If you’re an entrepreneur or inventor with a new medical device in the works; it’s essential to understand the importance of clean room classifications. A clean room is a controlled environment where particulate matter is limited to protect product quality. Without proper classification, your new device could be at risk for contamination and diminished performance. Here we’ll discuss various clean room classifications and why they’re essential for the development of medical devices.
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What Are Clean Rooms And Why Are They Important?
Many medical device manufacturers use clean rooms to maintain the sterility of products and minimize the risk of cross-contamination. A clean room is a space in which the concentration of airborne particles is controlled to specified limits. The cleanliness of a room is determined by the number and size of particles present in the air and the level of contamination on surfaces.
The International Standards Organization (ISO) has established classifications for cleanliness levels in clean rooms. These range from ISO 8 (the highest level of cleanliness) to ISO 9 (the lowest level of cleanliness).
To meet the requirements for ISO 6, 7, 8, or 9 classifications, rooms must be designed and constructed using certain materials. These are materials that do not release particles, and must be equipped with filters that remove particles from the air. In addition, regular cleaning and maintenance procedures must be strictly followed to prevent contamination. Clean rooms are essential for medical device manufacturers who wish to maintain the safety and sterility of their products.
If a medical device is exposed to unsanitary conditions, the risk of patient injury or infection is significantly increased. The most common reason for medical device manufacturers to establish clean rooms is that clean rooms are necessary for the sterile manufacture of medical devices. These include the creation of:
- Surgical systems
- Orthopedic devices
- Diagnostic systems
- The testing of, cleaning, and maintenance of the sterility of devices (patches, appliances, or sutures)
- Preparations for packaging
Electrical Safety
In the world of electrical medical devices; there are a variety of electrical connections used to transmit power and other electrical signals. Some are simple wires, while others use complex electrical circuits. Regardless of the type of electrical connection used, these devices must be manufactured according to strict safety guidelines to protect workers, patients, and the public from electrical hazards.
Electrical safety protocols vary depending on the type of device being manufactured. For example, electronic circuits in complex medical equipment require careful monitoring by skilled engineers to operate safely and efficiently. At the same time, simple wires connected to traditional medical devices such as ECGs or IV pumps typically only require basic electrical training for workers responsible for maintaining or repairing these types of connections.
Regardless of the electrical connection setup used in medical devices, all manufacturing facilities must implement rigorous electrical safety programs that include extensive training and compliance testing. This ensures that employees have sufficient knowledge to carry out their tasks safely and that patients and members of the public remain protected from electrical hazards at all times. Ultimately, electrical safety is critical to ensuring the well-being of everyone who has contact with these essential health care tools.
Quality Control
Many medical devices are multi-use devices requiring frequent or long-term evaluation and adjustment. Therefore, a medical device quality assurance program (QAQC) is integral to pharmaceutical manufacturing. This involves sampling, testing, and continually analyzing the production, quality assurance, and shipping activities.
Quality control measures help to assure that the end product meets and maintains a defined quality standard. However, it is also essential to implement a QAQC program during the device manufacturing process. This ensures that products can reach the final stage of completion and testing.
Inspection
When a medical device is manufactured, it goes through several steps to ensure quality and process control. During the initial stages of production, devices are carefully inspected for any defects or imperfections, which are then systematically eliminated. As manufacturing technology becomes more advanced and automated, this task becomes more challenging to do by hand.
This is why modern medical device manufacturers rely on sophisticated quality assurance techniques and advanced data analytics tools. These techniques help to ensure that each medical device meets the highest standards of quality and safety. Additionally, by monitoring production processes in real time and identifying trouble areas before the products leave the factory, manufacturers can ensure that every medical device is safe and effective for patients. Thus, while risk factors cannot be eliminated, robust quality control checks help to minimize them during medical device manufacturing.
Routine Testing
In the medical device industry, quality control is of the utmost importance. To ensure that devices are safe and effective, manufacturers must perform regular testing and inspections. However, these tests can only provide a snapshot of the quality of a device at a given point in time. Annual routine testing allows manufacturers to track quality over time and identify trends that may indicate a need for process improvements. By staying on top of these issues, medical device manufacturers can help to ensure that patients receive the highest quality care possible.
National or State Regulations
The Federal Food and Drug Administration (FDA) administers the Medical Device Directive. Certain states, such as Massachusetts, have established medical device manufacturing guidelines. The FDA also has guidelines for the “Medical Device Return Program” to help patients who have experienced problems with a particular device. These guidelines help to protect consumers from unknown defective or substandard devices that may threaten their health.
The FDA’s medical device regulations are subject to change; so manufacturers must adhere to them regardless of whether they are located within or outside of the U.S. At Pathway NPI, we are committed to providing medical device manufacturers with the highest quality clean rooms for their production processes.
Our ISO class 6, 7, and 8 clean rooms have been designed and maintained to meet the strictest industry and international regulatory standards. In addition, each of our ISO class clean rooms is equipped with environmental control systems that help keep the air inside immaculate, ranging from ISO 1 at the lowest classification level to ISO 9 at the highest. This allows medical device manufacturers to confidently produce products in our highly controlled environments, ensuring that every medical device made in our clean rooms meets or exceeds all quality requirements. So whether you are looking for ISO class 6, 7, or 8 clean room capabilities for your next medical device project; you can rely on Pathway NPI to deliver exceptional results!
