Sterilization of dresses used in Sterile Work Area

1.     Purpose:-                         

                          To ensure effective sterilization of protective clothing.
2.     Scope:-

                      This procedure applies to sterilization process for protective dresses used when performing sterility tests in Microbiology lab.
3.     HSE Statement:-

                                           Asbestos Gloves
4.     Responsibilities:-

                               i)      Manager Quality Control is responsible to ensure that procedure & formats are followed entirely as approved.
                             ii)       Microbiologist is responsible to perform the sterilization process.
    5.  Materials:-
             5.1 Jump suit
             5.2 Shoe covers
             5.3 Pairs of Gloves
             5.4 Butter Paper
             5.5 Masking Tape
             5.6 Autoclave

       6. Definitions:-

       6.1. Sterilization:-
                                  Rendering an object or substance free of viable microbes but not of microbial toxins,        such as, endotoxinby destroying or removing all viable microorganisms, including viruses. An object cannot be slightly sterile or almost sterile- it is either sterile or not sterile
7. Flow Chart:-

   8. Description:-
 8.1. Procedure:
8.1.1 The jump suit set used in Microbiology Lab, comprises of five separate pieces.
a.        Jump suit                      -                    One
b.         Head Cover                 -                       One
c.         Mask                           -                       One
d.         Shoe Cover                 -                       One pair
e.         Gloves                         -                       One pair

8.1.2 Wrap all the above components except pair of gloves in a butter paper.
8.1.3 Place parachute jump suit. If required fold 1/3 of the arms and the legs of the jump suit inside out.
8.1.4 Wrap gloves separately in butter paper.
8.1.5 Wrap the dress by folding and sealing the butter paper with masking tap Now take another butter paper sheet and place the wrapped suit in inverted position on the butter sheet.
8.1.6  Similarly wrap this paper as done before.
8.1.7  Mark on one side having jump suit upward to open the dress from this side. Also mark with date.    
8.1.8 Place the wrapped jump suits set in nylon bag, close the bag and button or tie.
8.1.9 Sterilize the nylon bag containing jump suit set and gloves in autoclave at 121 0C for not less then 30 minutes.
8.1.10 Use a Thermo log – S integrator with each load that indicates completion of sterilization.
8.1.11Un- used sterile dresses should be removed from the sterile area after 72 hour
9. Records:- Sterilization log  (Autoclave)
10. References:-

                         United States Pharmacopoeia 35
11. Distribution:-

This SOP has to be distributed in below mentioned Departments:-

Sr. NO
Distributed to
Quality Control Department

Quality Management Department

12. Revision History:-
Date                                        Changes