Utensils Cleaning & Storage, Purpose:
Utensils Cleaning & Storage, To lay down the procedure for Cleaning and Storage of Dispensing and Production Utensils.
Utensils Cleaning & Storage, Scope:
This SOP is applicable for the Production Area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]To follow the laid down procedure
Executive, Production
[][]To monitor and check the laid down procedure
Manager, Production
[][]To implement this correctly
Manager, Quality Assurance
[][]To approve the Document
Annexure:
[][]N/A.
Procedure:
Precaution :
[][]Do not clean/disinfect the area when the process is running.
[][]Do not touch the cleaned equipment/utensils without wearing hand gloves.
[][]Always store small items like dispensing scoop, spatula, spoon, mug etc. in polythene bags in
[][]closed condition in clean equipment store after cleaning
[][]If clean equipments/ utensils remain unused for more than three days or 72 hours clean them again before use.
[][]Unclean equipments/ utensils must be cleaned after completion of work on regular basis.
Cleaning Tools / Agents
[][]Cloth & wiper
[][]Potable water and Purified water
[][]Nylon brush
Cleaning of Utensils
[][]Place all unclean production utensils on a trolley or in a polythene bag and label it as
[][]‘TO BE CLEANED’ and transfer them to washing area for cleaning.
[][]First wiping with dry cloth to remove loose dust. Clean them using cloth and potable water. Use hot water and nylon brush if required.
[][]After cleaning with potable water, finally rinse them with purified water. Then wipe with clean lint free cotton cloth to remove water.
[][]After final cleaning let them drying by dryer.
[][]After drying take them separately in closed polythene bag and then keep them in an equipment
[][]cabinet & label with ‘CLEANED’ status label.
[][]Clean hoses/pipes first with potable water and cloth and finally with purified water. Use hot water if required. After cleaning wrap them with polythene. Removal of water then label as ‘CLEANED’status label.
[][]These cleaned items will directly be taken for processing purpose.
[][]Frequency of Cleaning
[][]During product to product change over.
[][]Dispensing scoop, spatula, spoon used in production area to be cleaned during batch to batch change over.
Cleaning of Containers (SS/HDPE)
[][]Clean the containers used for holding intermediate bulk products after each stages of manufacturing activities by following below mentioned procedure. For holding coated tablets, use the same containers holding compressed tablets after wiping with dry cloth to remove loose dust.
[][]Transfer unclean container with a label ‘TO BE CLEANED’ to washing area for cleaning.
[][]Clean the container and lid with dry cloth to remove loose dust then with potable water.
[][]Finally clean with purified water and wipe with clean lint free cloth to remove water.
[][]Remove the ‘TO BE CLEANED’ label and label as ‘CLEANED’ status label.
[][]Frequency of Cleaning
[][]During product to product change over.
[][]Dry clean during batch to batch change over.