SOP for Calibration of Laboratory Glassware in Pharmaceutical Industry

One Master copy of the SOP shall be prepared. A soft copy of the Master copy shall be securely maintained with the Head QA. Hard "Controlled copy" shall be issued to the Head of the User Departments.

1. Purpose:

For Calibration of Laboratory Glassware to check the accuracy of glassware used for analysis and is within the tolerance limits of nominal volume.

2. Scope:

This SOP shall be used in the Quality Control Department at ( Company name & Location) for the Calibration of Laboratory Glassware

3. Responsibilities:

QC Executive/Designee: To understand the procedure and to apply it in practice.

QC Head/Designee: To review the SOP and its implementation.

QA Head/Designee: To approve the SOP and ensure its implementation.

4. Material and Equipment:

Volumetric Flasks, Pipettes and Burettes

5. Procedure:

5.1 Precaution:

5.1.1 Ensure the cleanliness of glassware before calibration.
5.1.2 Clean the wet outer surface of glassware with tissue paper while taking weight.
5.1.3 Wipe it with tissue paper if the upper meniscus is wet
5.1.4 At the time of aligning the meniscus. Your eye should kept at the same level.
5.1.5 Water should be added dropwise with a pipette to adjust the meniscus precisely to the ring mark.
5.1.6 If the volume is more than the marking level, tissue paper or a pipette should be used to remove it
5.1.7 Ensure that the burette tip does not touch the wall of the beaker while transferring Water.

5.2 For Calibration of Laboratory Glassware:

5.2.1 Before calibration, immerse the glassware in chromic acid for 30 minutes for cleanness by removing grease.

5.2.2 At first, running tap water is used to rinse the glassware. Again, di-ionized Water is used to rinse, and it should be dried for 60 minutes at 60-65° C. Ensure that glassware is appropriately dry.

5.2.3 After removing the glassware from the oven, put it in desiccators. The ambient temperature should be set to 25°C±2°C.

5.2.4 At the time of calibration, the temperature of the water bath should be maintained at 25°C±0.5°C.

5.2.5 For Volumetric Flask: Keep the volumetric flask on the balance, which should be calibrated, and note the weight (A). Take out the volumetric flask from equilibrium, and the distilled Water is transferred at 25°C so that the meniscus of Water in the volumetric flask is at the mark level. The volumetric flask should be weighed, and the weight (B) should be noted.

5.2.6 For Pipette and Burette: Place the dry beaker on the balance and note the weight (A). Fill the pipette and burette with distilled Water at 25°C up to the mark. The outside pipette and burette should dry, and then the Water should be filled in a previously weighed beaker. After that, the cup should be considered again, and the weight (B) should be noted.

5.2.7 The glassware volume is calculated using the following formula, i.e. (B-A)/0.99602.

5.2.8 Record all values and findings for the volumetric flask, pipettes, and burette in the Logbook for Calibration of Laboratory Glassware.

5.3 Limits:

5.3.1 5.3.2	Volumetric Flask
	Nominal Capacity (ml)	5	10	20	25	50	100	250	500	1000
	Tolerance ± (ml) (A)	0.025	0.025	0.04	0.04	0.06	0.1	0.15	0.25	0.4
	Tolerance ± (ml) (B)	0.05	0.05	0.08	0.08	0.12	0.2	0.3	0.5	0.8
	For One Mark Pipettes (Bulb Pipettes)
	Nominal Capacity (ml)	1	2	5	10	20	25	50	100
	Tolerance ± (ml) (A)	0.007	0.01	0.015	0.02	0.03	0.03	0.05	0.08
	Tolerance ± (ml) (B)	0.015	0.02	0.03	0.04	0.06	0.06	0.1	0.16
	For Graduated Pipettes
	Nominal Capacity (ml)	1	2	5	10	25
	Subdivision (ml)	0.01	0.02	0.05	0.1	0.2
	Tolerance ± (ml) (A)	0.007	0.01	0.03	0.05	0.1
	Tolerance ± (ml) (B)	0.01	0.02	0.05	0.1	0.2
	For Burettes
	Nominal Capacity (ml)	10	25	50	100
	Subdivision (ml)	0.0.5	0.05	0.1	0.2
	Tolerance ± (ml) (A)	0.03	0.03	0.05	0.1
	Tolerance ± (ml) (B)	0.05	0.05	0.1	0.2
	The calibration of glassware passed the measured volume found within tolerance limits and failed if found outside tolerance limits.

6.0 Abbreviations:

6.1 SOP: Standard Operating Procedure

6.2 QC: Quality Control

6.3 QA: Quality Assurance

6.4 ml: Mililitre