1.0 Objective
To lay down a procedure for the Calibration and Handling of Glassware (Class A and Class B)
2.0 Scope
This Standard Operating Procedure is applicable for calibration and Handling of Glassware (Class A and Class B).
3.0 Responsibility
3.1 All Microbiologist/Quality Control officers are responsible to follow the SOP.
3.2 Quality Control Head or his/her designee is responsible for compliance of this SOP.
4.0 Accountability
4.1 Department Head & QA Head shall be accountable for implementation of this SOP.
5.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
°C : Degree Centigrade
SP : Specific
USP : United State Pharmacopeia
IP : India Pharmacopeia
6.0 Procedure
6.1 Class ‘A’ glass Apparatus:
6.1.1 These are used directly for analysis purpose and are received with calibration certificate
6.2 Calibration of Class `B’ Glass Apparatus:
6.2.1 On receiving class ‘B’ Apparatus, allot ID. No. as follows;
6.2.1.1 Volumetric Flask, VF-01
6.2.1.2 Transfer pipettes, TP-01
6.2.1.3 Burettes, BT-01
6.2.2 Before using Class ‘B’ apparatus, they should be calibrated as following procedure.
6.2.3 In all step during calibration of glassware the water temperature should be 25 °C.
6.2.4 Calibration procedure:
6.2.4.1 Take all volumetric flasks up to 1000 mL, transfer pipettes, Burettes for calibration.
6.2.4.2 For volumetric flask:
6.2.4.2.1 Weigh accurately a previously dried volumetric flask.
6.2.4.2.2 Make up the volumetric flask up to the mark with purified water.
6.2.4.2.3 Wipe dry the outside of the volumetric flask and then weigh.
6.2.4.2.4 Find out the weight of water by subtracting the empty weight of volumetric flask from total weight (Empty volumetric flask weight and water weight).
6.2.4.2.5 Calculate the volume by taking correction factor 0.99602 gm (i.e. 1 mL of purified water at 25°C = 0.99602 g) Record the observations in Calibration Format as per Annexure-I.
6.2.4.3 For pipette and Burette:
6.2.4.3.1 Weigh accurately previously dried empty beaker.
6.2.4.3.2 Fill the pipette and burette with purified water up to the mark with the help of bulb.
6.2.4.3.3 Wipe dry the outside of the transfer pipette & burette and then transfer the water in pre-weighed beaker and weigh.
6.2.4.3.4 Find out the weight of water by subtracting the empty beaker weight from total weight (Empty beaker weight and water weight).
6.2.4.3.5 Calculate the volume by taking correction factor 0.99602 gm (i.e. 1 mL of purified water at 25°C = 0.99602 g). Record the observations in Calibration Format as per Annexure-I.
6.2.4.4 Perform the calibration in triplicate and Calculate and record the average of observed volume.
6.2.4.5 Calculate the difference between Labeled Volume and average of observed volume of glassware as per following formula
Difference in Volume = Labeled Volume – Average of Observed Volume
6.2.4.6 Ensure that the difference in volume shall be within the tolerance limits as listed in Table I
Table- I Glassware Tolerance
Volumetric flask |
LabeledVolume, mL |
10 |
25 |
50 |
100 |
200 |
250 |
500 |
1000 |
Tolerance, ± mL |
0.04 |
0.06 |
0.10 |
0.16 |
0.20 |
0.24 |
0.30 |
0.60 |
|
Transfer Pipettes |
LabeledVolume, mL |
1 |
2 |
5 |
10 |
20 |
25 |
50 |
100 |
Tolerance, ± mL |
0.012 |
0.012 |
0.02 |
0.04 |
0.06 |
0.06 |
0.10 |
0.16 |
Burettes |
LabeledVolume, mL |
1 |
2 |
5 |
10 |
20 |
25 |
50 |
100 |
Tolerance, ± mL |
0.012 |
0.012 |
0.02 |
0.04 |
0.06 |
0.06 |
0.10 |
0.16 |
Frequency: Initially when volumetric glassware is purchased.
