HTM 2030: Ultrasonic Bath Test Schedule

HTM 2030: Testing Ultrasonic Baths
Installation, Commissioning and Periodic Test Schedule.

Below is the HTM 2030 installation, commissioning and periodic test schedule for ultrasonic baths.

Manufacturer schedules take precedent over the schedule from HTM 2030. 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 Test Person (Sterilisers)*.

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

* Please Note: Although HTM 2030 does not cover sterilisers, Test Person (Sterilisers) is still the term used by the standard to describe a qualified test engineer - Ref: HTM 2030: Validation & Verification Section 1.28.

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
HTM 2030
Validation & Verification
Remove & Clean Strainers & Filters Etc. 7.0
Table 5g
         
HTM 2030
Validation & Verification
Weekly Safety Checks 7.8        
HTM 2030
Validation & Verification
Yearly Safety Checks 7.10                
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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
HTM 2030
Validation & Verification
Residual Soil Detection: Visual Inspection 10.50          
HTM 2030
Validation & Verification
Cleaning Efficacy by Residual Soil Detection 10.37            
HTM 2030
Validation & Verification
Cleaning Efficacy Test: Chamber Walls & Load Carriers 1 10.16        
HTM 2030
Validation & Verification
Cleaning Efficacy Test: Reference Load 1 10.20        
1: Cleaning efficacy test on Reference Load is performed directly after a successful cleaning efficacy test on Walls and Load Carriers - Ref: 10.20.
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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
HTM 2030
Validation & Verification
Automatic Control Test 1 12.4    
HTM 2030
Validation & Verification
Verification of Calibration of WD Instruments 1 9.311    
1: These tests can be performed at the same time - Ref: 9.312.
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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
HTM 2030
Validation & Verification
Chemical Dosing: Reproducibility of Volume Admitted 1 9.279          
HTM 2030
Validation & Verification
Chemical Dosing: Indication of Insufficient Chemical Additives 2 9.285            
HTM 2030
Validation & Verification
Residual Chemical Additives 3 9.343              
1: Also referred to as 'Additive Dosing Tests: Reproducibility' - Ref: Table 2g (No.9), and 'Chemical Dosing: Accuracy & Repeatability' - Ref: Table 1 (No.10).
2: 
Also referred to as 'Chemical Dosing: Low Level indicator' - Ref: Table 1 (No.10), and 'Chemical Additive Dosing Tests: Low Level Detection' - Ref: Table 2g (No.9).
3: 
Also referred to as 'Process Residuals- Ref: Table 1 (No.9), and 'Process Residues: Chemical Additives' - Ref: Table 4g (No.3).
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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
HTM 2030
Validation & Verification
Free Draining of Chamber & Load Carriers 9.38          
HTM 2030
Validation & Verification
Free Draining of Tanks 9.38          
HTM 2030
Validation & Verification
Pipework Flow to Discharge Point 9.38          
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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
HTM 2030
Validation & Verification
Doors & Door Interlocks: Cycle Start Interlock 9.253        
HTM 2030
Validation & Verification
Doors & Door Interlocks: In-Cycle Interlock 1 9.257        
HTM 2030
Validation & Verification
Doors & Door Interlocks: Door Opening Force 9.266          
HTM 2030
Validation & Verification
Failed Cycle Interlock 2 9.271                
HTM 2030
Validation & Verification
Fault Indication on Sensor Failure 3 9.274          
1: Also referred to as 'Doors & Interlocks: Loading/Unloading' - Ref: Table 1 (No.8).
2: 
Also referred to as 'On Fault Condition' - Ref: Table 1 (No.8).
3: 
Also referred to as 'Fault Interlock' - Ref: Table 2g (No.7) and Table 5g (No.7).
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Ultrasonic Activity Test

Factory
Testing
Installation
& Commissioning
Periodic
Testing
Document Specific Title Reference TT WT IQ OQ PQ D W Q Y
HTM 2030
Validation & Verification
Test for Ultrasonic Activity 19.3          
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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
HTM 2030
Validation & Verification
Load Carriers: Fitting, Stability, Alignment, Force to Move, Effect in Cycle.  9.313                
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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
HTM 2030
Validation & Verification
Load Dryness Test 9.336          
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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
HTM 2030
Validation & Verification
Chamber Wall Temperature Test 1  2 9.317        
HTM 2030
Validation & Verification
Load Carrier Temperature Test 1  2 9.323        
HTM 2030
Validation & Verification
Over-Temperature Cut-Out Test 9.330          
HTM 2030
Validation & Verification
Thermometric Test for Thermal Disinfection 2 11.4      
1: These tests may be performed at the same time - Ref: 9.328.
2: Thermometric testing is only required if heat is used during the process - Ref: Table 5g (Footnote No.2).
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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
HTM 2030
Validation & Verification
Water System: Hardness 9.140          
HTM 2030
Validation & Verification
Water: Overflow test 2.237            
HTM 2030
Validation & Verification
Water System: Supply Temperature 9.89            
HTM 2030
Validation & Verification
Volume of Water Used per Stage 9.245            
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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
HTM 2030
Validation & Verification
Aerosol Discharge Test 11.4            
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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
HTM 2030
Validation & Verification
Sound Pressure 1  2 9.353            
1: Please Note: Although the standard lists this as an OQ and Yearly requirement by the Test Person, the standard also states that this test is only performed by the manufacturer to BS 4196 Part 6 during Type Tests (Ref HTM 2030 Validation & Verification Section 9.353 and 9.357). 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 (No.6).
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Table Key

Validation Test Abbreviations
TT Type Test By the manufacturer during the machine design stage. HTM 2030 Ref: 3.1
Validation & Verification
WT Works Test By the manufacturer prior to releasing the machine. HTM 2030 Ref: 2.21
Validation & Verification
IQ Installation Qualification By the manufacturer, contractor or supplier on delivery. HTM 2030 Ref: 2.26
Validation & Verification
OQ Operational Qualification By the TP(S) after IQ. HTM 2030 Ref: 2.31
Validation & Verification
PQ Performance Qualification By the TP(S) after IQ and OQ. HTM 2030 Ref: 2.33
Validation & Verification
D Daily Periodic By the User or by delegation to the Operator. HTM 2030 Ref: 2.46
Validation & Verification
W Weekly Periodic By the User (or Operator) or TP(S). HTM 2030 Ref: 2.46
Validation & Verification
Q Quarterly Periodic By the TP(S). HTM 2030 Ref: 2.46
Validation & Verification
Y Yearly Periodic By the TP(S). HTM 2030 Ref: 2.46
Validation & Verification
Validation Contacts, Personnel & Miscellaneous Abbreviations
MAN Manufacturer The manufacturer of the machine. HTM 2030 Ref: 1.36
Validation & Verification
SUP Supplier The supplier of the machine.
Often also the manufacturer.
HTM 2030 Ref: 1.37
Validation & Verification
CON Contractor Hired to perform IQ.
Often also the manufacturer.
HTM 2030 Ref: 1.37
Validation & Verification
USER User Has final responsibility for machine performance/operation. HTM 2030 Ref: 1.24
Validation & Verification
TP(S) Test Person (Sterilisers) A qualified engineer and test person in decontamination. HTM 2030 Ref: 1.28
Validation & Verification
OPT Optional Test The standard states that this is an optional test requirement. N/A
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