Translated from Indonesian to English - www.onlinedoctranslator.

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Oven Calibration Guide

(Draft)

1. Introduction
This manual is made as a guide for the harmonization of oven calibration
procedures carried out by calibration laboratories accredited by KAN and
other laboratories that require it.
This guide refers primarily to documents AS 2853 1986: Enclosure-
Temperature-controlled-performance testing and grading, with some
simplifications, and other relevant documents.
Oven calibration is carried out to determine the uniformity of the temperature in the

oven and as a reference to determine the suitability of the oven for certain purposes.

2. Scope
What is meant by an oven is an engineering facility that allows the
realization of selectively determined values of air temperature in a closed
volume within a working range.
This guide applies to the determination of the temperature characteristics of ovens used in

industry. The temperature characteristics in question are determined in a no-load state in a

steady state (steady state).

Determination of this temperature characteristic does not take into account

other parameters such as humidity, air flow and wall emissivity which can be
controlled.
This manual applies to all ovens of all sizes/dimensions, temperature ranges, modes of

operation, construction methods as well as types and purposes.

The working area is the part of the oven whose temperature characteristics will be

determined. For most ovens, the workspace is the entire interior space of the oven.

3. Reference documents

AS 2853 1986: Enclosure-temprrature-controlled-performance testing, NATA,

Australia

Dec 2011 - GZ 1/9 Oven Calibration Guide - Draft

 ASTM International, ASTM E 145 – 94 (2006): Standard Specification for Gravity-

Convection and Forced Ventilation Ovens, PA, US

DKD, Guideline DKD-R 5-7: Calibration of climatic chambers, BraunschweigG-20:
Guidelines for Calibration and Checks of Temperature Controlled Enclosures:
Thailand Laboratory Accreditation Scheme (TLAS)
Abdelaziz, YES, Guidelines for assessment of temperature uniformity and
investigation of the measurements uncertainty within laboratory oven,
Proceedings, XVII IMEKO World Congress, June 2003, Dubrovnik, Croatia
USBR 1020 89, Procedure for Calibrating Oven, Colorado

4. Calibration principle

4.1. Temperature measurements are carried out at certain measuring point locations in the

oven working space for 1 hour or 5 cycles after a stable temperature is reached. The total

variation is calculated from the maximum and minimum temperature values of all

measuring point locations. The total variation is an indicator of the performance of the

calibrated oven.

4.2. The determination of the number of measuring point locations and the number of temperature sensors

used is as described in section 6.1.

4.3.During the calibration process takes place the ambient temperature should not change more than 10

oC. The power supply should not be changed by more than 10% or as
required by the oven manufacturer.
4.4. If the temperature reading and/or recording is done manually, the reading should be taken

so that short-term temperature variations (due to the influence of the temperature control

cycle) can be recorded.

5. Temperature Sensor

5.1. The temperature sensor used must be calibrated within the appropriate range for the

usage range. The selected temperature sensor has an uncertainty of not more than 1/3

(one third) of the maximum allowable total variation.

5.2. The resolution of the temperature sensor indicator used should not be more than 1/10

(tenth) of the maximum allowable total variation.

5.3. The temperature sensor must have a faster response time than the temporal variation

of the oven.

Dec 2011 - GZ 2/9 Oven Calibration Guide - Draft

5.4. All temperature sensors used must have the same response time. For
example by using a thermocouple that comes from the same coil.
5.5. The temperature sensor is placed at the measuring point location without being attached to the

oven wall.

6. Calibration procedure

6.1. Determination of the number of measuring point locations and the number of temperature sensors

used. To calculate the number of measuring point locations and the required number of temperature

sensors, the following steps are taken:

6.1.1. Determination of the nominal calibration temperature and its temperature tolerance, t.

The temperature tolerance value can be obtained in one of the following ways. 6.1.1.1.From the

oven specifications contained in the owner/user manual, or

6.1.1.2. If there is no information from the manual, tolerances can be requested from the customer.

In this case the temperature tolerance is defined as the desired tolerance value, which is not

necessarily achieved, or

6.1.1.3. The temperature tolerance is 1.5x the uncertainty of the temperature sensor used.

6.1.2. Determine the value of the theoretical total variation,Ro, with Equation 1

Ro = 2 t (1)

6.1.3. Calculate the theoretical grading factor,f, with the equation 2

f = (100 Ro ) (100+ D) (2)
where D is the difference between the nominal calibration temperature and room temperature.

