SOP FOR GLASSWARE CALIBRATION
OBJECTIVE
1.1 To lay down a procedure for the Calibration of glassware used for analysis in the Quality Control Laboratory.
2.0 SCOPE
2.1 This procedure applies to the Pharmaceutical Manufacturing Facility of _____________________________________________
3.0 RESPONSIBILITY
3.1 Chemists.
4.0 ACCOUNTABILITY
4.1 Head - Quality Control
5.0 PROCEDURE
5.1
For all
Class A glassware received with manufacturer calibration certificate, So
In-house calibration is not required and class B glassware shall be calibrated
before
use.
5.2
All glassware shall comply with the tolerance limits
as given in Table 1 and can be used
for outline analysis.
5.3
In the case of
glassware, which is not, comply with per tolerance limits as mentioned in the table- 1 shall be marked for the
correction in the volume.
5.3.1
Identification number is given serially for all
calibrated glassware.
Table-1
a)
Volumetric flasks & Measuring cylinder:
|
Nominal Capacity (ml) |
10 ml |
25 ml |
50 ml |
100ml |
250ml |
500ml |
1000ml |
|
Tolerance:
±ml |
|||||||
|
Class B |
0.04 |
0.06 |
0.08 |
0.15 |
0.30 |
0.40 |
0.80 |
b)
Pipettes:
|
Nominal Capacity (ml) |
1ml |
2ml |
5ml |
10ml |
20ml |
25ml |
50ml |
100ml |
|
Tolerance: ±ml |
||||||||
|
Class B |
0.02 |
0.02 |
0.03 |
0.04 |
0.05 |
0.06 |
0.08 |
0.12 |
c)
Burettes:
|
Nominal Capacity (ml) |
10ml |
25ml |
50ml |
100ml |
|
Sub division (ml) |
0.05 |
0.1 |
0.1 |
0.1 |
|
Tolerance:
±ml |
||||
|
Class B |
0.02 |
0.06 |
0.1 |
0.2 |
5.4
Calibration is based on the weight of water held by
the particular glassware and converting the same into ml.
5.5
Conversion factors for 1gm of water at different
temperatures are given below. (Refer to textbook of Quantitative chemical analysis
by Vogel 5th Edition. Page No. 87);
5.5.1 At 20°C, 1gm is equivalent to 1.0027ml.
5.5.2
At 24°C, 1gm is equivalent to 1.0037ml.
5.5.3
At 25°C, 1gm is equivalent to 1.0041ml.
5.5.4
At 26°C, 1gm is equivalent to 1.0044ml.
5.6 Perform the calibration as below.
5.6.1
Volumetric flask and measuring cylinder:
5.6.1.1
Take empty flask weight (W1) put water up to the
mark.
5.6.1.2
Take the weight of flask with water (W2).
5.6.1.3
Calculate the weight of water (W2-W1) and multiply
with the conversion factor to get the value in ml.
5.6.1.4
If it is more than 100ml volumetric flask or measuring
cylinder fill the beaker up to the mark, transfer the water in 100 ml beaker
and take the weight of the transfer water by deducting the final weight and initial
weight.
5.6.2 Pipette:
5.6.2.1
Take an empty dried beaker, place it on a balance, and
take the tare weight of the beaker.
5.6.2.2
Pipette out water exactly up to the mark, transfer it into the beaker and weigh.
5.6.2.3
Calculate the weight of the water alone and convert
the weight of water into the volume by multiplying it with the water conversion factor.
5.6.3 Burette:
5.6.3.1
Take out the empty dried beaker, place on a balance, and
take tare weight of the beaker.
5.6.3.2
Fill water in the burette up to the marking transfer it into the beaker and weigh.
5.6.3.3
Calculate the weight of the water alone and convert it
into the volume by multiplying it with the conversion factor.
5.7
Care
shall be taken to maintain the water temperature at 26°C for all calibration purposes.
5.8
Record
results of the calibration.
6.0 ABBREVIATIONS
6.1 Nil.
7.0 REFERENCES
7.1 Nil
8.0 ANNEXURES
8.1
Nil.
END OF THE DOCUMENT
1. List of All SOPs and Documents for the Microbiology Laboratory
2. List of All SOPs and Documents for In-vitro Laboratory
3. List of All SOPs and Documents for the In-vivo Laboratory.
4. List of All SOPs and Documents for Clinical Research
5. List of Instruments and Equipment Used In Laboratory Animal Facility
6. List of All SOPs and Documents for the Animal House Facility
No comments:
Post a Comment