Installation Qualification / Operational Qualification / Performance Qualification Protocol Schmidt + Haensch Polarimeter

Installation Qualification / Operational Qualification /
Performance Qualification Protocol

Schmidt + Haensch Polarimeter
Schmidt + Haensch GmbH & Co.

Waldstraße 80/81
D-13403 Berlin
innovators by tradition since 1864

Protocal Approval S+H 3Q Pol
Schmidt + Haensch Polarimeter

Model Unipol L, Polartronic N, M and H Series
Installation Qualification, Operational Qualification
and Performance Qualification
Protocol
Number:
Company:
Address:
Protocol
Date:
prepared by:
Equipment
Model:
Serial #:
PROTOCOL APPROVAL
Name/Title Signature Date

Protocal Approval S+H 3Q Pol
Release History
Part Number Release Publication
Date
SH_01 I February 2015
Notices
Except as specifically set forth in its terms and conditions of sale, Schmidt+Haensch makes
no warranty of any kind with regard to this document, including, but not limited to, the
implied warranties of merchantability and fitness for a particular purpose.
Schmidt+Haensch shall not be liable for incidental or consequential damages in connection

with the furnishing or use of this document.
Copyright Information
This document contains proprietary information that is protected by copyright.
All rights are reserved. No part of this publication may be reproduced in any form whatsoever
or translated into any language without the prior, written permission of Schmidt+Haensch,
GmbH&Co.
Copyright © 2015 Schmidt+Haensch, GmbH&Co.
Trademarks
Registered names, trademarks, etc. used in this document, even when not specifically marked
as such, are protected by law.
Schmidt+Haensch is a registered trademark of:
SCHMIDT+HAENSCH GmbH & Co.

Opto-electronic Measuring Instruments
Waldstraße 80 / 81
13403 Berlin
Germany
Tel: +49 / (0)30 41 70 72 0

Fax: +49 / (0)30 41 70 72 99
e-Mail: sales@schmidt-haensch.de
Website: www.schmidt-haensch.de
Table of Content S+H 3Q Pol
Table of Content
SCOPE OF THIS DOCUMENT .............................................................................................. 1
PART I INSTALLATION QUALIFICATION ...........................................................1
GENERAL REMARKS .................................................................................................... 3
Instrument Identification ..................................................................................... 4
LOCATION REQUIREMENTS ............................................................................................ 5
Environmental Requirements............................................................................... 5
Toxic Fumes .................................................................................................... 5
Waste Disposal................................................................................................ 5
Operating Conditions ......................................................................................... 6
Storage Conditions ......................................................................................... 6
Chemicals ....................................................................................................... 6
Electrical Requirements ....................................................................................... 7
Hazards and Safety Precautions........................................................................... 7
IEC 1010 Compliance ......................................................................................... 7
Electrical Protection ............................................................................................ 7
Insulation ........................................................................................................ 7
Installation category ........................................................................................ 7
Pollution Degree ............................................................................................. 7
Electrical Safety................................................................................................... 7
Electromagnetic Compatibility (EMC) .................................................................. 8
Firmware ............................................................................................................ 8
INSTALLATION QUALIFICATION ....................................................................................... 9
DOCUMENTATION ...................................................................................................... 9
Equipment Manual ............................................................................................. 9
Purchase Order Certification ............................................................................... 9
INSTALLATION CHECKLIST ............................................................................................10
INSTALLATION QUALIFICATION VERIFICATION ....................................................................11
INSTALLATION VERIFICATION .........................................................................................11
INSTALLATION QUALIFICATION CERTIFICATE ......................................................................12
PART II OPERATIONAL QUALIFICATION ...........................................................7
OPERATIONAL QUALIFICATION ......................................................................................14
OPERATING PROCEDURE REFERENCES .............................................................................14
Standard Operating Procedures Pertaining to the Schmidt+Haensch Polarimeter.14
Customer Orientation Script ..............................................................................14
Operating Procedure References (continued) ......................................................15
System Familiarization and Orientation Verification ............................................15
Change Control .................................................................................................15
S+H 3Q Pol
OPERATIONAL TESTING ...............................................................................................16

