Balance/Scale Logbook

For Qualification of Sartorius Weighing Instruments

Balance/Scale Logbook

Preface

The use of inspection, measuring and test equipment in a quality management system requires a detailed description
and documentation of the results of measurements and of confirmation. Processes and standard operating
procedures must have traceable documentation and be kept on file.

This Balance/Scale Logbook is intended to ensure compliance with the standards and requirements derived from many
earlier quality systems, such as GLP/GMP, ISO9000 and the following, EN45000 and the following, as well as QS9000
(VDA 6.1).

This Logbook will help the user document all activities involving the qualification and monitoring of weighing
instruments in routine operation. It will also serve as a basis for daily work using balances and scales, and provides
the required proof of compliance for inspections and audits.

Contents
Page
General Information on the Balance/Scale 3
Definitions of Terms 4
Equipment Qualification (EQ) 5
Installation Qualification (IQ) 7
Setting the Application Parameters 8
Operational Qualification (OQ) 9
Performance Qualification (PQ) 10
Device Qualification/ Final Report 10
Routine Tests 11
Results of Routine Tests 12
Appendix – Design Qualification 22
Appendix - Testing of Balances/Scales 27
by Sartorius Customer Service
Appendix - Standard Operation Procedure - USP 37
Balance/Scale Logbook

Please enter the particular General Information on the Balance/Scale

designations or information
in the spaces provided.
Logbook number:
Place of use:

Manufacturer:

Model
Serial number
Test equipment number:
Inventory number:
ID number:
Weighing capacity/range levels: Scale division(s):
For verified weighing instruments:
Min: Verification scale interval, e: Max:

Accessories connected:

Location of Instruction Manual(s):

Accessories connected:
Date instrument was taken out of service:

If service is required, please call at:

Qualified, reviewed and released by

(QM)

(Head of the Test Unit)/Person

responsible for test equipment
Balance/Scale Logbook

Definition of Terms
Confirmation The term “confirmation“ covers all action that is suitable for maintaining the
established specifications and performance of measuring equipment.
Interval of confirmation An interval of confirmation means the time difference between two dates of
confirmation.
Verification Official testing and marking of a weighing instrument according to national
regulations.
Adjustment Correcting the difference between the displayed and nominal weight value. Also
referred to as calibration in some non-EU countries.
Calibration Determining the difference between the displayed and nominal weight value.
Linearity Linearity, or linearity error, is the deviation from the theoretically straight-lined
slope of two interdependent values obtained by loading a weighing instrument and
displaying these values.
Its influence on the accuracy of a weighing instrument is negligible in the light
sample weight range. For heavier sample weights (>10% of the weighing capacity),
linearity can affect the accuracy.
Uncertainty of measurement The uncertainty of measurement specifies the range for a measured value, within
which the unknown, error-free result lies, usually with a statistical certainty of 95%.
Repeatability* The repeatability defines the ability of a weighing instrument to display
corresponding results under constant testing conditions, when the same load is
repeatedly placed onto the weighing pan in the same manner. In general, the
standard deviation, or the difference between the largest and the smallest result for
a defined number of measurements, is used to specify this quantity. For evaluating
the quality of a weighing instrument on the basis of its technical specifications,
both values (smallest and largest result) are approximately comparable with each
other if the minimum/maximum specification is compared with three times the
standard deviation. Within the standard deviation times three, you will find 99.7 %
of all representative values of a measurement series. This range is therefore yielded
by the difference between the maximum and minimum values. On some weighing
instruments, the repeatability is nearly independent of the load on them, and can
be designated as the most important metrological feature because its influence on
the uncertainty of measurement – particularly in the case of lightweight samples –
becomes a dominant factor.
Traceability The property of a result of a measurement whereby this result must be related to a
national or international standard, through an unbroken chain of documented
comparisons.
Validation Validation is the documented proof that a process, operation or method is suitable,
to a high degree of certainty, for performing a specific task.
* Some use this term interchangeably with “reproducibility“
Balance/Scale Logbook

Equipment Qualification (EQ)

Equipment Qualification is subdivided into 4 sections:
1. Design Qualification DQ
2. Installation Qualification IQ
3. Operational Qualification OQ
4. Performance Qualification PQ

