HTM 01-05: Ultrasonic Bath Test Schedule

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

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

Manufacturer schedules take precedent over the schedule from HTM 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
HTM 01-05 Remove & Clean Strainers & Filters 14.3          
HTM 01-05 Drain Machine at End of Day/Session 14.3            
HTM 01-05 Weekly Safety Checks 15.14            
HTM 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
HTM 01-05 Cleaning Efficacy (Visual Inspection) 14.3
Refers to
ISO 15883
         
HTM 01-05 Protein Residue Test 14.3
Refers to
ISO 15883
           
HTM 01-05 Cleaning Efficacy Test 14.3
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
HTM 01-05 Automatic Control Test
15.3            
HTM 01-05 Verification of Calibration
14.2
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
HTM 01-05 Chemical Dosing Test (Where Automated) 14.2
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
HTM 01-05 Drainage Test 14.2
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
HTM 01-05 Lid (i.e. Door) Interlock 14.2
Refers to
ISO 15883
             
HTM 01-05 Fluid Emission 14.2
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
HTM 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
HTM 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. HTM 01-05 Ref: 12.3
(Mentioned in testing sterilisers)
WT Works Test     By the manufacturer prior to releasing the machine. HTM 01-05 Ref: 12.3
(Mentioned in testing sterilisers)
IQ Installation Qualification     By the manufacturer / contractor / supplier or CP(D) upon delivery. HTM 01-05 Ref: 14.2
OQ Operational Qualification     By the CP(D) or Service Engineer after IQ. HTM 01-05 Ref: 14.2
PQ Performance Qualification     By the CP(D) or Service Engineer after IQ and OQ. HTM 01-05 Ref: 14.2
D Daily Periodic     By the User or by delegation to the Operator. HTM 01-05 Ref: 14.3
W Weekly Periodic     By the User (or Operator) or CP(D). HTM 01-05 Ref: 14.3
Q Quarterly Periodic     By the CP(D) or Service Engineer. HTM 01-05 Ref: 14.3
Y Yearly Periodic     By the CP(D) or Service Engineer. HTM 01-05 Ref: 14.3
Validation Contacts, Personnel & Miscellaneous Abbreviations 
MAN Manufacturer     The manufacturer of the machine. HTM 01-05 Ref: 9.3
SUP Supplier     The supplier of the machine.
Often also the manufacturer.
HTM 01-05 Ref: 9.3
CON Contractor     Hired to perform IQ.
Often also the manufacturer.
HTM 01-05 Ref: 9.3
USER User     Has final responsibility for machine performance / operation. HTM 01-05 Ref: 9.3
CP(D) Competent Person (Decontamination)     A qualified engineer and test person in decontamination. HTM 01-05 Ref: 9.3
ENG Service Engineer     Engineer certified by the service provider or manufacturer. HTM 01-05 Ref: 9.3
OPT Optional Test     The standard states that this is an optional test requirement. N/A
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