are provided already by the 5 different indicator

levels without using a PCD.

The indicators are put in a holder (art. no. 800-100 or

800-102) which can be fixed on a tray. 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 3 adapters

of 2, 3 and 4 mm internal split.

Small splits at the same flow rate create a higher inter-

nal flow through speed and therefore better cleaning

efficacy as larger splits will create lower flow through

speed and create worse cleaning conditions. Therefore

the limits for the processing of endoscopic cleaning

can be fully evaluated using up to 15 test conditions.

Performance Characteristics

The technical specification EN ISO/TS 15883-5 de-

scribes 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 equip-

ment (spray rig test) to be able to compare real soils,

test soils of the standard and the different gke Clean-

Record® cleaning 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

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.

gke Clean-Record® Test sheets for ultrasonic cleaning baths

3. Cleaning indicators for bedpan washers

Cleaning indicators for bedpans are designed to be

washed off in water without detergents. However the

water quality and temperature also influences the

wash-off speed. The indicator is self-adhesive and can

be adhered directly on the bedpans. This test enables

the user to check the cleaning efficacy over a long

period and provides control and documentation about

the result.

Benefits of the gke Clean-Record® indicators:

Use of synthetic test soils on plastic carrier instead

of using natural test soils with blood prevent trans-

fer of pathogenic germs and offers long-term sta-

bility and long expiry dates.

Cost-effective due to the use of plastic carriers and

printed test soils.

Permanent economical batch monitoring is, for the

first time, possible because of a cost-effective pro-

duction of the indicators.

The 5 indicator levels require different mechanical

force to be washed off and therefore, the use of

PCDs is not required.

Easy documentation because of self-adhesive indi-

cators.

All parts of the holder and PCD are made of dura-

ble materials and are maintenance free. They can

be used for an unlimited number of cycles.

Easy to use.

Additional benefits of the cleaning indicators

For WDs

The gke cleaning indicators provide constant

cleaning characteristics in comparison to natural

test soil which may change their cleaning proper-

ties during storage time.

The indicators are validated against test soils

according to EN ISO/TS 15883-5 with a special

spray equipment designed by gke.

For ultrasonic baths

Special test sheets to monitor ultrasonic baths.

Test of mechanical cleaning conditions of ultra-

sonic baths with 4 different indicators.

The cleaning efficacy can be tested in all 3 dimen-

sions of the volume using special holders.

The cleaning efficacy of the bath can be controlled

over time.

For bedpan washers

A special adopted indicator for this application is

available.

The adhesive property allows easy fixation.

Documentation of results is possible.

Order Information

Cleaning indicators to monitor WDs and endoscope WDs

gke GmbH Your gke sales partner:

Auf der Lind 10

D-65529 Waldems-Esch

Germany

+49 61 26 - 94 32- 0

+49 61 26 - 94 32- 10

info@gke.eu

http://www.gke.eu

700-021 EN V16 11/2012

Test sheets for ultra sonic cleaning baths

Art.-No. Product Code Quantity Test Difficulty Application

800-014 W-U-L1-4 4 Level 1-4 each Level 1-4 Introduction pack

to test and select the right indicator

810-111

810-112

810-113

W-U-L1

(colour: yellow)

40

120

240

Level 1 Low

High

Test sheets for

routine monitoring

to test the cleaning efficiency

in ultrasonic cleaning baths

with 4 different indicators

810-211

810-212

810-213

W-U-L2

(colour: green)

40

120

240

Level 2

810-311

810-312

810-313

W-U-L3

(colour: blue)

40

120

240 Level 3

810-411

810-412

810-413

W-U-L4

(colour: red)

40

120

240 Level 4

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 in the WD for batch monitoring 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

3 adapters (split 2, 3 and 4 mm)

2 LL connectors and 0,5 m silicone tube

Hollow Flow PCD to be connected

in endoscope WD machines

to simulate hollow devices

Holder for ultrasonic cleaning indicators

800-115 W-U-HO-B 1 Stainless steel / plastic holder To fix an ultrasonic indicator at the bottom

of an ultrasonic bath

800-116 W-U-HO-S 1 Tripod holder To fix an ultrasonic indicator in the volume

of an ultrasonic bath

Art.-No. Product Code Quantity Test Difficulty Application

800-004 W-WA-L1-4 16 Level 1-4

each + 3 holders 1-4

Introduction pack

to test and select the correct indicator

810-001

810-002

810-003

W-WA-L0

(colour: orange)

160

480

960

Level 0 Low

High

Refill pack for

validation and monitoring

810-101

810-102

810-103

W-WA-L1

(colour: yellow)

160

480

960

Level 1

810-201

810-202

810-203

W-WA-L2

(colour: green)

160

480

960

Level 2

810-301

810-302

810-303

W-WA-L3

(colour: blue)

160

480

960

Level 3

810-401

810-402

810-403

W-WA-L4

(colour: red)

160

480

960

Level 4

810-900

810-901

810-902

810-903

W-WA-MLC

(colours:

green, blue, red)

64

160

480

960

Multi-Level Indicator

containing Level 2, 3 and 4

Cleaning

difficulty

Cleaning

difficulty

Holders and PCDs