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
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