Operation and Calibration Procedure for Disintegration Test apparatus
1.0 OBJECTIVE -To lay down the procedure for operation and calibration of disintegration test
Apparatus.
2.0 SCOPE -This SOP is applicable for operation and calibration of disintegration test apparatus
3.0 RESPONSIBILITY – Execution – officer QC
Checking – Assistant Manager
4.0 ACCOUNTABILITY – Manager Quality Control
5.0 PROCEDURE
5.1 Ensure that the power supply to the apparatus is switched OFF before cleaning. Clean the
Equipment with a clean dry cloth per day. Occasionally wet cloth dipped in dilute soap solution
May be used. Precaution has to be taken to clean the equipment immediately with dry cloth to
Remove the moisture.
5.2 Clean the beaker and basket at the end of every operation.
6.0 OPERATING INSTRUCTIONS
6.1 Ensure the apparatus is properly connected to the power supply.
6.2 Switch ON the power.
6.3 Fill the beaker of DT apparatus with Purified water in sufficient quantity and adjust the
Temperature 37°C ( between 35°C to 39°C)
With Keys located on the front side of the instrument
6.4 Fix the beaker in its position and adjust the level of water so that when the basket is in upper most position,
wire mesh of the basket is 25 mm below the water level, and when it is at lower most position the wire mesh is at least 25 mm above the bottom of the beaker.
6.5 Once the set temperature is attain 37 ± 2 OC.
6.6 start the instrument and carefully watch. Observe the tablets.
6.9 In case of dispersible tablets, water temperature should be maintained within 15 to 25 OC.
6.1.1 Place on tablet / capsule in each of the tube and insert a disc in each of the tube.
6.1.2 Start the apparatus and Note the time taken by the last tablet / capsule for complete
Disintegration.
6.1.3 Switch OFF the apparatus and power supply after the test is over, clean the basket, discs and
Beaker.
7.0 CALIBRATION PROCEDURE
7.1 Start the basket – rack assembly and Timer simultaneously.
7.2 Place the standardized calibrated thermometer to record the actual temperature against the
Temperature set.
7.3 Note the temperature of water in the beaker and Oscillation per minute of the basket-rack
Assembly.
7.4 Switch OFF the apparatus and record the observations in the calibration record as per
Annexure –1.
Report and discrepancy observed during calibration or operation of the instrument to Quality
Manager and notify the defect to Service Engineer to rectify the defect. Affix ‘Under
Maintenance ‘label on the instrument.
8.0 ACCEPTANCE CRITERIA
8.1 The temperature shall be between 37 ± 2 OC.
8.2 Oscillation per minute of basket rack shall be between 29 to 32 per minute.
9.0 FREQUENCY OF CALIBRATION
Once in 6 month and after each maintenance job.
10.0 ABBREVIATIONS & ANNEXURES
DT = Disintegration test
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 operation of infrared moisture balance
sop for preparation of mobile phase
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 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
