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SOP for Operation of Suppository Hardness Tester

OBJECTIVE
This SOP describes the procedure for the operation of ERWEKA Suppository Hardness Tester Type SBT-2.

SCOPE
This SOP applies to the Operation of the Suppository Hardness Tester.

RESPONSIBILITY:
It is the responsibility of QC Executives to follow the procedure without deviation. 

ACCOUNTABILITY:
Assistant Manager – Quality Control 
Manager – Quality Assurance 



DEFINITIONS
  • Tempered suppository: The suppository whose temperature has been adjusted/ reset to measure temperature.
  • Thermostat: A device that monitors temperature and automatically maintains it at certain levels

PRECAUTIONS
  • Before operating the thermostat, the water bath must be filled with water to the marked filling level. Otherwise, the thermostat can be damaged.
  • Do not touch the dry heating rods on the thermostat. You may burn yourself!!!
  • Make sure that the water bath has reached the necessary operating temperature before you start a test.
  • In case of any failure, the housing should only be opened by qualified staff.
  • Before opening the housing, pull the mains plug.

PROCEDURE

Sample Preparation
  • The suppositories to be tested should be rested for at least 24hrs at the required measuring temperature before starting the test. Usually, this temperature is at +25°C.
  • Measure the actual temperature in the measuring chamber using a thermometer.
  • If required, adjust the temperature in the measuring chamber using the thermostat.

Performing Test
  • Set the tester temperature to the required value by using the thermostat.
  • Put the tempered suppository into the holding bracket that is made of red plastic with a tip pointing up.
  • Carefully add the suspension rod assembly.
  • Place the testing assembly into the testing chamber and start the time counting using a stopwatch. The measurement starts. The initial load, determined by the weight of the complete rod assembly is 600g.
  • After one full minute of testing, add an additional weight of 200g (one disc weight).
  • After one minute, add the next weight.
  • Continue the procedure until the suppository breaks under the corresponding total weight.
  • Check the time of the test run on your stopwatch.

Evaluation of Test Results
  • If the suppository collapses under the initial weight of the suspension rod assembly i.e 600 grams, it has a strength value of less than 600 grams implying that the suppository is too soft and therefore not usable.
  • When the suppository collapses within the range of added weights, the strength value is calculated as the total of the suspension rod assembly (600 grams) plus the value of the added weights (200 grams each).
  • The value of the last weight added before the suppository collapses depends on the moment at which the collapse occurs.
  • If the collapse occurs within 20 seconds from the moment the weight is applied, then the value of the weight is rated as zero.
  • If the collapse occurs within 20 to 40 seconds from the appliance of the weight, the value of this weight is counted as 100 grams.
  • If the collapse occurs after 40 seconds from the weight application, then the full value of 200 grams is included in the total applied load sum.

ABBREVIATIONS
QC – Quality Control
QA – Quality Assurance

REVISION HISTORY
Nil

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