6.1.4. Determine the theoretical (Grade) class, G, using the equation 3

G = 8 6.64 log f m (3)
Where fm is the closest theoretical maximum grading factor obtained
from table 1 using the f value obtained from the previous 6.1.3 step.

Dec 2011 - GZ 3/9 Oven Calibration Guide - Draft

 Table 1. Oven class and grading factor
Maximum Maximum permissible overall variation (Rm) °C
Grade
allowed grading
(G) D = 30 D = 100 D = 300 D = 1000
factor (fm)

1 11.3 15 23 45 120
2 8.0 10 16 32 88
3 5.66 7.4 11 23 62
4 4.00 5.2 8.0 16 44
5 2.83 3.7 5.7 11 31
6 2.00 2.6 4.0 8.0 22
7 1.41 1.8 2.8 5.7 16
8 1.00 1.3 2.0 4.0 11
9 0.707 0.92 1.4 2.8 7.8
10 0.500 0.65 1.0 2.0 5.5
11 0.354 0.46 0.71 1.4 3.9
12 0.250 0.33 0.50 1.0 2.8
13 0.177 0.23 0.35 0.71 2.0
14 0.125 0.16 0.25 0.50 1.4

6.1.5. Determine the number of measuring point locations and the required number of

temperature sensors using equation 4.

N = 3+ (3 G0.6 ) V 0.2 (4)

Where
N = number of measuring point

locations G = class or grade

V = volume of the oven working area

Maximum number of measuring point locations, Nmax is 40.

6.2. Placement of temperature sensor

The temperature sensor is placed at the location of the measuring point according to

the sequence in Figure 1 for a rectangular oven and Figure 2 for a cylindrical oven.

Dec 2011 - GZ 4/9 Oven Calibration Guide - Draft

 The temperature sensor is placed at the location of the measuring point without being

attached to the wall of the oven. A tool holder can be used to help place the temperature

sensor by paying attention to the effect of temperature on the tool.

10 17E 15F
6A 3A

19E
8F
4F

13A
20E
9A
1C 12F

11F
14A

18E

2A 5A
16E
7F

Position code:
C = Center
F = Center of face
A = Corner

Figure 1. Location of the temperature sensor placement measuring point for a rectangular oven

Diameter
7 1 12

16* 18* 17* 15* 14*

2 11 20 6 9 13 4 10 5 19 8 3

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 (part)
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

180 315 225 90 0 135 225 90 0 270 45 315 180 270 45 135 0 (level)

* for length/diameter ratio greater than 5

Figure 2. Location of the measuring point for placing the temperature sensor for a cylindrical oven

Dec 2011 - GZ 5/9 Oven Calibration Guide - Draft

6.3. Oven temperature setting

The oven temperature is set according to the nominal calibration temperature by using the buttons

provided on the oven. If there is no temperature indicator in the oven, the temperature setting button

is considered as the temperature indicator value at the same time.

6.4. Data retrieval

The reading is done after 1 hour or 5 cycles from the time the oven reaches
temperature stability. The observed and recorded data are the maximum and
minimum designations. Table 2 shows an example of a table for recording data
and their calculations.

Table 2. Example of measurement data recording table for 9 measuring point locations

Standard value Temperature range

Sets: °C Middle value (oC)
(°C) (oC)

No. TC tmax tmin tmax-tmin (tmax + tmin)

1
2
3
4
5
6
7
8
9
Indicator

Room temperature

6.5. If calibration is carried out for more than one nominal temperature value,
then steps 6.3 to 6.4 are carried out again for the next nominal temperature
value.

Dec 2011 - GZ 6/9 Oven Calibration Guide - Draft

7. Data processing
Data processing is carried out, first, by filling in Columns 4 and 5 of Table 2 with data

on the difference between the maximum and minimum temperatures and the mean

value for each temperature sensor. Next, is calculated to determine other parameters

as follows:

7.1. Oven indicator temperature = Indicator middle value

7.2. Rated oven temperature = [(tmax)max + (tmin)min]

7.3. Temperature Variation:

7.3.1. Spatial variation (based on position in oven) = (Middle Value)max - ( Middle

value)min
7.3.2. Temporal variation (by time) = (tmax – tmin)max
7.3.3. Total variation, Ro, = (tmax)max – (tmin)min

The difference between the indicator temperature (7.1) and the measured oven temperature (7.2) must be less

than Ro.

