Visitor Entry and Exit Procedure in the Manufacturing Area is essential in pharmaceutical industries to prevent contamination and cross-contamination.
1.0 Purpose: This document outlines the procedure for managing the entry and exit of visitors within the manufacturing area.
2.0 Scope: This procedure is related to the entry and exit of visitors in the manufacturing area.
3.0 Responsibilities: Officer, Executive- Production and Quality Assurance Department.
Manager- Production and Quality Assurance Department
4.0 Definitions:
No
5.0 Procedure:
5.1 Entry Procedure into Primary Change Room:
5.1 Enter the primary change room.
5.1.1 Wash hands using water from the sink in the washroom and dry them.
5.1.2 Retrieve the apron, cap, and shoe cover from the designated rack.
5.1.3 Put on the shoe cover before crossing the crossover bench.
5.1.4 Wear the dedicated cap and apron.
5.1.5 Use the mirror to ensure proper gowning.
5.1.6 Sanitize hands with a 70%v/v IPA solution before entering the secondary change room.
(Note: Cross the bench by sitting and swinging legs alternately, ensuring the shoe cover doesn’t touch the entry floor.)
5.2 Entry Procedure into Manufacturing Area:
5.2.1 Enter the secondary change room.
5.2.2 Takes fresh shoe covers, a secondary overgown, and a nose mask.
5.2.3 Wear washed shoe covers over the existing ones when crossing the crossover bench.
5.2.4 Put on the secondary overgrown and then wear the nose mask.
5.2.5 Sanitize hands with a 70%v/v IPA solution before entering the processing area.
5.3 Exit Procedure from Manufacturing Area:
5.3.1 Remove the secondary gown.
5.3.2 Dispose of used secondary gowns in the provided cabinet.
5.3.3 Discard the used shoe covers (worn in the secondary change room) and nose mask in the designated waste bin.
Related SOP: SOP on Preparation of Cleaning and Sanitizing Solution in Manufacturing Area
5.4 Exit Procedure from Primary Change Room:
5.4.1 Enter the primary change room.
5.4.2 Cross the bench.
5.4.3 Remove the apron, cap, and shoe cover, and discard them in their respective bins.
5.4.4 Exit through the main door of the changing room.
6.0 Abbreviations:
SOP: Standard Operating Procedure
No.: Number
IPA: Isopropyl Alcohol
v/v: Volume by Volume
7.0 References:
No specific references apply to this procedure.
8.0 Annexures:
None