HTM 01-05 Protein Residue Test

What is it?

This is a chemical test to detect levels of protein on a processed load that cannot be seen by visual inspection.

HTM 01-05 Protein Residue Test

If an instrument is not clean it cannot be sterilised.

Dirty instruments that are processed through a sterilisation cycle will not be sterile at the end of the decontamination process.

A record must be kept of each protein residue test as evidence.


What Equipment and Materials are Required?

  • Ultrasonic Cleaner Log Book
  • Protein Residue Test Pens
  • Protein Residue Test Incubator
  • Swab Moisturiser
 D = Day | W =Weekly | Q = Quarterly | Y = Yearly | CP(D) = Competent Person (Decontamination) | ENG = Engineer

When is it Performed, and by Who?

Document Specific Title Reference Installation & Commission Periodic Testing
HTM 01-05 Protein Residue Test 14.3
Refers to
ISO 15883





What is the Procedure, and Pass/Fail Criteria

Document Test Procedure Pass or Fail Criteria
HTM 01-05

Test method using the 3M Cleantrace Sensitive Protein Test & Isopharm Biuret Incubator:

1. Start the test incubator, selecting the appropriate test time of 55°C for 15 minutes.

2. It is recommended that appropriate PPE should be worn when carrying out tests for protein.

3. Take a test pen, remove the swab and moisten with two drops of Cleantrace Moisturiser.

4. Swab a defined area of the load (defined within the test kit instruction manual). Replace the swab into the pen and click down so that the swab penetrates into the cap.

5. Shake the pen rapidly from side to side for at least five seconds.

6. A negative control as an example of no protein contamination and a pass result may also be created if required. Remove a second swab, moisten with two drops of Cleantrace Moisturiser, replace back in to the pen and click into the cap. This can be used to compare the actual test swab colour reaction.

7. Place the pen(s) into the test incubator and incubate for 15 minutes at 55°C.

8. Compare the colour of the swab and solution against the pass or fail criteria on the Cleantrace label. If a negative control has also been created also compare the colour against that of the test swab and solution.

Green indicates a pass result. No further action is required.

Grey or purple indicates a fail result. The load items should be reprocessed and the test repeated.

Only take note of the colour at the time of the test. The chemical reaction is ongoing and the swab and solution may produce a purple reaction regardless of the actual test result.