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1.0 OBJECTIVE
To set up a procedure for the operation, cleaning and calibration of Dose Uniformity Sampling Apparatus (DUSA) for DPI.
2.0 SCOPE
This SOP is applicable for operation, cleaning and calibration of Dose Uniformity Sampling Apparatus (DUSA) for DPI.
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 QC Manager or his/her nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 When testing DPI, air flow should be drawn continuously through the system to avoid loss of drug into the atmosphere.
5.2 The filter disk must be compatible with solvent that are used to rinse the drug from the filter.
5.3 When assembled, the joints between the components of the apparatus should be air tight so that when a vacuum is applied to the base of the filter all of the air drawn through the collection device passes through the inhaler mouthpiece.
5.4 Ensure that the instrument is clean and dry before use.
5.5 During calibration ensure that all the equipment viz. stop clock, pressure gauge are calibrated.
6.0 PROCEDURE
6.1 Operation
6.1.1 Attach the mouth peace adapter at one end of the collection tube.
6.1.2 Attach filter support base with an open mesh filter support and a 47 mm diameter suitable filter paper at other end of the collection tube which is ultimately connected with a system comprising vacuum source throw critical flow controller.
6.1.3 Attach a hose Connecting P1 of critical flow controller and a small port at the side wall of the DUSA.
6.1.4 Turn on the power of the vacuum pump and critical flow controller.
6.1.5 Set a high value on the timer.
6.1.6 Adjust the flow rate as describe in the test method using screw valve.
6.1.7 After few seconds of the vacuum pump running, set the DPI capsule holder in front of the mouth peace so that it became air tight and then discharge the capsule by pressing the button both side of the capsule holder into the apparatus through mouthpiece adapter. After discharge the adequate number of capsule wait for a little while and then turn off the pump.
6.1.8 Detach the inhaler from the dosage unit sampling apparatus and disconnect the vacuum.
6.1.9 Rinse the filter and the interior of the connection tube with the prescribed quantity of diluent as specified in the respective testing procedure (STP) and collect for analysis.
6.1.10 Fluid tight caps can be used to enclose both ends of the connection tube, including the filter and the mouthpiece adapter, during the dissolution of active ingredient in a fixed volume of ringing solvent.
6.1.11 Shake to dissolve the active ingredient completely.
6.1.12 Open one end of the collection tube and transfer the solution to a sample container.
6.2 Cleaning Procedure
6.2.1 All the parts of the DUSA should be washed firstly with sufficient quantity of water then with methanol (GR grade) thoroughly and then dried immediately.
6.2.2 Fill up the log book for Dose Uniformity Sampling Apparatus (Annexure-I).
6.3 Calibration
6.3.1 Fit a fitting cap on to one side and fill the DUSA with water.
6.3.2 Close the open end of the DUSA with the other sealing cap.
6.3.3 Shake well and check whether the DUSA is liquid tight.
6.3.4 If not check and change the gasket if required. Repeat the procedure again.