Design Qualification DQ
In design qualification, the user defines his or her requirements on the
test or measuring equipment. Parameters, such as accuracy, method of
measurement, and requirements on the supplier that relate to design
validation or services, must be defined and documented before purchasing
(procurement). The purpose of design qualification is to ensure that the
measuring equipment – in this case, the balance, scale or weighing system
– is suitable for the particular application.
Design qualification is not part of this Logbook, which can only provide
information and suggestions that should be considered when selecting a
weighing instrument. The requirements for measuring equipment in the
International Standard ISO10012, which are rather specific in most
instances, can be taken as a basis. This Standard can be used to compile a
short list of measures to be taken within the scope of using measuring
instruments to meet the basic requirements.
Because of various influential factors, every measured result has a specific
degree of uncertainty.
Therefore, the selection of a suitable measuring instrument must be based
on answering the question of how great the measurement uncertainty may
be to allow reliable evaluation of the measured results (compliance with
the required tolerances). A good approach to answer this question is to
apply the “Golden Rule” of metrology that says that the measurement
uncertainty of a measuring device may only be 1/10 of the tolerance of the
measured values. For economical reasons (frequency of use in relation to
investment volume), this ratio can be reduced to 1/3 if these tolerances are
met through suitable, supportive measures (frequency of testing).

The basis for the selection of a measuring instrument is provided by

the manufacturer’s technical specifications, such as repeatability,
linearity or temperature coefficient. Besides these instrument
parameters, additional factors that may affect the results of a
measurement must be considered. These include the ambient
conditions at the place of measurement, qualification of the
operator, test object and test procedure.
Balance/Scale Logbook

Installation Qualification IQ
Installation qualification describes start-up and the detailed
sequence of setting up the measuring equipment. Special attention
must be paid to the completeness and correct installation of the
equipment supplied (see page 7).
The most important influence quantities at the place of installation are
gravitational acceleration, mechanical disturbances, temperature, humidity
and barometric pressure, as well as electromagnetic radiation, whether or
not caused by electricity flowing through the power cord. To operate
high-resolution analytical and microbalances, you should essentially
consider using specially designed anti-vibration balance tables. In addition,
the climate conditions (particularly the temperature) should be kept as
constant as possible.

Operational Qualification OQ
Operational qualification describes the metrological testing of a
weighing instrument at the place of installation. Adequately trained
personnel must test weighing instruments using the corresponding
auxiliary equipment and weights that have the appropriate
accuracy. In addition, the test results must be documented in a
calibration certificate or test report of the weighing instrument.
This testing must be performed at established intervals (known as
“intervals of confirmation”).

Performance Qualification PQ
All manufacturers’ specifications refer to nearly ideal measurement
conditions as recommended in the installation and operating
instructions. In practice, however, operators frequently operate
weighing instruments under conditions that differ from these.
Therefore, performance qualification requires verification that
measuring equipment functions as intended in its normal operation
environment (e.g., weighing a sample under a laboratory fume
hood).

Device Qualification/ Final Report

Once all qualification procedures described above have been
successfully performed and the adequate performance of the measuring
equipment has been verified, device qualification along with a final report
is completed.
Balance/Scale Logbook

Installation Qualification (IQ)

You will find a detailed description on how to install Sartorius
balances and scales in their respective Installation and Operating
Instructions. We recommend that you file these manuals in the
Appendix of this Logbook.
Locational conditions

Laboratory bench Special balance table

Ambient conditions:
Very stable Unstable
Stable Very unstable
Special conditions:
Instrument under a hood
Instrument in a glove box
1. Instrument complete
2. Instruction manual available
3. No visible damage
4. Dust cover attached
5. Peripherals connected
6. AC adapter undamaged
7. AC adapter (connected)
8. Balance/scale (leveled)
9. Balance/scale (warmed up)
Recommended warm up times for electronic balances/scales:
Precision balances/scales (d = 1 mg) At least 30 min
Analytical balances (d = 0.1 mg) At least 4 h
Semi-microbalances (d = 0.01 mg) At least 12 h
Microbalances (d = 000.001 mg) At least 24 h
Remarks

Application program selected:

Counting Net-total formula
Weighing in percent Mass unit conversion
Density Backweighing
Calculation Checkweighing
Differential weighing Other
Balance/Scale Logbook

Setting the Application Parameters

This section is used to document the individual settings of the operating
software of a weighing instrument (menu settings, application programs).
In the list provided below, all settings that differ from the factory settings
as well as the application program settings must be indicated (the factory
settings are given in the Installation and Operating Instructions).

