Standard Operating Procedure of Sop For Unloading Of Ampoules/Vials Form Hot Air Oven is describe in this post.
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1 PURPOSE
1.1 To provide the method for the unloading of ampoules/vials from autoclave in inject able section.
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 Close the valve of steam supply.
6.2 Open the valve of drain pipeline.
6.3 Open the door of autoclave, after attaining pressure zero.
6.4 Unload the autoclave, transfer trays of filled ampoules/vials to transfer trolley for shifting.
6.5 Clean the autoclave with Lint-free cloth. (After making sure that door is closed from other side)
7 DOCUMENTS / RECORDS
7.1 Machinery/Equipment Cleaning Logbook
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