SOP on Decartoning of Vials.

September 24, 2016March 5, 2024 Pharma Editor

Objective:

To lay down a procedure for Decartoning of Vials.

Scope

This SOP is applicable for Decartoning of vials.

Responsibility

Production officer / Executive.

Accountability

Production Head and Head QA shall be accountable for the compliance of SOP.

Abbreviations

Not Applicable

Procedure

Get the vials issued as per the batch requisition slip from warehouse and verify the quantity and analytical report number.

Dedust the shipper of vials using a lint free cloth in decartoning room.

Cut and remove the outer poly bag of the shipper, clean the shipper with lint free cloth in the vial decartoning room.

Keep the shipper on the loading station. Open the box from topside.

Activate the pneumatic mechanism such that the platform is raised slightly above the level of the inspection station.

Transfer the vials manually by pushing with the stainless steel plate to the inspection station.

Inspect the vials for any defects like, Moulding, Vial neck, Crack/Broken defects, and Black and Brown spot. and keep the defective vials in the rejected trays.

Push the good inspected vials in to the plastic tray and load these vials in vial washing machine.

Count the rejected vials and enter the rejected vials in Batch Production Record.

Record the operation details in Batch production record.

Forms and Records (Annexures)

Not Applicable

Distribution

Master copy – Quality Assurance

Controlled copies- Quality Assurance, Production

History

Date	Revision Number	Reason for Revision
–	00	New SOP

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