Line Clearance: What is it and How to Perform One

Line Clearance What is it and How to Perform One

Last Updated on February 11, 2024 by Ossian Muscad

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 line clearance 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 critical quality assurance procedure used in manufacturing, particularly in pharmaceutical, food, and consumer goods production. It refers to the systematic process of cleaning and organizing a production line between batches or product changes to eliminate residual materials, products, or packaging components from the previous run. This ensures that the area is free from contaminants and ready for the next production cycle, thereby preventing mix-ups or contamination, ensuring product integrity, and complying with regulatory standards.

 

How to Perform Line Clearance

To perform a line clearance effectively, it is essential to follow a structured approach. The process can typically be broken down into three key steps: Clearing, Cleaning, and Checking. Each phase has specific goals and practices that ensure the production line is set to meet the highest standards of quality and safety.

Clearing

The clearing step involves the removal of all materials, products, and documents from the previous production batch. Operators must systematically ensure that raw materials, in-process goods, finished products, and any associated documentation are cleared from the production area. This also includes the removal of any rejected or partially completed products to prevent any possible mix-up or contamination.

Cleaning

Once clearing is complete, the next step is thorough cleaning. This involves using appropriate solvents, detergents, or disinfectants to clean all equipment and surfaces that come into contact with products. The cleaning process must be validated to ensure it effectively removes all residues and contaminants from the previous batch.

Proper cleaning is a crucial step during line clearance to ensure the absence of cross-contamination. Different types of cleaning methods are employed, depending on the nature of the production line and the level of cleanliness required. These can generally be categorized into three types: Type A, Type B, and Type C Cleaning.

  • Type A Cleaning: Type A Cleaning is typically a surface-level cleaning procedure aimed at removing visible particles and residue. This method involves wiping down equipment and surfaces with cloths or brushes paired with suitable cleaning agents. It’s often used during production runs where the same product is continuously manufactured, with minimal risk of cross-contamination.
  • Type B Cleaning: Type B Cleaning requires a more thorough approach involving dismantling equipment where necessary. It’s used when manufacturing different products on the same line or after producing potent or allergenic materials. The procedure might involve scrubbing, using stronger detergents, and more rigorous washing techniques to remove all traces of the previous batch.
  • Type C Cleaning: Type C Cleaning is the most comprehensive cleaning process, often called a deep clean. This type of cleaning is necessary for changeovers from one product to another, particularly when the next product is highly sensitive to potential contaminants. It may also include sterilization processes and is common in industries where contamination can lead to significant health risks, such as in pharmaceutical manufacturing. Type C Cleaning ensures the highest level of cleanroom conditions and may require validation to confirm that all residues have been eliminated to the required specifications.

Checking

The final step of line clearance is checking. This is a meticulous inspection of the production line to verify that clearing and cleaning have been completed and that there are no remnants from the previous batch. It often involves quality assurance personnel reviewing checklists and assessing the cleanliness before approving the line as clear to start a new batch.

The Checking Phase is a critical component of the line clearance process. The following comprehensive checklist is designed to ensure all aspects of the clearance and cleaning have been performed to the highest standard before the commencement of a new batch:

Equipment Inspection

  • Verify that all equipment has been dismantled (if required) and thoroughly cleaned.
  • Check for the absence of previous product residues or debris.
  • Ensure that any filters or sieves have been either replaced or cleaned appropriately.
  • Validate the cleaning process for critical equipment, if necessary.

Surface Assessment

  • Confirm that all surfaces, including floors, walls, and countertops, show no signs of residue.
  • Inspect for proper waste disposal and cleanliness around the waste disposal area.
  • Ensure cleaning agents and tools have been removed from the production area.

Document Review

  • Ensure all previous batch records and documents are filed and removed from the line.
  • Check for proper labeling on all equipment and storage areas for the next batch.

Contamination Control

  • Inspect the line for any potential cross-contamination points.
  • Review the status of pest control measures and look for any signs of pest activity.

Quality Control Validation

  • Quality control sign-off that all necessary samples have been taken and tested, if applicable
  • Ensure the availability and calibration of necessary measurement and testing devices.

