The document discusses the qualification of analytical equipment like electronic balances and pH meters. It explains that qualification includes design, installation, operational and performance qualification to ensure equipment is properly installed and functioning accurately. Specific steps for qualifying balances, such as daily calibration checks with internal weights and yearly checks with external weights, are provided. The two-point calibration method for pH meters using buffer solutions is also described. Acceptance limits and record keeping procedures are outlined to ensure equipment remains calibrated over time.

1. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1
QUALIFICATION OF WEIGHTS
AND MEASURES
A Seminar as a part of curricular requirement
for I year M. Pharmacy II semester
Presented by
P. PAVAN KALYAN
(Reg. No.20L81S0705)
Department of Pharmaceutical Analysis

2. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2
• Introduction to Qualification
• Electronic Balance
• Qualification of Electronic Balance
• pH meter
• Qualification of pH meter
• References
contents

3. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3
• Qualification is a part of validation. It is action of proving and documenting the
equipment, which are properly installed.
• Qualification is of 4 types:
1. Design Qualification
2. Installation Qualification
3. Operational Qualification
4. Performance Qualification
INTRODUCTION TO QUALIFICATION

4. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4
ELECTRONIC BALANCE

5. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5
 Many types of balances are used in chemical and biological tests.
These balances must be calibrated to ensure the accuracy of the data
produced by it.
Different types of balances used are as follows :-

6. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Requirements of the balance :-
It should work under optimal conditions like weighing room, weighing
bench, temperature, light, air etc.
S.NO REQUIREMENTS ACCEPTANCE
1) Weighing bench Should be non-magnetic vibration
proof& dust free
2) Temperature Constant temperature should be
maintained.
Deviations should not exceed 5°c
3) Atmospheric humidity Should be between 40% to 60%
4) Light Should be protected from directsunlight
5) Weighing vessel
Smallest possible weighing vessel
used. Weighing vessel and sample
it contains should have same
temperature. 13

7. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7
Design Qualification :-
Selection of a manufacturer that can satisfy the needs of the laboratory
Installation Qualification :-
Checking of all requirements set during the selection of instrument such as
electricity, humidity, temperature, etc.
Allowing sufficient shelf space for the equipment, SOPs, operating manuals, etc.
Comparing equipment, as received, with purchase order, including accessories,
spare parts, etc.
QUALIFICATION OF ELECTRONIC
BALANCE

8. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8
Checking documentation for completeness like operating manuals,
maintenance instructions, health and safety instructions, etc.
Checking equipment for any damage.
Reading the supplier’s safety instructions, if there are any.
Installing hardware following the manufacturer’s recommendation.
Switching on the electronic balance and ensuring that all the modules power up.
Preparing an installation report.

9. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
T
est procedure Acceptance
limits
T
est frequency Remarks
• Measurement of reference
weight by using 10mg,
50mg, 100mg, 500mg, 1g,
5g, 10g and 20g.
• Comparing the actual
results with reference
weights.
0.1% • Daily or when used,
whatever is longer
with internal reference
weights.
• Yearly with traceable
external weights
through instrument
vendor.
External
standard
should
be
traceable
to
national
standard.
Operational Qualification:-

10. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10
Defining weights and weight classes to be used.
Defining acceptance limits of results.
Defining test intervals.
Defining corrective actions on what to do if the electronic balance does not meet the
criteria, in other words if the results are out of specification.
Performance Qualification:-

11. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11
Calibration of Electronic Balance

12. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12
pH METER

13. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Two Point Calibration Method:-
This is the method in which pH meter is calibrated with 2 different buffers of
known pH and then checking the pH meter against pH 7.0 standard buffer to
confirm the calibration.
Again place the tip of the electrode in the second calibration buffer i.e .
either in pH 4.0 or 9.2 and repeat the procedure.

14. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
PROCEDURE:-
Check the level of the 3M KCL electrode filling solution (electrical
conductor between reference & sample) to ensure that it is within 25mm of the
filling hole (small circular hole on the side of the electrode).
Then rinse the probe with de-ionized water & blot dry with wipes & then
place the tip of the electrode into the pH 7.0 buffer solution and pH 4.0
buffer or pH 9.2 buffer.
The pH meter will automatically read the endpoint when the reading is
stable & appropriate buffer symbol will appear on the display and record the
pH value.

15. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 15
Design Qualification:-
Selection of a manufacturer that can satisfy the needs of the laboratory
Installation Qualification :-
Checking of all requirements set during the selection of instrument such as
electricity, humidity, temperature, etc.
Allowing sufficient shelf space for the equipment, SOPs, operating manuals,
etc.
Comparing equipment, as received, with purchase order, including accessories,
spare parts, etc.
QUALIFICATION OF pH METER

16. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16
Checking documentation for completeness like operating manuals,
maintenance instructions, health and safety instructions, etc.
Checking equipment for any damage.
Reading the supplier’s safety instructions, if there are any.
Installing hardware following the manufacturer’s recommendation.
Switching on the pH meter and ensuring that all the modules power up.
Preparing an installation report.

17. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Test
procedure
Acceptance
limits
Test
frequency
Remarks
• Calibration with
buffer solution
at pH 7 and pH 4.
• V
erification with
buffer solution at
pH 5 or pH 6.
<0.005 pH
units
Before
each use
• Buffer solutions are commercially
available in either tablet or
solution form.
• Some pH meters also have a
temperature sensor, which should
be calibrated every six months.
• The electrodes should be
washed between each
measurement and the buffers
should be visually checked for
cleanliness and absence of
microbial growth before each use.
Operational Qualification:-

18. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Performance Qualification:-
.
Parameter to be
checked
Typical frequency Typical tolerance limit
Slope Each day of use or before each
series of measurements
95.0 to 105.0%
Offset (pH asymmetry) +/-30mV (offset of
manufacturer
+/-
0.5 pH units
at defined
temperature)
Reference buffer
solution
+/-0.05 pH units
A log book is prepared for operators and service technicians to record
all equipment related activities in chronological order.

19. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Date & Time
(DD-MM-YY
&
am or pm)
Observed pH
4.01
Buffer
(±0.05)
7.00Buffe
r
(±0.05)
9.2Buffer
(±0.05)
Room
temp
(°C)
Cal. Status
(Pass/Fail)
Calibrated by
(Name &Sign)
Checked By
(Name
&Sign)
Daily pH meterCalibration

20. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 20
Precautions :-
Do not allow the filled solution to run dry and add filled solution when ever the
level falls 25mm below.
Do not leave the electrode in organic solvents as the tip and body may be damaged.
Discard used buffer solutions daily. Do not reuse it.
Interference :-
The electrode can be stored for up to one week in pH 7.0 or 4.0 not in distilled
water.
For longer storage periods remove the wetting cap and fill it with 3M KCL solution
and push it onto the tip of the electrode.

21. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 21
• Qualification of Equipment Calibration/Qualification of pH Meters PA/PH/OMCL
(13) 86 DEF.
• Qualification of balances to the OMCL network Guidelines “Qualification of
Equipments” PA/PH/OMCL (12) 77 R11.
• P. Bedson, M. Sargent: The development and application of guidance
on equipment qualification of analytical instruments. Accred. Qual.
Assurance (1996) 1, 265–274
Reference:

22. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 22