The manufacturing of medical devices requires everything to be processed following a strict set of guidelines that guarantee the quality of a finished product. Manufacturers often use a detailed procedure known as Line Clearance as a way of adhering to them.
Let’s take a look at what this procedure is all about and why it is necessary for the manufacturing of medical devices.
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.
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.
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.
Performing Line Clearance
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.
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 from the previous device. Never assume that things won’t get mixed up if they stick around — clear them out.
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.
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.
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.
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.
Risks Found in the Line Clearance Process
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.
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.
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.