Entry and Exit Procedure into injection Parenteral Area

1.0 OBJECTIVE:
1.1 To lay down the Procedure for Entry and Exit into Injection Parenteral Area.
2.0 SCOPE:
2.1 This SOP is applicable for Entry and Exit Procedure into Injection (Parenteral) Area at ……

3.0 RESPONSIBILITY:
3.1 All Officer/Executive/Employee
4.0 ACCOUNTABILITY:
4.1 Production Head
5.0 PROCEDURE:
NOTE: Personnel authorized to enter into Ampoule Washing /Manufacturing/Unit preparation Aseptic Area of Production shall remove the street clothes and keep them in respective provided lockers and wear the factory garments.
5.1 FOR ENTRY (Visitors)
5.1.1 Visitors shall be come with authorized personnel.
5.1.2 Clean the street shoes on the foot mattress provided at the main entrance room.
5.1.3 Press the interlock button, push the door and enter into the Production Change Room.
5.1.4 Wash the hand with liquid soap in the washbasin and dry with automatic hand dryer provided in Change room.
5.1.5 Take a shoes cover provided in SS tray on Cross over bench.
5.1.6 Sit on cross over bench, wear the shoes cover in a manner should not touch the floor and swing leg one by one cross over bench.
5.1.7 Sanitized the hands with 70% IPA Solution.
5.1.8 Take a clean visitor apron, disposal cap and nose mask provided in Garment cabinet.
5.1.9 Wear the nose mask, visitor apron and disposal cap

5.1.10 Check the attire in front of mirror and ensure that hair completely covered under cap and properly gowned.
5.1.11 Sanitized the hands with 70% IPA Solution.
5.1.12 Press the interlock button, pull the door and enter in production corridor.
5.2 FOR EXIT (Visitors)
5.2.1 Press the interlock button, push the door and enter into the change room.
5.2.2 Swing over the cross over bench.
5.2.3 Remove the apron disposed into garment bin.
5.2.4 Remove the nose mask, disposal cap and shoes covers and disposed into waste bin.
5.2.5 Press the interlock button, pull the door come out from the change room entry door.
5.3 FOR ENTRY (Staff)
5.3.1 Only authorized personnel are allowed to enter into the production area.
5.3.2 Clean the street shoes on the foot mattress provided at the main entrance room.
5.3.3 Press the interlock button, push the door and enter into the Production Change Room.
5.3.4 Remove street footwear and keep in shoe locker provided in change room.
5.3.5 Wash the hand with liquid soap in washbasin and Dry with automatic hand dryer provided in change room.
5.3.6 Swing over the cross over bench.
5.3.7 Wear factory slippers provided in cross over bench.
5.3.8 Sanitize the Hands with 70% IPA solution.
5.3.9 Take a clean apron, cap and nose mask.
5.3.10 Wear the apron, cap and nose mask.
5.3.11 Check the attire in front of mirror and ensure that hair completely covered under cap and properly gowned.
5.3.12 Sanitized the hands with 70% IPA Solution.
5.3.13 Press the interlock button, pull the door and enter in production corridor.

5.4 FOR EXIT (Staff)
5.4.1 Push the door and enter into the change room.
5.4.2 Remove the factory slippers.
5.4.3 Swing over the cross over bench.
5.4.4 Remove the Nose mask, apron cap and disposed into garment bin.
5.4.5 Wear street footwear.
5.4.6 Press the interlock button, pull the door and come out from the change room entry door.
5.5 FOR ENTRY (Operator/Helper)
5.5.1 Only authorized personnel are allowed to enter into the production area.
5.5.2 Clean the street shoes on the foot mattress provided at the main entrance room.
5.5.3 Press the interlock button, push the door and enter into the Production change room.
5.5.4 Remove street footwear and keep in shoe locker provided in change room.
5.5.5 Wash the hand with liquid soap in washbasin and Dry with automatic hand dryer provided in change room.
5.5.6 Swing over the cross over bench.
5.5.7 Wear the factory slipper.
5.5.8 Sanitize the Hands with 70% IPA solution.
5.5.9 Collect the factory garments from SS locker.
5.5.10 Wear factory garments in order of cap, shirt and pant.
5.5.11 Check proper gowning in front of mirror and ensure that hair completely covered under cap.
5.5.12 Sanitize hands with 70% IPA solution.
5.5.13 Press the interlock button, pull the door and enter in production corridor.
5.6 FOR EXIT (Operator/Helper)
5.6.1 Press the interlock button, push the door and enter into the change room.
5.6.2 Remove the factory slippers.

5.6.3 Swing over the cross over bench.
5.6.4 Remove the factory Garment disposed into garment bin.
5.6.5 Wear the Street Cloth/footwear from provided in locker.
5.6.6 Press the interlock button, pull the door and come out from change room personnel entry door.

6.0 ABBREVIATIONS:

Sr.No.	Abbreviation used	Full form of abbreviation used
1.	SOP	Standard Operation Procedure
2.	Ltd.	Limited
3.	PI	Injection Parenteral
4.	IPA	Isopropyl alcohol