Line clearance is a critical process which is performed in pharmaceutical industries before start-up of Dispensing process, manufacturing process or Packaging process.
Definition Of Line Clearance
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.
Explanation of line clearance
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,
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.
All the equipment or components which are online or inline are cleaned properly.
Cleaning is usually of three types which are given as follow,
- Type A Cleaning
- Type B Cleaning
- Type C Cleaning
Type A Cleaning
Type A cleaning is also known as minor cleaning or batch to batch cleaning and it is a short cleaning activity.In type A cleaning,washing of equipment or area is not required, just the area is cleared and equipment are cleaned from outside with lint-free cloth. Type A cleaning is performed during the following cases,
- Between Batches of Same product
- Same product but strength is changed in Ascending order mean from lower strength to higher strength.
- Minor Preventive maintenance in which parts which are in direct contact with the product are not exposed.
Type B Cleaning
Type B cleaning is also known as major cleaning.It is a long activity and all the equipment and area is washed during Type B cleaning. All the equipment are washed with food-grade detergent and rinsed with purified water.Then all the equipment are dry with a lint free cloth and are disinfected with 70% IPA.
Type B cleaning is performed during following cases,
- During product change over.
- During Same product but strength is changed in descending order mean from higher potency to lower potency.
- Same product but colour is changed.
- Same product but the flavour is changed.
- Major preventive Maintenance.
- When area is used after expiration of cleaning validation time of equipment.
Type C Cleaning
Type C cleaning is the general cleaning which is performed at the end of the shift and where the work is to be started again on the next day.In this type of cleaning all the materials from line are properly closed or stored in containers or polythene bags.Any component or material is not left exposed.
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.
In some pharmaceutical industries, these packaging lines are separated by partitions or colour markings on the floor but in some pharmaceutical industries no partition or marking lines are available which increases the chances of mix up.
If Partitions are installed between lines, these partitions should be at such a height that nobody can throw any component of packaging material over the partition from one line to the other line.
The recommended height of the partition between two lines is 2 meters.
The best practice for packaging lines is that each packaging line should be installed in a separate room so that there should be no chances of mix up.
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