Certificate ID
CH0001-057-210228-EP
Mettler-Toledo GmbH
Im Langacher 44
CH-8606 Greifensee
Tel.: (41) 44 944 22 11
Certificate Ph. Eur. General Chapter 2.1.7
"Balances for Analytical Purposes"
Customer
Company: Omega Pharma Manufacturing
Address: 1900 Polaris Pkwy
City: Columbus Contact: John Doe
Zip/Postal: 43235 Order Number: PO12345
State/Province: OH
Weighing Device
Manufacturer: Mettler Toledo Instrument Type: Weighing Instrument
Model: XPR205DR Asset Number: 1111111111
Serial No.: 1234567890 Terminal Model: N/A
Building: GD Terminal Serial No.: N/A
Floor: 4th floor Terminal Asset No.: N/A
Room: GD610 Alternate Asset No.: EP98493211
Range Max. Capacity Readability (d)
1 81 g 0.00001 g
2 220 g 0.0001 g
Procedure
Reference Document: Ph. Eur. General Chapter 2.1.7
METTLER TOLEDO Work Instruction: Pharmacopeial Certificate WI 10000027820
This certificate contains measurements for the As Found and As Left tests.
The sensitivity of the weighing instrument was adjusted before the As Left tests.
As Found Test Date: 28-FEB-2011 Service Technician:
As Left Test Date: 28-FEB-2021 Klaus Fritsch
Issue Date: 28-FEB-2021
Next Test Date: 28-FEB-2022
Software Version: 5.0 © METTLER TOLEDO
Report Version: 1.0 This is an original document and may not be partially reproduced without the
Form Number: 123 written permission of the issuing calibration laboratory. Page 1 of 3
Certificate ID
CH0001-057-210228-EP
Summary of Results
Repeatability As Found As Left
Test Smallest Net Weight Tare Load Assessment Assessment
RP_SNW_0.05g 0.05 g N/A
Accuracy As Found As Left
Sensitivity
Measurement Results
Repeatability
Repeatability Test RP_SNW_0.05g
Smallest Net Weight: 0.05 g Tare Vessel ID: N/A
Test Load: 10 g Tare Vessel Description: N/A
Tare Load: N/A
As Found As Left
1 10.00002 g 10.00000 g
2 10.00003 g 10.00001 g
3 10.00001 g 9.99998 g
4 10.00001 g 10.00000 g
5 9.99999 g 10.00000 g
6 10.00001 g 10.00001 g
7 10.00001 g 10.00000 g
8 10.00001 g 9.99999 g
9 10.00002 g 9.99999 g
10 9.99999 g 10.00001 g
Mean Value 10.000010 g 9.999999 g
The "d" in the graph represents the
Standard Deviation 0.000012 g 0.000010 g readability of the range/interval in which
Assessment 1) 0.05 % 0.04 % the test was performed.
Requirement 0.10 % 0.10 % The results of this graph are based upon the
Minimum Weight 2) 0.02494 g 0.01989 g absolute values of the differences from the
mean value.
1)The repeatability test is passed if 2 * standard deviation / smallest net weight ≤ 0.10 %. If the calculated standard deviation results in a
value smaller than the rounding error of 0.41*d where d is the readability of the range/interval in which the test was performed, then the
standard deviation is replaced by 0.41*d for the assessment.
2) Minimum weight = 2000 * standard deviation. If the calculated standard deviation results in a value smaller than the rounding error of
0.41*d where d is the readability of the range/interval in which the test was performed, then the standard deviation is replaced by 0.41*d.
In this case, minimum weight = 2000 * 0.41 * d.
All calculations are performed in the software to 16 decimal places, however the printed results are rounded according the following rules:
The standard deviation is rounded mathematically to one digit further than the readability of the range/interval in which the test was
performed. The minimum weight is rounded mathematically to three significant figures. For the repeatability assessment, the printed
result of the formula (2*standard deviation / smallest net weight) or (2 * 0.41*d / smallest net weight, respectively) is rounded
mathematically to the same readability as the repeatability requirement (0.10%), i.e. with two digits after the decimal when presented as a
percentage.
Software Version: 5.0 © METTLER TOLEDO
Report Version: 1.0 This is an original document and may not be partially reproduced without the
Form Number: 123 written permission of the issuing calibration laboratory. Page 2 of 3
Certificate ID
CH0001-057-210228-EP
Accuracy
Sensitivity
As Found As Left
Test Load 200 g 200 g
CMV 200.0001 g 200.0001 g
Indication 199.9996 g 200.0002 g
Deviation 1) - 0.0005 g 0.0001 g
Requirement 0.1000 g 0.1000 g
1)The sensitivity test is passed if the absolute value of the deviation ≤ 0.05 % of the test load value. The requirement for the assessment
of sensitivity is 0.05 %. This ensures adherence to the overall accuracy requirement of 0.10 % because other balance properties might
also limit the accuracy of the instrument.
Reference Weights
All weights used for metrological testing are traceable to national or international standards. The weights were
calibrated and certified by an accredited calibration laboratory.
Weight Set 1: OIML E2
Weight Set No.: WS12345_E2 Date of Issue: 04-JAN-2021
Certificate Number: 34567890 Calibration Due Date: 03-JAN-2023
Remarks
N/A
Software Version: 5.0 © METTLER TOLEDO
Report Version: 1.0 This is an original document and may not be partially reproduced without the
Form Number: 123 written permission of the issuing calibration laboratory. Page 3 of 3
