SOP for collection and disposal of waste & rejected material from plant

November 26, 2016February 3, 2023 Pharma Editor

Objective:
To lay down a procedure for collection and disposal of waste & rejected material from plant.
Scope:
This SOP is applicable for collection and disposal of waste & rejected material from plant.
Responsibility:
Officers or above – Production.
Accountability:
Production Head.

Abbreviations
SOP : Standard Operating Procedure.
S.S. : Stainless Steel
WFI : Water for Injection

Procedure:
Critical area:Collect the broken and rejected vials & rubber stoppers in S.S. tray.
Transfer these trays to the controlled area through Dynamic pass box.
Collect waste water or disinfectant solution used for cleaning/mopping in a Pressure vessel.
Attached compressed air line with tube to the inlet of pressure vessel and discharge outlet nozzle to flexible discharge tube to the drain provided in equipment wash area through the S.S. connecting pipe provided in the wall panel.
Slightly open the compressed air valve and allow the waste water to drain out.
Rinse the vessel with fresh WFI and dispose the rinse water.
Transfer the used sterile area garments from return change room to garment washing room for further washing.
Transfer the used hand gloves from return change room to Equipment wash Area and discard the hand gloves.
After cleaning & sanitization of critical area take out the used sponge pieces from return change room and discard them and lint free duster for washing & Sterilization.

Controlled area:
Collect the broken and rejected vials, rubber stopper, flip of seals and waste material in poly bag.
Check the material in poly bag and transfer for disposal as per SOP.
Uncontrolled area:
Collect the rejected printed packaging material like unit cartons, pack insert & vial label in poly bag.
Inspect the rejected printed material & ensure that no unused material in poly bag.
Collect the rejected waste packaging material like corrugated box, WFI, ampoules & rejected shippers of vials, rubber stoppers & seals in a separate poly bag.
Destroy the collected material in scrap yard area.

Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control
History

Date Revision Number
Reason for Revision

– 00 New SOP

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