Operation cleaning and calibration of Karl Fischer Apparatus

Operation cleaning and calibration of Karl Fischer Apparatus



1.1 To lay down a procedure for Operation, cleaning and calibration of Karl Fischer Apparatus.


2.1 This Procedure is applicable for Karl Fischer Apparatus in Quality Control Department


3.1 QC Officer or QC Executive

4.1 QC Manager

5.0 Operating Procedure
5.1.1 Check calibration status of instrument.
5.1.2 If calibration is due, then, inform QC Manager
5.1.3 Switch ‘ON’ the mains.
5.1.4 Fill the reagent bottle with Karl Fischer reagent.
5.1.5 Check the molecular sieves. They shall be light brown in colour. If dark brown, replace them with fresh molecular
sieves. The molecular sieves can be regenerated.
5.1.6 Switch ON the Power.
5.1.7 Rinse the titration vessel with methanol. and fill the methanol up to mark the electrode dip in
5.1.8 After pressing start the neutral the methanol access moisture present in it. Instrument give
Buzzer. Press the buzzer button to stop the buzzer.
5.1.9 To start your analysis, weight the bottle filled with water and put carefully one or two drops

of water in titration vessel.

5.1.10 press start when titration is complete instrument give buzzer. Note down the burette reading.

5.1.11 take similarly two concordant reading and determine the kf factor by avg of two reading and
RSD limit NMT 1.0%

5.1.13 Calculate the moister by applying formulae:
Vol. Of kf regent consumed in ml×100 × factors (mg)
Wt of sample in mg
5.2 Cleaning Procedure For Karl Fischer Apparatus

5.2.1 Remove the solution from the Titration vessel and wash with methanol.
5.2.2 Open the Titration Vessel and clean the vessel and the electrode with the help of the tissue
5.2.3 Switch ‘OFF’ the instrument and switch ‘OFF’ the mains.
5.2.4 Collect the waste solution in the waste beaker to be discarded to avoid corrosion.
5.2.5 Clean the outer surface of the instrument with Isopropyl alcohol and dry it with tissue paper
5.3.1 Frequency: Once in a 6 Month.
5.3.2 Weigh about 150, mg of Disodium Tartrate in to titration vessel (KF Grade).
5.2.3 Operate the instrument as per the procedure given above.
5.2.4 Note down the burette reading.
5.2. 5 calculate the % water content by using the formulae
Vol. Of kf regent consumed in ml×100 × factors (mg)
Wt of sodium tartrate in mg
5.2.6 The performance of instrument satisfactory if the difference between obtained value with in the
Tolerance limit of 15.66% ± 5% i.e 14.87% to 16.44%.
5.2.7 Repeat the steps 5.2.2 to5.2.5 and take three reading record the result in annexure


 Abbreviation Extended Form
QC Quality Control
SOP Standard Operating Procedure
ml milliliter
gm gram
mg milligram
No. Number

