- 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.
- 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
- 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
|Tolerance, ± mL||0.04||0.06||0.10||0.16||0.20||0.24||0.30||0.60|
|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
Master copy – Quality Assurance
Controlled copies – Quality Assurance & Quality Control
Reason for Revision
Calibration of Glassware
|Name of Glassware:||ID. No.:|
|Analytical Balance ID. No.:||Calibration done on:|
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
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
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
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube