Shelf life and storage of sterilized items.

1.0 OBJECTIVE 

1.1 To lay down a procedure for shelf life and storage of sterilized items.

2.0 SCOPE 

2.1 This procedure shall be applicable for the products/ components sterilized being used for filtration, and filling of products aseptically.

3.0 RESPONSIBILITY  

3.1 Incharge – IPQA.

4.0 ACCOUNTABILITY  

4.1  Incharge – QA 

5.0 PROCEDURE  

5.1 All the vials sterilized through the tunnel sterilizer to be used on the same day.

5.2 At the end of the filling activity left over vials on the turntable of filling machine and tunnel sterilizer shall be removed and sent to Warehouse as PMRR

5.3 Unload the items sterilised by steam steriliser and store till use in the following areas after unloading: Garments are to be hanged to the hooks provided in cupboard in second change room and the UV lamp to be switched “ON”

5.4 Rubber stoppers, filling, filtration items, Rubber stoppering machine components, Filling vessels to be stored under LAF adjacent to steam sterilizer unload.

5.5 Disinfectant items to be stored in the designated area under LAF in Sterile storage.

5.6 All items sterilized using steam sterilizer should be used within 48hrs from the time of unloading, if not so re-sterilize.

5.7 If bulk solution is sterile filtered using filtration assembly (Off line filtration) it should be used with in 48hr or as specified in the BPCR from the time of completion of sterile filtration. In case the filling stopped in between and it is decided to do filling next day the solution in the vessel, which is already connected, shall be re-filtered.

5.8 If the sterile filtered product is not used within a period of 48 hr or as specified in the BPCR take out the vessels and re filter into freshly sterilized filling vessels.

5.9 In case of power failure for more than 1 hour, take out all the sterilized components (except rubber stoppers used for Fulford products which are to be destroyed) and sterile bulk solution from the sterile storage area and resterilize after resumption of power.

5.10 All the sterilized items should be identified with sterilization indicators with Sterilized on date and Use before date.

6.0 ANNEXURES

NIL

7.0 CHANGE HISTORY