CFPP 01-06: EWD Test Schedule

CFPP 01-06: Endoscope Washer Disinfector
Installation, Commissioning and Periodic Test Schedule.

Below is the CFPP 01-06 installation, commissioning and periodic test schedule for endoscope washer disinfectors.

Manufacturer schedules take precedent over the schedule from CFPP 01-06. If no information is available from the manufacturer then the schedule below should be followed.

Type Tests and Works Tests are carried out by the Manufacturer.

Installation and commissioning (IQ OQ PQ) is carried out by either the equipment Supplier or a qualified Competent Person (Decontamination).

Periodic testing is carried out routinely by the User (or by delegation to the Operator), and also a qualified Competent Person (Decontamination).

Testing Categories

Tests, References and Schedules

A key to the various abbreviations used can be found at the bottom of this page.

Housekeeping and Safety Checks

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Validation & Verification
Remove and Clean Strainers and Filters 2.17
             
CFPP
01-06

Validation & Verification
Weekly Safety Checks 4.55        
CFPP
01-06

Validation & Verification
Yearly Safety Checks 4.56                
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Cleaning Efficacy

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Residual Soil Detection: Visual Inspection 1 16.49          
CFPP
01-06

Testing Methods
Cleaning Efficacy by Residual Soil Detection 16.33            
CFPP
01-06

Testing Methods
Cleaning Efficacy Test: Chamber Walls & Load Carriers 2 16.22        
CFPP
01-06

Testing Methods
Cleaning Efficacy Test: Reference Load 2 16.28        
1: Presented as an optional periodic test, not scheduled - Ref: 16.9 (Testing Methods).
2: Cleaning efficacy test on Reference Load is performed directly after a successful cleaning efficacy test on Walls and Load Carriers - Ref: 16.28 (Testing Methods).
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Automatic Control Test
& Verification of Calibration
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Automatic Control Test 1 3.1    
CFPP
01-06

Testing Methods
Verification of Calibration 1 9.1    
CFPP
01-06

Validation & Verification
Instrumentation: Legibility Section 3
Table 1
               
1: These tests can be performed at the same time - Ref: Section 9.2 (Testing Methods).
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Chemical Additives,
Reproducibility & Residues
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Chemical Dosing: Reproducibility of Volume Admitted 1  8.1        
CFPP
01-06

Testing Methods
Chemical Dosing: Indication of Insufficient Chemical Additives 2 8.8          
CFPP
01-06

Testing Methods
Chemical Additive Residual Levels 3 13.2              
CFPP
01-06

Testing Methods
Disinfection Tests: Disinfectant Concentration Test 19.1              
1: Also referred to as 'Chemical Dosing: Accuracy and Repeatability' - Ref: Table 1 (Validation & Verification).
2: Also referred to as 'Chemical Dosing: Low Ievel Indicator'
 - Ref: Table 1 (Validation & Verification).
3: 
Also referred to as 'Process Residuals' - Ref: Table 1 (Validation & Verification).
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Free Drainage

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Free Draining of Tanks 1 4.15                
CFPP
01-06

Testing Methods
Free Draining of Chamber and Load Carriers 1 4.15          
CFPP
01-06

Testing Methods
Free Draining of Pipework 1 4.15          
CFPP
01-06

Testing Methods
Efficacy of Discharge Through the Trap 4.17            
CFPP
01-06

Testing Methods
Estimation of Dead Volume of Pipework 4.23          
1: Also collectively referred to as 'Pipework: Free Draining' - Ref: Table 1 (Validation & Verification), and 'Drainage: Free Draining' - Ref: Table 3 (Validation & Verification).
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Doors, Interlocks
& Fault Indications
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Cycle Start Interlock 1 7.1        
CFPP
01-06

Testing Methods
In-Cycle Interlock 2 7.5        
CFPP
01-06

Testing Methods
Double-Ended EWDs 7.8            
CFPP
01-06

Testing Methods
On Sensor Failure 7.12          
CFPP
01-06

Testing Methods
Door Opening Force 7.14          
CFPP
01-06

Testing Methods
Failed Cycle Interlock 3 7.20             
CFPP
01-06

Testing Methods
Fault Indication on Sensor Failure 7.23          
CFPP
01-06

Testing Methods
Blocked Drain Protection 4.2            
CFPP
01-06

Validation & Verification
Doors and Interlocks: With Services Table 1                
1: Also referred to as 'Doors and Interlocks: Cycle Start' - Ref: Table 1 (Validation & Verification).
2: 
Also referred to as 'Doors and Interlocks: Loading/Unloading' - Ref: Table 1 (Validation & Verification).
3: 
Also referred to as 'On Fault Condition' - Ref: Table 1 (Validation & Verification).
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Leak, Disconnection
& Channel Patency
Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Leak Test 17.1      
CFPP
01-06

Testing Methods
Lumen Patency Detection Test 17.9      
CFPP
01-06

Testing Methods
Lumen Disconnection Detection Test 17.14      
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Load Carriers

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference   TT WT  IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Load Carriers 1 10.1              
1: Also referred to as 'Load Carriers: Fitting, Stability, Alignment, Force to Move, Effect in Cycle' - Ref: Table 1 (Validation & Verification).
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Load Dryness

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Load Dryness 12.1          
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Disinfection During Routine Cycle

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Temperature During Routine Cycle 1 11.25      
CFPP
01-06

Testing Methods
Microbiological: Disinfection Efficacy 20.3                
1: Only required if heat is used during the process - Ref: 11.1 (Testing Methods).
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Thermometric Self-Disinfection Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Chamber Wall Temperature for the Self-Disinfection Cycle (if applicable) 1  2 11.4      
CFPP
01-06

