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SOP for Entry in and Exit from the Suspension Manufacturing


Standard operating procedure of entry in and exit from Form Fill Seal (FFS) filling area.

1.0 PURPOSES: 

This document deals with the procedure for entry in and exit from the Suspension Manufacturing and Form Fill Seal filling area.

2.0 SCOPE: 

Applicable suspension manufacturing and FFS filling area.

3.0 RESPONSIBILITY: 

Personnel working in Form Fill Seal department.

4.0 ACCOUNTABILITY:

Head of Department

5.0 PROCEDURE:

5.1 Entry procedure :

5.1.1 Press the green colour “ Door Release “ push button, to release the door interlock of door opening into change room I
5.1.2 Enter into change Room I, remove the factory clothing and foot wear and keep them in the cubicle.
5.1.3 Wipe the palms with Sterillinium.
5.1.4 Press the green colour “ Door Release “ push button, to release the door interlock of door opening into change room II
5.1.5 Enter the Change Room II by opening the door of second change room with the elbow, without contaminating the wet hands.
5.1.6 Pick up a pair of sterile hand gloves from the glove box kept in the Garment Cubicle. Put on the gloves and dispose the wrapper in the waste bin provided.
5.2.1 Enter Return change room I by pushing with elbow the door opening into Return change room I.
5.1.6.1 Pick up a bag of sterilized garments from the garment cubicle and wear in the following manner
5.1.6.2 Open the bag and remove the set of sterile garment and place the empty bag on the hook provided in the garment cubicle.
5.1.6.3 Open the zipper of the sterile suite and hold the sleeve ends to the garment waist.
5.1.6.4 Gather the material of the coverall, making the length of the coverall as short as possible, still allowing room for feet to enter into the leg opening.
5.1.6.5 Place each foot in the gathered coverall leg and release the coverall material as it is pulled up the leg.
5.1.6.6 Once both the legs are in the coverall, place each arm carefully in the sleeves and pull upper portion on.
5.1.6.7 Put on the Hood fasten the nose covering. Tuck in the lower part of the hood in the neck of the coverall.
5.1.6.8 Completely Zip the Zipper of the coverall. Fasten the sleeve end adjustment, if available and tuck the sleeves in the hand gloves.
5.1.6.9 Fasten the straps of the bootie and waist belt provided Press the green colour “ Door Release “ push button, to release the door interlock of door opening into change room III
5.1.8 Disinfect the gloved hands with Sterillium and enter into change room III by pushing with the elbow the door opening into change room III.
5.1.8 Pick up the second pair of powder free sterilized hand gloves and put on the previous hand gloves. Care should be taken not to contaminate outside of the gloves with the hands. wrapper in the waste bin provided.
5.2.1 Enter Return change room I by pushing with elbow the door opening into Return change room I.
5.1.9 Press the green colour “ Door Release “ push button, to release the door interlock of door opening into aseptic area
5.1.10 Swab the gloves with disinfectant solution and enter into aseptic room by pushing with the elbow the door opening into the aseptic area.

5.2 Exit Procedure –

5.2.1 Press the green colour “ Door Release “ push button, to release the door interlock of door opening into aseptic area
5.2.2 Enter into change room III by pulling with the handle the door opening in the aseptic area.
5.2.3 Press the green colour “ Door Release “ push button, to release the door interlock of door opening into change room III
5.2.4 Enter in change room II by pulling with the handle the door opening in change room III.
5.2.5 Pick up the garment bag from the hook of garment cubicle.
5.2.6 Press the green colour “ Door Release “ push button, to release the door interlock of door opening into change room II
5.2.7 Enter in change room I by pulling with the handle the door opening in change room II.
5.2.8 Remove the gloves and dispose in the waste bin.
5.2.9 Remove the garment and place in the garment bag, dispose them in the bin provided.
5.2.4 Wear the factory clothing and foot wear.
5.2.5 Press the green colour “ Door Release “ push button, to release the door interlock of door opening into change room I
5.2.12 Come out of change room I by pulling with the handle the door opening in change room I.
NOTE: Maximum No. of person allowed to enter in the Filling area : 4 Persons. Suspension manufacturing : 2 Persons.

6.0 ABBREVIATIONS:

FFS: FORM FILL SEAL
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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