Below is the NI/CFPP/02 installation, commissioning and periodic test schedule for ultrasonic baths.
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).
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 |
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Document | Specific Title | Reference | TT | WT | IQ | OQ | PQ | D | W | Q | Y | |||||
NI/CFPP/02 | Remove & Clean Filters & Strainers Etc. | 4.35 CFPP 01-01 Part D |
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NI/CFPP/02 | Weekly Safety Checks | 2.66 CFPP 01-01 Part D |
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NI/CFPP/02 | Yearly Safety Checks | 2.68 CFPP 01-01 Part D |
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Cleaning Efficacy | Factory Testing |
Installation & Commissioning |
Periodic Testing |
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Document | Specific Title | Reference | TT | WT | IQ | OQ | PQ | D | W | Q | Y | |||||
NI/CFPP/02 | Cleaning Efficacy by Residual Soil | 2.268 CFPP 01-01 Part D |
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NI/CFPP/02 | Cleaning Efficacy Test: Chamber Walls & Load Carriers 1 | 2.242 CFPP 01-01 Part D |
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NI/CFPP/02 | Cleaning Efficacy Test: Reference Load 1 | 2.247 CFPP 01-01 Part D |
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1: Cleaning efficacy test on Reference Load is performed directly after a successful cleaning efficacy test on Walls and Load Carriers - Ref: 2.247 (CFPP 01-01 Part D). | ||||||||||||||||
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Automatic Control Test & Verification of Calibration |
Factory Testing |
Installation & Commissioning |
Periodic Testing |
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Document | Specific Title | Reference | TT | WT | IQ | OQ | PQ | D | W | Q | Y | |||||
NI/CFPP/02 | Automatic Control Test 1 | 2.304 CFPP 01-01 Part D |
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NI/CFPP/02 | Verification of Calibration 1 | 2.181 CFPP 01-01 Part D |
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1: These tests can be performed at the same time - Ref: Section 2.182 (CFPP 01-01 Part D). | ||||||||||||||||
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Chemical Additives, Reproducibility & Residues |
Factory Testing |
Installation & Commissioning |
Periodic Testing |
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Document | Specific Title | Reference | TT | WT | IQ | OQ | PQ | D | W | Q | Y | |||||
NI/CFPP/02 | Chemical Dosing: Reproducibility of Volume Admitted 1 | 2.159 CFPP 01-01 Part D |
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NI/CFPP/02 | Chemical Additive(s): Low Level Detection | 2.168 CFPP 01-01 Part D |
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1: Also referred to as 'Chemical: Reproducibility' - Ref: Table 4 (CFPP 01-01 Part D). | ||||||||||||||||
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Free Drainage | Factory Testing |
Installation & Commissioning |
Periodic Testing |
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Document | Specific Title | Reference | TT | WT | IQ | OQ | PQ | D | W | Q | Y | |||||
NI/CFPP/02 | Free Draining: Chamber & Load Carriers | 2.85 CFPP 01-01 Part D |
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NI/CFPP/02 | Free Draining: Tanks | 2.86 CFPP 01-01 Part D |
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NI/CFPP/02 | Free Draining: Flow to Discharge Point | 2.87 CFPP 01-01 Part D |
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Doors, Interlocks & Fault Indications |
Factory Testing |
Installation & Commissioning |
Periodic Testing |
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Document | Specific Title | Reference | TT | WT | IQ | OQ | PQ | D | W | Q | Y | |||||
NI/CFPP/02 | Doors & Door Interlocks: Cycle Start Interlock | 2.132 CFPP 01-01 Part D |
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NI/CFPP/02 | Doors & Door Interlocks: In-Cycle interlock | 2.136 CFPP 01-01 Part D |
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NI/CFPP/02 | On Sensor Failure |
2.144 CFPP 01-01 Part D |
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NI/CFPP/02 | Doors: Opening Force | 2.146 CFPP 01-01 Part D |
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Ultrasonic Activity Test | Factory Testing |
Installation & Commissioning |
Periodic Testing |
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Document | Specific Title | Reference | TT | WT | IQ | OQ | PQ | D | W | Q | Y | |||||
