NEW
USB interface
Entire Sartorius Line
Cross
reference an
old model with new
Micro (1-0.1µg)
SE/ME Series
LE26P Balance
CP2P Series
Analytical (0.1-0.01mg)
Genius
- Pro
LE - isoCAL
LA - Pro
CP - Standard
ED - Extend
GC - Gem
TE - Economy
Milligram (0.001g)
LE - isoCAL
LA - Pro
CP - Standard
ED - Extend
GW
- Gem
GC - Gem
Precision (0.01-0.1g)
LE - isoCAL
LA - Pro
CP - Standard
ED - Extend
GW
- Gem
GP - Gem
Legal for Trade
Diamond
Scale
Pharmacy
Scale
Portable (0.1-0.001g)
TE Series
GE -
Gem
ELT Series
High Cap (16kg-64kg)
LE - isoCAL
LA - Pro
CP - Standard
Moisture Analyzers
MA
Professional
MA
- Standard
MA - Economy
Explosion-proof
FC-Ex Series
Bench Scales
EA/EB
Scales
Filter Balances
SE2F 2g x 0.1ug
ME5-F 5g x 1ug
CP2P-F 2g x 5ug
LA130S-F x 0.1mg
Industrial Scales
QC Washdown
Floor Scales
Mass Comparators
21g 0.001mg
10kg x 0.01mg
303kg x 1g
3,000kg x 10g
Used / Demo Units
Micro Balances
Analyticals
Accessories
Cal Weights
Mass
Sets
Certified Weights
Specific Gravity
Printer
Static Eliminator
Winwedge Software
Weigh Dishes
Weigh Boats
Beakers
Titration Cups
Moisture Pans
Glassine Paper
AL Dishes
Weighing Canoes
Manufacturers
Acculab
AdamLab
Cas
Chatillon
Dillon
Health-o-Meter
Mettler Toledo
My-weigh
Ohaus
Other Brands
Salter Brecknell
Sartorius
Scientech
SECA
Medical
Siltec
Tanita
Toyo
Used
VMC
Weigh South
|
 |
Pharmaceutical laboratories compliant with the
USP (United States Pharmacopoeia) it's the "Measurement
Uncertainty" or minimum sample quantity is very important
during an FDA audit. This is the USP guideline which determines
the minimum sample weight you can weigh on a particular balance.
Measurement uncertainty is defined by the USP (section <41>
Weights and Balances) as three times the standard deviation
divided by the amount weighed. This should not exceed
0.001 (0.1%). This should be determined experimentally
using the appropriate class weights as defined in the USP and
performing at least 10 replicates of that weight.
The standard deviation is used to evaluate a balance with regard
to its reproducibility. For a confidence interval of ±
3 , 99.7% of the values measured lie within these limits
around the mean. (Pertch,T.- GIT Lab Journal Volume 7, 2003
pp 90-92) |
|
|
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Calculating
minimum sample weight that you can weigh on balance
|
| |
| 1.
Take 10 weightings on balance with the appropriate class weight
as defined by USP. There is an entirely separate paragraph
within the USP that clearly defines what class of weight is
used with balances of different readabilities. The USP
clearly defines when Class
1, Class 2 and Class 3 weights should be used. |
| |
| 2.
Determine the standard deviation from the 10 readings recorded. |
| |
|
3.
Calculate the min sample weight by using the following formula:
[Standard deviation x 3] x 1000 = minimum sample weight
|
|
The
in house calibration technician would perform the about test
and the minimum sample weight that is calculated would be
enter into the Sartorius
Genius Balance via the keypad. If someone attempted
to weigh something below the "minimum sample weight"
that was calculated the Sartorius Genius
Balance would warn the operator by being prompted via
the display.
The above example for calculating the minimum sample weight
is for reference and should not be considered the present
requirement for pharmaceutical guidelines. Please review
the current specifications called out with the United States
Pharmacopeia (USP) before performing any weighing in a production
applications.
Calibration technicians required to comply USP specifications
should obtain a copy of the current USP 28 NF-23 and read
the sections regarding the use of balances in full.
Regulations can change and this web page should not be consider
the current guidelines. You can review an example of
a calibration procedure
that includes SQmin here.
|
| |
From the technical specifications for Sartorius
balances, we can estimate what the minimum sample quantity
will be for each balance.
( Minimum Sample Weight is based on manufacturer's specified
data.)
|
Model
|
Readability
|
Reproducibility
|
Uncertainty
|
Minimum Sample Weight**
|
|
SE2
|
0.0001 mg
|
0.00025 mg
|
0.00075 mg
|
0.75 mg
|
|
ME5
|
0.001 mg
|
0.001 mg
|
0.003 mg
|
3 mg
|
|
CP2P
|
0.001 mg
|
0.001 mg
|
0.003 mg
|
3 mg
|
|
MC21S
|
0.001 mg
|
0.002 mg
|
0.006 mg
|
6 mg
|
|
CP2P-F
|
0.001 mg
|
0.002 mg
|
0.006 mg
|
6 mg
|
|
ME235P
|
0.01 mg
|
0.015 mg
|
0.045 mg
|
45 mg
|
|
CP225D
|
0.01 mg
|
0.02 mg
|
0.06 mg
|
60 mg
|
|
ME235S
|
0.01 mg
|
0.025 mg
|
0.075 mg
|
75 mg
|
|
ME254S
|
0.1 mg
|
0.07 mg
|
0.021 mg
|
21 mg
|
|
LA230S
|
0.1 mg
|
0.1 mg
|
0.3 mg
|
300 mg
|
|
CP423S
|
0.001 g
|
0.001 g
|
0.003 g
|
3 g
|
|
CP4202S
|
0.01 g
|
0.01 g
|
0.03 g
|
30 g
|
|
CP8201
|
0.1 g
|
0.1 g
|
0.3 g
|
300 g
|
|
LA2200
|
0.1 g
|
0.05 g
|
0.15 g
|
150 g
|
|
LP34000
|
1 g
|
0.5 g
|
1.5 g
|
1500 g
|
| ** These numbers are the minimum
sample weight according to manufacturers specs.
To obtain the true minimum sample weight, this must
be calculated at the location where the balance is being
used. |
|
|
To assist our customers in determining the minimum sample
quantity for their balances, Sartorius has incorporated this
calculation on the Genius
Series and some of the CP and LA
Series of balances. This new feature, called SQmin,
will soon be available on many Sartorius semi-micro, micro
and ultra-micro balances. For more information, contact Sean
Carey ext. 8807 or Rich Stressler ext. 8330 at Sartorius Corporation
(1-631-254-4249).
The USP<41> test and the activation of the SQmin program
on Sartorius balances is performed by Authorized Sartorius
Service Personnel as follows:
- NIST traceable weights of the appropriate weight and class
are used to perform the replicate weightings (at least 10x)
- All weight traceability data and data from the replicate
weighings are entered onto a USP<41> Test Certificate
- Calculations are performed in strict accordance to USP<41>
- SQmin is activated by an Authorized Service person through
the Service Menu
- The experimentally determined value for Sqmin is entered
into the balance
- A signed test certificate for testing according to USP<41>
is provided by the Authorized Service person to accompany
the balance calibration and maintenance documents.
Please note setting SQmin can not be done by end users.
Setting the SQmin is achieve using propriety software connect
through the RS-232 interface of the balance. At this
time Sartorius will NOT release this software to the end user
enabling the end user to set the SQMin feature.
|
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Precision Weighing Balances , All
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