Parameter Factory setting Changed Changed

setting on:
(Example)
Place of Installation 112 111
(ideal)

Installation and startup were performed correctly. The instrument/system

is ready to operate.

Prepared by: Tested by:

Date: Date:
Signature: Signature:
Balance/Scale Logbook

Operational Qualification (OQ)

The calibration certificates and test reports for the weighing
instruments are filed in the Appendix of this Logbook.
Initial test at the place of installation, completed along with
test report (See Appendix for test report)
User has been trained to operate the instrument
Person trained Signature Date Trained by Signature

Remarks
– Minimum Sample Weight according to the USP
Based on the United States Pharmacopoeia, it may be necessary to
determine the smallest allowable sample weight, or minimum sample
weight, that can be measured by a weighing instrument.

According to the USP, the minimum sample weight is calculated as

three-thousand times the standard deviation (3,000 * s).
Minimum initial sample weight established
(for this specification, see Test Report in the Annex)
– Uncertainty of measurement according to the certificate

Uncertainty of measurement determined

(see the calibration certificate in the Appendix)
Location of design qualification DQ:
– The requirements for design qualification are met.
–
Prepared by: Tested by:
Date: Date:
Signature: Signature:
Balance/Scale Logbook

10

Performance Qualification (PQ)

The weighing instrument is operable
under the conditions of the application Yes No
(For a detailed description, please see the Appendix)

Prepared by: Tested by:

Date: Date:
Signature: Signature:

Device Qualification / Final Report

The instrument / system meets all requirements established by
design qualification and was correctly installed, configured and tested.

Prepared by: Tested by:

Date: Date:
Signature: Signature:
Remarks
Balance/Scale Logbook

11

Routine Tests
Established test interval (for calibration and adjustment)
The weighing instrument must be tested at intervals of
______ days, weeks, months.
Test weight(s)
Nominal mass value: Error limits acc. to OIML, R111:

Nominal mass value: Error limits acc. to OIML, R 111:

Nominal mass value: Error limits acc. to OIML, R 111:

Nominal mass value: Error limits acc. to OIML, R 111:

Test procedure:
1. The balance/scale must be leveled and warmed to the correct
operating temperature.
2. The test weight must be conditioned to the ambient
temperature.
3. Unload the balance/scale (clear the weighing pan/platform) and
clean, if necessary.
4. Tare/zero the balance/scale.
5. Center the test weight(s) on the weighing pan/load plate.
6 Read off the value when the balance/scale has stabilized.
Permissable tolerance:
(Recommended: permissible tolerance = uncertainty of measurement of
the balance/scale + error limit of the weight used.)
7. Assessment of the value(s) displayed:
If the value displayed is within the tolerance range, the test has been
passed.
If the value displayed is outside the tolerance range, the weighing
instrument must be adjusted (calibrated).
If the value displayed is considerably out of tolerance, the head of the
testing facility must be informed. If necessary, the weighing
instrument must be taken out of service until the cause for the
considerable deviation can be found (inform your Service Center).
8. Document the test on the following pages of the Logbook
Balance/Scale Logbook

12

Results of Routine Tests

Date: Performed by: Test equipment used: Within tolerances:
Yes No
Balance/Scale Logbook

13

Results of Routine Tests

Date: Performed by: Test equipment used: Within tolerances:
Yes No
Balance/Scale Logbook

14

Results of Routine Tests

Date: Performed by: Test equipment used: Within tolerances:
Yes No
Balance/Scale Logbook

15

Results of Routine Tests

Date: Performed by: Test equipment used: Within tolerances:
Yes No
Balance/Scale Logbook

16

Results of Routine Tests

Date: Performed by: Test equipment used: Within tolerances:
Yes No
Balance/Scale Logbook

17

Results of Routine Tests

Date: Performed by: Test equipment used: Within tolerances:
Yes No
Balance/Scale Logbook

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Results of Routine Tests

Date: Performed by: Test equipment used: Within tolerances:
Yes No
Balance/Scale Logbook