If necessary, Class (GradeThe actual ) of the oven can be calculated

using equations 2 and 3 in Sections 6.1.3 and 6.1.4.
7.3.4. Room temperature = Middle value Room temperature

7.4. Table 3 can be used to summarize the calculation results with the number of rows depending on the

number of nominal values of the temperature being measured.

Table 3. Summary of calculation results

Settings Temperature Temperature Variation Variation Total Variation

(°C) Indicator Measured Spatial Temporal (°C) (°C)

(°C) (°C) (°C)

Dec 2011 - GZ 7/9 Oven Calibration Guide - Draft

8. Calculation of measurement uncertainty

8.1. The estimation of measurement uncertainty is based on the measurement

model as follows
'
K = t 'Correct tindicator

with:
K= correction that must be given to the oven indicator indication to obtain the

correct value of the temperature in the oven

t'indicator oven indicator designation = center value of indicator t'Correct

Approximate true value of temperature in the oven

t'Correct measured oven temperature = [(Middle Value)max + (Middle Value)min]

8.2. Source of measurement uncertainty

The sources of uncertainty that contribute to the combined standard

uncertainty are as follows.
a. Temperature sensors and indicators used.

The uncertainty values and coverage factors are obtained from the calibration certificate

of the equipment.

U95
ub=
1
k
b. Drift temperature sensor and indicator

The drift uncertainty of the temperature sensor and indicator is obtained from the old value (n

long) and new (nnew) on the calibration certificate assuming the distribution is rectangular.

1 2(nold n )new
ub=
2
3
c. The measured temperature variation consisting of

a. Spatial temperature variation

1 2(var iasi _ spatial)

ub3 =
3
b. Temporal temperature variation

1 2(var iasi _ temporal)

c ub4 =
3
The values of spatial variation and temporal variation were obtained from the calculations in the

previous section (Section 7).

Dec 2011 - GZ 8/9 Oven Calibration Guide - Draft

 d. Oven indicator reading
1 2 NST
ub5 = for digital indicators, or
3

1 2 NST
ub5 = for analog indicators.
6
e. Variation of the indication of the oven temperature indicator

The standard uncertainty of the indicator variation is obtained from the difference between the

largest and smallest values in the instrument readings from each measuring point assuming the

distribution is rectangular.

1 2(teng ,max teng )

u6 = ,min

f. Combined uncertainty

uc = (u 2 b1 + ub22 + ub32+ ub4 2+ ub5 +2 ub6 )2

g. Uncertainty spread at 95% confidence level, with coverage factor, k= 2.

U95 = uc .k

9. Determination of CMC

For the purpose of determining the CMC of a calibration laboratory, the uncertainty originating from

the spatial variation and the empirical variation of the oven is eliminated so that it becomes as

follows.

uc= (u 2 b1 + ub22 + 2u+b52 ub6 )

10. Recalibration

The calibration interval depends on the use of the oven, but recalibration is carried out once

every 5 years at most. Recalibration must also be carried out if repairs or modifications have

been made which are expected to affect the temperature characteristics.

Dec 2011 - GZ 9/9 Oven Calibration Guide - Draft

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Analytical Balance Calibration (Updated)

Procedure to calibrate the Analytical Weighing Balance as Drift check, Performance check and Measurement uncertainty check as per USP.
CALIBRATION OF TOP PAN BALANCE
Calibration procedure
Internal calibration
It shall be performed as per the manufacturer’s instructions.
Drift check
For the calculation of the drift 10 mg weight shall be used. Note down the 10 measurements of the 10 mg weight in the performance check log.
(Attachment no. 01) Variation in the observed weight from the mean value does not exceed ± 0.2 mg.