Testing Methods
Load Carrier Temperature During Self-Decontamination (if temperature used) 1  2 11.10        
CFPP
01-06

Testing Methods
Over-Temperature Cut-Out (when temperature is used for self-disinfection) 1 11.18          
1: Only required if heat is used during the process - Ref: 11.1 (Testing Methods).
2: Also referred to as 'EWD Self-Disinfection Test - Thermal Disinfection' - Ref: 18.4 (Testing Methods).
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Chemical Self-Disinfection Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
EWD Self-Disinfection Test - Chemical Disinfection 18.4                 
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Venting & Process Emissions Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Load Contamination from Ductwork 5.1          
CFPP
01-06

Testing Methods
Droplet Emission 5.2          
CFPP
01-06

Testing Methods
Chemical Vapour Emission 5.8          
CFPP
01-06

Validation & Verification
Fluid Emission: Chamber Leak-Proof Table 1              
CFPP
01-06

Validation & Verification
Pipework: Venting System Table 1                
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Water Quality & Supply

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Validation & Verification
Final Rinse Water System: TOC 1  2 Table 5          
CFPP
01-06

Testing Methods
Water Supply Temperature 6.15              
CFPP
01-06

Testing Methods
Water Supply Pressure 6.22              
CFPP
01-06

Testing Methods
Appearance 3 6.28          
CFPP
01-06

Testing Methods
pH 6.35            
CFPP
01-06

Testing Methods
Electrical Conductivity 4 6.41    
CFPP
01-06

Testing Methods
Hardness 5 6.51      
CFPP
01-06

Testing Methods
Total Viable Count 6.63      
CFPP
01-06

Testing Methods
Environmental Mycobacteria 6.84                  
CFPP
01-06

Testing Methods
Volume of Water Used per Stage 6 6.91          
CFPP
01-06

Validation & Verification
Microbiological: Disinfection of Water Treatment System Table 1                
CFPP
01-06

Validation & Verification
Endoscope Lumen Decontamination Test 4.47           
1: TOC abbreviation is Total Organic Carbon - Ref: Table 1 (Testing Methods).
2: 
Also referred to as 'Water System: TOC' - Ref: Table 3 (Validation & Verification).
3: 
Also referred to as 'Final Rinse-Water tests: Appearance' - Ref: Table 5 (Validation & Verification).
4: 
Also referred to as 'Final Rinse-Water Conductivity (if pure water used)' - Ref: Table 3 (Validation & Verification).
5: 
Also referred to as 'Water Hardness (all process stages)' - Ref: Table 5 (Validation & Verification).
6: 
Also referred to as 'Water Quality Used: Water Volume' - Ref: Table 1 (Validation & Verification).
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Drying Cabinets

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Validation & Verification
Check the air pressure within the cabinet using the in-built Manometer 6.11          
CFPP
01-06

Validation & Verification
Differential pressure across HEPA filter 6.12              
CFPP
01-06

Validation & Verification
Lumen Airflows 6.15                
CFPP
01-06

Validation & Verification
Calibrate the in-built manometer 6.20                
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Air Quality

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Air Quality 14.1          
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Electromagnetic Interference

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Validation & Verification
Electromagnetic Interference Table 1                
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Sound Pressure

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-06

Testing Methods
Sound Pressure Test 1 15.1            
1: Please Note: Although the standard lists this as an OQ and yearly requirement by the CP(D), the standard also states that this test is only performed in a specially designed and equipped test room, and that it is not required for an installed EWD (Ref CFPP 01-06: Testing Methods Section 15.1). Therefore it is unlikely to be required at installation, commissioning or periodically. If in doubt, manufacturer instructions should be obtained.
2: 
Also referred to as 'Sound Power' - Ref: Table 1 (Validation & Verification).
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Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. CFPP 01-06 Ref: 3.1
Validation & Verification
WT Works Test By the manufacturer prior to releasing the machine. CFPP 01-06 Ref: 1.30
Validation & Verification
IQ Installation Qualification By the manufacturer, contractor or supplier upon delivery. CFPP 01-06 Ref: 1.35
Validation & Verification
OQ Operational Qualification By the Competent Person (Decontamination) after IQ. CFPP 01-06 Ref: 1.39
Validation & Verification
PQ Performance Qualification By the CP(D) after IQ and OQ. CFPP 01-06 Ref: 1.41
Validation & Verification
D Daily Periodic By the User or by delegation to the Operator. CFPP 01-06 Ref: 1.55
Validation & Verification
W Weekly Periodic By the User (or Operator) or CP(D). CFPP 01-06 Ref: 1.55
Validation & Verification
Q Quarterly Periodic By the CP(D). CFPP 01-06 Ref: 1.55
Validation & Verification
Y Yearly Periodic By the CP(D). CFPP 01-06 Ref: 1.55
Validation & Verification
Validation Contacts, Personnel & Miscellaneous Abbreviations 
MAN Manufacture The manufacturer of the machine. CFPP 01-06 Ref: 1.25
Validation & Verification
SUP Supplier The supplier of the machine.
Often also the manufacturer.
CFPP 01-06 Ref: 1.25
Validation & Verification
CON Contractor Hired to perform IQ.
Often also the manufacturer.
CFPP 01-06 Ref: 1.27
Validation & Verification
USER User Has final responsibility for machine performance/operation. CFPP 01-06 Ref 1.18
Operational Management
CP(D) Competent Person (Decontamination)     A qualified engineer and test person in decontamination. CFPP 01-06 Ref: 1.3
Validation & Verification
OPT Optional Test     The standard states that this is an optional test requirement. N/A
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