Objective: To provide a written guideline for leak testing of welded caps by Blue Bath Test.
Scope: This SOP shall be applicable for Autoclave Area.
Associated Documents: Form No. PS001-01 Batch Manufacturing Record
Responsibility:
1. Engineering Officer/Asst. Engineering Officer shall be responsible for testing the welded caps.
2. Sr. Asst. Manager, Engineering or his/her Designee shall be accountable for the implementation of the procedure.
Abbreviations: Not applicable.
Precautions: Not applicable.
Procedure:
1. Eight numbers of cap welded bottles (take one bottle from each heater of Cap Welding Machine) shall be collected from the collection bin located in autoclave area.
2. These bottles (cap facing downward) shall be kept in the desiccator, which contains blue coloured water (food colour used). The lid of the desiccator shall be closed and the vacuum pump shall be started. The vacuum pressure of desiccator shall be raised to 50 – 60 cm mercury and the test shall be continued for three minutes. Then the vacuum pump shall be stopped and the vacuum pressure of desiccator shall be released by opening valve. After releasing the vacuum pressure, the bottles shall be taken out and the welded caps shall be checked.
3. If bottles are not properly sealed, blue color shall penetrate through the faulty welded zones of the cap heads. If welding is proper, there shall be no scope of such penetration. The results of the test shall be recorded in checklist (Form No. PS001-01). The test shall continue in every 30 minutes during production.
4. If result shows faulty welding, Autoclave operator shall immediately inform it to Bottelpack Officer. Bottelpack Officer shall then do the necessary adjustment of cap welding machine.
5. In addition, all the bottles during the time interval between test failure and the previous testing time shall be tested. Responsible Engineering Officer must be present there to verify this testing.