The 10 mg weight shall meet the performance check criteria of the mass value i.e. 0.1% of actual mass value. E.g. For all the 10 measurements of
10 mg weight, variation in the weighing cannot exceed 0.01mg.
Performance check
After the Auto calibration put 1 mg, 2 mg, 5 mg, 10 mg and 20 mg weights individually. The measurement shall be within the 0.1% of the actual mass
value of the individual weight as given in the performance check log. (Attachment no. 02)
Measurement uncertainty check
The measurement of uncertainty shall be carried out by using 10 mg weight.
Put the external weight of 10 mg on the pan and note the 10 measurements. (Attachment no. 03)
Calculate the measurement of uncertainty as follows.
Measurement Uncertainity = Standard Deviation X 2
Actual Mass Value
Measurement of uncertainty shall be Not More Than 0.10.
Calibration frequency
It shall be performed daily, after any maintenance, after the relocation and after the power failure of the balance.
Each manufacturer supplies the maximum loading condition of the balance. The calibration of the balance shall be designed in such a way that the
performance check weights cover the entire loading range of the balance. Lower and higher load limits shall be checked for the performance check.
Before calibration make sure that the level bubble is in the center of the indicator and if internal calibration facility is available in the balance then it
shall also be performed daily before performance check of the balance.

Always use a check weight appropriate for the particular balance. E.g. a 100 – mg check weight might be selected for a balance that has a load limit
of 150 mg. Thus the operator must know the maximum capacity of the balance to select the correct check weight.

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Attachment-1: Performance Check Log of Microbalance

Instrument:_____________________ Code No :______________
Make :_____________________ Model :_______________

Date Level 1 mg 2 mg 5 mg 10 mg 20 mg Weight Done by Checked Remark

indicator box no. by
check and valid
Std. Wt. Cal No. Þ upto

Limit Bubble + 0.1% of + 0.1% of + 0.1% of + 0.1% of + 0.1% of

Þ should be Std. Weight Std. Weight Std. Weight Std. Weight Std. Weight
in Center ( to ( to ) ( to ) ( to ( to
) ) )

Attachment-2: Auto Performance Check Log of Microbalance

Instrument:_____________________ Code No :______________
Make :_____________________ Model :_______________
Check level indicator (Bubble should be in center) : _________________________________

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(Paste Performance check chart here)

Calibrated by : _______________ Date : ____________________

Checked by : _______________ Date : ____________________

Attachment-3: Measurement Uncertainity Check of Microbalance

Instrument:_____________________ Code No :______________
Make :_____________________ Model :_______________

Date Std. Wt. Std. Wt. Observation of Uncertainty Weight Done Checked Remark
Cal. No. Less than or equal box no. by by
to 0.001 and
valid
upto
10 mg

Calculation
Measurement = Standard Deviation X 2
uncertainty Actual Mass Value

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20/03/2023, 12:16 Calibration of Centrifuge Apparatus : Pharmaguideline
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Calibration of Centrifuge Apparatus

Learn how to verify the performance of centrifuge apparatus using calibrated tachometer, digital thermometer and stop watch.
PROCEDURE

Ensure that all connection of instrument are proper

Operate the instrument as per the operating instructions

Use duly calibrated tachometer, digital thermometer and stopwatch during calibration of the equipment.

Calibration of time

Set the time for five minutes using set parameters. Record the results by using a digital stopwatch. Repeat the test for ten minutes.

Calibration of revolutions per minutes (RPM)

Fixed angle rotor

Set the RPM of rotor to 12000. Record the results by using tachometers.
Set RPM of rotor to 6000. Record the results by using tachometers
Swing out rotor

Set the RPM of rotor to 4000. Record the results by using tachometers.
Set RPM of rotor to 2000. Record the results by using tachometers.

Calibration of temperature
Fixed angle rotor

Fill the two sample tubes with ethylene glycol and place it in the sample holder. Set the parameters like temperature 5°C, RPM: 12000
and time 45 minutes.
Record the temperature of the sample solution by using digital thermometer.

Fill the two sample tubes with ethylene glycol and place it in the sample holder. Set the parameters like temperature 10°C, RPM: 12000
and time 45 minutes. Record the temperature of the sample solution by using digital thermometer
Fill the two sample tubes with ethylene glycol and place it in the sample holder. Set the parameters like temperature 20°C, RPM: 12000
Site
and time 45 minutes. Record the temperature of the sample solution by using digital thermometer Malicious
Rate
0.0
Swing out rotor

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Fill the two sample tubes with ethylene glycol and place it in the sample holder. Set the parameters like temperature 5°C, RPM: 4000 and
time 45 minutes.
Record the temperature of the sample solution by using digital thermometer.

