SOP FOR UNLOADING OF AMPOULES OR VIALS FORM HOT AIR OVEN

SOP for Unloading of Ampules/Vials from Hot Air Oven

Purpose:

To ensure the safe and efficient unloading of ampules/vials from the hot air oven.

Scope:

This SOP applies to the unloading of ampules/vials from the hot air oven in the pharmaceutical manufacturing facility.

Responsibilities: The operator is responsible for unloading the ampules/vials from the hot air oven.
The quality assurance (QA) inspector is responsible for verifying that the ampules/vials have been unloaded in accordance with this SOP.

Procedure:

Large Scale:

Close the valve of the steam supply.
Open the valve of the drain pipeline.
Open the door of the autoclave, after attaining pressure zero.
Unload the autoclave, and transfer trays of filled ampoules/vials to the transfer trolley for shifting.
Clean the autoclave with a lint-free cloth. (After making sure that door is closed from the other side)

Small Scale

The operator will open the door of the hot air oven.
The operator will use a pair of tongs to carefully remove the ampules/vials from the oven.
The operator will place the ampules/vials on a clean, dry surface.
The QA inspector will visually inspect the ampules/vials to ensure that they are free of cracks, chips, or other defects.
The QA inspector will sign and date the logbook to verify that the ampules/vials have been unloaded in accordance with this SOP.

Records: A logbook will be maintained to record the date, time, and name of the operator who unloaded the ampules/vials from the hot air oven. 

Machinery/Equipment Cleaning Logbook    

Deviations:

Any deviations from this SOP must be documented and investigated.

Training:

All personnel who are responsible for unloading ampules/vials from the hot air oven must be trained on this SOP.

Review:

This SOP will be reviewed annually to ensure that it is still current and accurate.

Reference

 Quality Management Manual

Defination

List of GMP Techniques

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