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.

Benchtop Steriliser CP(D) or Engineer Validation

A machine validation proves that the machine is performing as required by the manufacturer. This is done by completing all daily and weekly periodic tests, as well as additional quarterly and annual tests.

For a benchtop steriliser, 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:

  • HTM 01-05 Automatic Control Test - All sterilisers
  • HTM 01-05 Steam Penetration Test - Type B & Type S vac only
  • Weekly Safety Checks - All sterilisers
  • HTM 01-05 Air Leakage Test - Type B & Type S vac only
  • HTM 01-05 Residual Air Test - Type S vac & Type N non-vac only
  • HTM 01-05 Steam Generator Overheat Cut-Out Test - All sterilisers
  • HTM 01-05 Thermometric Test for Sterilisation - All sterilisers
  • HTM 01-05 Load Dryness Test - Type B & Type S vac only
  • Yearly Safety Checks - All sterilisers

What Equipment and Materials are Required?

  • Benchtop Steriliser 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
 * Check with the machine manufacturer whether this test should be performed with either a Helix or Bowie Dick Pack.
 ** 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 benchtop Steriliser 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 Automatic Control Test 15.3 
SUPPLIER
or
ENGINEER

USER  

USER  

CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05

Steam Penetration Test

Type B & Type S vacuum only

Table on page
56 Refers to
MDA DB 2002(06) 

SUPPLIER
or
ENGINEER

USER 

USER  

CP(D)
or
ENG 

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

CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05

Air Leakage Test

Type B & Type S vacuum only

Table on page
56 Refers to
MDA DB 2002(06) 

SUPPLIER
or
ENGINEER
 
USER  

CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05

Residual Air Test

Type S vacuum & Type N non-vacuum only

Table on page
56 Refers to
MDA DB 2002(06) 

SUPPLIER
or
ENGINEER
 
USER 

CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05 Steam Generator Overheat Cut-Out Test Table on page
56 Refers to
MDA DB 9804 

SUPPLIER
or
ENGINEER
   
CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05 Thermometric Test for Sterilisation Table on page
56 Refers to
EN 13060

SUPPLIER
or
ENGINEER
   
CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05

Load Dryness Test

Type B & Type S vacuum only

Table on page
56 Refers to
EN 13060 

SUPPLIER
or
ENGINEER
   
CP(D)
or
ENG 

CP(D)
or
ENG 
HTM 01-05 Yearly Safety Checks 15.16 
SUPPLIER
or
ENGINEER
     
CP(D)
or
ENG 

What is the Procedure, and Pass/Fail Criteria

Document Test Procedure Pass or Fail Criteria
HTM 01-05

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

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

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

Also performed quarterly and annually by a qualified Validation Engineer as stated within the relevant section of the Isopharm website. The engineer may use the method of test as described in BS EN 13060, which is a more involved process than the weekly User procedure.

Also performed quarterly and annually by a qualified Validation Engineer as stated within the relevant section of the Isopharm website. The engineer may use the method of test as described in BS EN 13060, which is a more involved process than the weekly User procedure.

  • Steam Generator Overheat Cut-Out Test

A qualified Validation Engineer will test to ensure that the sterilisation cycle will abort should the temperature within the chamber begin to rise to a level that may damage the load items.

  • Thermometric Test for Sterilisation 

A qualified Validation Engineer will use the test method described in BS EN 13060 which involves placing temperature sensors within the chamber and reservoir to map the entire process. This includes the holding time which should be at the appropriate temperature band for the correct amount of time to ensure sterilisation is taking place, for example 134ºC to 137ºC for three minutes.

  • Load Dryness Test

A qualified Validation Engineer will use the test method described in BS EN 13060 which involves ensuring that a sterilised wrapped load that has been processed in a vacuum cycle has little or no residual moisture. Moisture presents an environment for bacteria to thrive.

The test criteria is as stated within the relevant section of the Isopharm website, or as described within BS EN 13060.