sop for operation and calibration of friability test apparatus
1.0 OBJECTIVE
To lay down the procedure for operation and calibration of friability test apparatus
2.0 RESPONSIBILITY
Quality Control Chemist / QA Chemist
3.0 ACCOUNTABILITY
Quality Control Manager / QA Manager.
4.0 PROCEDURE
GENERAL CLEANING
4.1 Clean the apparatus free of dust with dry cloth from out side every day.
4.2 Clean the rotating disc and unloading pan from inside with dry cloth at the start and end of every operation.
Wet cloth may be used occasionally if cleaning is not proper with dry cloth but this should follow drying of
the inner surface by first wiping with dry cloth and exposure to atmosphere air.
5.0 OPERATING INSTRUCTIONS
5.1 Ensure that apparatus is properly connected with power supply.
5.2 Weigh tablets to be tested and record the weight (WI)
5.3 Switch on the main switch of power supply.
5.4 Press MODE key and select count mode.
5.5 Press SET button and set the RPM to 100 with the help of keys.
5.6 Press SET and then press START button.
5.7 The apparatus will ask for the weight of the tablets. Enter the weight of the tablet with the help of
keys and press ENTER.
5.8 Load the weighed tablets in the drum, close the lid and secure it by tightening he screw and press ENTER and then press START to run test.
5.9 After the completion of set rotations, the apparatus will automatically unload the tablets into the tray. Observe the tablets.
5.10 Dedust the tablets, weigh and record the weight {W2} and enter the observed weight with the help of
keys and press ENTER.
5.11 Some type friability tester will display the percentage friability or Calculate the percentage Friability by the following formula;
Initial Wt. of Tablets (W1) – Wt. of tablets After 100 rotation (W2) x 100
Initial Wt. of Tablets (W1)
5.12 Destroy the tested tablets as per SOP
6.0 CALIBRATION PROCEDURE
6.1 Switch on the power supply.
6.2 Set the RPM to 25 and start the machine simultaneously with the stop watch. Count the actual rotations and not the time required for the same.
6.3 Similarly set the RPM to 100 and note the time required and actual rotations.
6.4 Apparatus is in proper working condition if,
(I) Time required for 25 rotations is 1 min ± 05 sec.
(II) Time required for 100 rotations is 4 min ± 20 sec.
6.5 Record the observation in the calibration record as per Annexure – 1.
6.6 Affix a “Calibration Status” label on the instrument.
6.7 In case of any discrepancy , report the observations to QC manager / QA Manager and notify the defect to Engg. Department.
Affix an ‘UNDER MAINTENANCE” label on the instrument.
7.0 FREQUENCY :
Once in a month and after each maintenance work
ANNEXURE – 1
Name of Instrument
: Friability Test Apparatus
Instrument Ser. No. :
Make & Model :
Calibration date :
Calibration due on :
| Sr. No. | SET ROTATION | ROTATIONS DISPLAYED | ROTATION OBSERVED MANUALLY | TIME | ACCEPTANCE CRITERIA |
| 1 | 25 | 1 min ± 05 sec | |||
| 2 | 100 | 4 min ± 20 sec |
REMARKS : Satisfactory / Not satisfactory.
CALIBRATED BY: CHECKED BY :
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