Dear sir /mam
What is
Sop of decartoning of vials ?
SOP of ‘Decartoning of vials’ should include following aspects,
- Objective / Purpose
- Scope
- Responsibilities
- Detailed procedure of decartoning activity (as specified below)
- The room conditions (Temp. & RH) / area details where decartoning will be carried out (Cleanliness class)
- How the vials containing cartons will be transferred to this room
- Collection of vials after decartoning (into closed trays) & transfer to vials washing machine & drying depyrogenation tunnel
- How to transfer and dispose off empty cartones
- Cleaning of area before & after decartoning
- Line clearance checks & certification by QA before start of decartoning activity
- Documentation of entire activity (Log book entries, BMR recording etc.)
- Any other useful information
- References
- Revision History of SOP
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No need to record temperature and relative Humidity
Decartoning is done under class “D”
Temperature and Relative humidity is also to be maintained and monitored as per Clean room class"D" requirements.
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