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Dictionary of Weighing Terms

Calibration and use of balances in quality systems requires: 1) Regular calibration of measuring equipment according to accepted methods and documentation of methods and procedures. 2) Use of suitable test weights and an internal audit system to ensure balances meet specifications for accuracy, reproducibility, and other quality metrics. 3) Determination of measurement uncertainty based on factors like reproducibility, temperature sensitivity, and calibration weight errors to ensure measurements meet requirements like USP 0.1% maximum uncertainty.

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Armando Saldaña
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132 views

Dictionary of Weighing Terms

Calibration and use of balances in quality systems requires: 1) Regular calibration of measuring equipment according to accepted methods and documentation of methods and procedures. 2) Use of suitable test weights and an internal audit system to ensure balances meet specifications for accuracy, reproducibility, and other quality metrics. 3) Determination of measurement uncertainty based on factors like reproducibility, temperature sensitivity, and calibration weight errors to ensure measurements meet requirements like USP 0.1% maximum uncertainty.

Uploaded by

Armando Saldaña
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPT, PDF, TXT or read online on Scribd
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Calibration and use of Balances in a Quality System

Calibration and Daily use of


Balances

• Choosing the right balance


• Uncertainty of measurement
• Setting appropriate pass fail criteria
• Summary and Open Question Session
Good Laboratory Practice (GLP)
Requires:

• Qualified and competent


personnel
• Defined appropriate equipment
and conditions
• Testing facility designed to
minimise problems
• Record management/Archive
Good Laboratory Practice (GLP)
Requires:
• Suitable Test and Reference Standards and
Internal Audit System
• Documented Methods or SOP’s
• Regular Calibration of Measuring
Equipment According to Accepted Methods
For GLP Balances have printouts to
identify:

• Model & Manufacturer


• Serial number
• Software version
number
• All adjustment routines
For GLP Premium Balances have:

• Internal Adjustment
Weights & isoCAL
• Real Time Clock
• Alpha Numeric Data
Input
• Bar Code Scanner
Connectivity for sample
ID’s
Typical GLP/GMP Compliant
Printout
10.04.2005 11.45.23
Sartorius AG
Model ME235S
Ser. no. 60419914
Ver. no. 01-30-01
ID QC Lab 22
SQmin 45mg
-----------------------------------------------
Internal Calibration
Start: isoCAL/temp
Diff. + 0.00007g
Internal adjustment completed
Diff. + 0.00000g

-----------------------------------------------
10.04.2005 11.46.23
Name:
Calibration and Daily use of
Balances
• Terminology - How to understand
specifications
• Weight Units
• Basic Principle of an Electronic Balance
• Care in the use of balances
• Hazards to avoid
Understanding The Technical data:
Readabilit
y

• The smallest difference that


can be measured.
• Resolution or
Discrimination
Weighing Capacity

• The maximum weight


that can be applied
before overloading
occurs
Reproducibility of a
Balance

± 0.01g

x= average weight
s= standard deviation

68.3% of the weights measured lie within the range x  s


95.5% of the weights measured lie within the range x  2s
99.7% of the weights measured lie within the range x  3s
Reproducibility of a
Balance

± 0.03g

x= average weight
s= standard deviation

68.3% of the weights measured lie within the range x  s


95.5% of the weights measured lie within the range x  2s
99.7% of the weights measured lie within the range x  3s
Linearity
Deviation from a Theoretical Strait
Line
Weight
readout
1 kg

(500+)
g
0.01g

500 g 1 kg Weight loaded


Sensitivity Drift – with 4 place
balance
• ± 1x10-6 per degree Celsius or:
• ± 1 part per million per degrees Celsius

200.0000g/1,000,000
= 0.0002g
Sensitivity Drift –with 5 place
balances
• ± 1x10-6 per degree Celsius or:
• ± 1 part per million per degrees
Celsius

200.00000g/1,000,00
0
= 0.00020g
Sensitivity Drift

• Normal use of 5 decimal place balance is to


weigh small amounts into containers

10.00000g/1,000,000
= 0.00001g
Response Time

• How long it takes the


balance to become
stable
Terminology

Was this you?


• Accuracy
• Readability
• Sensitivity
• linearity Error
• Repeatability
• Uncertainty
Accuracy

• Is the extent to which the


readout approaches the true
value of the object.
• Can not be specified
• Can be determined
Errors - out of level weighing

• Balance table 1m x 1m
• Raise one side 5mm
• Before 200.00000g
• After 199.99850g
• Difference 0.00150g
Errors - changes in regional gravity

• Ground Floor 200.00000g


• First Floor 199.99974g
• Difference 0.00026g
Good Weighing Practice

• Keep Balance Clean


• Site Balance on Firm Surface
• Level the balance
• Free from Drafts
• Not in Direct Sunlight
• Not near a Radiator
Good Weighing Practice
Hazards to Accuracy

