CP(D) or Engineer Validation

What is it?

A CP(D) or Engineer validation proves that the machine is performing as required by the manufacturer.

Ultrasonic Cleaner CP(D) or Engineer Validation

The need to have an engineer validate an ultrasonic cleaner is open to interpretation. More often than not the tests performed by an engineer are the same as those performed periodically by the practice themselves. 

HTM 01-05 states that manufacturer recommendations take precedent over all other advice and this should be adhered to. However, Isopharm have interpreted the requirements as follows:

If the unit is in a warranty period then the manufacturer may have stated that the ultrasonic cleaner needs to be returned to them for a service/validation every 12 months. Therefore if this is the case Isopharm would advise following manufacturer’s instructions in order to uphold the warranty.

If the unit is not within a warranty period then we recommend that the practice performs the necessary validation tests themselves.

A quarterly and annual validation comprises of the following periodic tests:

  • Remove and Clean Strainers and Filters
  • Safety Checks
  • HTM 01-05 Cleaning Efficacy (Visual)
  • HTM 01-05 Cleaning Efficacy Soil Test
  • HTM 01-05 Protein Residue Test
  • HTM 01-05 Automatic Control Test
  • HTM 01-05 Ultrasonic Activity Test

These tests, along with up to date Daily and Weekly test records provides an excellent internal practice validation schedule, ensuring that the ultrasonic cleaner is checked for the important cycle factors which are:

  • The ability to remove live contamination on actual loads (validated daily by visual inspections and weekly by protein residue tests)
  • The ability to remove heavy contamination (validated by cleaning efficacy soil tests)
  • The ultrasonic activity is even and appropriate (validated by ultrasonic activity tests)
  • The process temperature is as recommended by the manufacturer (validated by the automatic control test)
  • The process temperature is as required for the specific detergent being used (validated by the automatic control test)

As well as performing the tests it is also necessary to ensure that the staff who are carrying out the procedures above know how to perform them properly and also know how to interpret the results.

If tests do provide a fail result, we always recommend a re-test, should a fail be registered a second time then that is when an engineer or the manufacturer must be involved.

 

What Equipment and Materials are Required?

For Remove and Clean Strainers and Filters, & Safety Checks:

  • Ultrasonic Cleaner Log Book

For the Cleaning Efficacy (Visual) Test:

  • Ultrasonic Cleaner Log Book

For the Cleaning Efficacy Soil Test:

  • Ultrasonic Cleaner Log Book
  • Correct Test Soil for your machine

For the Protein Residue Test:

  • Ultrasonic Cleaner Log Book
  • A Protein Residue Test such as a swab or pen

For the Automatic Control Test:

  • Ultrasonic Cleaner Log Book
  • Stopwatch
  • Thermometer

For the Ultrasonic Activity Test:

  • Ultrasonic Cleaner Log Book
  • Ultrasonic Activity Foil Kit
  • Stopwatch

 D = Day | W =Weekly | Q = Quarterly | Y = Yearly | CP(D) = Competent Person (Decontamination) | ENG = Engineer
* The machine manufacturer must provide frequency of User testing in addition to HTM 01-05 periodic requirements.

When is it Performed, and by Who?

Document Specific Title Reference Installation & Commission Periodic Testing
D W Q Y
HTM 01-05 Remove and Clean Strainers and Filters 14.3
Refers to
ISO 15883

SUPPLIER
or
ENGINEER


USER


USER

 


CP(D)
or
ENG


CP(D)
or
ENG
HTM 01-05  Safety Checks 15.14
SUPPLIER
or
ENGINEER
 
USER

CP(D)
or
ENG

CP(D)
or
ENG
HTM 01-05  Cleaning Efficacy (Visual) 14.3
Refers to
ISO 15883

SUPPLIER
or
ENGINEER

USER

USER

CP(D)
or
ENG

CP(D)
or
ENG
HTM 01-05  Protein Residue Test 14.3
Refers to
ISO 15883

SUPPLIER
or
ENGINEER
 
USER

CP(D)
or
ENG

CP(D)
or
ENG
HTM 01-05 Cleaning Efficacy Test 14.3
Refers to
ISO 15883

SUPPLIER
or
ENGINEER
 


USER


CP(D)
or
ENG


CP(D)
or
ENG
HTM 01-05 Automatic Control Test 15.3
SUPPLIER
or
ENGINEER
   
CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05 Ultrasonic Activity Test 15.6
SUPPLIER
or
ENGINEER
   
CP(D)
or
ENG 

CP(D)
or
ENG 

What is the Procedure, and Pass/Fail Criteria

Document Test Procedure Pass or Fail Criteria
HTM 01-05

Each test should be performed as stated within the relevant section of the Isopharm website:

The test criteria is as stated within the relevant section of the Isopharm website.