NI/CFPP/02: Clinical Large Porous Load Test Schedule

NI/CFPP/02: Clinical Large Porous Load Steam Steriliser
Installation, Commissioning and Periodic Test Schedule.

Below is the NI/CFPP/02 installation, commissioning and periodic test schedule for clinical large porous load steam sterilisers.

Manufacturer schedules take precedent over the schedule from NI/CFPP/02. 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
NI/CFPP/02
Weekly Safety Checks 2.104
CFPP 01-01 Part C
           
NI/CFPP/02 Yearly Safety Checks 2.105
CFPP 01-01 Part C
               
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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
NI/CFPP/02 Non-Condensable
Gas Test
 1  2
3.207
CFPP 01-01 Part C
           
NI/CFPP/02 Steam Dryness
Test
 1  2
3.233
CFPP 01-01 Part C
           
NI/CFPP/02 Steam Superheat
Test
 1  2
3.223
CFPP 01-01 Part C
           
NI/CFPP/02 Steam Chemical Putiry Tests 2 3.295
CFPP 01-01 Part C
             
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
2: The document refers to NI/CFPP/01 for pass criteria.
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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
NI/CFPP/02 Air Leakage Test 1  2  3 2.69
CFPP 01-01 Part C
     
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
NI/CFPP/02 Automatic Control
Test
 1  2  3
 2.60
CFPP 01-01 Part C
       
NI/CFPP/02 Verification of Calibration of Steriliser Instruments 1 2.62
CFPP 01-01 Part C
             
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
NI/CFPP/02 Thermometric Test
for a Small Load
 1
2.73
CFPP 01-01 Part C
       
NI/CFPP/02 Thermometric Test
for a Full Load
 1
2.74
CFPP 01-01 Part C
         
NI/CFPP/02 Test for PRQ as required by the User 2 2.26
CFPP 01-01 Part C
               
NI/CFPP/02 Bowie Dick Test for Steam Penetration (Thermometric Test) 2.80
CFPP 01-01 Part C
               
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
2: PRQ abbreviation is Performance Re-Qualification.
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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
NI/CFPP/02 Air Detector Function Test 1 2.71
CFPP 01-01 Part C
     
NI/CFPP/02 Air Detector Performance Test for a Small Load 1 2.71
CFPP 01-01 Part C
         
NI/CFPP/02 Air Detector Performance Test for a Full Load 1 2.71
CFPP 01-01 Part C
           
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
 1
2.76              
CFPP
01-01
Part C
Load Dryness -
Full Load Textiles 1
2.76            
CFPP
01-01
Part C
Load Dryness -
Metal Load
 1  2
2.76              
NI/CFPP/02 Production Load Dryness Test 3 2.78
CFPP 01-01 Part C
             
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
2: Where required by the AE(D) - Ref: Table 3 (CFPP 01-01 Part C).
3: This test may be carried out at the same time as 'Test for PRQ as required by the User' - Ref: NI/CFPP/02 Page 8.
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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
NI/CFPP/02 Bowie-Dick Test for Steam Penetration 1 2.80
CFPP 01-01 Part C
 
NI/CFPP/02 Hollow Load Test 1 2.81
CFPP 01-01 Part C
           
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
NI/CFPP/02 Dynamic Pressure
Test 
1  2
2.83
CFPP 01-01 Part C
             
1: Type Test requirement as stated in BS EN 285:2006 - Ref: Table 4 (BS EN 285:2006).
2: This test is only required if damage is being caused to the instrument tray wrap(s). Manufacturer advice should be obtained for test procedure - Ref: NI/CFPP/02 Page 8.
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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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