Accuracy and Pharmacutical

Solution Weighing
Team

Contents

ƒ Weighing Errors

ƒ Weighing Technology

ƒ Accurate scale with Pharmaceutical

Why is accuracy / precision important ?

ƒ Knowing the error of your results helps

- To avoid Under/Overfilling
- Ensure product and human safety
ƒ Weighing within defined tolerances all the time
- Ensures certain quality standards
- Ensures stable production process
- Ensures reproducible production
ƒ Use Qualified Equipment (DQ, IQ, OQ, PQ)
- Traceability, Required for GMP

Be sure of the quality of your measurement !

What is Resolution

ƒ The weighing range divided by the display readability gives the scale
resolution.
ƒ A quality scale has a high resolution and is very accurate at the same time.
ƒ The resolution of a quality scale is certified
by Weights & Measures institutes (e.g. PTB).
ƒ A certified resolution is also called “approved
resolution” and can be used for legal for trade.
ƒ A high readability automatically results is a high
resolution but does not automatically result in
high accuracy.
ƒ This relationship can be affected by different scale technologies.

Resolution = Capacity = 150 kg = 15,000d

Readability 0.01 kg(d)

What does resolution mean to you ?

ƒ You need to consider the resolution of a scale when you are worried about:
- Weighing errors
- Legal for trade applications
8Resolution need to be approved by Weights & Measure
8Ensures that result has certain accuracy
- Stability of displayed weighing result
- Ambient conditions
8Wind
8Temperature
8Vibrations
ƒ How can you technically influence the resolution ?
8Scale technology (Stain Gauge / Electromagnetic force compensation)
8Indicator

High resolution does not always mean high accuracy

Approved Resolution

ƒ Notified bodies certify scale accuracy related to scale class

- Certified resolution is indicated with “e” (difference between two display steps
“d” following each other
ƒ Certified or approved scales can only display the „e“ value
ƒ For legal for trade applications, scales have to be certified in the EU and US.
- EU / OIML
- US / NTEP

7,583kg
Class II e d
Benefits of Approved Resolution

ƒ Approved resolution “e” certifies scale accuracy

- Confirmed by Weights & Measures Institutes (Notified body)
- Approved or certified resolution “e” is the true value
- Displayed resolution “d” can be anything and does not inform about scale
performance
ƒ Different scale classes indicate scale performance
- Typical classes use for industrial weighing applications
8Class II => High precision
8Class III => Medium precision

Cap.3 kg
Class II 10,000e and 100,000d
Readability=3,000g/(10,000e-100,000d) = 0.5g - 0.05g

Display value “d” is just a dummy value

Typical Certifiable Resolution of Scales

ƒ Class II scales can have different certifiable resolution ranges

- From 5000e up to 60000e (Single range, delta range, e=10d)
- Typically within a temperature range of 0-40°C

ƒ Class III scales can have different certifiable resolution ranges

- Standard: 1x3000e (e.g. 30 kg scale => 0-30kg / 10g, e=d)
- 2x3000e Multi-Range (e.g. 30kg scale => 0-15kg / 5g, 15-30kg / 10g )
- 2x3000e Multi-Interval (e.g. 30kg scale => 0-15kg / 5g, 15-30kg / 10g )
- 3x3000e Multi-Range/Multi-Interval)
- 1x7500e (e.g. 30kg scale => 0-30kg / 5g, e=d)
- Typically within a temperature range of -10 to 40°C

Precision scales ensure high resolution within large

temperaure range

Typical Errors according OIML

MPE Chart

OIML states maximum allowed error

 What is precision?

ƒ The degree of agreement between repeated measurements of the same quantity. The
numeric value of precision is normally expressed as the result of the calculation of the
standard deviation.
ƒ Precision can also be expressed as repeatability (reproducibility).
ƒ Precision depends only on the size of the differences observed while repeatedly
weighing the same object and it is not concerned with freedom from error of the final
result.

What does precision mean to you ?

ƒ You need to consider the precision of a scale when you are worried about:
- Reproducible and stable production
- Ensure similar batch quality
- Major influence of weighing tolerances of low quantities on big scales
- Same weighing result regardless on what area of the scale the product is placed
8Reducing operating errors
- How can you technically influence precision ?
8Scale technology (Stain Gauge / Electromagnetic force compensation)
8Direct force weighing technology / Lever weighing system

High precision does not always mean high accuracy

What is corner load error?