Fill the two sample tubes with ethylene glycol and place it in the sample holder. Set the parameters like temperature 10°C, RPM: 4000
and time 45 minutes. Record the temperature of the sample solution by using digital thermometer
Fill the two sample tubes with ethylene glycol and place it in the sample holder. Set the parameters like temperature 20°C, RPM: 4000
and time 45 minutes. Record the temperature of the sample solution by using digital thermometer

Frequency
Perform the calibration after every six months. Record the results in the calibration record format.
Maintenance and cleaning

Only neutral agents may be used for cleaning and disinfection (70% isopropanol/ water mixture or an alcohol -based disinfectant)
After cleaning with detergent, the rubber seals in the rotor chamber should be rinsed well in water and lubricated with glycerin in order to
prevent the seals from becoming brittle.
If condensation water forms in the rotor chamber after freezing occurs, dry with a soft absorbent cloth.
The rotor and bucket must be cleaned regularly to prevent contamination caused by residue.
When instrument does not comply with the specified limits the instrument should be labeled as “out of calibration” and should get repaired
/serviced.

After servicing /repairing the instrument must be calibrated as per above-mentioned procedure.

QUALITY ASSURANCE DEPARTMENT

CALIBRATION RECORD FOR THE EPPENDORF CENTRIFUGE MACHINE
Page 1 of 2

SOP Reference : Date :

Instrument No. : Frequency : Every six months

Make : Model : Site

Malicious
Rotor Type Used : Swing Out Rotor Rate
0.0
A] Speed Measurement

Instrument Used : Digital Tachometer (Non contact Version)

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Sr. No. RPM Set RPM on Display RPM on Tachometer Tolerance RPM

1 4000 ±100

2 2000 ±100

Remark : Satisfactory / Not satisfactory.

Performed by : Checked by:

Date : Date :

B] Temperature Measurement

Instrument Used : Digital Thermometer

Sr. No. Temp Set (°C) Temp on Display (°C) Temp on Thermometer (°C) Tolerance (°C)

1 5 ±2

2 10 ±2

Remark : Satisfactory / Not satisfactory.

Performed by : Checked by:

Date : Date :

C] Time Measurement :

Instrument used : Stop Watch

Sr. No. Time Set (Min.) Time on Display (Min.) Time on Stop watch (Min.) Tolerance (Min.)

1 5 ±2

2 10 ±2

Remark : Satisfactory / Not satisfactory.

Performed by : Checked by:

Date : Date :
Site
Malicious
Rate
0.0

QUALITY ASSURANCE DEPARTMENT

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CALIBRATION RECORD FOR THE EPPENDORF CENTRIFUGE MACHINE

Page 2 of 2
SOP Reference : Date :

Instrument No. : Frequency : Every six months

Make : Model :

Rotor Type Used : Fixed Angle Rotor

A] Speed Measurement
Instrument Used : Digital Tachometer (Non contact Version)
Sr. No. RPM Set RPM on Display RPM on Tachometer Tolerance RPM
1 12000 ±100
2 6000 ±100
Remark : Satisfactory / Not satisfactory.
Performed by : Checked by:
Date : Date :
B] Temperature Measurement
Instrument Used : Digital Thermometer
Sr. No. Temp Set (°C) Temp on Display (°C) Temp on Thermometer (°C) Tolerance (°C)
1 5 ±2
2 10 ±2
3 20 ±2
Remark : Satisfactory / Not satisfactory.
Performed by : Checked by:
Date : Date :
C] Time Measurement :
Instrument used : Stop Watch Site
Malicious
Sr. No. Time Set (Min.) Time on Display (Min.) Time on Stop watch (Min.) Tolerance (Min.)Rate
0.0
1 5 ±2
2 10 ±2

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Remark : Satisfactory / Not satisfactory.