Instrument Testing .............................................................................................16
Operational Testing (continued) .........................................................................17
Instrument OQ - Certificate Instructions .............................................................17
Instrument OQ - Certificate Instructions (continued) ...........................................18
General Procedure .........................................................................................18
Parameter Testing ..............................................................................................18
Parameter Testing (continued)............................................................................19
Sign Off .............................................................................................................24
1. After completing the tests listed above, record any comments you have in the
Remarks section (page 31 of the Instrument OQ - Certificate)............................24
INSTRUMENT OQ CERTIFICATE ...................................................................................25
Instrument OQ - Certificate (continued) .............................................................26
IQ/OQ PROTOCOL CERTIFICATION .................................................................. 35
CERTIFICATION ..........................................................................................................36
PART III PERFORMANCE QUALIFICATION ...................................................... 37
Instrument PQ - Certificate.................................................................................38
Instrument PQ - Certificate (continued) ..............................................................43
Instrument PQ - Certificate (continued) ..............................................................44
PQ PROTOCOL CERTIFICATION ....................................................................... 45
CERTIFICATION ..........................................................................................................46
S+H 3Q Pol
Scope of this Document

This Installation Qualification, Operational Qualification, and Performance
Qualification (IQ/OQ/PQ) protocol will be performed on the
Schmidt + Haensch Model Unipol L, Polartronic N, M and H Series

Polarimeter:
Located at:
This protocol will define the methods and documentation that will be used to
evaluate S+H Models Unipol and Polartronic Polarimeter installation, and
will determine that Polarimeter operation is within the manufacturer's
specifications. Successful completion of this protocol confirms that the
S+H Models Unipol and Polartronic Series Polarimeter were installed correctly
and are operating as intended.
 Installation checks will be performed to document that this Polarimeter

is installed with proper connections and utilities (where applicable).
 All instrument calibrations/adjustments will be verified.
 The S+H Model Unipol L, Polartronic Series Polarimeter will be tested

for proper operation and software/firmware will be functionally tested.
 Qualification studies will be performed by trained, knowledgeable

personnel.
 Any exceptional conditions encountered during the qualification studies

will be identified for review. Exceptional conditions will be investigated
and the appropriate course of action determined. All data will be
documented.
On any page where a written entry is made, or data is gathered by a

Schmidt+Haensch representative, that page must be signed and dated
by the Schmidt+Haensch representative and verified by a customer
representative.
1
Part I – Installation Qualification
Part I – Installation Qualification S+H 3Q Pol
General Remarks
Equipment Description
Instrument Name: S+H Model Unipol and Polartronic Series

S+H Model Unipol L, Polartronic Series are highly accurate circular
polarimeters. Four Polartronic series are available:
 Polartronic N Series
 Polartronic M Series
 Polartronic H Series (illumination unit LED)
 Polartronic H Series (illumination unit sodium and/or mercury spectral

lamps)
They are fully automatic and simple to use, ensuring that they are suitable for
both research and routine use.
S+H Model Unipol L, Polartronic Series Polarimeter use the automatic optical
null principle. Monochromatic radiation is selected by a filter, then passed
through an aperture, polarizer, sample cell and analyzer to the photomultiplier
(photodiode for Unipol series).
The Model Series H is available as LED or spectral version. The spectral version
has two light sources: a Mercury (Hg) high pressure lamp and a Sodium (Na) gas
discharge lamp. The spectral lines are selected using the instrument keypad are:
Na-589 nm, Hg-578 nm, Hg-546 nm, Hg-436 nm and Hg-365 nm. Some
instruments may be equipped with optional additional filters and may deviate
in their filter configuration.
 The Model Series UniPol L 1000 uses a single light source:
Power LED 589nm (others on request).
 The Model Series UniPol L 2000 uses a double light source:

Power LED 589nm and 405nm.
3
 Polartronic N, M and H (LED) Series can be delivered with one or two

wavelengths, whereby 589 nm is the standard wavelength.
Instrument Identification
Manufacturer Schmidt+Haensch GmbH & Co.
Model
Equipment Serial #
4
Location Requirements
Environmental Requirements
The polarimeter should be sited indoors in an area that should be free of dust,
smoke and corrosive fumes.
The temperature of the environment should be in the range 15 °C to 35 °C (60
°F to 95 °F) and the relative humidity should be 10 % to 75 % non-condensing.
If a circulatory thermostat is included it should be sited near the polarimeter

