The manufacturing of medical devices requires everything to be processed following a strict set of guidelines that guarantee the quality of a finished product. The manufacturing process must adhere to these guidelines at every step.
Manufacturers often use a detailed procedure known as Line Clearance as a way of adhering to them.
But what is line clearance? Proper line clearance procedures are essential for maintaining quality standards and preventing cross contamination between production runs. Similar practices are required in the pharmaceutical industry where product quality is strictly regulated.
Let’s take a look at what this procedure is all about and why the line clearance process is necessary for the manufacturing of medical devices.
Many facilities are upgrading their current line clearance process to meet new regulatory standards.
What is Line Clearance?
Line clearance is the physical procedure of clearing the space, equipment and materials used in manufacturing to get ready for the production of a new medical device.
Consistent line clearance procedures help prevent cross-contamination.
The production line must be completely cleared before introducing new materials. This approach has been adapted from the pharmaceutical industry which pioneered many modern quality protocols.
This process should be part of any manufacturer’s standard operating procedure as a means of reducing the risk of cross-contamination and even mix-ups in packaging, creating issues with the finished product.
The line clearance process must be thoroughly documented to ensure compliance. An effective manufacturing process depends on proper line clearance. Cross contamination can compromise product integrity and patient safety.
What is line clearance in the context of compliance?
Line clearance is part of maintaining a high level of compliance and traceability in the production of many goods, especially those in regulated industries like medical devices. When a workspace is clean and free from anything left behind by previous processes, production of the new medical device can move forward smoothly and efficiently without any safety or quality concerns.
A well-executed line clearance process ensures this safety. Implementing standardized line clearance procedures is a regulatory expectation. A comprehensive line clearance checklist is an essential compliance tool. Quality control measures must be implemented at every stage of the process. The pharmaceutical industry follows similar compliance frameworks for line clearance.
Performing Line Clearance
What is line clearance when broken down into its components? Line clearance can be done in a few different ways, but it almost always comes down to three parts: clearing, cleaning, and checking. And all are rather simple steps as long as they are thoroughly performed each and every time.
Standardizing the line clearance process helps maintain consistency across production runs. The entire manufacturing process benefits from this standardization. Well-designed line clearance procedures address each component thoroughly and minimize the risk of cross contamination. A line clearance error at this stage can compromise an entire batch and product quality.
Clearing
Clearing means physically clearing the workspace of everything that doesn’t pertain to the new medical device. This means getting rid of any materials, parts, labels, and even packaging and labeling materials from the previous device. Never assume that things won’t get mixed up if they stick around — clear them out.
The initial step of the line clearance process is critical to prevent contamination. Line clearance procedures must specify what items need to be removed. The production line should be completely visible for inspection and quality control.
Cleaning
Cleaning requires the disinfecting of all surfaces and equipment, removing any trace of the previous device or particulate before starting on the new product. Depending on the type of machine, this may involve dismantling it in order to make sure it is thoroughly cleaned.
A reliable manufacturing process requires thorough cleaning. Detailed line clearance procedures should designate appropriate cleaning agents that effectively eliminate potential cross contamination sources. Every production line has specific cleaning requirements.
What is line clearance’s impact if not properly executed? Keep in mind that you will want the surfaces to fully dry before proceeding as you don’t want the chemicals in the cleaner to interact with anything associated with the new device. Often, the manufacturing specifications will indicate how and with what solutions the cleaning needs to be performed. The pharmaceutical industry often uses more stringent cleaning validation protocols than other industries.
Documentation of the line clearance process should include cleaning agents used. A proper line clearance checklist includes verification of drying times. Assessing your current line clearance process can help identify improvement opportunities.
Checking
Checking is done by the person overseeing the line clearance, whether a manager or supervisor. They must inspect every detail of it before the production on the next device can begin. Checking also usually involves ensuring that the room conditions are properly set so that everything goes smoothly with the next batch.
Line clearance procedures must include comprehensive checklists for inspectors. The production line supervisor must verify all steps have been completed.
Confirmation that this process has been done is usually signed off by the one who did the checking, citing the date and time of the inspection. Traceability is critical in maintaining evidence of this function being completed.
Regular audits of the line clearance process help identify areas for improvement. Quality control is an essential component of any manufacturing process.
Risks Found in the Line Clearance Process
What is line clearance’s significance in risk mitigation? Line clearance is so important when dealing with any industry — especially within the medical field. The manufacturing of medical devices has to be perfect without any room for error as it could potentially mean the difference between life and death.
Failure to follow line clearance procedures can lead to serious consequences. A single line clearance error can affect numerous patients.
What if there is a mix-up with the medical devices and the labeling? What if a chemical used in the previous product interacts with the new?
Any time the line clearance process is not performed to required and validated specification, the manufacturer poses risk for product efficacy and patient safety.
A validated line clearance checklist helps minimize these risks. Each production line should have specific protocols tailored to its products.
Manufacture Medical Devices with Coastline International
Choosing the right nearshoring manufacturer for your medical device is crucial. You want to make sure you find one that adheres to all requirements and guidelines set forth for compliance — including line clearance and other ISO 13485 and/or FDA requirements.
Our comprehensive line clearance process exceeds industry standards. Our line clearance procedures are regularly reviewed and updated. Our production line setup is optimized for efficiency and safety.
At Coastline International, we have been manufacturing for over 40 years, providing high-quality services to meet the production requirements of your medical devices. Contact us today to learn more about our superior manufacturing process.