Line clearance is defined as,
The process which assures that all the leftovers of the previous product are properly cleaned before the start-up of the next process.
The concept of line clearance in pharmaceutical industries is established to prevent mix-ups and to enhance product quality. As the name indicates Line Clearance have two components,
Line
Clearance
What is a Line?
A line may be any room, area or a place in a pharmaceutical industry where dispensing, manufacturing or packaging activity is performed.
All the equipment or components which are online or in-line are checked critically during line clearance.
What is Clearance?
We use the word “To Take Line Clearance” in pharmaceutical industries.Mean clearance is a sort of certificate for line, which is provided by the Production officer and then by the QA officer to state that line is ready for performing activity.Clearance approval allows the operators to start the activity in respected area.Before taking the clearance certificate of the line, the line is Cleared,cleaned or washed depending on the requirements.
3 C of Line Clearance
For general understanding, line clearance has 3 C which are given as follow,
Clearing Of Line
Cleaning Of Line
Checking Of Line
Clearing Of Line
The clearing is the first C of the line clearance and it consists of clearing of the line. In this stage, all the previous product leftovers e.g labels, polythene bags,unit cartons etc are removed from the line.
Cleaning of Line
Clearing of the line is 2nd C of the line clearance. After completion of one operation and before the start of the next operation, first we clear the line and then the cleaning of the line is performed.
Checking Of Line
Checking of the line is 3rd C of line clearance. After clearing and cleaning, checking of the line is done. The area supervisor checks the line thoroughly for any deficiencies then he calls the Production Officer and the production officer checks the parameters of the line to be cleared.He checks the area, equipment and then the product which is to be started or processed.
After Checking by the production officer a request is sent to the Quality Assurance officer for checking of the line.
Quality assurance officer checks following,
Cleaning of doors, walls and ceiling.
Cleaning of windows and HVAC ducts etc
Checking of equipment.
Surface below the equipment should be checked for the previous product leftovers.
Calibration status of weighing balance.
Temperature and humidity of the area.
Differential pressure of the area.
After ensuring all the requirements of the area and equipment the product to be processed is checked.Batch
Following general parameters are checked
Batch number of the product.
Lot number of the product.
Quantity or weight of the ingredients or components.
Importance of Line clearance
Prevents chances of mix up.
Assures the quality of the product.
Assures cleaning of the area and equipment.
Critical Note for Packaging Lines.
It is commonly observed that three, four or more packaging lines are installed in a packaging hall, in pharmaceutical industries.