with a water tap and sink in the vicinity.
The bench top should be smooth, level, free from vibration and able to support
of
 12 kg. The bench space required is at least 650 x 315 x 160 mm
(W x H x D) for polarimeter Unipol Series.
 28 kg. The bench space required is at least 733 x 160 x 365 mm
(W x H x D) for polarimeter Polartronic series
Do not leave the instrument in direct sunlight.
Always leave enough space around the instrument to allow adequate cooling.
Toxic Fumes
If you are working with volatile solvents or toxic substances, etc., you must
provide an efficient laboratory ventilation system to remove vapors that may
be produced when you are performing analyses.
Waste Disposal
Waste containers may contain corrosive or organic solutions and small amounts
of the substances that were analyzed. If these materials are toxic, you may
have to treat the collected effluent as hazardous waste. Refer to your local
safety regulations for proper disposal procedures.
Mercury lamps and other spectral lamps are maintained under reduced
pressure. When disposing of lamps that are defective or otherwise unusable,
handle them correctly to minimize the implosion risk. Also, refer to your local
safety and environmental regulations for proper disposal procedures.
5
Operating Conditions
Explosive Atmosphere
This instrument is not designed for operation in an
WARNING explosive atmosphere.
Storage Conditions
You can store the instrument safely under the following conditions:
 Ambient temperatures of -20 ºC to +60 ºC (-4 ºF to 140 ºF).
 Ambient relative humidity 20 % to 80 %, without condensation.
 Altitude up to 2000 m (above mean sea level).
When you remove the instrument from storage, before putting it into
operation allow it to stand for at least a day under the approved
operating conditions.
Chemicals
Use, store, and dispose of chemicals that you require for your analyses in
accord
regulations.
Hazardous Chemicals
Some chemicals used with this instrument may
be hazardous or may become hazardous after
completion of an analysis.
The responsible body (for example, Laboratory
Manager) must take the necessary precautions
to ensure that the surrounding workplace is
safe and that instrument operators are not
WARNING exposed to hazardous levels of toxic substances
(chemical or biological).
Venting for fumes and disposal of waste must

be in accordance with all national, state and
local health and safety regulations and laws.
OSHA: Occupational Safety and Health Administration (U.S.A.)

ACGIH: American Conference of Governmental Industrial Hygienists
(U.S.A.)
COSHH: Control of Substances Hazardous to Health (U.K.)
6
Electrical Requirements
The polarimeter can operate on electricity supplies of 50 or 60 Hz and on
voltage ranges 85 to 260V. It has a maximum power consumption of 200 VA.
The instrument requires one power outlet and a second will be required for the
printer.
If possible, do not use photocopiers, discharge lamps, radio transmitters and

other equipment with large or frequent transient loads on the same supply
circuit.
Hazards and Safety Precautions
IEC 1010 Compliance

This instrument has been designed and tested in accordance with IEC 1010-1:
Safety requirements for electrical equipment for measurement, control, and
laboratory use, and Amendment 1 to this standard.
Electrical Protection
Insulation
Class I as defined in IEC 1010-1.
Installation category
This instrument is able to withstand transient overvoltage according to
Installation Category II as defined in IEC 1010-1 and IEC 664.
Pollution Degree
The equipment will operate safely in environments that contain non-
conductive foreign matter and condensation up to Pollution Degree 2 as
defined in IEC 1010-1 and IEC 664.
Electrical Safety
 Use only fuses with the required current rating and of the specified type
for replacement.
Do not use makeshift fuses or short-circuit the fuse holders.
7
 Whenever it is likely that the instrument is no longer electrically safe for

use, make the instrument inoperative and secure it against any
unauthorized or unintentional operation.
The instrument is likely to be electrically unsafe when it:
 Shows visible damage;

 Fails to perform the intended measurement;
 Has been subjected to prolonged storage under unfavorable
conditions;
 Has been subjected to severe transport stresses.
Electromagnetic Compatibility (EMC)
Pl supplied with the instrument.
Firmware
During the startup of the instrument, the Firmware version information is
being displayed. Please note the version number in the table below.
Version
Firmware update by /
Version number Date of update
signature
8
Installation Qualification
Documentation
Equipment Manual
Part No. Title
N/A Schmidt+Haensch GmbH & Co.
Purchase Order Certification
The Schmidt+Haensch Polarimeter:
Serial Number
Purchase Order Number
is in compliance with the specifications of the purchase order.
9
Installation Checklist
Schmidt+Haensch Polarimeter
Serial Number:
Result,
Deviation or
Description
Comment
(Initial)
Check that space requirements are met as specified in

1
this document.
Unpack the polarimeter carefully and check that the

2
device and any other equipment are undamaged.
Check that the parts provided are complete as listed in

3
the delivery note.
4 Remove any shipping packaging.
Perform the electrical connections as documented in

5
the Electrical Connections sub-section.
Connect any other devices (e.g. printers, thermostats

6
etc.)
Switch on the instrument as documented in

7
Manual.
Check the instrument serial number against the

8
paperwork supplied. Record any deviations.
9 Refer to customer familiarization training schedule.
10 Explain the warranty and available services.
10
Installation Qualification Verification