SOP for testing of ETP water

sop for Calibration and Maintenance of Laboratory Instruments and Equipment

Disposal of Residual Sample or Left Over Material

sop for for Laboratory Incident

standard operating procedure temperature monitoring

sop for drying of silica gel

sop for operation of infrared moisture balance

sop for preparation of mobile phase

sop for treated RO water

sop for Preparation and Issuance of Analysis protocol standard

sop of placebo and impurity stock solutions

sop for disposal of residual sample  

sop for handling of pharmacopoeial changes

sop for procedure for operation of ultrasonic cleaner

difference between UPLC and HPLC

sop for for Emergency Eyewash and Shower

sop for operation and calibration of total organic carbon analyzers

sop for operation of cobb tester

sop for Operation and calibration of atomic absorption spectrophotometer

sop for Operation and calibration of gas liquid chromatograph

sop for operation of humidity oven

sop for operation and calibration of serological water bath

sop for monitoring of drain trap

sop for destruction of analytical samples after testing and control samples

sop for destruction of used chemicals

Sop for Operation of suction pump

sop for Operation and calibration uv cabinet

sop for Operation and calibration of bulk density apparatus

sop for operation and calibration of shore hardness tester

sop for operation of rub proofness tester

sop for monitoring of purified water

sop for Retesting of packaging materials

sop for Retesting and resampling of raw materials

sop for Control of issuance of record of analysis green sheets

sop for Control of computer passwords

sop for sampling of packaging materials PM

sop for sampling of sterile raw material

sop for sampling of intermediates and finished products

sop for operation and calibration of friability test apparatus

sop for approval and rejection of packaging materials

sop for non conformance of RM PM and finished product

sop for collection storage and disposal of control samples

sop for trend analysis of finished products

sop for Chromatographic practices and system suitability

SOP For Good Laboratory Practices

sop for cleaning and operation of sieve shaker

general specification of packing material cartons

sop for Password for Analytical Instrument and LIMS software

sop for Rounding off numerical analytical results

sop for sampling of bulk and finished product

sop for cleaning of spillage material

sop for Handling of Reference Standard

sop for hplc column maintenance and washing

procedure for sampling and handling of bulk sample

STP for borewell generation point (raw water storage tank)

sop for preparation and standardization of 0.1M Zinc Sulphate

Operation &calibration of analytical balance (dhona)

Operation and Calibration Procedure for Disintegration Test apparatus

sop for preparation and standardization of 1 M Hydrochloric Acid

Preparation and standardization of 0.1 M ceric ammonium sulphate solution

sop for preparation and standardization of 0.05 m iodine solution

validation of volumetric solution 0.1m ammonium thiocyanate

handling of reference standard and preparation of working standard

sop for water sampling and analysis

sop for operation for validation of excel worksheets

sop for laboratory cleaning

sop for stability of volumetric solutions

sop for preparation of raw material in process finish product packing material data sheets

sop for handling of hazardous chemicals

sop for handling of glassware and allocation of identification number

sop for operation cleaning and calibration of bursting strength tester

sop for rounding off the analytical test results

procedure for Analyst Qualification

sop for operation and calibration of dissolution Apparatus

procedure for maintenance of desiccators

sop for for hplc column receipt checking id no and regeneration

safety data sheet for laboratory chemicals

procedure for handling of poisonous chemicals

sop for cleaning of sampling devices

sop for calibration procedure of instruments

sop for specification and standard testing raw material packing material and finished product

procedure for operation and calibration of potentiometric titrator

procedure for operating and calibration of digital hardness tester

procedure for disposal of expired chemicals, reagents and solvents

sop for behavior in quality control department

sop for preparation and standardization 0.1M sodium thiosulphate

sop for preparation and standardization 0.1M Disodium Edetate

preparation and standardization 0.1M Sodium Hydroxide Solution

Preparation and standardization of 0.1M Perchloric acid solution

sop for preparation 0.05M edetate disodium

sop for preparation 0.1M silver nitrate

sop for Operation and Calibration of High Performance Liquid Chromatography

sop for UV & Visible Spectrophotometer

procedure for Cleaning of laboratory glassware

Cleaning of Instrument, Instrument bench and surrounding area of Quality

Safety Precaution in Quality Control Department

Operation & Calibration of Analytical Balance

Calibration of Glassware in Quality Control Department

handling of samples received in Quality Control

Cleaning and Operation of Refrigerator

Operation, Cleaning and Calibration of water bath

Operation & Calibration of Refractometer

Operation and Cleaning of Centrifuge Apparatus

cleaning, operation & calibration of Vernier caliper

Calibration of Fourier Transform Infrared Spectrophotometer (FTIR)

Cleaning and operation of Moisture Analyzer

Cleaning & Operation of Vacuum pump in Quality Control Department

Operation and Calibration of Polarimeter

Cleaning and operation of Magnetic Stirrer

Cleaning Operation and Calibration of Melting Point

Operation Cleaning and Calibration of Muffle Furnance in Quality Control Department

procedure of operation and Cleaning of Sonicator

Operation Cleaning & Calibration of pH meter in Quality Control Department

Entry and Exit in Quality Control Department

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