Considering their life-saving potential, biomedical devices are subject to numerous regulations and compliance mandates. A keener eye is required to oversee their manufacturing process compared to consumer devices. AssetPulse RFID tracking solutions for biomedical device manufacturing can help increase operational efficiency at every step of the process while ensuring regulatory compliance and preventing critical delays and errors.
A large part of biomedical device manufacturing happens in clean rooms that require frequent sanitization to maintain a particulate and pathogen-free environment. Our RFID inventory trackers and tags are built and tested to withstand chemical wipe-downs and autoclave processes while maintaining readability.
There are several areas in the biomedical device manufacturing process where AssetPulse RFID tracking solutions can be incorporated.
Biomedical device manufacturers can leverage our RFID medical equipment tracking solutions to ease the pain points involved in managing their raw material and component inventory. Our solutions can automatically track the arrival of materials and their storage. On the line, our solutions monitor the position of material bins, continually verifying and validating if they are in the right place. The system also tracks the usage of material and components, sends alerts if any bin requires replenishment, and updates the ERP simultaneously to record the transactions, updates Device History Records, and plan for future orders.
Equipment visibility is critical to the success of any manufacturing process, more so when they are used to make biomedical devices. Tracking tools and equipment on a fast-moving production line can be a challenge. AssetPulse medical device manufacturing RFID Tool Tracking solutions provide a real-time inventory of the tools and equipment on the line, showing which specific tool is used where and on what product. The system continually verifies if the tools are on the correct workstation, and sends instant alerts if they are moved elsewhere on the line. Tool removal, re-entry, and calibration status are also monitored. The system can also identify unused tools and equipment to ensure optimal asset utilization.
Line changeover is a key aspect in streamlining manufacturing. Re-equipping lines to manufacture a different product is a meticulous process that is time consuming and prone to human errors. Our biomedical RFID tracking solutions can help ensure a fast and error-free changeover.
The system automatically records the equipment, tools, material bins, and relevant documents at each workstation before the changeover process and validates their removal. During every step of the changeover process, the system automatically performs a validation to ensure that the equipment, tools, and raw materials are placed at the right locations on the line, and sends instant alerts if an incorrect placement is detected.
AssetPulse RFID tracking solutions can also help enforce pre-staging before the actual changeover happens. The system ensures that the right items are pre-staged, and sends alerts if they skip this step.
The solution also allows for automated record keeping, which is essential given the strict compliance requirements that govern biomedical device manufacturing. Details about raw materials or components, including their part numbers, lot numbers, and batch numbers, etc. can be automatically recorded at each point of the manufacturing line during the changeover process.
AssetPulse's medical device RFID solutions provide real-time visibility of a product as it makes its way through the production line. The WIP Tracking System automatically records start time and end time at each workstation and updates the Device History Record. If the product gets stuck at a particular production stage or skips a workstation altogether, the system alerts the production management to investigate. The system also tracks the location of the work order to ensure it stays along with the product as it progresses through each stage of production.
AssetPulse's manufacturing RFID solutions can also track the technicians working on the assembly line. The system automates their workstation logins and logouts and constantly monitors which technician is working at a particular workstation. The system also records details of the products that they work on, the time they take to perform their task, and the length of their breaks. The data collected can be used to update the Device History Record, train technicians and optimize their productivity. The system continually tracks the location of technicians on the factory floor and allows for automated mustering in case of an emergency.
Creating and maintaining detailed Device History Records is a critical aspect in the manufacturing of medical devices, as regulations insist on end-to-end traceability for medical devices. Traceability ensures better supply chain visibility, so that if any defects arise, manufacturers can quickly pinpoint the source of error.
This process can be efficiently automated with AssetPulse RFID tracking solutions. The system gathers intricate data detailing every step of a device's journey through the production line, including the raw materials and components used, the technicians who worked on it, the tools and equipment employed in its manufacture, and its post-production inspection and quality control results. This allows medical equipment manufacturers to effortlessly trace the cause of the error and take corrective actions with minimal downtime.
As an additional benefit, operating a comprehensive traceability framework can help prove to your clients your commitment to international quality standards. Moreover, you can also extract valuable insights from the data obtained, which can be leveraged to improve quality control, optimize operations, and provide you an edge over the competition.
Tracking a product doesn't stop once it reaches the end of the production line. AssetPulse's medical device RFID solutions continue to track finished products through inspection, quality control, and shipment, all the way till they reach the final point of distribution. The system verifies the final paperwork and ensures that the finished goods are shipped to their intended locations including warehouses, distributors, or customers. For products sold on consignment, our RFID tracking solutions can be programmed to monitor inventory in real-time and send alerts whenever stock replenishments are required.
A comprehensive solution to accurately and efficiently track all your lab equipment:
Not only do they know where 100% of their lab assets are, but they also are proactively managing preventive maintenance and calibrations. They know what exactly is out to a third party for calibration and when it is returned so they can be put back to use.