ATAGO AP-300 User manual

P-OQ0612-5291-E03
1/7
Operational
Qualification (OQ
）
Automatic Polarimeter
AP-300
Operational Qualification of Automatic Polarimeter AP-300
Preface
The Operational Qualification performance test of the Automatic Polarimeter AP-300 is d escribed
herewith.
The instructions below assume that the performance test of the AP-300 is cond ucted by a regular
user of the unit who is familiar with the operation. For daily check and maintenance, please refer
to the Standard Operational Procedure document (SOP).
1. Test Environment and Preparation
Conduct the performance test in an environment which meets the conditions outlined below.
Keep the measurement sample and the AP-300 at an am bient temp erature of 18.0°C to 22.0°C
for at least 30 minutes to let them acclimate to the ambient temperature.
If the following environmental conditions are not met, an appropriate measurement result
may not be obtained.
Environment for performance test
2. Establishing a Discretionary Measurement Standard
A performance test requires a discretionary measurement standard.
Establish a set measurement standard for your samples, taking the accuracy of the AP-300
into account. Please refer to the product literature and/ or the instruction manual for the
specifications, features, and measurement accu ra cy of th e AP-300. These specifications are
guaranteed at the time the AP-300 is shipped as a brand-new product. It is d ifficu lt to obtain
an accuracy level greater th an the p rod u ct sp ecification s under different environmental
conditions. It is recommended setting the discretionary measurement standard lower than the
stated specifications.
Example: Judgment standard measurement
Accu r acy: Angle of rotation ±0.03°
3. Confirmation of Measurement Accuracy (Accuracy and Repeatability)
Check the accuracy (accuracy and repeatability) of the m easurement values by measuring a
sample of a known concentration.
The AP-300 is an optical instrument designed to measure the angle of rotation of a sample
solution by utilizing two polarizing plates.
Ambient temperature: 18.0°C to 22.0°C Relative humidity: less than 75%
Power supply: AC 100 to 240V, 50/ 60Hz
※The Automatic Polarimeter AP-300 should be used indoors and placed on a flat,
level surface, such as a work desk or laboratory table.

P-OQ0612-5291-E03
2/7
Operational
Qualification (OQ
）
Automatic Polarimeter
AP-300
The accuracy and the repeatability as well as the span of the AP-300 can be checked by
measuring various points within the measurement range. This performance test is almost
equivalent to calibration.
The accu racy of the AP-300 is expressed as ±0.0X°. The accuracy is written like so: Angle of
rotation measurement value±0.0X°.
4. Items to Prepare
1) Standard quartz control plate（with traceability certificate)
Available from ATAGO
Part number RE-72045 Quartz control plate 34°
Part number RE-72044 Quartz control plate 17°
Part number RE-72043 Quartz control plate 8°
※Use a Quartz control plate with an angle of rotation similar to the samples usually
measured.
Quartz control plates, u nlike sucrose solutions, require minimum preparation. To
ensure accuracy, the angel of rotation and International Sugar Scale are certified to
two d ecimal places and are documented on the traceability certificate included with
each quartz control plate.
2) If a quartz control plate is not available, prepare a standard sucrose solution of 100 °Z
(Refer to ※below) in a 200mm observation tube.
3) Recording chart for measurement data
※How to make standard sucrose solution of 100°Z
Put 26.000g of pure sucrose in a graduated cylinder and add distilled water to the
pure sucrose, until the total volume is 100ml.
5. Preparation of Instrument
1) Turn on the power of the AP-300. The measurement screen appears 3 seconds after the
opening message is displayed. If an exclusive p rinter is con nected , the opening message
will be printed out.
2) Leave the unit on for at least 30 minutes.
3) Make sure “MODE-1” is displayed on the measurement screen.
4) Check the date and time on the display screen of the Automatic Polarimeter AP-300.
5) If u sing an exclusive printer, check the settings of the printer.
Set the date, time, average values, sample numbers, etc.
Measurement values displayed on the LCD will be printed out.
6) For measurements of standard quartz control plates, ensure the unit is set to read in the
Angle of Rotation Scale. For measurements of standard sucrose solutions, ensure the unit
is set to read in the International Sugar Scale (with Automatic Temperature
Compensation).
* The printer paper supplied with the printer is a heat-sensitive rolled paper. ATAGO

