- Objective:To lay down the procedure for calibration of laboratory glassware.
- Scope:This SOP is applicable for calibration of laboratory glassware in Quality Control Department at pharmaceutical company name with location.
- Responsibility:Chemist or above of QA shall be responsible to follow the procedure mentioned in this SOP.
- Accountability:Department Head & QA Head shall be accountable for implementation of this SOP.
- Procedure:
- Class ‘A’ glass Apparatus:
- These are used directly for analysis purpose and are received with calibration certificate
- Calibration of Class `B’ Glass Apparatus:
- On receiving class ‘B’ Apparatus, allot ID. No. as follows;
- Volumetric Flask
- Transfer pipettes
- Burettes
- Before using Class ‘B’ apparatus, they should be calibrated as following procedure.In all step during calibration of glassware the water temperature should be 25 °C.
- Calibration procedure:
- Take all volumetric flasks up to 1000 mL, transfer pipettes, Burettes for calibration.
- For volumetric flask:
- Weigh accurately a previously dried volumetric flask.
- Make up the volumetric flask up to the mark with purified water.
- Wipe dry the outside of the volumetric flask and then weigh.
- Find out the weight of water by subtracting the empty weight of volumetric flask from total weight (Empty volumetric flask weight and water weight).
- Calculate the volume by taking correction factor 0.99602 gm (i.e. 1 mL of purified water at 25°C = 0.99602 gm) Record the observations in Calibration Format.
- For pipette and Burette:
- Weigh accurately previously dried empty beaker.
- Fill the pipette and burette with purified water up to the mark with the help of bulb.
- Wipe dry the outside of the transfer pipette & burette and then transfer the water in pre-weighed beaker and weigh.
- Perform the calibration in triplicate and Calculate and record the average of observed volume.
- Calculate the difference between Labeled Volume and average of observed volume of glassware as per following formula:
- Find out the weight of water by subtracting the empty beaker weight from total weight (Empty beaker weight and water weight).
- Calculate the volume by taking correction factor 0.99602 gm (i.e. 1 mL of purified water at 25°C = 0.99602 gm). Record the observations in Calibration Format.
Diffrence in Volume = Labeled Volume – Average of Observed Volume
- Ensure that the difference in volume shall be within the tolerance limits as listed in Table I. Table- I Glassware Tolerance
| Volumetric flask | Labeled
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 | Labeled
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 |
- Forms and Records (Annexures)
Calibration of Glassware – Annexure-I
- Distribution
Master copy – Quality Assurance
Controlled copies – Quality Assurance & Quality Control
- History
| Date | Revision Number |
Reason for Revision |
| – | 00 | 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):__________gm Weight of volumetric flask/ Beaker and water, in gm (W2):______________________ gm Weight of water, in gm (W3): = (W2 – W1) = _________________________________ gm Observed volume of the glassware: W2 – W1 /D = ___________________________ ml |
| Obsevation II:
Weight of pre-weighed dry, empty, volumetric flask / Beaker, in gm (W1):____________gm Weight of volumetric flask/ Beaker and water, in gm (W2):_______________________ gm Weight of water, in gm (W3): = (W2 – W1) = __________________________________ gm Observed volume of the glassware: W2 – W1 /D = ____________________________ ml |
| Observation III:
Weight of pre-weighed dry, empty, volumetric flask / Beaker, in gm (W1):__________ gm Weight of volumetric flask and water, in gm (W2):____________________________ gm Weight of water, in gm (W3): = (W2 – W1) = ________________________________ gm Observed volume of the glassware: W2 – W1 /D = __________________________ ml |
| Where: D = 0.99602 (Density of water at 25 °C in gm/ml)
Average of three observed volume = Sum of three Observation /3 = Difference in Volume = Labeled Volume – Average of Observed Volume Remarks: Glassware calibration complies / does not comply. |
| Analysed By / Date | Approved By / Date |
Note -For Tolerance Limit refer to Table – I
