SOP for Entry and Exit into Form Fill Seal (FFS) Area

1.0 PURPOSE

To lay down the procedure for entry in and exit from the Form Fill Seal area.

2.0 SCOPE

This procedure is applicable for entry in and exit from the Form Fill Seal area.

3.0 RESPONSIBILITY

Production Operator/Officer

4.0 ACCOUNTABILITY

HOD Production

5.0 PROCEDURE

5.1 Entry in FFS Area

5.1.1 Enter into change Room I, remove the factory clothing and footwear and keep them in the cubicle.
5.1.2 Wipe the palms and feet with Sterillinium (disinfectant). Use a sterile cloth soaked with Sterillinium for foot wiping.
5.1.3 Dispose of used cloth in the waste bin.
5.1.4 Enter the Change Room II by opening the door of second change room with the elbow, without contaminating the wet hands.
5.1.5 Pick up a pair of sterile hand gloves from the glove box kept in the Garment Cubicle. Put on the gloves and dispose of the wrapper in the waste bin provided.
5.1.6 Pick up a bag of sterilized garments from the garment cubicle and wear in the following manner.
5.1.6.1 Open the bag and remove the set of the sterile garment and place the empty bag on the hook provided in the garment cubicle.
5.1.6.2 Open the zipper of the sterile suite and hold the sleeve ends to the garment waist.
5.1.6.3 Gather the material of the overall, making the length of the coverall as short as possible, still allowing room for feet to enter into the leg opening.
5.1.6.4 Place each foot in the gathered coverall leg and release the coverall material as it is pulled up the leg.
5.1.6.5 Once both the legs are in the overall, place each arm carefully in the sleeves and pull upper portion on.

5.1.6.6 Put on the Hood fastens the nose covering. Tuck in the lower part of the hood in the neck of the overall.
5.1.6.7 Completely Zip the Zipper of the overall. Fasten the sleeve end adjustment, if available and tuck the sleeves in the hand gloves.
5.1.6.8 Fasten the straps of the bootie and waist belt provided.
5.1.7 Disinfect the hands with Sterillinium 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.
5.1.9 Swab the gloves with disinfectant solution and enter into the aseptic room by pushing with the elbow the door opening into the room.

5.2 Exit from FFS Area

5.2.1 Enter Return change room I by pushing with the elbow the door opening into Return change room I.
5.2.2 Enter into Return change room II by pushing with the elbow the door opening in Return change room II.
5.2.3 Remove the hand gloves and dispose of them in the waste bin.
5.2.4 Remove the garment and dispose of them in the bin provided.
5.2.5 Wear the factory clothing and footwear and come out of the change room.
NOTE: Maximum No. of person allowed to enter in the Filling area: 4 Persons.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 FFS - Form Fill Seal

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