Performed by : Checked by:
Date : Date :
Conclusion : Instrument working is Satisfactory / Not satisfactory.
Next calibration due on :

Performed by : Checked by :
Date : Date :

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blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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20/03/2023, 12:16 Calibration of Glassware (Class A and Class B) : Pharmaguideline
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Calibration of Glassware (Class A and Class B)

Learn how to calibrate the Volumetric Glassware including flasks, pipettes and burettes.
Calibration of volumetric flasks
Weigh a clean & dry volumetric flask. Calibrate the flask by filling it with recently boiled and cooled distilled water at room temperature up to the mark
and weigh the flask. Determine the volume in ml by the formula;

Volume (in ml) = (Weight in g / 0.99602)

Where 0.99602 g is the weight of 1 ml water determined at temperature 25°C.
For the volumetric flasks having capacity more than 100 ml, dispense the water from 100 ml burette (class A) in multiple steps if required and note
the final volume (i.e. total volume dispensed).

Calibration of one mark pipette/ graduated pipette/ burette

Calibrate the one mark pipette / graduated pipette/ burette by filling it with recently boiled and cooled distilled water at room temperature up to the
mark. Collect the water from the pipette into a clean, dry previously weighed beaker [For burette – drain the water up to the lower mark]. Take the
weight of beaker with water. Check the weight of water by subtracting the wt. of empty beaker from the weight of beaker with water.
Determine the volume in ml by the formula;

Volume (in ml) = (Weight in g / 0.99602)

Where 0.99602 g is the weight of 1 ml water determined at temperature 25°C.

Tolerance limit
Volumetric flasks
Capacity in ml 5 10 25 50 100 200 250 500 1000
Tolerance Class A 0.02 0.02 0.03 0.04 0.06 0.08 0.1 0.15 0.2
(±ml) Class B 0.04 0.04 0.06 0.08 0.15 0.2 0.2 0.3 0.8
One mark pipette
Capacity in ml 1 2 5 10 15 20 25 50 100
Tolerance Class A Strategic
0.006 0.006 Consulting
0.01 Solutions
0.02 0.02- Full 0.03 0.03 0.04 0.06
(±ml) Class B 0.02 0.02 0.03 0.04 0.04 0.05 0.06 OPEN 0.08 0.12
Burettes
Phase Support Strategy
US & EU regulatory consulting experts propharmagroup.com

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Capacity in ml 10 25 50 100
Subdivision in ml 0.05 0.05 0.1 0.1
Tolerance Class A 0.01 0.03 0.05 0.1
(±ml) Class B 0.02 0.06 0.1 0.2
Frequency : Initially when volumetric glassware is purchased.
Note: When the volumetric glassware does not comply with the requirement as specified above, the volumetric glassware should be returned back to
the party.
REFERENCE
Indian Pharmacopoeia.
United States Pharmacopeia.

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blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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20/03/2023, 12:17 Calibration of Heating Block : Pharmaguideline
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Calibration of Heating Block

Learn how to calibrate the heating block used for Endotoxin testing.
1. Calibration frequency once in six months
2. Operate the heating block as per SOP for operating instruction for the heating block.
3. Insert five BET tubes in a different location of wells and then add 200 ml SWFI (Sterile Water for Injection) with the help of micropipette.
4. Now insert a calibrated thermometer into the tubes containing 200 ml SWFI.

5. Set the heating block for five different temperature points firstly 30°C second 37°C third 50°C fourth 70°C and fifth 90°C.
6. After attaining the heating block temperature, noting down the temperature for 1 hour at the interval of 10 minutes for each set temperature points.
7. Compile the data and find out the temperature uniformity throughout the 1 hour period. It should be ± 1°C.
8. After calibration, immediately put the “CALIBRATION” tag duly filled with necessary information.

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blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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Calibration of Micropipettes
Learn how to calibrate the Micropipettes using distilled water.
1.0 Equipment Required
Micropipettes
Micro tips
Calibrated balance
2.0 Material Required
Distilled water
3.0 Procedure
3.1 Calibrate the micropipettes in a vibration-free room at a constant temperature of water between 20 to 25°C.
3.2 Calibrate the Micropipettes for a volume of 100 and 1000 ml, and for 20 and 200 ml.
3.3 Set the desired volume using the volume-setting knob.
3.4 Carefully fit tip into tip cone and flush with distilled water by pipetting the adjusted volume at least 3 – 4 times.
3.5 Carefully aspirate the liquid and pipette the sucked volume of distilled water into a tare 10 ml volumetric flask.
3.6 Repeat at least ten times and record the result.
3.7 Calculate the pipetted volume, taking the temperature into account.
3.8 After calibration, immediately put the “CALIBRATION” tag duly filled with necessary information