ƒ Cornerload refers to the ability of an instrument to deliver the same weight

reading for a given object anywhere on the weighing pan.
ƒ Scale technology has a major influence to corner load errors.
ƒ Scales with mechanical lever system have much lower corner load erros.

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What is Linearity Error?

ƒ Linearity refers to the quality of delivering identical sensitivity throughout the

weighing capacity of a balance or scale. Test this characteristic by weighing
two stable objects separately, each of approximately one half the weighing
capacity. The sum of the two readings should equal the reading obtained
when both objects are weighed together.

What is Hysteresis error?

ƒ Property of load cells, and other weighing systems dependant on elastic materials, such
as spring balances, resulting in a different indication at the same load, depending upon
the direction of approach to that load, i.e. whether it is approached by increasing the
load or decreasing the load.

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What is Accuracy?

ƒ The degree of agreement between the result of a measurement and the true
value of the quantity measured.
ƒ The sum of all individual scale errors are relevant for the accuracy of a scale
and therefore also for its weighing certainty.
ƒ Corresponding to the international guidelines of the EC and the OIML, there
are different classes of scale in order of increasing accuracy defined in the EC
directive 90/384:

- Class I Special (e.g. high precision balance)

- Class II High (e.g. high precision industrial scale)
- Class III Medium (commercial scale)
- Class IIII Ordinary (e.g. high capacity scale)
What does accuracy mean for you ?

ƒ You need to consider the accuracy of a scale when you are worried about:
- Over/Underfill of product
- Product safety
- Minimizing operating errors
- Weighing Speed
- Weighing of light and heavy products on same scale
- Changing ambient temperatures
- Quality of your weighing in general

Accuracy is defined by scale and sensor technology

Contents

ƒ Weighing Errors

ƒ Weighing Technology

ƒ Accurate scale with Pharmaceutical

Sensor Technology

ƒ Strain Gauge technology

- A metallic or semiconductor material of small cross sectional area that is bonded to
a surface and elongates or contracts with that surface. This deformation results in a
change in its electrical resistance, providing means for subsequent measurement.
- Used for most electronical scales (e.g. bathroom-, kitchen, supermarket- and
industrial scales)

Cheap technology for mass production

Strain Gauge Benefits

ƒ Economical sensor with acceptable accuracy

- Typically 3000e-7500e resolution
ƒ Large range of capacities form gram to several tons
ƒ Rugged and robust
ƒ Flexible use for many different scale types
ƒ Easy to service
ƒ Due to analog interface universal connection to terminals

Cheap technology for mass production

Sensor Technology

ƒ Electromagnetic Force Compensation (Monobloc)

- The principle of EMFC is based on the electrodynamicconversion principle. The
Monobloc consits of a high-strength aluminium alloy. A complex pattern is eroded
out of the compact block.

ƒ Weigh scale sensors based on the EMFR

principle are typically 10–1000 times more
accurate than strain-gauge-based industrial
load cells and other devices based on the
measurement of deformation.

High quality technology for high precision weighing

Monobloc Benefits

ƒ High precision sensor with high accuracy

- Up to 60000e approved resolution
ƒ Internal calibration
- Ensures scale performance
- Required for GMP
ƒ Digital communication
- Easy maintenance due to plug & play scale-terminal connection
- Weight is generated in weighing cell
8Less electical noise disturbance during data transmission

Excellent technology for high precision weighing

Scale Technology

ƒ In addition to the weighing sensor, the scale construction has a major

influence to the scale accuracy.
- Precision / Repeatability
- Linearity
- Corner Load errors
- Stabilization time
- Hysteresis
ƒ Depending on the application various scale constuctions can be used.
- Single point direct force construction (e.g. bench scales)
- 4-point direct force construction (e.g. large industrial floor scales)
- Single point lever force construction (high precision scales)

Mettler Toledo uses all construction types

Scale Technology – Single Point

ƒ Single point direct force construction

- Used with bench scales up to 600kg
- Standard accuracy type scales (Strain Gauge)
- High precision scales (Monobloc)
- 1 loadcell per scale
- Capacity of loadcell is more or less similar to scale capacity

Strain Gauge Loadcell

Monobloc Loadcell

Mettler Toledo uses all construction types

Benefits Single Point Scales

ƒ Main application: bench and portable

ƒ Large variation of different scales
- Sizes
- Capacities (typically 3-600kg)
- Material (painted, galvanised, stainless steel) PBA330
- Different resolutions / Accuracy
- From IP44 to IP69k BBA449-A15
- Hygienic designs
ƒ Simple design ensures easy service
ƒ Used in all type of industries
ƒ Analog and digital versions
BBA425
PBA430-B60

