CFPP 01-01 Part C: Clinical Large Porous Load Test Schedule

CFPP 01-01 Part C: Clinical Large Porous Load Steam Steriliser
Installation, Commissioning and Periodic Test Schedule.

Below is the CFPP 01-01 installation, commissioning and periodic test schedule for clinical large porous load steam sterilisers.

Manufacturer schedules take precedent over the schedule from CFPP 01-01 Part C. 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
01-01
Part C
Weekly Safety Checks 2.104            
CFPP
01-01
Part C
Yearly Safety Checks 2.105                
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Steam Quality

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-01
Part C
Non-Condensable
Gas Test
 1
3.207            
CFPP
01-01
Part C
Steam Dryness
Test
 1
3.233            
CFPP
01-01
Part C
Steam Superheat
Test
 1
3.223            
CFPP
01-01
Part C
Steam Contaminants Table 5              
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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Air Leakage Test

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-01
Part C
Air Leakage Test 1  2  3 2.69      
1: The test is performed once for the weekly periodic requirement - Ref: Table 4 (CFPP 01-01 Part C).
2: The test is performed three times for OQ and the quarterly and yearly periodic requirement. The first as the weekly method (to ensure air leakage value is acceptable under normal conditions), the second with all sensors in place for thermometric testing (to ensure air leakage value is acceptable with sensors placed), the third as the weekly method (to ensure air leakage value is acceptable after thermometric testing and the sensors have been removed)
 - Ref: Table 3 and Table 4 (CFPP 01-01 Part C).
3: 
Type Test and Works Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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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
01-01
Part C
Automatic Control
Test
 1  2  3
 2.60        
CFPP
01-01
Part C
Verification of Calibration of Steriliser Instruments 1 2.62              
1: These tests can be performed at the same time - Ref: 2.62 (CFPP 01-01 Part C).
2: This test can be performed at the same time as the thermometric test (small load) and bowie dick test for steam penetration - Ref: Table 3 (CFPP 01-01 Part C).
3: During the quarterly and yearly periodic test the temperature and pressure sensors used for thermometric testing should be attached - Ref: 2.62
 (CFPP 01-01 Part C).
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Thermometric Tests

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-01
Part C
Thermometric Test
for a Small Load
 1
2.73        
CFPP
01-01
Part C
Thermometric Test
for a Full Load
 1
2.74          
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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Air Detector Tests

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-01
Part C
Air Detector Function Test 1 2.71      
CFPP
01-01
Part C
Air Detector Performance Test for a Small Load 1 2.71          
CFPP
01-01
Part C
Air Detector Performance Test for a Full Load 1 2.71            
1: Type Test and Works Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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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
01-01
Part C
Load Dryness - Small Load Textiles 2 2.76              
CFPP
01-01
Part C
Load Dryness - Full Load Textiles 2 2.76            
CFPP
01-01
Part C
Load Dryness - Metal Load 1  2 2.76            
CFPP
01-01
Part C
Production Load Dryness Test 2.78                
1: Where required by the AE(D) - Ref: Table 3 (CFPP 01-01 Part C).
2: 
Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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Steam Penetration

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-01
Part C
Bowie-Dick Test for Steam Penetration 1 2.80  
CFPP
01-01
Part C
Hollow Load Test 1 2.81            
1: Type Test and Works Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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Dynamic Pressure

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
CFPP
01-01
Part C
Dynamic Pressure Test 1  2 2.83                
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
2: The manufacturer should be contacted for frequency of periodic test - Ref Table 4 (CFPP 01-01 Part C).
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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
01-01
Part C
Sound Pressure
Test 1
2.15                
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
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Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. CFPP 01-01 Ref: 4.20
Part B
WT Works Test By the manufacturer prior to releasing the machine. CFPP 01-01 Ref: 4.24
Part B
IQ Installation Qualification By the manufacturer, contractor or supplier upon delivery. CFPP 01-01 Ref: 4.28
Part B
OQ Operational Qualification By the Competent Person (Decontamination) after IQ. CFPP 01-01 Ref: 4.34
Part B
PQ Performance Qualification By the CP(D) after IQ and OQ. CFPP 01-01 Ref: 4.37
Part B
D Daily Periodic By the User or by delegation to the Operator. CFPP 01-01 Ref: 4.60
Part B
W Weekly Periodic By the User (or Operator) or CP(D). CFPP 01-01 Ref: 4.60
Part B
Q Quarterly Periodic By the CP(D). CFPP 01-01 Ref: 4.60
Part B
Y Yearly Periodic By the CP(D). CFPP 01-01 Ref: 4.60
Part B
Validation Contacts, Personnel & Miscellaneous Abbreviations 
MAN Manufacturer The manufacturer of the machine. CFPP 01-01 Ref: 4.20
Part B
SUP Supplier The supplier of the machine.
Often also the manufacturer.
CFPP 01-01 Ref: 4.20
Part B
CON Contractor Hired to perform IQ.
Often also the manufacturer.
CFPP 01-01 Ref: 4.21
Part B
USER User Has final responsibility for machine performance/operation. CFPP 01-01 Ref: 6.54
Part A
CP(D) Competent Person (Decontamination)     A qualified engineer and test person in decontamination. CFPP 01-01 Ref: 4.18
Part B
OPT Optional Test     The standard states that this is an optional test requirement. N/A
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