Tool and Accessory Check

  • Inventory check for the return of all tools and accessories to their appropriate places
  • Verify that no unrelated materials or items are present in the production zone

Safety Equipment

  • Ensure that all safety equipment is available, functioning, and accessible for use
  • Verify that emergency exits and pathways are clear and unobstructed

New Batch Readiness

  • Confirm the arrival and correct staging of the new batch’s raw materials and packaging components
  • Check that the next batch’s documentation is in place and ready for use

Sign-Off

  • Final sign-off by line clearance personnel, supervisors, and quality assurance
  • Documentation of the line clearance process is completed and recorded

 

This checklist is a guide to maintain quality control and to ensure that stringent line clearance protocols are adhered to, helping to prevent any potential errors or contamination when transitioning between production batches.

 

Why is Line Clearance Important for Manufacturers

Line clearance is essential for maintaining the manufacturing line’s efficiency, quality, and safety. 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:

  1. Assignment of responsibility for equipment cleaning and maintenance.
  2. Cleaning, sanitizing, and maintenance schedules.
  3. 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.
  4. Identification and removal of previous batch materials, products, and documents.
  5. Prevention of contamination for clean equipment prior to use.
  6. A thorough inspection of equipment for cleanliness before use.
  7. 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.

 

Frequently Asked Questions (FAQs)

Q1: What is the main goal of line clearance in manufacturing?

The main goal of line clearance is to prevent cross-contamination and ensure that all previous product residues, debris, and documentation have been removed before a new production batch begins. This process safeguards product integrity and aligns with Good Manufacturing Practices (GMP).

Q2: How often should line clearance be conducted in a manufacturing facility?

Line clearance should ideally be conducted each time a production run is completed and before the commencement of a new batch, especially when switching between different products or after maintenance activities. The exact frequency may depend on the specific industry’s regulatory requirements and the facility’s production schedules.

Q3: Who is responsible for conducting line clearance in a manufacturing setting?

Responsibility for conducting line clearance typically falls on designated quality assurance personnel trained to understand and execute the protocols. They may be supported by production staff who understand the equipment and processes involved.

Q4: Can line clearance procedures be customized for different facilities or products?

Yes, line clearance procedures can be tailored to meet the specific needs of different facilities, equipment, or products. While the basics of line clearance remain constant, the specifics might change depending on factors like the type of manufacturing process, the sensitivity of the products, and the risk of contamination.

Q5: What should be done if a discrepancy is found during the checking phase of the line clearance?

If a discrepancy is found, production should remain on hold until the issue is resolved. The discrepancy should be thoroughly investigated, corrective action taken, and the clearance process should be repeated to ensure the line meets the required standards before production can resume.

Q6: How is line clearance documented, and who reviews these records?

Line clearance is documented using detailed checklists and logs, which typically include information about the cleaning, inspection, and clearance of the production line. These records are then reviewed by quality assurance personnel and may also be subject to review by regulatory authorities during inspections or audits. Documentation also provides traceability and accountability for the clearance process.

 

Streamline the Line Clearance Process with DATAMYTE

DATAMYTE is a quality management platform with low-code capabilities. Our Digital Clipboard, in particular, is a low-code workflow automation software that features a workflow, checklist, and smart form builder. This tool lets you create custom line clearance checklists and workflows to meet your specific production needs.

DATAMYTE also lets you conduct layered process audits, a high-frequency evaluation of critical process steps, focusing on areas with the highest failure risk or non-compliance. Conducting LPA with DATAMYTE lets you effectively identify and correct potential defects before they become major quality issues.

With DATAMYTE, you have an all-in-one solution for streamlining and documenting your line clearance process, ensuring compliance with regulatory standards, and maintaining the quality of your products. Book a demo now to learn more.

 

Conclusion

Line clearance is a critical procedure that underpins the operational integrity and adherence to regulatory standards in manufacturing. By implementing a thorough line clearance process, manufacturers can mitigate the risks of cross-contamination, protect the quality of their products, and maintain consumer trust. While the process demands meticulous attention to detail, the product safety and compliance rewards are substantial. As manufacturers continue to evolve and adapt to ever-changing industry standards, the protocols associated with line clearance will remain a cornerstone of a robust quality management system.

 

 

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