Line clearance is a critical process that is performed in pharmaceutical industries before the start-up of the 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 has 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 a line, which is provided by the Production officer and then by the QA officer to state that the line is ready for performing activity. Clearance approval allows the operators to start the activity in a 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 is given as follows,
- 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 follows,
- 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 is cleaned from outside with lint-free cloth. Type A cleaning is performed during the following cases,
- Between Batches of the Same product
- Same product but strength is changed in Ascending order meaning from lower strength to higher strength.
- Minor Preventive maintenance in which parts that 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 areas are washed during Type B cleaning. All the equipment is washed with food-grade detergent and rinsed with purified water. Then all the equipment is dry with a lint-free cloth and are disinfected with 70% IPA.
Type B cleaning is performed during the following cases,
- During product change over.
- During the Same product but strength is changed in descending order mean from higher potency to lower potency.
- Same product but color is changed.
- Same product but the flavour is changed.
- Major preventive Maintenance.
- When the area is used after the expiration of the cleaning validation time of equipment.
Type C Cleaning
Type C cleaning is the general cleaning that 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 the 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 that 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.
The quality assurance officer checks the following,
- Cleaning of doors, walls, and ceiling.
- Cleaning of windows and HVAC ducts etc
- Checking of equipment.
- The 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
- The 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 color 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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