Most frequently used scales for bench applications

Scale Technology – 4 Point

ƒ 4 point direct force construction

- Used with floor scales
- Standard accuracy type scales (Strain Gauge)
- Sum of all loadcell capacities is higher than scale
capacity (preload possible)
- Typically 4 loadcell per scale

Mettler Toledo uses all construction types

Benefits 4 point scales

ƒ Main application: Floor scales

ƒ Large variation of different scales
- Sizes
- Capacities (typically from 150-6000kg)
- Material (painted, galvanised, stainless steel) PUA579
- Different resolutions / Accuracy
- From IP65 to IP68 DNE…sk with
- Hygienic designs raisable stainless
steel load plate
ƒ Simple design ensures easy service
ƒ Used in all type of industries
PTA455
ƒ Analog and digital versions

PFA574

Most frequently used for floor scale applications

Scale Technology – Lever System

ƒ Single point lever construction

- Used with bench and floor scales
- High precision accuracy (Digital strain gauge + Monobloc)
- Capacity of scale depends on lever system
- 1 loadcell per scale
- 2 loadcell capacities (15 and 32kg) for complete weighing
range from 15 kg – 3 tons

1.5 ton scale

15 kg loadcell
Levers

Perfect technology for high precision applications

Benefits Lever Based Scales

ƒ Main application: Bench, portable and floor

ƒ Large variation of different scales
- Sizes KCC / MCC 150 /
- Capacities (from 15-6000 kg) 300s
- Material (painted, galvanised, stainless steel)
- High readability (up to 3.2 Mio points)
- Excellent precision and accuracy
- High IP ratings
- GMP
KA / MA15s
ƒ Digital version
- Plug & Play installation (terminal/scale)
- Change of scale / terminal without recalibration
ƒ Used in all type of industries KE/ME 3000 with
raisable loadplate

Excellent scales where accuracy is important

Comparision – Bench Scales

Mobobloc technology is > 10 times more accurate

Comparision – Floor Scales

Mobobloc technology is > 10 times more accurate

 Contents

ƒ Weighing Errors

ƒ Weighing Technology

ƒ Accurate scale with Pharmaceutical

Accuracy scale to Pharma process

1. API Synthesis 2. Dispensing 3. Mixing 4. Tableting 5. Packaging

Courtesy Roche

Dispensing: Where exact amounts count

1. API Synthesis 2. Dispensing 3. Mixing 4. Tableting 5. Packaging

Raw material
identification

Raw material
weighing

ƒ High Resolution digital scales

ƒ Precision balances XP Line
ƒ Analog scales
ƒ Weighing indicators IND449,
IND690, ID30
ƒ Formulation solutions

Courtesy Roche
 Weighing in the dispensing room
Portable scale Weighing
FormWeigh.Net indicator
application either with
indicator or IND690/690xx
running on ID30
with connection hooked-up to
of any three the IND690/
weighing 690xx or ID30
systems

Floor scale
hooked-up to
the IND690/ Bench scale
690xx or ID30 hooked-up to
the IND690/
690xx or ID30

Weighing in the dispensing room

Wireless data exchange over Wired data exchange over CL,
Bluetooth™ or WLAN RS232, Profibus® DP or Ethernet

Printer
IND690

Barcode
scanner for
product
identification

Product
identification
with RFID
Weighing station #1 Weighing station #2 Weighing station #3 technology

High resolution portable High resolution bench Easy to clean floor scale
scale KA 15kg/0.1g scale KCC 150kg/1g PUA579 600kg/100g

Mixing and granulation

1. API Synthesis 2. Dispensing 3. Mixing 4. Tableting 5. Packaging

Granulates /
Pellets making

Sieving and
Drying
Mixing of API
with excipients

ƒ Formulation solutions
ƒ Weigh modules for reactors,
tanks, mobile vessels

Courtesy Roche
 For accurate weighing and material transfer

ƒ Converters and
indicators IND560
IND130
- IND130
- IND560
ƒ Platforms
- Full range of K-line high resolution platforms KES1500

- Full range of analog platforms

ƒ Weigh modules
- Ultramount
- Ringmount
- Flexmount
Flexmount

Ultramount
Ringmount

Packaging solutions

1. API Synthesis 2. Dispensing 3. Mixing 4. Tableting 5. Packaging

Packaging,
bottling
Final product
inspection

ƒ Checkweigers
ƒ Metal metectors
and X-ray systems

Courtesy Roche

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