Standard Operating Procedure of Loading Of Ampoules And Vials In Hot Air Oven For Sterilization in Phamra is describe in this post.
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1 PURPOSE
1.1 To provide the method for placing the washed ampoule and vials in the dry heat sterilizer oven
2 SCOPE
2.1 This SOP applies to the loading of glass vials and ampoules in the dry heat sterilizer (oven) in sterile Injectable area
3 RESPONSIBILITIES & AUTHORITIES
3.1 Section Pharmacist
3.2 Section Supervisor
3.3 Quality Assurance officer
3.4 Operator
4 REFERENCE
4.1 Quality Management Manual
5 DEFINITIONS
5.1 List of Technical Definition
6 PROCEDURE
6.1 Open the door from loading side ensuring that the door is closed from other side
6.2 Clean the drying oven with some lint free cloth
6.3 Load the ampoules loaded trays (ampoule should be in inverted position) in the sterilizer
6.4 Close the door of the sterilizer
6.5 Switch ON blower by pressing red button on the switchboard
6.6 Adjust the time and temperature on PLC
6.7 Adjust required temperature and time on controller panel
7 DOCUMENTS / RECORDS
7.1 Area Cleaning & Sanitation (Sterile Working Area)
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