4.0 Precaution
4.1 Use an analytical balance with a readability of 0.1 mg.
5.0 Frequencies
Quarterly
6.0 Limits/ Acceptance Criteria
Micropipettes ID Volume in ml Tolerance Limit in ml
Min Max
A 100 99.9 100.1
1000 999.0 1001.0
Site
B 20 19.98 20.02 Malicious
Rate
200 199.8 200.2 0.0

7.0 Abbreviation
SOP: Standard Operating Procedure
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20/03/2023, 12:16 Calibration of Vernier Caliper : Pharmaguideline
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Calibration of Vernier Caliper

Learn how to verify the performance of Vernier Caliper used for measurements in Quality Control.
PROCEDURE
Place the standard Lengths of 25 mm between the measuring jaws of the caliper at three different positions and determine the length.
Determine the average length and record the observations.

Repeat the above procedure for the remaining standard lengths (50 mm, 75 mm, 100 mm and 125mm).
Tolerance: + 0.05 mm
Frequency: Once in a month
Maintenance & repairs:
When the instrument does not comply with the requirement specified above; the instrument should be labeled as “Out of Calibration” and should get
repaired/ serviced.

After repairing/ servicing the instrument before taking for use, the instrument must be calibrated as per the above-mentioned procedure.

QUALITY ASSURANCE DEPARTMENT

CALIBRATION REPORT OF VERNIER CALIPER
Reference – Date -
Frequency - Once in a Month Instrument No. -
Make –
Place the standard length between measuring jaws of the caliper at three different positions and determine the length.
Sr. No. Standard Reading of Measuring Jaws at Position (mm) Average Limit (mm)
Length Rods Reading (mm)
(mm) Upper Center Lower Min. Max.

1 25 24.95 25.05
2 50 49.95 50.05
3 75 74.95 75.05
4 100 99.95 100.05
5 125 124.95 125.05

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20/03/2023, 12:16 Calibration of Vernier Caliper : Pharmaguideline

Conclusion : Calibration is satisfactory / not satisfactory.

Next Calibration Due On :

Done By : Checked By :
Date : Date :

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blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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20/03/2023, 12:17 Calibration of Viscometer : Pharmaguideline
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Calibration of Viscometer
Learn how to calibrate the Viscometer using different viscosity standards.
Calibration Procedure
1. Ensure that instrument is ready for use.
2. Calibrate the instrument by using different calibration standards. (i.e. 50, 500, 1000 and 5000 cps, Use “BROOKFIELD CALIBRATION FLUID”)
3. Select the spindle as per requirement, by pressing the “SELECT SPINDLE” key, on the display “S” line will begin to blink for four seconds.
4. Press “UP or DOWN” (­↑↓) arrow keys while blinking, two digit character values will change accordingly. (UP for increase in spindle no. and DOWN
for Decrease in spindle no.) Release the arrow key to halt further scrolling and re-press the “SELECT SPINDLE” key.

5. Select the speed as per requirement, by pressing the “SET SPEED” key, on the display “0.0” line will begin to blink for four seconds.
6. Select the rpm speed by pressing the “UP or DOWN” (­↑↓) arrow key, the current rpm speed will display on the bottom line of the screen and RPM
will blink. [UP for increase the RPM speed & DOWN for Decrease the RPM speed.] Re-press the “SET SPEED” key.
7. Attach the selected spindle to the lower shaft, lift the shaft slightly, holding it firmly with one hand while screwing the spindle on with the other hand.
8. Put the test solution beaker below the spindle center and insert the spindle until the fluid level is at immersion groove in the spindle shaft middle of
the “SPINDLE MARK LINE”. (Ensure that no air bubble is trapped to the surface of the spindle).
9. Press the “MOTOR ON/ OFF” key to run the test.
10. Allow time to stabiles the reading, (The time required for the stabilization is depend on the speed of running & characteristics of the sample fluid.)
11. Record the stabilized reading in CPS unit in calibration log.
12. Press the “MOTOR ON/ OFF” key to stop the test and put ‘off’ the instrument mains.
13. Clean the spindle & instrument after use.
14. Affix the calibration label on the instrument.
Related: Determination of Viscosity by Using Ostwald-type, Suspended-level and Rotating Viscometer

