SOP for Entry, Exit and Gowning procedure for Powder Processing Area

PURPOSE

To define Procedure for Entry, Exit, and Gowning procedure for the Powder Processing Area.

SCOPE

This procedure is applicable to the Entry, Exit, and Gowning of personnel for the Powder Processing Area in the Production Department at PharmaInfo Ltd.

RESPONSIBILITY

Assistant –Production

Executive - Production

ACCOUNTABILITY

Head - Production

PROCEDURE

Entry Procedure

• All operating personnel assigned to work in the powder processing area of the Production block will enter the first airlock.
• Remove the helmet and place in the cupboard.
• Enter into the gowning room and wear shoe covers and a head cap.
• Cross over to the other side.
• Put on the bunny suit.
• Disinfect the hands with disinfectant and wear the hand gloves.
• Look into the mirror to ensure the integrity of the gowning.
• Enter the corridor after ensuring that the corridor is at a higher pressure than the change room, it should not be less than 1.25 mm of the water column.
• Enter into the powder processing area corridor, from there to the wet area (centrifuge, dryer) compaction, milling, sifting, blending, packing, and quarantine area.

Exit Procedure

• After completing the activity in the powder processing area enter the corridor.
• Enter into the gowning room.
• Remove the bunny suit, head cap, and shoe covers and put them in the bin. Put the hand gloves in the used gloves bin.
• Cross over to the other side.
• Enter into the airlock and wear a helmet.
• Enter into the corridor.

ANNEXURE

Nil

REVISION HISTORY

Nil

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