Verify the following list and mark as appropriate:
Description Yes No
1 Instrument is identified
3 Adequate electricity supply available
4 Adequate room for servicing the equipment
5 Operator manual from Schmidt+Haensch is identified
6 Purchase order certification
7 Certificate of Conformity
8 Start-up diagnostics run to completion
Installation Verification
The Schmidt+Haensch:
Model:
□ UniPol ________ □ Polartronic Series ________ Polarimeter
Serial Number
was installed according to the Installation Checklist on page 10 of this

document.
11
Installation Qualification Certificate
Installation Qualification Certificate

Model: □ UniPol □ Polartronic ________ Polarimeter
REMARKS
This is to certify that the Installation Qualification procedures for the

Schmidt+Haensch
Model □ UniPol ________ □ Polartronic ________ Polarimeter
Serial number _________________
have been performed and the configuration installed * meets [ ] /
does not meet [ ] the installation procedures described in this document.
This certificate does not affect Schmidt+Haensch

conditions of sale, including the terms of the instrument warranty.
Schmidt+Haensch assumes no responsibility for test results.
Performed by authorized
Schmidt+Haensch
Representative
Reviewed by authorized
Customer Representative
Approved by authorized
Date
* Tick/Check as appropriate
12
Part II – Operational Qualification
Part II – Operational QualificationOperational Qualification S+H 3Q Pol
Operational Qualification
Operating Procedure References

Standard Operating Procedures Pertaining to the
Schmidt+Haensch Polarimeter
Customer Orientation Script

Description
1 Explain the basic theory of the instrument.
2 Briefly explain the system features.
3 Show the customer the power-up procedure.
Show the section of the manual that describes the different methods
4
available.
5 Demonstrate how to run a simple reading.
6 If a printer has been installed, explain how to print.
7 Demonstrate the power-down procedure.
14
Part II – Operational Qualification S+H 3Q Pol
Operating Procedure References (continued)

System Familiarization and Orientation Verification
Person Attending Provided by Date
Change Control
A change in the version of the operating software, firmware, hardware
components or the data acquisition procedure may necessitate requalification.
15
Operational Testing
Instrument Testing
Be sure to record all settings and readings, and to record the originals in
the final report.
Use the instructions in this section (under the sub-heading Parameter Testing,
page 20) for the following tests:
Name of Test Description

Measure the rotation value and compare it
1 Rotation
with the quartz standard certificate value.
Measure the reproducibility of the rotation
2 Angle Reproducibility value compared with the quartz standard
certificate value.
Point 3 only if required and solution made available by costumer.
Rotation with D (+) Measure the rotation value of 10% and 20%
3
sucrose D (+) sucrose in H2O and calculate  20
D
Fill in and record data on the Polarimeter Instrument OQ - Certificate (page 25

and following). All materials and calibration tools used to calibrate the
instrument are logged on the Instrument OQ - Certificate.
16
Operational Testing (continued)

Instrument OQ - Certificate Instructions

Configurations Covered All configurations
Estimated Certificate Testing Time
Pre-test Stabilization 0.5 Hours
Testing Time 1.0 Hour
Materials Required
Part Description
Number
Documentation N/A Methods listed in this documentation
IQ/OQ Certification Sticker
Test Equipment N/A Output device e.g. printer (optional)
Standards N/A Quartz Standard __________ (SN)

D (+) sucrose of purity of the Ph. Eur
N/A (only if required and solution made
available by costumer.)
17

Instrument OQ - Certificate Instructions (continued)
General Procedure
The following instructions apply to the Instrument OQ - Certificate on
page 25 (and following).
Complete the customer information in the spaces provided (i.e.

Customer Name, Address, Unit Location, User Name and Phone
1
Number, Date Tested, Recertification Due Date, Serial Number
and Service Report Number).
Fill in the Configuration tested with the Serial Number for each
component covered by this procedure. Record any
2
Accessories/Components not included by Model (or Part
Number) and Serial Number.
Record the Calibration Number and Expiration Date for each

3
item of Test Equipment used.
Record the Batch/Serial Number and Expiration Date of each

4
Test Standard used.
Parameter Testing
Refer to the information in this section for procedures to perform the tests
listed under the sub-heading Instrument Testing at the beginning of this
section (page 16).
18

