minimum weight, sqmin
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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 œ, 99.7% of the values measured lie within these limits around the mean. (Pertch,T.- GIT Lab Journal Volume 7, 2003 pp 90-92)
 
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

CPA2P

0.001 mg

0.001 mg

0.003 mg

3 mg

MC21S

0.001 mg

0.002 mg

0.006 mg

6 mg

CPA2P-F

0.001 mg

0.002 mg

0.006 mg

6 mg

ME235P

0.01 mg

0.015 mg

0.045 mg

45 mg

CPA225D

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

CPA423S

0.001 g

0.001 g

0.003 g

3 g

CPA4202S

0.01 g

0.01 g

0.03 g

30 g

CPA8201

0.1 g

0.1 g

0.3 g

300 g

LA2200

0.1 g

0.05 g

0.15 g

150 g

CPA34000

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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