P-OQ0612-5291-E03
3/7
Operational
Qualification (OQ
）
Automatic Polarimeter
AP-300
also offers heat-sensitive roll paper for long-term storage with limited fading. Contact
ATAGO for details.
6. Measurement
1) Make sure that the sample chamber is empty. Close the sample cham ber cover.
2) Press the ZERO key. Zero-setting is initiated.
3) ZERO SET EN D is displayed.
When a printer is connected, “ZERO SET EN D” will be printed .
4) Measure the standard quartz control plate and record the measured value on the
measurement data recording chart. (If a quartz control plate is not available measure a
standard sucrose solution of 100 °Z and record the measured value on the measurement
data recording chart.)
5) Repeat step 4) a total of four times. Record the measured values in the measurement
data recording chart.
7. Confirmation of Recorded Data
Check the measurement data of the Automatic Polarimeter AP-300.
1) Compare the measurement values recorded in the measurement data recording chart
with those printed by the printer. Check if they are consistent.
2) The AP-300 stores the measurement value of the last 30 measurements in the memory. If
the number of measurements exceeds 30, the newest measurement values will rep lace
the oldest measurement values.
3) The measurement values stored in the memory can be recalled on the screen to compare
with those in the measurement data recording chart.
4) The measurement values stored in the memory can also be exported and printed.
The measurement values on record and those in the memory can be checked for consistency
by the method described above.
8. Operation Qualification Results Report
1) Fill out the Operation Qualification test results report with the measurement data
obtained .
2) Calculate the average value and errors, and insert them in the report.
3) Assess the results, based on the judgment discretionary measurement standard.
4) Finally, the operator and an approved supervisor will sign the Operation
Qualification test results report.
Function Examination of Automatic Polarimeter AP-300
Preface
The Automatic Polarimeter AP-300 has variou s functions besides measuring angle of rotation.
When zero-setting is attempted with a sample outsid e the range by –5 to +5 °, an error message is

P-OQ0612-5291-E03
4/7
Operational
Qualification (OQ
）
Automatic Polarimeter
AP-300
displayed. It can also export signals to a printer. This chapter explains how to test such functions.
The function examination should be performed by a regular user of the AP-300 who is familiar
with the operation. The examination process includes unusual operations, such as displaying
error messages intentionally. Carefully follow the instructions in this manual.
1. Preparation of Instrument
1) If u sing an exclusive printer, connect it to the AP-300.
2) Turn on the power of the AP-300. The opening message will be printed out.
3) Leave the instrument on for at least 30 m inutes.
4) Make sure that “MODE-1” is set.
5) Check the date and time on the display screen of the AP-300.
6) Check the settings on the printer.
Set the date, time, average values, sample numbers, etc.
Measurement values displayed on the LCD will be printed out.
2. Items to Prepare
1) Standard quartz control plate（with traceability certificate)
Part number RE-72045 Quartz control plate 34°
Part number RE-72044 Quartz control plate 17°
Part number RE-72043 Quartz control plate 8°
※Use a Quartz control plate whose angle is close to the angle of rotation usually measured.
2) If a quartz control plate is not available, fill a 200mm observation tube with a prepare a
standard sucrose solution of 100°Z
3. Function Examination
After a performance test in MODE-1, the measurement screen will be displayed.
3-1. Key Fu nction s in Each Mode
1) Press the MENU key to d isp lay "SET UP MENU 1/ 2."
Press the cursor keys (↓,↑) to check if the pointer moves from the menu items (1) through
(6).
Select a number, using the cursor keys (↓,↑), and press the ENTER key to enter the
selected menu item. Check the display and set the values.
2) Press the MENU key in the “SET UP MEN U 1/ 2” screen to d isplay “SET UP MEN U 2/ 2.”
Press the cursor keys (↓,↑) to check if the pointer moves from the menu items (1) through
(8).
Select a number, using the cursor keys (↓,↑), and press the ENTER key to enter the
selected menu item. Check the display and set the values. Press the ENTER key to return
to the "SET UP MEN U 2/ 2" screen. Check all the menu item s (1) through (6) in the same
manner except for the items (7) and (8). These are the password functions and will be

