To lay down the procedure for Operation of Vacuum Test Apparatus.
This SOP shall be applicable for Vacuum test Apparatus in Packing Area at Production department.
3.1 Execution : Operator
3.2 Checking : Production Pharmacist & Above
HOD-Production / Assigned Designee
5.1 Check the Apparatus for cleanliness.
5.2 Take the desiccator & fill with 1 liter of purified water containing Methylene Blue solution up to the Mark. Change the purified water of desiccator every day and when required.
Note: About 5 ml of 0.1 % Methylene Blue solution to be used.
5.3 Place the number of strips or blisters as mentioned in respective BPR (batch packing record) in desiccator inside the plate.
5.4 Close the lid of the desiccator properly.
5.5 Switch “ON” the mains.
5.6 Apply vacuum to the mark of 15 inch Hg. for 30 Secs. & hold it for 2 minutes.
5.7 Release the vacuum slowly and wait for 5 minutes.
5.8 Switch “OFF” the mains.
5.9 Open the desiccator, remove the strips / blisters from it, and wipe the strips & dry with cotton cloth. Check the strips/ blister for leakage (by opening the tablets from strips/blisters & by Observing if there is any blue coloration of the tablets due to methylene blue solution).
5.10 Any tablet found in blue color on the surface of tablet it means fail in leak test, again repeat the test.
5.11 Destroy all the tablets taken for leak test by dissolving in water.
5.12 Repeat the Leak test as per the instruction on batch packing record and maintain the record.
5.13 Perform the vacuum tests again if found the above samples failed, in presence of Q.A. person.
5.14 If the above tests are not satisfactory, carry out the necessary adjustments of the Strip / Blister machine and perform more vacuum tests for the sample of strips/blisters withdrawn directly from the machine till the results are satisfactory.
5.15 If the leak test is not satisfactory, perform test for the samples from the packed
DFC during this period. All
the Strips/Blisters from the box which fails in vacuum test shall be reworked.
5.16 Water filled in the desiccator should be changed every day.
6.1 SOP: Standard Operating Procedure
6.2 BPR: Batch Packing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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