Method of entry for materials which cannot be sterilized by steam or dry heat sterilizers.

Scope:

Bulk material, Machine parts and tools etc, to be used in sterile Area for filling of antibiotic dry powder injections.

Procedure:

(A) Bulk Materials

1) Check label on drums for indentification, product Q.C release, R.R Lot number, manufacturing and expiry dates, in preparation and washing room and counter checked with M.O.


2) Clean container thoroughly with duster.


3) Mop container with 5% Phenol.


4) Take container into 1st changing room.


5) Again mop with 5% phenol solution and transfer to Air lock area (Buffer room).


6) Before use mop 5% phenol and open lid of the container.


7) Check bag for and damage.


8) If Satisfactory mop bag with 70% alcohol and remove it from container and take it to main filling room.


9) Put lable on bag and take it under laminar Flow Hood. Open the bag under laminar flow only.


10) Closer the bag immediately after use to minimise the powder exposure to room air.


(B) ROUTINE MAINTENANCE TOOLS WHICH COULD NOT BE STERILIZED :-


1) Clean thoroughly in preparation room.


2) Dip in 5% Phenol and take to 1st changing room.


3) Aganin mop with 70% alcohol or 5% Phenol before taking to buffer room.


4) Mop again with 70% alcohol in buffer room and take into main filling room.