Patients’ safety is dependent on the sterility of medical device packaging, which starts at the packaging and sealing stages of the packaging process before shipment. Any failed sterile seal leads to a repackaging or total scrapping. A medical device with a broken sterility seal can significantly affect a patient’s life. Therefore, the manufacturers usually pull samples of units from every batch at the end of every production line to ensure quality control. Here is more about boosting sterile packaging reliability.
The Manufacturer’s Test
Before the packages strike, medical devices leave the were houses for shipment. The manufacturers first do their tests to ascertain everything is done correctly, and all the devices are safe for transport and use. First, they will get samples from all the batch units of the production line. Then, once they have all the batches, they use two simple tests.
One, they measure the force used to open the package. If the force is too little, it means the packaging is poor. Second, they insert a visual microscopic inspection inside the packed device and look for bubbles or if there are any breaches in the seal.
If there is any issue, the whole batch is quarantined for further evaluation and testing. Unfortunately, this may also trigger the regulatory protocol, significantly affecting production and slowing it down by two to three weeks. This is pretty costly on the manufacturer’s side.
Quality testing of the sterile packaging is of the highest importance. It ensures all the devices are delivered to all the destinations while maintaining their sterility until use. The type of packaging used on a particular device is determined by its characteristics. Things like weight, size, profile, shape, and density irregularities all matter and must be considered during the process.
Additionally, all the raw materials used in the medical device packaging must be inspected, marked traceable, safe, and effective in offering the microbial barrier needed for packaging and preventing any physical damage to the medical device during the shipment process.
Ensuring Quality In Medical Device Manufacturing
Most of the time, the manufacturers may experience failure rates. When this happens, it is essential to implement signature waveform analysis and in-process testing to curb the issues. Adding thermal couplings and sensors helps monitor the temperature across the surface of the heated plate. The heat applied on the angles should be equal to ensure consistency of air supply in the pneumatic system and even contact.
This quality control system allows the manufacturer to identify the cause of all the failures sooner, thus reducing the impact on production schedules and overall product rework. Sterile packaging needs complete care and can take up a lot of time if you do not have the necessary testing requirements. Implementing this testing routine will help you save money and time by reducing reliance on expensive downstream inspections. In addition, you will achieve a high correlation between the visual quality check and automated test techniques.
Medical devices play a vital role in maintaining the health and well-being of patients. They also make the physicians’ work accessible by offering easier means of attending to the patients. Therefore, these devices must be appropriately packaged, maintaining their sterility from the warehouses until they reach their destinations and until use.
