Purpose :
The purpose of this SOP is to describe the procedure of container Washing and Handling system of Dialysis Fluid Unit at XX Pharmaceuticals Ltd.
Scope :
This SOP is applicable for the Production and Primary Packaging of Dialysis Fluid Unit at XX Pharmaceuticals Limited.
Definition / Abbreviation :
[][]HDPE: High Density Polyethylene
Responsibilities :
[][]The Roles and Responsibilities are as follows :
Operator
[][]To ensure that this procedure is followed.
Executive, Production
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly.
Head of Quality Assurance
[][]To approve the SOP.
Precautions :
[][]Ensure the Proper Safety Instruction Are Followed.
[][]Ensure that the Supply the Water (Potable, Hot & Purified).
Empty Container Washing Procedure :
[][]Send the ERP Requisition to the ware house, then they Provide QC passed Containers from General Warehouse.
[][]Places the containers (50pcs) at the Plastic Pallet and transfer to the container washing room.
[][]Ensure that all utility lines like compressed air, electric line, potable water (hot & normal) and purified water are in attendance.
[][]Put off the stopper plug.
[][]Placed the container perpendicularly (3Pcs at a time) at the washing machine then flow the potable water for 30 sec (inner & outer elevation).
[][]Supply the hot water (50 to 60o) into the containers for 30 sec (inner & outer elevation).
[][]Concluding Supply of Purified water into the containers for 30 sec (inner & outer elevation).
[][]After that washed container staging at the cage trolley, then transfer to the filling room.
[][]Ensure that area cleaning activity is recorded in Cleaning Log book
[][]Check and ensure that Containers Cleaning activity is recorded in respective ‘Equipment log book’
[][]Ensure that all Containers are labeled as CLEANED.
Annexure
Annexure-I: HDPE Container (10 L) Washing Record.