Cleanroom Services: Manufacturing for Sterilized Plastic
It’s well known that sterilization is a must when it comes to devices manufactured for medical use. For some patients rely upon these devices in a wide variety of uses, including invasive procedures such as implants. But how can a medical device’s sterility be guaranteed, especially when you consider the number of places each item must pass through just to get to the patient?
Manufacturers like Microdyne of Colton, California take extensive precautions in the making of these products by implementing what is known as a cleanroom service.
What is a Cleanroom?
Through a highly specialized process, a clean room is monitored to ensure that the environment does not become polluted beyond a specified number of particles of a specified size in a specified space.
A cleanroom or clean room is a controlled environment, with a low level of contaminants. These include pollutants in the air such as chemical vapors, microbes, particles and dust. Through a highly specialized process, a clean room is monitored to ensure that the environment does not become polluted beyond a specified number of particles of a specified size in a specified space.
Putting the “Cleanliness” into Perspective
Compare the environment of Microdyne’s clean room to a typical urban environment: 35,000,000 particles per cubic meter in the size range 0.5 μm and larger in diameter, while a typical clean room contains no particles of that size and about 12 particles per cubic meter in the 0.3 um size range!
Why does all of this matter?
Put simply, by measuring the sterility of a manufacturing environment, devices like plastic heart valves stand a lesser chance of becoming contaminated with various particles and even bacteria, and a patient stands a greater chance of receiving a device that could save his or her life. On the other hand, if a manufacturer is not vigilant in maintaining a clean environment for medical devices to be made, those who receive these devices could potentially suffer from contamination-caused risks and complications that could have been avoided.
What Types of Medical Devices Use Cleanroom Services
Over the years Microdyne Plastics, Inc. has worked closely with the inventors and designers of micro-precision plastic medical devices and components. Precision medical devices we manufacture may fall into one of these broad categories:
- Invasive or implanted
How Cleanroom Specialists Keep it Clean
In addition to holding a Food and Drug Administration (FDA) Device Manufacturing License from the California Department of Health Services, Food and Drug Branch, Microdyne has a current ISO 9001:2008 certification. By holding these licenses clients who chose Microdyne know that their products will be manufactured by a company that takes every precaution to ensure the final product is of the highest quality. These steps include:
- proper attire is worn by clean room staff
- eating, drinking, smoking, or gum chewing is prohibited
- selecting correct furniture and eliminating all nonessential equipment preventing or controlling the cutting, tearing or storage of cardboard, debris, etc
- cleaning the room and production equipment are to regulatory standards
- close and controlled use of entrance and exit locations
- prevention of contamination by materials like lead pencils
- Proper measurements of air quality
- ensuring cleanliness of raw materials, equipment and tools
The Future of Medical Device Capabilities
Companies like Microdyne, who specialize in the precision manufacturing of the highest quality medical devices, may be the makers of products that you or your loved ones benefit from in the future. In fact, new technologies are creating possibilities that were unheard of just a few years ago. This includes the use of in-home medical devices to perform procedures that traditionally required highly skilled professionals to implement their intended uses in a controlled environment. However, new possibilities that will allow devices, such as those used in dialysis made available for patients in the comfort of their homes, are now on the horizon.
These emerging capabilities are due to new technological gains and highly skilled professionals such as the engineers at Microdyne are dedicated to a new world of possibilities from creative innovations.