NI/CFPP/02 | Test for Ultrasonic Activity | 2.313 CFPP 01-01 Part D |
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Load Carriers | Factory Testing |
Installation & Commissioning |
Periodic Testing |
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Document | Specific Title | Reference | TT | WT | IQ | OQ | PQ | D | W | Q | Y | |||||
NI/CFPP/02 | Load Carriers | 2.183 CFPP 01-01 Part D |
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Load Dryness | Factory Testing |
Installation & Commissioning |
Periodic Testing |
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Document | Specific Title | Reference | TT | WT | IQ | OQ | PQ | D | W | Q | Y | |||||
NI/CFPP/02 | Load Dryness Test 1 | 2.209 CFPP 01-01 Part D |
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1: Only required if the process has a drying stage - Ref: 2.209 (CFPP 01-01 Part D). | ||||||||||||||||
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Thermometric Tests | Factory Testing |
Installation & Commissioning |
Periodic Testing |
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Document | Specific Title | Reference | TT | WT | IQ | OQ | PQ | D | W | Q | Y | |||||
NI/CFPP/02 | Over-Temperature Cut-Out | 2.202 CFPP 01-01 Part D |
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1: The method of test should be obtained from the manufacturer - Ref: NI/CFPP/02 Page 5. | ||||||||||||||||
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Water Quality & Supply | Factory Testing |
Installation & Commissioning |
Periodic Testing |
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Document | Specific Title | Reference | TT | WT | IQ | OQ | PQ | D | W | Q | Y | |||||
NI/CFPP/02 | Water: Hardness | 3.134 CFPP 01-01 Part D |
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NI/CFPP/02 | Water: Overflow test | 2.116 CFPP 01-01 Part D |
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NI/CFPP/02 | Water: Supply Temperature | 3.82 CFPP 01-01 Part D |
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NI/CFPP/02 | Volume of Water Used per Stage | 2.124 CFPP 01-01 Part D |
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Validation Test Abbreviations | ||||||||||||||||
TT | Type Test | By the manufacturer during the machine design stage. | CFPP 01-01 Ref: 2.9 Part D |
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WT | Works Test | By the manufacturer prior to releasing the machine. | CFPP 01-01 Ref: 4.24 Part B |
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IQ | Installation Qualification | By the manufacturer, contractor or supplier upon delivery. | CFPP 01-01 Ref: 4.28 Part B |
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OQ | Operational Qualification | By the Competent Person (Decontamination) after IQ. | CFPP 01-01 Ref: 4.34 Part B |
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PQ | Performance Qualification | By the CP(D) after IQ and OQ. | CFPP 01-01 Ref: 4.37 Part B |
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D | Daily Periodic | By the User or by delegation to the Operator. | CFPP 01-01 Ref: 4.60 Part B |
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W | Weekly Periodic | By the User (or Operator) or CP(D). | CFPP 01-01 Ref: 4.60 Part B |
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Q | Quarterly Periodic | By the CP(D). | CFPP 01-01 Ref: 4.60 Part B |
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Y | Yearly Periodic | By the CP(D). | CFPP 01-01 Ref: 4.60 Part B |
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Validation Contacts, Personnel & Miscellaneous Abbreviations | ||||||||||||||||
MAN | Manufacture | The manufacturer of the machine. | CFPP 01-01 Ref: 4.20 Part B |
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SUP | Supplier | The supplier of the machine. Often also the manufacturer. |
CFPP 01-01 Ref: 4.20 Part B |
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CON | Contractor | Hired to perform IQ. Often also the manufacturer. |
CFPP 01-01 Ref: 4.21 Part B |
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USER | User | Has final responsibility for machine performance/operation. | CFPP 01-01 Ref: 6.54 Part A |
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CP(D) | Competent Person (Decontamination) | A qualified engineer and test person in decontamination. | CFPP 01-01 Ref: 4.18 Part B |
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OPT | Optional Test | The standard states that this is an optional test requirement. | N/A | |||||||||||||
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