19

Results of Routine Tests

Date: Performed by: Test equipment used: Within tolerances:
Yes No
Balance/Scale Logbook

20

Results of Routine Tests

Date: Performed by: Test equipment used: Within tolerances:
Yes No
Balance/Scale Logbook

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Results of Routine Tests

Date: Performed by: Test equipment used: Within tolerances:
Yes No
Appendix

DESIGN QUALIFICATION (DQ)

Functional and Operational Requirement
Description of intended use

Specification
Part 1
Weighing Indicator

Housing Material High Grade ABS Stainless Steel AISI 304

Display LCD segment display Dot-Matrix Graphic display
Backlit Vacuum Fluorescent (VFD)
Integrated check-weighing Red-Yellow-Green display
Alphanumeric Entry YES NO
Ranges Single Multi range
Multi-interval
Date / Time function YES NO
Power Supply AC VAC Hz W/VA max
Power Supply (Optional) DC 24 Volt Car Battery 12V
Rechargeable battery pack
Environmental Conditions

Ingress Protection IP 44 IP 54
IP 65 IP 67
Interface protection According to EN45501
o o
Temperature Range From C to C
Appendix

23

Applications

Application Programs / Weighing Counting

Software Checkweighing Classification 3 / 5
Totalization Net-total formulation
Filling Weighing in Percentage
Neutral Measurement Animal weighing
Product Memory 300 / Tare memory 30
Input function for Entering 4 x Alphanumeric ID tests
Dosing / Receipt management
Average Weigh Control / Statistical process Control
Interfaces

Requirement on Interfacing / RS232 (SBPI/XBPI) RS485 (XBPI)

Communications RS422 (XBPI) Analog 0-20mA/4-20mA/0-5V
Profibus Bluetooth wireless
TCP / IP
Digital output ports (Checkweighing Tower display)
PC Keyboard / Bar Code input port

Interfacing Accessories Dot Matrix Printer YDP03-0CE

Label / Stripe Printer YDP12IS / YDP04IS
Alibi Memory
Remote Display (2nd Display)
Red-Green-Red Checkweighing display
External Hand / Foot switch
Multi I/O Relay box
PC
Weighing platforms / Scales
Bar Code scanner / PC Keyboard
Indicator Mounting

Bench Top YES NO

Wall mounting YES NO
Mount on Column YES NO
Column Height mm
Appendix

24

Part 2
Weighing Platforms

Weighing Capacity: (kg)

Resolution (kg)
Verifiable Legal for Trade Non-legal for Trade
Ranges 2 x 3,000 e 3,000 e
30,000 d 15,000 d
Platform Size (W x D x H) mm W mm x D mm x H mm
Platform Material / Finishing Painted steel Stainless Steel AISI 304
Electro-polished AISI 316 Ti Stainless steel
Thread plate Load plate
Platforms Construction

Load plate with Lifting Device YES NO

Pit Installation YES NO
Pit Frame Painted steel Stainless Steel AISI 304
Drive on Ramp YES NO
Painted steel Stainless Steel AISI 304
Ranges Electro-polished AISI 316 Ti Stainless steel
Thread plated
Roller conveyor YES NO
Painted steel Stainless Steel AISI 304
Roller-ball load plate YES NO
Weighing System

Weighing Technology Monolithic weighing system

Electromagnetic Force compensation
Strain Gauge
Appendix

25

Environmental Conditions

Ingress Protection IP 54 IP 65
IP 67 IP 68
Overload protection kg Minimum 150% of Maximum weighing Capacity
o o
Temperature Range From C to C
Calibration System

Span Adjustment by External weights

Built-in motorized Internal weights
isoCAL / isoTEST Fully Automatic Calibration and Adjustment

Documentation
Operational Manual YES NO
Manufacturer Certificate YES NO
Material Mill Certificate YES NO
Dimensional Drawing YES NO
Qualification Manual YES NO
Quality Documentation YES NO

Qualified Scales / Balances

Model Number
Model Number
Model Number

Accessories Connected
Model Number
Model Number
Model Number
Appendix

26

Remarks

Approval of Design Qualification

Prepared by Date

Qualified, reviewed and released by Date

Appendix

27

OPERATIONAL QUALIFICATION
These qualification tests must be performed periodically. The periodicity may be recorded on the
data sheets in the maintenance and repair log. These test must also be performed whenever the
balance is moved from the original setup location.
Level the Balance
With the balance set up in the permanent location, adjust the
leveling feet on the balance until the air bubble is centered
within the circle of the level indicator. The position of this
indicator must be verified before each start up.