Parameter Testing (continued)
1. Rotation Test
Note: The rotation values can be tested by means of the quartz

standards.
a) Test the rotation values by using the optical rotation method setting.
b) Select the test wavelength, e.g. 589 nm.
c) Press the Zero key and follow the instructions on the instrument.
d) Insert the quartz standard into the sample compartment.
e) If the quartz standard plate is equipped with a temperature sensor,

please plug in the cable in the plug within the sample compartment.
f) Close the sample compartment and read off the rotation value and
enter the Actual Value Angle on the Instrument OQ - Certificate. The
Certificate Rotation Angle is the Certified Quartz Rotation from the
calibration certificate. Enter the Quartz Standard Tolerance from the
calibration certificate, at this specific wavelength. Add the Quartz
Standard Tolerance to the Instrument Tolerance to obtain the Total
Admissible Tolerance for this accuracy test, and enter the value in the
Total Admissible Tolerance column. Next, calculate the Deviation of
Measurement, which is the deviation of the Actual Value Angle
relative to the Certificate Rotation Angle, and enter the result in the
Deviation of Measurement column. If the Deviation of Measurement
is less than or equal to the Total Admissible Tolerance, then the test
result is deemed PASS at that specific wavelength.
g) For instruments equipped with multiple wavelengths, repeat steps (a)

through (f) for each of the available wavelengths.
h) Record and calculate the appropriate data at each wavelength. For

each wavelength, calculate the Deviation of Measurement and
determine the PASS or FAIL result.
Note: In general, no quartz standard reference values are available
for optional filters installed in the instrument.
19

2. Angle Reproducibility Test

a) Test the rotation values by using the optical rotation method setting.
b) Select the test wavelength, e.g. 589 nm.
c) Press the Zero key.
d) Insert the quartz standard into the sample compartment.
e) Close the sample compartment and read the rotation value, and
enter this rotation as the Initial Rotation Angle for the appropriate
test wavelength on the Instrument OQ - Certificate.
f) Remove the quartz standard from the sample compartment.
g) Close the sample compartment and re-zero the instrument.
h) Insert the quartz standard into the sample compartment once again.
Close the sample compartment and read the rotation. Enter this
Measured Angular Rotation as measurement 1, and compare this
rotation to the Initial Rotation Angle. Calculate the Deviation from
Initial Rotation Angle. If this deviation is less than the reproducibility
specification of the polarimeter (depends on the model), then the
test result is deemed PASS, if greater than specified, it is FAIL. Remove
the quartz cell from the sample compartment.
i) Repeat the steps (g) and (h), a total of (maximal) nine more times,
calculating the Deviation from Initial Rotation Angle in each case.
Determine the PASS/FAIL result in each case.
j) Repeat steps (b) through (i) for each applicable wavelength for the
quartz standard. Again, for each measurement, read the Measured
Angular Rotation and enter it in the appropriate column of the
Instrument OQ - Certificate. Compare each Measured Angular
Rotation to the respective Initial Rotation Angle at the applicable
wavelength, and calculate the Deviation from Initial Rotation Angle.
Determine the PASS or FAIL result.
20

Only if required and solution made by costumer!
3. Rotation with D (+) sucrose
a) The pharmacopoeia suggests to use 10% g/ml and 20% g/ml sucrose
solutions for checking polarimeters. For volumetric preparation it is
depending on the temperature and with volumetric measurement it is
quite critical to achieve the necessary precision we suggest to prepare
sugar solutions gravimetric only.
b) Sugar solutions can be prepared by a gravimetric method using a high

precision analytical balance having at least ±0.0001g resolution.
c) For that it is necessary to use :
 A 4 decimal balance with a range of mininum 300 g

 Erlenmeyer flask of 250 ml with stopper
 Magnetic stirrer with sticks or automatic shaker
 Purest sucrose according to the pharmacopoeia rules
 Dist.water
d) Place a 250ml Erlenmeyer glass bottle on the balance and tare it.
For a 10% solution fill a minimum/maximum amount of 10g/13g sugar,

and for a 20% solution fill minimum/maximum amount of 20g/26g sugar
into the Erlenmeyer glass flask. Put the sugar into glass flask and weigh
the exact amount of sugar that is in it.
Now open the provided software tool sugarsolution (calculations made

accrording to ICUMSA SPS-1). Choose the Type of Solution you want to
create (10% or 20%) and type in the amount of sugar you used (unit is
gram). Next step is to add distilled or deionised water in the flask until
the total mass is as close as possible to the value in the field Theoretical
Weight of Solution (gr) . Formula for this value:
 10% solution: weight sugar/9,659*100
20% solution: weight sugar/18,633 *100
(Formula integrated in sugarsolution, no need to calculate manually)
Carefully Dry the inside wall of the neck of the ﬂ ask with ﬁ lter paper if
any water splashed on it !
21
e) Type in the actual weight of your solution into the field Real weight of
solution at sugarsolutions. Add the exact value of your instruments
wavelength into the field Wave length (nm) and press the button
Calculate . Note value Degree and put it into the field Theoretical
Degree Value at the table Rotation Test with D (+) sucrose at page 33.
f) Take out flask and in case of using a magnetic stirrer add a stir bar into
the mixture and close the flask tightly to avoid evaporation loss. Place
the mixture on a magnetic stirrer and wait for approximately 20 minutes
to dissolve the sugar completely. As the solution gets totally clear and
no crystals are visible anymore, the solution is ready for polarimetric
tests.
g) Perform the measurements according to the usermanual of the

