This video is about Qualification of Vial washing machine part 04 of 04, Visible Particle Removal Test
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What is vial or Ampole?
A vial and ampoule washing machine clean the vial and ampoules by removing foreign particles, contaminants, dirt etc. from the internal and external surface of the vial or ampoule by the use of water.
List of tests to be carried out for vial washing machine qualification:
Soluble matter removal study.
Insoluble particulate matter removal study
Residual water determination test
Visible particle removal test
Procedure:
Prepare 5% w/v sodium chloride solution. (qty. as per requirement)
Mark the required nos. of vials with permanent marker for identification.
Spike the unwashed vials with prepared NaCl solution and dry the spiked vials overnight or at least 8 hours under UAF.
Place the spiked vials in series on the infeed of the vial washing machine.
Keep positive controls of spiked vials separately for testing.
Run the vial washing machine as per SOP.
After washing collect the marked washed vials from the outfeed.
Send the washed vials and unwashed vials (Positive control) separately to QC lab for chloride content testing.
If any failure observed then initiate deviation as per SOP.
Acceptance Criteria:
All the challenged vials should show negative results i.e. absence of chloride content.
Positive control vials should show presence of chloride content.
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