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.

Washer Disinfector CP(D) or Engineer Validation

A machine validation proves that the machine is performing as required by the manufacturer and is performed by completing all periodic tests as well as additional quarterly and annual tests.

For a washer disinfector, these quarterly and annual tests must be carried out by a trained and qualified validation engineer.

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

  • Routine Housekeeping & Safety Checks
  • HTM 01-05 Protein Residue Test
  • HTM 01-05 Cleaning Efficacy Soil Test
  • HTM 01-05 Automatic Control Test
  • HTM 01-05 Chemical Dosing Test
  • HTM 01-05 Thermometric Disinfection Test

What Equipment and Materials are Required?

  • Washer Disinfector Log Book
  • The Validation Engineer should provide the equipment necessary to perform each test.
 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.
 ** Check with the machine manufacturer if quarterly engineer validation is required as some require only yearly.

When is it Performed, and by Who?

The table below shows the full periodic schedule for the tests associated with the Washer Disinfector CP(D) or Engineer Validation.

This is so that the User can see when they perform the test on a daily or weekly basis in relation to when the qualified validation engineer carries out the tests quarterly and annually.

The methods for the User during Daily and Weekly testing can be found in the relevant sections on the Isopharm website.

Document Specific Title Reference Installation & Commission Periodic Testing
D W Q Y
HTM 01-05 Remove and Clean Strainers and Filters 13.3
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 Protein Residue Test 13.3
Refers to
ISO 15883

SUPPLIER
or
ENGINEER
 
USER  

CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05 Cleaning Efficacy Test

Also known as, but not referenced in HTM 01-05, a Manufacturer Soil Test

13.3
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 Chemical Dosing Test 13.2
Refers to
ISO 15883

SUPPLIER
or
ENGINEER
   
CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05 Thermometric Test - Load 13.2
Refers to
ISO 15883

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

Performed quarterly and annually by a qualified Validation Engineer as stated within the relevant section of the Isopharm website.

Performed quarterly and annually by a qualified Validation Engineer as stated within the relevant section of the Isopharm website.

Performed quarterly and annually by a qualified Validation Engineer as stated within the relevant section of the Isopharm website.

Performed quarterly and annually by a qualified Validation Engineer as stated within the relevant section of the Isopharm website.

Performed quarterly and annually by a qualified Validation Engineer as stated within the relevant section of the Isopharm website.

  • Chemical Dosing Test - Where automated

A qualified Validation Engineer will use the test method described in BS EN ISO 15883 which involves measuring the amount of chemical dosed and comparing with the requirements of the manufacturer.

  • Thermometric Test - Load

A qualified Validation Engineer will use the test method described in BS EN ISO 15883 which involves placing temperature sensors within the washer disinfector to map the entire process. This includes the disinfection stage which should be at the appropriate temperature band for the correct amount of time to ensure thermal disinfection is taking place.

The test criteria is as stated within the relevant section of the Isopharm website, or as described within BS EN ISO 15883.