polarimeter. The angle of optical rotation, by which the substance
22
measured rotates the polarisation plane of the D-line of sodium light

(=589 nm) at a certain temperature, is measured.
The readability of the polarimeter must be at least 0.01° (degree). After

determination of the sample and room temperature, measure the
optical rotation of the self created solution, tempered to room
temperature by measuring each solution five times in a row at a short
time range and calculating the respective average value. Put this value
into the table Rotation Test with D (+) sucrose at page 33.
Calculation example (integrated in sugarsolution, no need to calculate

manually!):
This example prepares a 10% solution:
Weight of sugar: 12.664 g
Theoretical Weight of solution: 12.664g/9.659*100 = 131.1109 g
Real weight of solution: 131.1289 g
Real value = 12,664g/131.1289g*100 = 9,6576 Bx
Formula to convert (factors based on ICUMSA SPS-1 (2002), 5.1):

(-5.8352343064E-05+3.8346537954*Bx+1.5017128181E-02*Bx²+
5.4295122595E-05*Bx³-1.5270891598E-07*Bx4)/2,888000106
Converted value = 13,325° (38,482 °Z/factor)
The factor 2.888000106 calculates the angular degree from °Z for
589,44 nm in vaccum respective 589,3 nm in air.
This is what the instrument should show ! Unlike to the pharmacopeia the
ICUMSA is using the wavelength in air.
Factors for other wavelengths:

365 nm 405 nm 546,2271 nm 579 nm 589,44 nm
0.990508831 1.262670765 2.452362852 2.779665059 2.888000106
f) Look up the instrument tolerance for optical rotation and put this value
into the field Instr. Tolerance .
g) Calculate mean value of your five measurements.
h) Subtract the mean value of the Measured Value Angle from

Theoretical Degree Value and type in the result in the field Deviation.
Compare to Instrument Tolerance and if the deviation is smaller, the
test is Passed .
23

Sign Off
1. After completing the tests listed above, record any comments you have in
the Remarks section (page 34 of the Instrument OQ - Certificate).
2. Mark on the Instrument OQ - Certificate as appropriate, depending if the

instrument meets [ ] or does not meet [ ] the Schmidt+Haensch specifications
listed on the Certificate.
3. Sign the Instrument OQ - Certificate and record your name/employee

number.
4. Attach any recordings or printouts made during the test procedure to the
original Instrument OQ - Certificate. Leave the original with the customer.
Retain a copy for your office records.
5. Complete and sign off the IQ/OQ Protocol Certification (page 36).
6. Complete and affix an IQ/OQ Certification Sticker to the instrument.
24
Instrument OQ – Certificate
Instrument OQ - Certificate
Serial Number
Customer
Address
Unit Location
User Name
Telephone
Date Tested
Recertification Period Recommended at 12 Months
Recertification Due Date
25
Instrument OQ - Certificate (continued)
Configuration Tested
Model Serial Number
UniPol
Polartronic
Lot, Batch, or Expiration Operators

Test Standards Used
Serial Number date initials
Quartz Standard,
Quartz Standard,
D (+) sucrose of purity

of the Ph. Eur
Customer
Customer Supplied Comments
Initials
26

Serial Number: Date Tested:
Rotation Test
Quartz Standard
Measuring Temperature T = Ambient
SN:
Deviation PASS
Certificate Actual Quartz Instru- Total
Wave- of
Rotation Value Std. ment Admissible or
length Measure-
Angle Angle Tolerance Tolerance Tolerance*
ment FAIL
589
    0  0
nm
578
    0  0
nm
546
    0  0
nm
506
    0  0
nm
436
    0  0
nm
365
    0  0
nm
for more than one QCP (optional)
Quartz Standard
Measuring Temperature T = Ambient
SN:
Deviation PASS
Certificate Actual Quartz Instru- Total
Wave- of
Rotation Value Std. ment Admissible or
length Measure-
Angle Angle Tolerance Tolerance Tolerance*
ment FAIL
589
    0  0
nm
578
    0  0
nm
546
    0  0
nm
506
    0  0
nm
436
    0  0
nm
365
    0  0
nm
* The admissible deviation is calculated by adding the instrument tolerance and the rotation
tolerance determined from the quartz-standard certificate.
27
Angle Reproducibility Test - Quartz Standard :
Wavelength _____________ nm
Initial Rotation Angle = Measuring Temperature T = Ambient
Measured Angular Angle Reproducibility Deviation from Initial