CALIBRATION LOG
Instrument:____________ Code No:______________
Make :_____________ Model: _______________

Sr. No. BookViscosity

Your SpotLot. No. Set Spindle No. Set Temp. Observed Viscosity Value in cps
Sign Up
Listen toStandard
an Engaging Mix of Presentations and Interviews in the RPM
Field of Academia Malvern (Label claim+ 1.0 % CPS)
Panalytical
1 50 cps

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20/03/2023, 12:17 Calibration of Viscometer : Pharmaguideline

2 100 cps

3 500 cps

4 1000 cps

5 5000 cps

Calibration Status : Satisfactory / Not Satisfactory

Next Calibration Due :
Calibrated By : Checked By :
Date : Date :

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blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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20/03/2023, 12:10 Difference among Calibration, Validation & Qualification : Pharmaguideline
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Difference among Calibration, Validation & Qualification

Definition of Calibration, Qualification and Validation, Qualification and calibration are the important parts of Validation.
A lot of pharmaceutical professionals are having a big confusion among calibration, validation and qualification, hence I am trying to wash out the
confusion. I think it will make a clear image of these three concepts and their definitions.

Calibration:

The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring
(for example, weight, temperature and pH), recording, and controlling, or the values represented by a material measure, and the corresponding is
known values of a reference standard.

Limits for acceptance of the results of measuring should be established. Always remember any reference standard is always used in calibration.

Validation:
The action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results.

It can better understand that the validation is a documented evidence to and done to prove the consistency of the expected results of any process,
procedure or method.

Related: Validation in Pharmaceutical Manufacturing

Qualification:
The action of proving and documenting that any premises, systems and equipment are properly installed, and/or work correctly and lead to the
expected results. Qualification is often a part (the initial stage) of validation, but the individual qualification steps alone do not constitute process
validation. Qualification is a part of validation.

Also see: Water for Injection (WFI) System Validation

Injection Molding Machine
Lisong is a professional plastice injection molding machine manufacturer from Open
China.
Lisong Injection Machine

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20/03/2023, 12:13 Handling of Out of Calibration Instruments and Equipment : Pharmaguideline
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Handling of Out of Calibration Instruments and Equipment

Learn the procedure for the Instruments and Equipment those are Out of Calibration.
Procedure for Instruments / Equipment other than Quality Control Laboratory
1. Stop usage of instrument/ equipment if it fails in calibration test or if there is a sudden malfunction in the instrument.
2. Affix “UNDER MAINTENANCE” label to the instrument/ equipment.
3. Fill an “Incident Report” and inform engineering department.
4. Engineering department shall carry out the investigation to find the reason for failure. The effect of failure on the quality of the product since the
last calibration shall be evaluated.
5. Hand over the instrument/ equipment for repairs to the engineering department
6. Refer the instrument to outside agencies, if the instrument cannot be repaired in-house.
7. Calibrate the instrument/ equipment as per respective SOP after completion of repairs.
8. Replace the instrument/ equipment with identical instrument/ equipment if the same is beyond repairs. The replaced instrument/ equipment ideally
should be of the same make, model, size, range, least count. If instrument/ equipment of same make, model, size, range, and least count are not
available, the change should be done through change control procedure.

Procedure for Instruments/ Equipment in Quality Control Laboratory

1. Stop usage of instrument/ equipment if it fails in calibration test.
2. Affix “UNDER MAINTENANCE” label to the instrument/ equipment.
3. If any sudden malfunctions / or Out of calibration results are obtained from instruments in regular use. Contact the manufacturer/ supplier and call
the Service Engineer.
4. The service engineer shall investigate and rectify the problem.
5. After the repairing/ maintenance of the instrument/ equipment, partial or complete calibration shall be performed.
6. The service report detailing the cause of failure, an action is taken and remarks if any shall be filed into the respective calibration/ maintenance file
along with the partial/ complete calibration report.
7. The reason for failure and the effect of failure on the quality of the product since the last calibration shall be covered during the investigation.
8. Head QA shall evaluate the necessity to re-analyze the previous sample/ samples for the correctness of results to ensure that there is no product
failure due to out of calibration.
Also see: Cleaning Validation of Manufacturing Equipments

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blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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