SOP for Vial Washing

Purpose

This procedure provides an establishment of standard procedure for Vial Washing.

Scope

It applies to the HPLC section of the Quality Control department at PharmaInfo Ltd.

Responsibilities

QC Analyst

QC Worker

Procedure

Vial washing is done in two steps

1. Pre-washing

2. Final washing

Pre- Washing

• Wear the mask and cover the hair properly with a cap.
• Stack the vial cartons received from the store on the clean pallet in the de-cartoning area.
• Wash thoroughly the sinks of the washing station and drain out any dirty water.
• Fill the sinks of washing stations up to half with tap water.
• In sink-1, add one bottle of liquid hands to make lather.
• Pick up one carton of the vial from the de-cartoning area, remove its secondary packing, and dip the vials in the sink. Discard primary packing in the dust bin kept for this purpose in the de-cartoning area.
• Add to the 2-3 vials cartons similarly.

• Brush each of the vials in a sink with nylon material from inside and outside.
• Transfer each of the brushed vials to sink-2.
• In sink-2 give the vial individually a rinse of tap water by filling the vials with water in the sink and emptying in the same sink.
• Rinse each of the vials two times in this way and drop it into the sink -3.
• In sink-3, the rinsing process is repeated and the vials are arranged in the washed SS trays.
• In the trays, vials are placed with their neck downward These vials are ready for final washing.
• A cycle of washing from Sink-1 to Sink-3 is repeated for the whole batch.
• Water in the three sinks is changed with a fresh one after it gets dirty.

Final washing

Give the pre-washed a final washing on the “ vial washing machine” following the Standard Operating Procedure for “Vial Washing Machine.

Abbreviations

SOP: Standard Operating Procedure

QC: Quality Control

Annexure

Nil

Revision History

Nil

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