P-OQ0612-5291-E03
5/7
Operational
Qualification (OQ
）
Automatic Polarimeter
AP-300
explained later in the manual.
Press the QUIT key in the “SET UP MEN U 2/ 2” screen. The measurement screen is
displayed. Press the SCALE key to change the display. Press the SCALE key until the
angle of rotation screen appears.
3-2. Error Messages
“ZERO SET ERROR”
1) Set the standard quartz control plate or the standard sucrose solution of 100°Z in the
sample chamber.
2) Close the sample chamber cover. Press the ZERO key.
3) “ZERO SET Read ing” will be displayed.
4) “ZERO SET ERROR will be displayed.
Zero-setting can be performed within the range of –5° and + 5° of Angle of Rotation.
When it is outside of this range, “ZERO SET ERROR” will be displayed.
“OUT OF RANGE”
1) Set the Upper and Lower Limit Bars.
2) Select “4. LIMIT BAR” from “SET UP MENU 1/ 2” and press the ENTER key.
3) “LIMIT BAR” is displayed. Enter appropriate values and the name of the sample in “No.
SAMPLE NAME.” Select “AN GLE OF ROTATION” for “SCALE.”
4) For the item “LIMIT,” enter “10.00” in HIGH [ ] and “0.00” in LOW [ ]. Press the
ENTER key.
5) The display returns to the “SET UP MENU” screen. Press the QUIT key. The display
returns to the measurement screen.
6) Set a standard Quartz control plate or a standard sucrose solution of 100°Z in the sample
cham ber.
7) Close the sample chamber cover. Press the START key.
8) “OUT OF RANGE” will be displayed after measurement is completed.
“TEMP. ERROR”
1) Press the SCALE key in the measurement screen to display the International Sugar Scale
TC (Automatic Temperature Compensation) screen.
2) Remove the thermal sensor from the sample chamber.
3) Set a standard Quartz control plate or a standard sucrose solution of 100°Z in the sample
cham ber.
4) Close the sample chamber cover and press the START key.
5) “TEMP. ERROR” will be displayed after approximately 45 second s.
6) Re-install the thermal sensor.
3-3. Password Function
The password “2222” and the system level “0” are the default factory settings of the
password function. Use this default password to change the password for the first time.
The password and the system level are important security settings. This chapter only
explains how to check the initial screens of 7. SYSTEM LEVEL and 8. PASSWORD
CHANGE. The password function can be changed once the user decides on the password
and system level.

P-OQ0612-5291-E03
6/7
Operational
Qualification (OQ
）
Automatic Polarimeter
AP-300
7. SYSTEM LEVEL
Press the MENU key in the measurement screen to display “SET UP MENU 2/ 2.”
Select “7. SYSTEM LEVEL” and press the EN TER key. The “SYSTEM LEVEL” screen
ap pears. Make sure the “SYSTEM LEVEL” is 0.
Press the QUIT key. The screen returns to “SET UP MENU 2/ 2.”
Press the QUIT key again to return to the measurement screen.

P-OQ0612-5291-E03
7/7
Operational
Qualification (OQ
）
Automatic Polarimeter
AP-300
Operation Qualification Results Report
Items
Descriptive contents
Remarks
Date of test
Product name
and model name
Serial number
Printer name
Serial number
Environmental
conditions
Temperature °C
Relative humidity %
1. Performance Test Data
Standard value
Standard quartz
control plate (34.77°)
standard sucrose
solution of 100°Z
1st test
2nd test
3rd test
4th test
Average value
Difference
Judgment standard Accuracy Angle of rotation ±0.03 °
2. Function Examination
Functions Contents
Switch function
□ Power supply switch
Key functions
□ZERO □QUIT □MENU □SCALE
□START □ENTER □Arrow keys
□NUMERIC keypad
Display functions
□ Opening message
□ Date and tim e
Error messages
□ ZERO SET END □OUT OF RAN GE
□ TEMP. ERROR
Output functions □ Printer output □RS-232C output
*check each box □.
3. Evaluation
The results of the performance test and a functional examination were evaluated.
□ Pass □ Fail
Date of operation
: Yea r M on th Da y
Date of approval: Yea r Month Day
Operator signature: ___________________ Supervisor signature: ____________________