PASS or FAIL
Rotation Specification Rotation Angle
1. < 0.0  0
2. < 0.0  0
3. < 0.0  0
4. < 0.0  0
5. < 0.0  0
6. < 0.0  0
7. < 0.0  0
8. < 0.0  0
9. < 0.0  0
10. < 0.0  0
28

PASS or FAIL
1. < 0.0  0
2. < 0.0  0
3. < 0.0  0
4. < 0.0  0
5. < 0.0  0
6. < 0.0  0
7. < 0.0  0
8. < 0.0  0
9. < 0.0  0
10. < 0.0  0
29

PASS or FAIL
1. < 0.0  0
2. < 0.0  0
3. < 0.0  0
4. < 0.0  0
5. < 0.0  0
6. < 0.0  0
7. < 0.0  0
8. < 0.0  0
9. < 0.0  0
10. < 0.0  0
30

PASS or FAIL
1. < 0.0  0
2. < 0.0  0
3. < 0.0  0
4. < 0.0  0
5. < 0.0  0
6. < 0.0  0
7. < 0.0  0
8. < 0.0  0
9. < 0.0  0
10. < 0.0  0
31

PASS or FAIL
1. < 0.0  0
2. < 0.0  0
3. < 0.0  0
4. < 0.0  0
5. < 0.0  0
6. < 0.0  0
7. < 0.0  0
8. < 0.0  0
9. < 0.0  0
10. < 0.0  0
32

Rotation Test with D (+) sucrose
10 % Solution Solution Temp. C° Instr. Tolerance:  0.0 
Wavelength Theoretical
Measured Value Angle Deviation PASS or FAIL
nm Degree Value
Sample 01 
Sample 02 
Sample 03 
Sample 04 
Sample 05 
Average 0   0 
20 % Solution Solution Temp. C° Instr. Tolerance:  0.0 

nm Degree Value
Sample 01 
Sample 02 
Sample 03 
Sample 04 
Sample 05 
33
REMARKS
This is to certify that the full tests for the SCHMIDT+HAENSCH GmbH
Serial number _________________
have been performed and the configuration tested meets [ ] /

does not meet [ ] the SCHMIDT+HAENSCH GmbH Specifications listed on
this certificate.
This certificate does not affect Schmidt+Haensch

conditions of sale, including the terms of the instrument warranty.
Schmidt+Haensch assumes no responsibility for test results.
Performed by authorized
Schmidt+Haensch
Representative
Reviewed by authorized
Approved by authorized
Date
* Tick/Check as appropriate
34
IQ/OQ Protocol Certification
IQ/OQ Protocol CertificationCertification S+H 3Q Pol
Installation Qualification and Operational Qualification
Certification
The Installation Qualification and Operational Qualification final report
for the Polarimeter Instrument
Model □ UniPol □ Polartronic
Serial number
has been reviewed and was found to meet the requirements necessary
FINAL REPORT
Reviewed by (Name and Title) Signature Date
Authorized Schmidt+Haensch Representative
Authorized Customer Representative
Customer QA Representative (if applicable)
36
Part III Performance Qualification
Part III – Performance QualificationCertification S+H 3Q Pol
Instrument PQ - Certificate
Angle Reproducibility Test:

PASS or FAIL
1. < 0.0  0
2. < 0.0  0
3. < 0.0  0
4. < 0.0  0
5. < 0.0  0
6. < 0.0  0
7. < 0.0  0
8. < 0.0  0
9. < 0.0  0
10. < 0.0  0
38

PASS or FAIL
1. < 0.0  0
2. < 0.0  0
3. < 0.0  0
4. < 0.0  0
5. < 0.0  0
6. < 0.0  0
7. < 0.0  0
8. < 0.0  0
9. < 0.0  0
10. < 0.0  0
39

PASS or FAIL
1. < 0.0  0
2. < 0.0  0
3. < 0.0  0
4. < 0.0  0
5. < 0.0  0
6. < 0.0  0
7. < 0.0  0
8. < 0.0  0
9. < 0.0  0
10. < 0.0  0
40

