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Wednesday, May 12, 2010

STANDARD OPERATING PROCEDURE Title: Shoes Washing

1. Purpose
1.1 It is established to provide a standard procedure for “Shoes Washing” used in general areas of sterile sections (i.e.; ampoule, sterile powder filling & ophthalmic).
1.2 Procedure is established to avoid dust/soil/dirt in sterile mfg areas carried by the personnel shoes.
2 Scope
2.1 It is applicable in Sterile Manufacturing Sections.
2.2 Procedure is applicable for collective shoes; for individual shoes appropriate washing procedure may be adopted dust/soil free shoe being the criteria.
3 Responsibilities
3.1 Production Pharmacist
3.2 Supervisor
3.3 Worker
4 Procedure
4.1 Schedule of Washing
4.1.1 Daily after working.
4.1.2 At any time when the shoes are dirty.
4.2 Washing Steps
4.2.1 Take 50 Liters of water in the clean tub/bucket etc.
4.2.2 Add to it sufficient of liquid detergent to give rich foam.
4.2.3 Dip in the above solution shoes one by one after cleaning & scrubbing with the nylon brush in order to remove any soil or sticky dirt.
4.2.4 Keep the shoes soaked in solution for 20 minutes.
4.2.5 Scrub each of shoes with nylon brush while dipped in solution.
4.2.6 Drain the solution & rinse the washed shoes with plenty of clean water.
4.2.7 Let the shoes dry.
4.2.8 Place the shoes in shoe rack kept in entrance buffer of sterile section after cleaning shoe rack.
4.2.9 Record the washing in Shoes Washing Log Book.
5 Required Quality Record
5.1 Shoe Washing Log Book. (QF/ 183/01)

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