Note: When the volumetric glassware do not comply with the requirement as specified above, the volumetric glassware should return back to party.
6.3 Handling of Glassware
6.3.1 New glassware received should be checked for appropriateness. In case of any broken glassware the same should be returned to the supplier.
6.3.2 Store the glassware in “Hot Air Oven”.
6.3.3 Issue the glassware as and when required.
6.3.4 Instruct the person using and cleaning the glassware to handle it carefully to avoid any breakage.
6.3.5 In case of any breakage of glassware the same should be destroyed.
6.3.6 The glassware should be checked for any breakage after drying and broken glassware should be destroyed.
6.3.7 Glassware, which requires calibration, should be calibrated at the time of issuance and before use.
6.3.8 All volumetric glassware should be calibrated as per SOP of glassware calibration.
6.3.9 Enter the result in the record and take approval of authorized.
6.3.10 Before singing the record, authorized person should ensure that calibration is done as per standard procedure and results obtained as well within limit.
7.0 Forms and Records (Annexures)
Calibration of Glassware – Annexure-I
8.0 References (if any)
8.1 IP & USP
9.0 Distribution
9.1 Master copy – Quality Assurance
9.2 Controlled copies- Quality Assurance, Quality Control
10. History
Date |
Revision Number |
Reason for Revision |
– |
– |
New SOP |
Annexure-I
Calibration of Glassware
Name of Glassware: |
ID. No.: |
Manufacturer: |
Labeled Volume: |
Analytical Balance ID. No.: |
Calibration done on: |
Observation I:Weight of pre-weighed dry, empty, volumetric flask / Beaker, in gm (W1):________________ gmWeight of volumetric flask/ Beaker and water, in gm (W2):__________________ gmWeight of water, in gm (W3): = (W2 – W1) = ________________________ gmObserved volume of the glassware: W2 – W1 = _________________ mlDWhere: D = 0.99602 (Density of water at 25 °C in gm/ml) |
Obsevation II:Weight of pre-weighed dry, empty, volumetric flask / Beaker, in gm (W1):________________ gmWeight of volumetric flask/ Beaker and water, in gm (W2):__________________ gmWeight of water, in gm (W3): = (W2 – W1) = ________________________ gmObserved volume of the glassware: W2 – W1 = _________________ mlDWhere: D = 0.99602 (Density of water at 25 °C in gm/ml) |
Observation III:Weight of pre-weighed dry, empty, volumetric flask / Beaker, in gm (W1):________________ gmWeight of volumetric flask and water, in gm (W2):__________________ gmWeight of water, in gm (W3): = (W2 – W1) = ________________________ gmObserved volume of the glassware: W2 – W1 = _________________ mlDWhere: D = 0.99602 (Density of water at 25 °C in gm/ml) |
Average of three observed volume = Sum of three Observation =3Difference in Volume = Labeled Volume – Average of Observed Volume=Tolerance Limit: ______________________ (refer to Table – I) |
Table – I
Volumetric flask |
Average Volume, mL |
10 |
25 |
50 |
100 |
200 |
250 |
500 |
1000 |
Tolerance, ± mL |
0.04 |
0.06 |
0.10 |
0.16 |
0.20 |
0.24 |
0.30 |
0.60 |
|
Transfer Pipettes |
Average Volume, mL |
1 |
2 |
5 |
10 |
20 |
25 |
50 |
100 |
Tolerance, ± mL |
0.012 |
0.012 |
0.02 |
0.04 |
0.06 |
0.06 |
0.10 |
0.16 |
|
Burettes |
Average Volume, mL |
1 |
2 |
5 |
10 |
20 |
25 |
50 |
100 |
Tolerance, ± mL |
0.012 |
0.012 |
0.02 |
0.04 |
0.06 |
0.06 |
0.10 |
0.16 |
