SIMULATION TRIAL RUN STUDIES

Cleaning and Disinfection of the Sterile Area after Simulation trial run studies.

v  Precautions:

§  Wiping of all surfaces should be done with a lint free mop.

§  Mops used for wiping of area and equipment where there is media spillage should be permanently discarded after cleaning and wiping.

§  All tubing used for Simulation trial run studies shall be destroyed and it should not be used for other products.

§  Flasks, trays etc. used for Simulation trial run studies shall be cleaned as per the standard procedure.

§  Vials and ampoule filling assemblies and accessories shall be cleaned as per the standard procedure.

v  Procedure:

§  At the end of the simulation run, promptly remove all unwanted materials from the sterile area including flasks and filling assemblies used for Simulation trial run studies.

§  Prepare sufficient quantity of approved disinfectant as per the schedule for disinfection of the area.

§  Clean and sanitize the filling line conveyors, turn tables, all SS surfaces with approved disinfectant.

§  Wipe all machine parts and areas where there are chances of spillage of media by approved disinfectant.  In all inaccessible areas, disinfectant solution shall be sprayed with the help of a spray gun and ensure that all inaccessible parts are thoroughly wetted by the disinfectant solution.

§  Walls and floors shall be sprayed with disinfectant solution.

§  Wipe exposed surface of all equipment and glass panels using 70% IPA.

§  Wipe SS stools, trolleys, LAF hood, pas box, switches, panels, handles, doors, light housings, risers, spray gun etc with 70% IPA.

§  Collect all washing water in SS pit in the sterile area using SS scoop and mop and throw out the washing water in the drain. Disinfect the drain immediately with the approved disinfectant.

§  Clean and Wipe the SS pit with 70% IPA.

§  After cleaning, all the equipments used for media preparation, filtration and filling shall be sterilized in autoclave.

§  Keep all the accessories used for Simulation trial run studies separately under lock and key.

v  Abbreviations

o   SOP              :          Standard Operating Procedure

o   QC                :          Quality Control

o   QA                :          Quality Assurance

o   WFI              :          Water for Injection

o   LAF              :          Laminar Air Flow

o   SS                 :          Stainless Steel