To : M/S.

IQ PROCEDURE & REPORT

Name ： AUTOCLAVE steam sterilizer

Model ： CL-*****
Serial number ：

The contents of this report are confirmed.

【 Confirmatin of distributor 】

Confirmed by Date

Name of person / Title

Approved Signatory Date

Name of perosn / Title

【 Confirmatin of user 】

Confirmed by Date

Name of person / Title

Confirmed by Date

Name of person / Title

ALP Co., Ltd.

Atuoclave IQ
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 Contents
１．【 Object 】

２．【 Measuring instrument 】

３．【 Installation inspection 】

４．【 Appearance inspection 】

５．【 Main parts inspection 】

６．【 Operation and various safety circuits inspection 】

７．【 Electric instruments inspection 】

８．【 ＩＱ general inspection 】

【 Attached documents 】

Inspection reports and traceability certificate of following instruments

・Main controller
・Pressure gauge
・Recorder
・Object temperature sensor
・Control sensor
・ＭΩ Hi TESTER
・CLAMP ON Hi TESTER
・Stopwatch

Atuoclave IQ
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 １．【 Object 】
This IQ procedure & report regulates IQ procedure for the model CL - **** which is installed at ***** and
certify inspection result of this autoclave.
Each inspection shall be done where this autoclave is instralled at the user’s site.

２．【 Measuring instrument 】

The following list is the list of measuring instruments used for each inspection. Original test data report of
each instrument shall be attached with this IQ procedure & report.

Instruments Manufacturer Model Serial No. Approved

ＭΩ Hi TESTER ＨＩＯＫＩ ３４５１－１４ □Yes □No
CLAMP ON Hi TESTER ＨＩＯＫＩ ３２８０－１０ □Yes □No
Stopwatch ＣＩＴＩＺＥＮ ８ＲＤＡ０６ □Yes □No

３．【 Installation inspection 】

Installation shall be checked if operation and usage of this CL-*** are in proper and compy with
manufacturing instruction. Then record its result.

３－１．Horizontal check of autoclave at installation

Horizontal check of autoclave, if autoclave is installed in a horizontal position and if sterilization, operation
and usage of autoclave have no problem, shall be done by means of water lebel check in chamber visually
putting some water in it.

Inspection item Installation location Levelness Approved

Autoclave □Good □Bad □Yes □No □Yes □No

３－２．Fixing inspeciton of main body and main parts

Fixing inspection shall be done to ckeck if Autoclave is fixed properly and if sterilization, operation and
usage of sterilization have no problem.

Inspection item How to fix autoclave Fixing Approved

Autoclave By two caster stppers □Good □Bad □Yes □No

３－３．Connection inspection of upstream power source cord

Check if power source cord is well connected with the connector of autoclave main body.

Inspection item How to connect Connection Approved

Power supply □Good □Bad □Yes □No

３－４．Connection inspection of piping

Check if draingage is connected to the pit or drain bottle.

Instpection item How to connect Connection Approved

Draing system (Hot water) By stainless drain hose □Good □Bad □Yes □No

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【 Comments 】

【 Confirmation of distrubutor 】

11
Name of person Date of confirmation (yy/mm/dd)

Judgment ： 【 □ Conformity ・□ Nonconformity 】

４．【 Appearance inspection 】

Appearance of this autoclave shall be checked visually if it is made compling with the instruction for
manufacturing. Than record its result.

４－１．Appearacne instpection
Appearance of chamber shall be checked visually if it is made compling with the instruction for
manufacturing. Then record its result.
Verify if there is any damage and/or defect which may spoil the function of autoclave

Inspection item Instruction Skar Appearance Approved

Inside the ♯400 buff finish □Yes □No □Good □Bad □Yes □No
chamber （Except welded part of
base plate）
Inside the lid Acid clreaning □Yes □No □Good □Bad □Yes □No

４－２．Appearance inspection of piping and electric wiring

Every sort of piping and electric wiring shall be checked visually if it is made compling with the instruction
for manufactruring. Then record its result.

Regarding to the piping and piping indication, check mainly its connection and instruction.
Regarding to the electric wiring of power source, check mainly its connection.

Inspection item Connection Approved

Piping Drainage ・ air exhaust piping □Good □Bad □Yes □No
Connection □Good □Bad □Yes □No
Electric wiring
Wiring □Good □Bad □Yes □No
※ Criteria ： Piping connection at every key point are in good condition
Joining terminal has no loose. Wiring is connected and fixed properly.

４－３．Inspection of indications

Every indications of this autoclave shall be checked visually if indications are located proper position
and its contents are complied with manufacturing instruction.Then record its result.

Inspection item Display positon Contents Approved

Rated label Backside of main body Model，Serial No.，Rating □Yes □No
Grounding Top end of main body Mandatory Grounding □Yes □No
Water lack prevention Top end of main body Check water □Yes □No
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【 Comments 】

【 Confirmation of distrubutor 】

11
Name of person Date of confirmation (yy/mm/dd)

Judgment ： 【 □ Conformity ・□ Nonconformity 】

５．【 Main parts inspection 】
Main parts shall be checked visually if they are made compling with manufacturing instrucation. Then record
its result.

Main parts playing an important function of sterilization shall be checked if test report provided by
manufacutuer is attached with those parts.
Original test report shall be attached with this IQ procedure & report.

５－１．Main measuring instruments specification inspection

Specification of main measureing instruments shall be checked if they are made compling with
manufacturing instruction, referring specification, drawings and parts list and so on. Then record its result.