After the appropriate warm up time, verify the operation of the balance and record performance
data where required.
SPECIFICATIONS (Fill in the balance specifications as found in the operation manual)
Capacity: Manual No.
Readability: Page No.
Linearity:
Reproducibility (Standard Deviation):
The following test shall be performed using appropriate calibration weights whose accuracy’s are
traceable to the local or international Authorized Metrology Organization. Record all data in the
spaces provided.
CALIBRATION WEIGHT INFORMATION
Traceability Number(s):
Weight Serial Number:
Date Calibrated:
Re-calibration Date:
Appendix

28

Linearity
! Tare the balance.
! Place 1/4 of the full load on the pan, record the display value.
! Place 1/2 of the full load on the pan, record the display value.
! Place 3/4 of the full load on the pan, record the display value.
! Place the full load on the pan, record the display value.

1/4 load display value: Accept

1/2 load display value: Accept
3/4 load display value: Accept
full load display value: Accept

(Reference log page ) Adjustment needed

(record in log)
Appendix

29

Corner load verification

Place a single calibration weight approximately equal to 1/4 to 1/3 of the total capacity in the center of
the pan (labeled 1) and tare the balance. Move the weight to each of the four corners (labeled 2, 3, 4, 5)
recording each reading. Each reading must be within the corner load tolerances as compared to the center
position (zero). Any deviation beyond the tolerance must be adjusted and entered in the maintenance log.

Position Displayed value Tolerance

1. Acceptable
2. Adjustment needed (Record in Log)
3. (Reference log page )
4. Acceptable after adjustment
5.
6.

Comments:
Appendix

30

Reproducibility verification
Place a single calibration weight less then or equal to the maximum capacity in the center of the
pan. (Example: 160g maximum capacity… Use a 100g weight) Tare the balance. Remove the weight and
place it back on the pan. Record the reading below. Repeat this procedure six (6) times. Calculate
the Standard Deviation of these six readings and record below.
Record readings:

1. 3. 5.
2. 4. 6.
Using a calculator, calculate the standard deviation with the below formula:
n
1
s% "
' $ xi & x
n & 1 i %1
#
2

s = Standard Deviation

xi = Each observation

n
x % $ xi
i %1

n = Number of observations (in this case, 6.)

Calculated standard deviation =

Standard Deviation Tolerance =

Acceptable
Adjustment needed (Record in Log)
(Reference log page )
Acceptable after adjustment
Appendix

31

Span Calibration
Calibrate the balance using traceable weights to the procedure located in the operations manual.
Record this manual number (Located on the cover page) and the page number in the manual that
references the calibration weight, below.

Manual Number: Page Number:

Weight set Single weights
No:
Class
Valid until

Test Weight used:

Display reading after calibration:

Acceptable
Adjustment needed (Record in Log)
Internal External Not Necessary
(Reference log page )
Test Weight used:
Display reading after calibration:
Acceptable after adjustment

FUNCTIONAL TESTS PERFORMED BY:

(Signature of Sartorius Technician)
DATE:

COMMENTS:
Appendix

32

PERFORMANCE QUALIFICATION
This balance is to be checked on a daily basis for performance. This check will consist of placing
two known calibration weights on the balance and recording the readings in the log. These two
weights will be approximately equal to the upper and lower range the balance will be used in.
(For example, if the balance is generally used in the range of 12.10g to 89.01g, a 10g and a 100g
weight shall be used for performance testing)
This daily performance test will ensure the weighing performance of the balance before any work
is done on the unit. If any readings are out of the tolerance, tag the unit as “Out of Service” and
contact your Supervisor. The Sartorius Service Center should be contacted to arrange for a
qualified service technician to rework the balance to factory specifications.
COMPLETING THE LOG SHEET:
CHECKED BY:
The person performing the test is to place his initials under this heading.
DATE:
Enter the date (MM/DD/YY) of the performance test. (Example 01/03/95)
WEIGHT #1:
Fill in the nominal weight for the upper weight range along with the plus or minus tolerance.
WEIGHT #2:
Fill in the nominal weight for the lower weight range along with the plus or minus tolerance.
IN SPEC Y/N:
If the readings are within acceptable tolerances, place a “Y” in the box. If the readings are outside
of the tolerance, place a “N” in the box and contact your supervisor.
Appendix

