If you work in a regulated industry, then line clearance is something that you are probably familiar with. It’s an important procedure to avoid cross-contamination, product mislabeling, or other costly errors. But what is line clearance, exactly? And more importantly, how do you perform line clearance in your manufacturing process?
This article will discuss what line clearance is and how to safely clear the line for the next process. We will also provide some tips for avoiding cross-contamination and product mislabeling. Stay safe and productive by using line clearance procedures in your manufacturing process!
What is Line Clearance?
Line clearance is a systematic process in manufacturing that ensures equipment and work areas are free of products, materials, and documents from a previous process. Line clearance is also important in preparing for the next scheduled process. This procedure is common in manufacturing and regulated industries such as food and beverage, medical devices, and pharmaceuticals.
How to Perform Line Clearance
A typical line clearance procedure can be broken down into three key parts:
- Clearing: the physical removal of all previous products, materials, and documents that are unnecessary for the current or next process.
- Cleaning: the drying and disinfection of all surfaces and equipment. The level of cleaning will depend on the product being manufactured and the regulatory requirements for that product. It will also depend on whether the line clearance took place between batches of the same product or during a complete product changeover.
- Checking and Verification: a final check to ensure that all surfaces are dry and free of contaminants. This step can also include recalibrating scales or checking the temperature of the work area. Checking and verification are typically done by the line supervisor or quality control department. These relevant people are notified to inspect the line thoroughly. The next scheduled process can only begin once the supervisor or quality manager gives the green light.
To effectively execute line clearance, operators often use line clearance checklists to ensure that all materials from the previous process have been removed and that the line is completely empty before starting the next process.
Why is Line Clearance Important for Manufacturers
Line clearance is an essential process for maintaining the efficiency, quality, and safety of the manufacturing line. At the same time, it also serves as a requirement of ‘Good Manufacturing Practices (GMP)’ within various industries.
The US Food and Drug Administration’s ‘Code of Federal Regulations Title 21‘ states, “Written procedures shall be established and followed for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.” These procedures shall include the following:
- Assignment of responsibility for equipment cleaning and maintenance.
- Cleaning, sanitizing, and maintenance schedules.
- A detailed description of the methods, materials, and equipment used in cleaning and maintenance operations. It also includes the methods of disassembling and reassembling equipment to ensure proper maintenance and cleaning.
- Identification and removal of previous batch materials, products, and documents.
- Prevention of contamination for clean equipment prior to use.
- A thorough inspection of equipment for cleanliness prior to use.
- Record keeping for maintenance, cleaning, sanitizing, and inspection.
Manufacturers that fail to perform and document line of clearance procedures will be subject to regulatory action and hefty fines.
Create Line Clearance Checklists with the DataMyte Digital Clipboard.
Did you know you can digitize your line clearance procedure? That’s right! With that DataMyte Digital Clipboard, you can create digital line clearance checklists to streamline the procedure and make it more efficient. The best part? You can also do it all from your handheld or portable devices!
The DataMyte Digital Clipboard is a workflow automation software that helps you digitize and manage your line clearance procedure from start to finish.
DataMyte Digital Clipboard lets you:
- Create line clearance checklists.
- Assign line clearance tasks to specific operators.
- Track line clearance progress in real-time.
- Generate line clearance reports.
The DataMyte Digital Clipboard is the perfect tool for streamlining your line clearance procedure. So get started today and see how it can help you improve efficiency, quality, and safety in your line clearance process!
Line clearance is an essential process for ensuring quality and safety in manufacturing. By digitizing your line clearance procedure with the DataMyte Digital Clipboard, you can improve the overall flow and efficiency of the process. So get started today and see how it can help you improve quality and safety in your line clearance process!