Decartoning of vials

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

No need to record temperature and relative Humidity

kindly tell about decartoning area under classify area? @sunilrbudhkar

Decartoning is done under class “D”

Temperature and Relative humidity is also to be maintained and monitored as per Clean room class"D" requirements.

1 Like