Follow
1.0 OBJECTIVE : To set up a procedure for the operation of Single Stage Impactor.
2.0 SCOPE : This SOP is applicable for the operation of Single Stage Impactor.
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 Ensure that the instrument is clean before use, including surrounding area.
5.2 Make sure that the instrument is arranged properly during analysis.
6.0 PROCEDURE
6.1 Place the actuator adapter in position at the end of the throat so that the mouthpiece end of the actuator, when inserted to a depth of about 10 mm, lines up along the horizontal axis of the throat and the open end of the actuator, which accepts the pressurised container, is uppermost and in the same vertical plane as the rest of the apparatus.
6.2 Introduce 7 ml and 30 ml of a suitable solvent into the upper and lower impingement chambers respectively.
6.3 Assemble the impactor carefully by connecting all the component parts.
6.4 Ensure that the assembly is vertical and adequately supported and that the lower jet-spacer peg of the assembly just touches the bottom of the lower impingement chamber.
6.5 Connect a suitable pump to the outlet of the apparatus using a flexible pipe.
6.6 Switch on the pump and adjust the air flow through the apparatus, as measured at the inlet to the throat, to 60 ± 5 liters/min.
6.7 Prime the metering valve by shaking for 5 s and discharging once to waste and then proceed as per Standard Test Procedure (STP) or Pharmacopoeia.
6.8 After the final discharge wait for not less than 5 s and then switch off the pump. Dismantle the apparatus.
6.9 Wash the inner surface of the inlet tube to the lower impingement chamber and its outer surface that projects into the chamber with a suitable solvent, collecting the washings in the lower impingement chamber.
6.10 Calculate the amount of the active substance collected in the lower impingement chamber per discharge and express the results as a percentage of the dose stated on the label as per Standard Test Procedure (STP).
6.11 Cleaning procedure:
6.11.1 Wash all the individual parts of the Single Stage Impactor firstly with water.
6.11.2 Then wash them with methanol (GR grade) thoroughly.
6.11.3 Finally dry the impinger with current of air and then store properly in the designated box.