Inspection item Model Specifications Serial No Approved

Main controller NCM225008-00F ＰＴ input 0.0～200.0℃ □Yes □No
Pressure gauge GK25-A18 ±3.0％FS 0～0.7MPa □Yes □No
Recorder TRM-10C ６ dots recording □Yes □No
Object temp. sensor 1 ＹＰ１００ ＰＴ sensor, class Ａ □Yes □No
Object temp. sensor 2 ＹＰ１００ ＰＴ sensor, class Ａ □Yes □No
Object temp. sensor 3 ＹＰ１００ ＰＴ sensor, class Ａ □Yes □No
Control sensor ＹＰ２１０ ＰＴ sensor, class Ｂ □Yes □No

５－２．Inspection of the test report of main measuring instruments

Main measuring instruments playing an important function of sterilization shall be checked if test report
provided by manufacutuer is attached with those parts and its advisability.
Original test report shall be attached with this IQ procedure & report.

Inspection item Model Test report Advisability

Main controller NCM225008-00F □Attached □Not attached □Yes □No
Prassure gauge GK25-A18 □Attached □Not attached □Yes □No
Recorder TRM-10C □Attached □Not attached □Yes □No
Object temp. sensor 1 ＹＰ１００ □Attached □Not attached □Yes □No
Object temp. sensor 2 ＹＰ１００ □Attached □Not attached □Yes □No
Object temp. sensor 3 ＹＰ１００ □Attached □Not attached □Yes □No
Control sensor ＹＰ２１０ □Attached □Not attached □Yes □No

５－３．Inspection of specification regarding to the main parts for piping

Main parts for piping shall be checked if their specifications are complied with manufacturing instrucation,

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 referring specification, drawings and parts list and so on. Then record its result.

Inspection item Model Specifications Approved

Exhaust valve VCS21-36G-4-02-D-Q Steam type □Yes □No

【 Comments 】

【 Confirmation of distrubutor 】

11
Name of person Date of confirmation (yy/mm/dd)

Judgment ： 【 □ Conformity ・□ Nonconformity 】

６．【 Operation and various safety circuits inspection 】

Operation and various safety circuits shall be checked by actual operation if they are complied with
manufacturing instruction, referring specification, drawings and parts list and so on. Then record its result.

Inspection shall be done by acutual operation. However in case of various warnings and safery circuits
inspection, due to the safety reason, inspection shall be done by changing parameter or by using pseudo-

signal

６－１．Inspection of lid inter lock system

Inspection item Contents Inspection method Approved

Check if operation doesn’t Open lock lever then check if
Disable operation start start when lock lever is operation doesn’t start and
□Yes □No
when lock lever is open. open. alarm beep when push the start
key.
Try to lid open during During operation, check if lock
Lid is locked during operation then check if lid lever is not released on
□Yes □No
Operation. cannot open. condition that pressure in
chamber is 0 MPa.
When power is cut during Cut off the power during
Lid is locked when operation, check if lid operation then check if lock
□Yes □No
power is OFF cannot open. lever is not released.

Try to open the lid during Check if lick lever is not

Lid is locked when
pressurization in chamber released during pressurization in
pressurization in □Yes □No
then check if lid cannot chamber.
chamber
open.

６－２．Inspection of confirming safe condition regarding pressure contorol

Inspection item Contents Inspection method Approved

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 When pressure in chamber Check if alream beep when
increase over specified wiring for pressure switch is
Confirming
pressure, check if alarm disconnected. □Yes □No
overpressure
beep and move to end of
cycle automatically.

６－３．Inspection of confirming safe condition regarding water lack

Inspection item Contents Inspection method Approved

When heating element Change the set value of water
Alarm of Water lack becomes overheated, stop lack, then check if alarm beep. □Yes □No
heating and alarm beep

６－４．Inspection of confirming safe condition regarding breaking of wire for control sensor

Inspection item Contents Inspection method Approved

Alarm of breakage When the wire for control Disconect wiring of control
of wire for the sensor is broken, disable sensor during operation then □Yes □No
sensor control and alarm beep. check if alarm beep

【 Comments 】

【 Confirmation of distrubutor 】

11
Name of person Date of confirmation (yy/mm/dd)

Judgment ： 【 □ Conformity ・□ Nonconformity 】

７．【 Electric instruments inspection 】

Insurating resistence value or current value of this autoclave shall be measured and checked if measured
value are complied with manufacturing instrucation, Then record its result
Inspection report and traceablity certificate of measuring instrument used for this inspection shall be
attached with this IQ procedure & report.

７－１．Inspection of value of Insurating resistence value of this autoclave

Mearuring
Inspection item Contents Approved
Instruments
Criterion measure :
Insurating mora then １００ＭΩ
Autoclave ＭΩ Hi TESTER □Yes □No
resistence value Measured value
ＭΩ

７－２． Inspection of current value of this autoclave

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 Mearuring
Inspection item Contents Approved
Instruments
Criterion measure :
Current value ２０Ａ -20%+10% CLAMP ON
Autoclave □Yes □No
（Max.） Measured value Hi TESTER
Ａ

【 Comments 】

【 Confirmation of distrubutor 】

11
Name of person Date of confirmation (yy/mm/dd)

Judgment ： 【 □ Conformity ・□ Nonconformity 】

８．【 ＩＱ general inspection 】

We hereby confirm in this article that inspections stipurated in this IQ procedure & report have been done.
IQ inspection shall be completed by this confirmation. Any corrective action regariding to IQ inspection shall
be stated in comment below.
Final confirmation by user and manufacturer shall be stated in front cover of this IQ procedure & report.

【 Comments 】

Atuoclave IQ
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 【 Confirmation of distrubutor 】

11
Name of person Date of confirmation (yy/mm/dd)

Judgment ： 【 □ Conformity ・□ Nonconformity 】

【 Confirmation of user 】

11
Name of person Date of confirmation (yy/mm/dd)

Judgment ： 【 □ Conformity ・□ Nonconformity 】

Atuoclave IQ
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