Follow
1.0 OBJECTIVE
To set up a procedure for the operation and cleaning of Tablet Friability Tester (Model: TA/TAR).
2.0 SCOPE
This SOP is applicable for the operation and cleaning of Tablet Friability Tester (Model: TA/TAR) at Quality Assurance Department of (Compnay Name).
3.0 RESPONSIBILITY
3.1 Operating personnel is responsible for carrying out the procedure.
3.2 Overall responsibility for training, implementation & follow-up with the Head of QA or his/her nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Make sure the knob is properly fitted on the shaft to assure the drum is held in position.
5.2 Do not hold the drum while they are rotating.
5.3 Do not use abrasive, aggressive material or solvents to clean the drum and the tray. If required use mild detergent.
5.4 Do not use wet drum. Make sure the drum is dry when in use.
5.5 Replace the fuse with the correct rating whenever required.
6.0 PROCEDURE
6.1 Operation
6.1.1 Connect the instrument to the mains.
6.1.2 Turn on the power switch of friability tester.
6.1.3 After power on, the drum would initialise itself to the loading position and the instrument will initialise the weighing scale.
6.1.4 The instrument is then ready for the setting of test parameter and to run the test.
6.1.5 Press middle ■ key to set the test parameter as the following way.
6.1.6 Press right ▲▼ keys for selection of rpm.
6.1.6 Then Press left ▲▼ keys for selection of time.
6.1.7 Press middle ► to start the test.
6.1.8 Press ■ key to stop the test, otherwise it will be automatically stopped.
6.2 Cleaning
6.2.1 Remove the knob by pressing gray colored button and open the drum.
6.2.2 Clean the drum with suitable dry duster or cloth.
6.2.3 If required use water and dry in air.
6.2.4 Place the drum properly and replace the knob.
6.3 Operation Log Book
6.3.1 Record the information in the operational log book- “OPERATION LOG BOOK OF FRIABILITY TESTER” as per FRM No.: FQA/085.
6.4 Cleaning Log Book
6.4.1 Record the information in the cleaning log book- “CLEANING LOG BOOK OF FRIABILITY TESTER” as per FRM No.: FQA/086.