33

PERFORMANCE QUALIFICATION LOG

CHECKED BY DATE WEIGHT #1 WEIGHT #2 IN SPEC
+/- +/- Y/N
Appendix

34

PERFORMANCE QUALIFICATION LOG

CHECKED BY DATE WEIGHT #1 WEIGHT #2 IN SPEC
+/- +/- Y/N
Appendix

35

MAINTENANCE AND REPAIR LOG

When it becomes necessary to perform periodic maintenance or needed repairs, this log must be
filled in. After performing maintenance or repair, the operational tests must be re-run to assure
compliance to the manufacturers’ specifications. File a copy of the Service Report in the Appendix
of this manual.

Pages must not be removed from this log.

All entries must be permanent and legible.
All data fields are to be filled in, if a field is not applicable place an “N/A” in the field.
Any errors shall be crossed out with a single line and initialed by the Technician.
Before and After readings are required if the balance is able to display a reading. If the
balance in unable to display a reading, place an “N/A” in the appropriate data field(s).
Place a copy of the service report in the appendix of this manual.
Appendix

36

Date of Maintenance or Repair: _________________

Work performed (Include Part Numbers)

Before Repair verify balance specifications (Enter actual readings)

Corner Loads:
1. 2. 3.
4. 5. 6.

Linearity 1/4 1/2 ¾ Full load

Calibration:
Reproducibility (Standard Deviation):

After Repair verify balance specifications (Enter actual readings)

Corner Loads:
1. 2 3
4 5 6

Linearity 1/4 1/2 ¾ Full load

Calibration:
Reproducibility (Standard Deviation):
Comments:

Verify specifications meet the manufacturers specifications (Installation Qualification Manual)

Sartorius Technician Date

Appendix

37

Standard Operating Procedure

Testing a Weighing Instrument Aqccording to the USP
Standard Operating Procedure
WKD-043-01

Testing a Weighing Instrument Aqccording to the USP

1 Purpose
These instructions describe the standard operating procedure for conducting a test to determine
the minimum sample weight of balances and scales used in the pharmaceutical industry according
to the USP. This test is required by FDA auditors.

2 Scope of validity
WKD (Service Centers of Sartorius AG)

3 Terms
USP United States Pharmacopeia
FDA Food and Drug Administration
OAW Organizational Instructions of Sparte Weighing Technology
WKD Sartorius AG Customer Service
KDM Service center personnel
WQM Quality management of Sparte Weighing Technology
Max Maximum capacity of the weighing instrument or partial weighing range
d Scale interval: the difference between two consecutively
displayed
values in the readout
4 Responsibilities

Sartorius AG Customer Service Managers are responsible for creating and maintaining this test, as
well as distributing it within the service organization.

Created 11-24-99 Reviewed 11-25-99 Released 11-26-99 QM element Reference

Ober Bertram Bornemann 10,16,19 organizational
2 Review 09-12-03
nd
Quality record instructions/
Kevin Yiu Yes / No in-house factory
standard
Standard Operating Procedure
WKD-043-1

5 Sequence
1. Fill out the upper portion of the WKD-043-1 record.
2. Determine the standard deviation “s” of the weighing instrument to be tested using the
WKD-037/038 tolerance list.
3. Multiply this value by 3,000. This is the calculated minimum load.
4. Select a weight “G” as the test load; it should be the same or slightly heavier (factor 1…2)
than this minimum load.
5. On the weighing record, enter the nominal value, deviation, uncertainty and class of the
test load “G” according to the calibration certificate.
If you are using more than one weight, the weights must be added.
6. Unload the weighing instrument and zero the display.
7. Place the tare container that, according to the user, should be used with the smallest
sample weight on the weighing pan. Enter the weight displayed in the readout on the
record.
8. Tare the weighing instrument.
9. Place the selected test load on the weighing pan in addition.
10. Write down the weight on the record.
11. Remove the weight from the weighing pan.
12. Repeat steps 8 through 11 nine more times.
13. Use a calculator and the following formula to determine the standard deviation “s” of the
10 weights “xi“ that have been measured:
1 10 2 10
s% "
' $ xi & x
9 i %1
# x % $ xi
i %1
Write this value in the “Evaluation” column on the record
14. Calculate the uncertainty according to the USP, U = 3 x “s” and write down this value on
the record.
15. Calculate the quotient Q % G
1000 * U