PASS or FAIL
1. < 0.0  0
2. < 0.0  0
3. < 0.0  0
4. < 0.0  0
5. < 0.0  0
6. < 0.0  0
7. < 0.0  0
8. < 0.0  0
9. < 0.0  0
10. < 0.0  0
41

PASS or FAIL
1. < 0.0  0
2. < 0.0  0
3. < 0.0  0
4. < 0.0  0
5. < 0.0  0
6. < 0.0  0
7. < 0.0  0
8. < 0.0  0
9. < 0.0  0
10. < 0.0  0
42
Instrument PQ - Certificate (continued)

Rotation Test with
Solution Temp. C° Instr. Tolerance:  0.0 
nm Degree Value
Sample 01 
Sample 02 
Sample 03 
Sample 04 
Sample 05 

nm Degree Value
Sample 01 
Sample 02 
Sample 03 
Sample 04 
Sample 05 
43
Instrument PQ - Certificate (continued)

Rotation Test with
nm Degree Value
Sample 01 
Sample 02 
Sample 03 
Sample 04 
Sample 05 

nm Degree Value
Sample 01 
Sample 02 
Sample 03 
Sample 04 
Sample 05 
44
PQ Protocol Certification
PQ Protocol CertificationCertification S+H 3Q Pol
Performance Qualification
Certification
The Performance Qualification final report for the Polarimeter
Instrument
Model □ UniPol □ Polartronic
Serial number
has been reviewed and was found to meet the requirements necessary
FINAL REPORT
Reviewed by (Name and Title) Signature Date
Authorized Schmidt+Haensch Representative
Authorized Customer Representative
Customer QA Representative (if applicable)
46

Installation Qualification / Operational Qualification / Performance Qualification Protocol Schmidt + Haensch Polarimeter

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Installation Qualification / Operational Qualification /

Performance Qualification Protocol

Schmidt + Haensch GmbH & Co.

innovators by tradition since 1864

Schmidt + Haensch Polarimeter

Name/Title Signature Date

SH_01 I February 2015

Schmidt+Haensch shall not be liable for incidental or consequential damages in connection

Copyright © 2015 Schmidt+Haensch, GmbH&Co.

Schmidt+Haensch is a registered trademark of:

SCHMIDT+HAENSCH GmbH & Co.

Tel: +49 / (0)30 41 70 72 0

OPERATIONAL TESTING ...............................................................................................16

Scope of this Document

Schmidt + Haensch Model Unipol L, Polartronic N, M and H Series

 Installation checks will be performed to document that this Polarimeter

 All instrument calibrations/adjustments will be verified.

 The S+H Model Unipol L, Polartronic Series Polarimeter will be tested

 Qualification studies will be performed by trained, knowledgeable

 Any exceptional conditions encountered during the qualification studies

On any page where a written entry is made, or data is gathered by a

Instrument Name: S+H Model Unipol and Polartronic Series

 Polartronic H Series (illumination unit LED)

 Polartronic H Series (illumination unit sodium and/or mercury spectral

 The Model Series UniPol L 1000 uses a single light source:

Power LED 589nm (others on request).

 The Model Series UniPol L 2000 uses a double light source:

 Polartronic N, M and H (LED) Series can be delivered with one or two

If a circulatory thermostat is included it should be sited near the polarimeter

Venting for fumes and disposal of waste must

OSHA: Occupational Safety and Health Administration (U.S.A.)

If possible, do not use photocopiers, discharge lamps, radio transmitters and

Hazards and Safety Precautions

IEC 1010 Compliance

 Whenever it is likely that the instrument is no longer electrically safe for

The instrument is likely to be electrically unsafe when it:

 Shows visible damage;

Electromagnetic Compatibility (EMC)

Pl supplied with the instrument.

Part No. Title

N/A Schmidt+Haensch GmbH & Co.

Purchase Order Certification

The Schmidt+Haensch Polarimeter:

Purchase Order Number

is in compliance with the specifications of the purchase order.

Check that space requirements are met as specified in

Unpack the polarimeter carefully and check that the

Check that the parts provided are complete as listed in

4 Remove any shipping packaging.

Perform the electrical connections as documented in

Connect any other devices (e.g. printers, thermostats

Switch on the instrument as documented in

Check the instrument serial number against the

9 Refer to customer familiarization training schedule.

10 Explain the warranty and available services.

Installation Qualification Verification

3 Adequate electricity supply available

4 Adequate room for servicing the equipment

□ UniPol □ Polartronic Series Polarimeter

Model □ UniPol □ Polartronic Polarimeter

Model □ UniPol □ Polartronic Polarimeter