Calibration of Glassware: Purpose
Calibration of Glassware; The purpose of this SOP is to ensure that all glass wares are properly handled, thoroughly cleaned and calibrated accurately before use.
Scope:
This procedure is applicable for glassware handling, washing and calibration used in the different analysis of quality control laboratory and microbiology laboratory of general block of XX Pharmaceuticals Ltd.
Definitions/Abbreviation:
[] ASTM: American Society for Testing and Materials
[] SOP : Standard Operating Procedure
Responsibilities:
[] Officer/Executive/Sr. Executive, Quality Control
[] To ensure that this procedure is followed.
[] To maintain the records properly as per SOP.
Manager, Quality Control
[] To ensure that this procedure is kept up to date.
[] To confirm that the SOP is technically sound and reflects the required working practices.
[] To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.
[] Schedule calibration of the instrument at the defined intervals.
Head of Quality Assurance
[] Approval of the SOP.
[] To ensure the overall implementation of the SOP.
Procedure:
Precaution(s):
[] Handle with care during cleaning of Glassware.
[] Before discard of glassware, observe the label on glassware and handle with care as the type of chemical.
[] Wear gloves, mask and protective clothing during glassware handling and cleaning.
[] Do not use laboratory glassware for drinking purpose.
[] Do not handle the hot glassware without heat resistant gloves.
[] Do not put the hot glassware on cold or wet surface or cold glassware on hot surface.
[] Avoid to heat glassware that is etched, cracked, chipped, nicked or scratched.
[] Do not heat directly thin glassware with flaming.
[] Never place the glassware from the freezer into warm water baths.
Handling Procedure:
[] Hold the beakers, bottles, flask the side and bottoms rather than by the tops.
[] Avoid over tighten the clumps.
[] Use always coated clumps to avoid breakage while the clumping glassware.
[] Cool the glassware slowly to prevent breakage.
[] Dispose the broken glass into specific waste bucket.
[] Keep all cleaned glassware at designated place.
Washing Procedure:
[] Transfer all used glassware to washing area.
[] Discard the solution from glassware into a designated container/place.
[] Rinse initially all glassware with sufficient potable water for removal the residual content of solution.
[] For pipette, pass sufficient potable water through the pipette by force at two or three times.
[] Wipe to remove the label with detergent powder or suitable solution.
[] Allow to soak the glassware with diluted detergent for 10-15 minutes to remove any contaminants.
[] Rinse the glassware with sufficient potable water until detergent is removed.
[] Finally rinse with purified water for two or three times for removal any contaminating substances that may be present in the potable water.
[] Discard the rinsing solution.
[] Place cleaned glassware into Glassware drying rack for removal of residual water from glassware.
[] Dry the glassware for QC analysis and sterilize the glassware at 200°C for 1 hour for use in Microbiological analysis.
Calibration Procedure:
Burette Calibration:
[] Take a burette and inspect to ensure smooth tap operation.
[] Observe the tip of the burette, ensure no cracks or chips.
[] Observe markings on burette which is legible.
[] Rinse the burette at several times with purified water.
[] Fill the glassware up to the mark.
[] Dispense into a pre-tarred 100 ml beaker.
[] Record final volume.
[] Record mass of water.
[] Repeat the same procedure for another two times.
[] Calculate the volume delivered from the equation below using recoded weight and density of water at the temperature of calibration. Take Tabulated Density of water at the temperature of calibration from the Annexure-II.
Volume of Burette= Weight/Tabulated Density of water at the temperature of calibration
[] Record calculated volumes, determine mean and compare the volume with that read from the burette and then determine the error as per Annexure – I.
Limit of error of the calculated volume should be as per following table (as per ASTM E-287)
| Nominal Volume, mL | 25 | 50 |
| Limit of error, mL | 0.03 | 0.03 |
| Limit of error, % | 0.12 | 0.10 |
Calibration of Pipette:
[] Take purified water into a beaker.
[] Record the temperature of the water used.
[] Weigh and tare another 100 ml beaker.
[] Dispense water as per pipette volume into tarred beaker.
[] Record the weight of purified water.
[] Repeat the same procedure for another two times.
[] Calculate the volume delivered from the equation below using recoded weight and density of water at the temperature of calibration. Take Tabulated Density of water at the temperature of calibration from the Annexure-II.
Volume of Pipette= Weight/Tabulated Density of water at the temperature of calibration
[] Record calculated volumes, determine mean and compare the volume with the nominal volume and then determine the error as per Annexure – I.
Limit of error of the calculated volume should be as per following table (as per ASTM E-969)-
| Nominal Volume, mL | 1 | 2 | 3 | 4 | 5 | 10 | 15 | 20 | 25 |
| Limit of error, mL | 0.006 | 0.006 | 0.01 | 0.01 | 0.01 | 0.02 | 0.03 | 0.03 | 0.03 |
| Limit of error, % | 0.60 | 0.30 | 0.33 | 0.25 | 0.20 | 0.20 | 0.20 | 0.15 | 0.12 |
Calibration of Volumetric Flask:
[] Observe the volumetric flask, ensure no cracks or chips.
[] Observe markings on volumetric flask, ensure they are legible.
[] Rinse volumetric flask at several times with purified water.
[] Rinse with acetone and air dry.
[] Tare volumetric flask on balance.
[] Add purified water and fill to mark.
[] Record weight of water.
[] Record the temperature of the water used.
[] Repeat the same procedure for another two times
[] Calculate the volume delivered from the equation below using recoded weight and density of water at the temperature of calibration. Take Tabulated Density of water at the temperature of calibration from the Annexure-II.
[] [] Volume of Volumetric Flask= Weight/ Tabulated Density of water at the temperature of calibration
Record calculated volumes, determine mean and compare the volume with the nominal volume and then determine the error as per Annexure – I.
Limit of error of the calculated volume should be as per following table (as per ASTM E-288)
| Nominal Volume, mL | 5 | 10 | 25 | 50 | 100 | 200 | 250 | 500 | 1000 | 2000 |
| Limit of error, mL | 0.02 | 0.02 | 0.03 | 0.05 | 0.08 | 0.10 | 0.12 | 0.15 | 0.30 | 0.50 |
| Limit of error, % | 0.40 | 0.20 | 0.12 | 0.10 | 0.08 | 0.05 | 0.05 | 0.03 | 0.03 | 0.025 |
Download All Annexure
Annexure I : Glassware Calibration Record
Annexure II : Density of Water