Standard Operating Procedure of Standard Operation Of Tablet De-Duster is describe in this post.
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1 PURPOSE
1.1 It is established to provide a system of operation for Tablet De-dusting.
2 SCOPE
2.1 It is applicable to Production Department of Pharmaceuticals.
3 RESPONSIBILITIES & AUTHORITIES
3.1 Supervisor
3.2 Machine Operator
4 REFERENCE
4.1 Quality Management Manual
5 DEFINITIONS
5.1 List of GMP Techniques
6 PROCEDURE
6.1 Replace ``CLEANED`` label with ``UNDER PROCESS`` label.
6.2 Align tablet feeding mouth of de-dusting machine with tablet outlet chute of compression machine.
6.3 Switch ``ON`` the equipment with the compression machine.
6.4 Collect the de-dusted tablet in a double poly lined bag containers.
6.5 Collect fine powder from powder collection box and treat it as recoverable.
6.6 On completion of operation ``OFF`` the equipment.
6.7 Remove the dusting collector cup from the shifter chamber.
6.8 Collect and weigh the dust.
6.9 Record the weight in the relevant document.
6.10 Replace the ``UNDER PROCESS`` label with ``TO BE CLEANED`` label.
7 PRECAUTION
7.1 Do not give sample from wet surface
7.2 Allow the water to run for 5 minutes before its use.
7.3 Do not allow stagnant water at any place in equipment / container.
7.4 Do not cleaned only the equipment desired for change over, all equipment in the same room will undergo cleaning in case of product change over.
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