WHTM 01-05: Ultrasonic Bath Test Schedule

WHTM 01-05: Testing Ultrasonic Baths
Installation, Commissioning and Periodic Test Schedule.

Below is the WHTM 01-05 installation, commissioning and periodic test schedule for ultrasonic baths.

Manufacturer schedules take precedent over the schedule from WHTM 01-05. 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, a qualified Competent Person (Decontamination) or Service Engineer.

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

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
WHTM
01-05
Remove and Clean Strainers and Filters 14.4          
WHTM
01-05
Drain Machine at End of Day/Session 14.4          
WHTM
01-05
Weekly Safety Checks 15.14            
WHTM
01-05
Yearly Safety Checks 15.16                
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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
WHTM
01-05
Cleaning Efficacy (Visual Examination) 14.4
Refers to
Manufacturer
         
WHTM
01-05
Protein Residue Test 14.4
Refers to
ISO 15883
           
WHTM
01-05
Cleaning Efficacy Test 14.4
Refers to
ISO 15883
           
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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
WHTM
01-05
Automatic Control Test
15.3            
WHTM
01-05
Verification of Calibration
14.4
Refers to
ISO 15883
           
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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
WHTM
01-05
Chemical Dosing Test (Where Automated) 14.3
Refers to
ISO 15883
             
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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
WHTM
01-05
Drainage Test (Where Applicable) 14.3
Refers to
ISO 15883
             
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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
WHTM
01-05
Lid (i.e. Door) Interlock 14.3
Refers to
ISO 15883
             
WHTM
01-05
Fluid Emission 14.3
Refers to
ISO 15883
             
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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
WHTM
01-05
Ultrasonic Activity Test 15.6              
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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
WHTM
01-05
Thermometric Test (Where machine also disinfects)
14.2
Refers to
ISO 15883
               
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Table Key

Validation Test Abbreviations
TT Type Test     By the manufacturer during the machine design stage. WHTM 01-05 Ref: 12.3
(Mentioned in testing sterilisers)
WT Works Test     By the manufacturer prior to releasing the machine. WHTM 01-05 Ref: 12.3
(Mentioned in testing sterilisers)
IQ Installation Qualification     By the manufacturer / contractor / supplier or CP(D) upon delivery. WHTM 01-05 Ref: 14.2
OQ Operational Qualification     By the CP(D) or Service Engineer after IQ. WHTM 01-05 Ref: 14.2
PQ Performance Qualification     By the CP(D) or Service Engineer after IQ and OQ. WHTM 01-05 Ref: 14.2
D Daily Periodic     By the User or by delegation to the Operator. WHTM 01-05 Ref: 14.4
W Weekly Periodic     By the User (or Operator) or CP(D). WHTM 01-05 Ref: 14.4
Q Quarterly Periodic     By the CP(D) or Service Engineer. WHTM 01-05 Ref: 14.4
Y Yearly Periodic     By the CP(D) or Service Engineer. WHTM 01-05 Ref: 14.4
Validation Contacts, Personnel & Miscellaneous Abbreviations 
MAN Manufacturer     The manufacturer of the machine. WHTM 01-05 Ref: 9.3
SUP Supplier     The supplier of the machine.
Often also the manufacturer.
WHTM 01-05 Ref: 9.3
CON Contractor     Hired to perform IQ.
Often also the manufacturer.
WHTM 01-05 Ref: 9.3
USER User     Has final responsibility for machine performance / operation. WHTM 01-05 Ref: 9.3
CP(D) Competent Person (Decontamination)     A qualified engineer and test person in decontamination. WHTM 01-05 Ref: 9.3
ENG Service Engineer     Engineer certified by the service provider or manufacturer. WHTM 01-05 Ref: 9.3
OPT Optional Test     The standard states that this is an optional test requirement. N/A
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