16. Result: Q > 1.5 Test passed, but repeat with a smaller test load
Q > 1 and Q < 1.5 Test passed, no need to repeat
Q<1 Test not passed, repeat with a heavier test load
17. Check the box with the correct test result (USP requirements fulfilled: “Yes” / “No”)
18. If necessary, repeat the test beginning at step 5 using a new test load > G
Q
19. Once the test has been completed, fill out the remaining section of the record, which is
self-explanatory.
Standard Operating Procedure
WKD-043-1

6 Information and Remarks

This standard operating procedure was newly created.
6.1 Referenced Documents
WKD-037-2, WKD-038-2
7 Documentation
This standard operating procedure should be retained for a period in accordance
with QM manual 10-016-01.
8 Update Service
The Customer Service Manager is responsible for the update service.
9 Routing
WQM Management
WKD Management
All WKD personnel and Service WT personnel
10 Enclosure
Form WKD-043-1 / 11.99
Standard Operating Procedure
WKD-043-1

Balance Test according to the USP Requirements

Company Dept.
Street City

Model Reason for Test: Installation/ Repir/ Maintainence/

Others
Manufacturer Sartorius Filter setting: very stable/ stable /unstable /very
unstable
Serial No. Ambient Conditions:
Inventory-No. strong draft yes no
Location strong vibrations yes no
Single Range/Multi Range/ Multi Interval Balance Weight Set
Range I II III IV Weight No.
Max = g Valid until:
d= mg

Minimum Sample Weight according to USP (US-Pharmacopeia)

Test Weight Test Weight
1 2
Nom. Value mg Standard Deviation mg Standard Deviation
Deviation mg s = ________ mg mg s = ________ mg
Uncertainty mg Measuring Uncertainty mg Measuring Uncertainty
Class U = 3 s = _______ mg U = 3 s = _______ mg
Tare Weight g U / Test Weight = ________ g U / Test Weight = ________
Weighing Displ. Value ( mg ) Displ. Value ( mg )
1
2
3
4 USP Requirement USP Requirement
5 (• •0.001) is fulfilled for (• •0.001) is fulfilled for
6 Minimum Sample Minimum Sample
7 Weights • •_______ g Weights • •_______ g
8
9
10
Comments: Date: Stamp:
Signature:
Standard Operating Procedure
WKD-043-1

Remarks.

Regarding item 2: The USP is a U.S. measurement regulation that also allows for an estimate of the
uncertainty of measurement, although the method used differs from that of the DKD. The USP
considers only the standard deviation from 10 measurements performed using a small test load. The
minimum sample weight determined should have an uncertainty of approx. 0.1% (factor 1000) within a
confidence interval of approx. 99 % (factor 3).

Although the USP measurement procedure has a few weaknesses (e.g., the rounding factor of the
balance or scale readout is not taken into consideration, the measuring uncertainty is not determined
over the entire weighing range), it is still the standard according to which the minimum sample weight
is defined in the U.S. pharmaceutical industry. Since German pharmaceutical companies export their
products to the U.S., among other countries, they are subject to audit by American inspectors and,
therefore, must provide documentation that they are complying with USP regulations. An important
preference of the user is to work with the smallest sample weights possible. For this purpose, the filter
levels of the weighing instrument used should always be optimized. If optimizing the filter levels does
not improve the situation, a balance with a smaller interval must be used (i.e., a microbalance or an
ultra-microbalance).

Regarding item 3: If a company is subject to the regulations of legal metrology, it must use weighing
instruments verified for use in legal metrology in areas relating to these regulations. If the minimum
sample weight for a balance or scale fulfills the USP requirements (mmin > 3000 s), it also fulfills the
German regulations for use in legal metrology (mmin > 100 d for Class I balances).