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3M Clean-Trace Protein Test Pens

 

For performing the HTM 01-05 Protein Residue Test.
Available in packs of 25, 50 and 100 test pens.

Scroll down for further information on prosduct features as well as when and how to test in accordance with HTM 01-05

 

Product Code Description Pack Size Cost Quantity
CLEAN025
Cleantrace Sensitive Protein Residue Tests
Pack 25
£56.50
CLEAN050
Cleantrace Sensitive Protein Residue Tests
Pack 50
£109.40
CLEAN100
Cleantrace Sensitive Protein Residue Tests
Pack 100
£209.00
CLEANMOIST
Cleantrace Moisturiser
Each 1
£3.59

3M Clean-Trace Protein Test Pens

High sensitivity protein pens that help provide evidence of validating a cleaning process.

Clean-Trace protein tests can be used to check instruments that have been processed prior to sterilisation.

Clean-Trace Protein tests are:

  • Easy to useCan be performed with minimal training.

  • Rapid – Results available in 15 minutes when used with an incubator.

  • Simple – Visual reading of colour change and interpretation of results.

  • Sensitive – Measures down to 3μg of protein when used with an incubator.

How this product helps you comply with HTM 01-05 (2013 Edition)
  • A protein Residue Test must be completed Weekly to confirm that the cleaning process used within your practice retains the capability of removing protein. This must be performed by the user. (HTM 01-05 2013 edition. Section 13.3 Washer Disinfector. Section 14.3 Ultrasonic Cleaners)

HTM 01-05 Testing Ultrasonic Cleaners

Document Specific Title Reference Periodic Testing
D W Q Y
HTM 01-05 Protein Residue Test 14.3
Refers to
ISO 15883
 
USER

CP(D)
or
ENG

CP(D)
or
ENG
D=Day | W=Weekly | Q=Quarterly | Y=Yearly | CP(D)=Competent Person (Decontamination) | ENG=Engineer

 

HTM 01-05 Testing Washer Disinfectors

Document Specific Title Reference Periodic Testing
D W Q Y
HTM 01-05 Protein Residue Test 13.3
Refers to
ISO 15883
 
USER

CP(D)
or
ENG

CP(D)
or
ENG
D=Day | W=Weekly | Q=Quarterly | Y=Yearly | CP(D)=Competent Person (Decontamination) | ENG=Engineer

HTM 01-05 Protein Residue Test Using 3M Clean-Trace

1. Remove the swab and dampen with drops of either the moisturiser or distilled water.

Tap water should not be used as this will present a failed result at the end of the test.

2. Swab the test area then replace back in the pen.

3. Press down to click the swab into the reaction fluid in the cap

4. Select the correct incubation time and temperature on the incubator. (Step 1)

Clean-Trace Sensitive requires 55°C for 15 minutes.

5. The incubator will require a few minutes to reach temperature. The LED will indicate that this is progressing. (Step 2)

When temperature is reached, the LED will move to ‘insert test’. Insert the Clean-Trace Sensitive pen and press START. (Step 3)

6. The LED will show that Incubation is in progress. (Step 4)

When incubation has completed the LED will move to ‘finished’ and the incubator will sound an alarm. (Step 5)

7. Remove the Clean-Trace Sensitive pen and check the colour of the swab in the cap.
8. A GREEN colouration indicates that there was no soiling on the swabbed area and that the test is a PASS
9. A PURPLE or GREY colouration indicates that there may have been soiling on the swabbed area and that the test is a FAIL
10. Record the test details in the machine log book.
11. There is no need to keep the pen as evidence as the chemical reaction is ongoing and the swab will eventually turn purple after a few hours anyway, even if the colour at the time of the test was green. 

Reasons Why the Test May Fail

Should the test fail a re-test should be performed. If the test fails a second time, a diagnosis of both the method of cleaning and method of testing is required.

The compliance team at Isopharm is also available to discuss the test and test method.

Possible fail reasons for a Protein Residue Test are:

Diagnosing the Method of Cleaning

  • Detergent residue may present a false positive. This is usually caused when the detergent used has been changed but the level of dosing has not.
  • Instruments handled excessively during testing may cause a false positive. Gloves should always be worn when performing a protein residue test.
  • In some cases it may be that the machine under test is not working correctly and an engineer may be required to diagnose further.

Diagnosing the Method of Test

  • Check that the test product used is within the expiry date provided.
  • Check what was used to moisten the swab. Tap water may present a false positive result. Always use Clean-Trace moisturiser as this has been validated for use within the test.
  • Gloves should always be worn when performing a protein residue test as this reduces the amount of contaminant from handling the test products.