• Electro Static Influences from


• Plastic Containers
• Oven Dried Glassware
• Some Samples
• Magnetic/ Electromagnetic Effects
• Stirring Bar!
• Steel Containers
Calibration and Daily use of
Balances
• Calibration weights
• Design
• Class of weights
• How to Adjust a Balance
• Internal v External Weights
• Daily Calibration Checks
Weight Units
Unit Unit Relation to
Symbol Base Unit
Nanogram ng ÷ µg 1000
Microgram µg ÷ mg 1000
Milligram mg ÷ g 1000
Gram g ÷ 1000
Kilogram kg Base Unit
Ton t x 1000
Calibration Weights and OIML

• Organisation International
de Metrology Legale

• Specifies
Design, Material, Surface
Quality, Tolerances,
Markings, & Manufacture
• RI 111
Classes of Calibration Weights

• E1 Solid Stainless Steel


No markings. 1kg +/- 0.5mg
• E2 Solid stainless Steel
No markings 1kg +/- 1.5mg
• F1 Stainless Steel with
adjustment cavity 1kg +/-
5.0mg
Handling and care of weights

• Weight Calibration Laboratories store


weights under a Glass Dome
• E2 and F1 store in Boxes supplied
• Suitable lining material
• Free from fibres
Handling and care of weights

• Use lifting devices


• Plastic forks
• Tipped forceps – keep clean!
• Cotton or chamois gloves
Handling and care of weights

• Remove dust with camel hair brush


• Never touch weights
• Fingerprints are acidic and greasy
• Clean weights with cotton or chamois
• Alcohol or steam cleaning removes
absorption layer
Calibration of Laboratory Balances
Calibration test with 10g weight
Hardware Validation or IQ/OQ

• Equipment Qualification
EQ
• What is it?
• Why?
• Description!!
Installation Qualification or IQ

• Completeness Check
• Record Serial #
• Software Version
• Location
• Accessories
• Appropriate Safety
Standards
Operational Qualification or
IQ

• Testing against
Specification
• Subject to Environmental
conditions
• Testing Functionality of
Balance
• Essentially a Full
Calibration
Performance Qualification PQ

• Performed by the Operator


• Daily or Weekly
• User Defined
• One or Two Calibration
Weights
• Outlined in the SOP
USP Measurement to 0.1% max Uncertainty

• United States Pharmacopoeia


- section 41
• Implemented by the FDA
Food and Drugs
Administration
USP Measurement to 0.1% max Uncertainty

• Pharmaceutical Laboratories
• All measurements to be
made with intended
accuracy
• 0.1% maximum uncertainty
What is Uncertainty?

• Sum of systematic and random errors

• Systematic errors:- from the balance

• Random Errors:- from operators, and the


environment,
Random Errors

• Operators
• Off Centre Loading
• Occasional Poor conditions
• Occasional Drafts
• Occasional Vibration
Systematic Errors

• Inherent performance flaws


• Errors in Calibration
• Temperature change
What is Uncertainty?

• Measured mass 20.0000g


• Determined Uncertainty 0.0003g

• Result is likely to lie between


19.9997 and 20.0003g
Measurement to 0.1% max Uncertainty
USP

• According to USP - section 41


• Maximum of 0.1% uncertainty in any
weighing
Measurement to 0.1% max
Uncertainty

• For USP Uncertainty is accepted as equal to


3 times the determined SD -in the place of
use
Measurements to 0.1% max Uncertainty

• To determine if balance is acceptable for


300mg
• Standard deviation = 0.1mg
• Uncertainty = 0.1 x 3
• Uncertainty = 0.3mg
Measurements to 0.1% max
Uncertainty

• So we would like to know if


• 0.3 mg ≤ 0.1% of 300mg
Measurements to 0.1% max Uncertainty

USP statement:
SD x 3 /sample weight ≤ 0.001
0.3/300 = 0.001
Measurements to 0.1% max Uncertainty

• Even easier
• Minimum weight is calculated:

• Measured SD x 3 x 1000
• 0.1mg x 3 x 1000
• 300mg
Typical Theoretical minimum
weights
Readability Typical Minimum
weight
• 1mg balance 3000mg
• 0.1mg balance 300mg
• 0.01mg balance 45mg
• 1µg balance 3mg
Determination of Uncertainty with 10g mass

• Reproducibility ≤ 0.07mg
• Temp drift 5C
• 10g x 1 x 10-6 x 5C = ≤ 0.05mg
• Max linearity = ≤ ± 0.15mg
• E2 calibration error = ≤ ± 0.015mg
• (200g max 0.3mg)
Determination of Uncertainty with 10g
mass
According to the Law of
Propagating errors

Sartorius
Sartorius
mg
change corrected

U = 0.21mg
Determination of Uncertainty with10g
sample

• We can now say:


• 10.0000g ± 0.21mg uncertainty with 95%
confidence
Finally: Setting pass fail limits

• You can determine what is possible


from your balance
• You have a measured value and
uncertainty for your calibration weight
• Set limits in accordance with tolerable
error in your assays
Verified Balances according to
90/384/EEC

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