At Proterial Cable America High Performance Medical Solutions (PCA-HPMS) we understand cleanliness and precision are critical factors to consider in the production of parts that will be used in medical devices. To make sure our components maintain our own high standards, we manufacture and package our parts in 30,000 square feet of ISO-certified Class 8 and Class 9 cleanrooms.
Our ISO-compliant cleanrooms are central to ensuring our parts are both manufactured and packed in a clean environment, so they arrive to customers in the same condition.
Read on to learn more about cleanrooms and why they are another reason HPMS is the manufacturer to go to for your medical device components.
In manufacturing, sometimes components need to be built in a cleaner area than typical. A cleanroom is a controlled environment where airborne particles, pollutants and contaminants have lower levels than a standard room.
Used to maintain contamination control, these controlled environments can help ensure a particle-free environment. Especially considering that some parts could have embedded particles that cannot be removed after being trapped inside a component.
The International Organization for Standardization (ISO) is an independent, non-governmental organization that develops standards to ensure quality, safety and efficiency for products, services and systems. One such area where ISO has created a standard is for medical cleanrooms.
ISO 14644 is the standardization created by the organization regulating air cleanliness in manufacturing spaces, which creates a classification for cleanrooms based on the number and size of particles per cubic meter of air in the room.
ISO cleanroom certification is crucial for medical device original equipment manufacturers because they need their devices to be assembled with pristine parts. The Class 8 and Class 9 cleanrooms at HPMS show customers we’re serious about what we do and delivering the highest quality products we can.
At PCA-HPMS, we have an ISO Class 9 cleanroom which allows 35,200,000 particles per cubic meter (or 293,000 particles per cubic foot) that are 0.5 microns or larger as well as a stricter ISO Class 8 cleanroom which only allows up to 3,520,000 particles per cubic meter (or 100,000 per cubic foot) that are 0.5 microns or larger.
For comparison, a typical office space has between 500,000 and 1 million particles per cubic foot, demonstrating that a Class 9 cleanroom is twice as clean as a typical room and our Class 8 cleanroom is vastly cleaner. 
Before entering a cleanroom, staff needs to enter an airlocked outer room where they put on personal protective equipment including shoe covers, a gown, hairnet, gloves and mask.
Norbert Ansay, HPMS Research and Development Manager, points out the machinery used needs to be altered to ensure the class 8 cleanroom meets standards.
“For the most part cleanrooms are maintained similarly and with gowning procedures, but essentially a class 9 is allowed much higher amounts of particulate than a class 8 so that would limit what kind of machinery could be used inside,” he says.
Cleanrooms used for different production can get stricter and stricter until a ISO Class 1 cleanroom, rarely used for things like nanotechnology, allows only 10 particles per cubic meter that are 0.1 micron or larger.
At HPMS, we use cleanrooms throughout production and packaging to guarantee our medical components meet the quality standards OE manufacturers need.
“Loose particles, like hair or lint, can be wiped off before packaging,” Ansay said. “But embedded particles can’t be removed once they’re inside.”
We offer customers an extra layer of protection by packaging our products in the cleanroom. Packaging in a controlled environment promises the items are as clean as possible, meaning customers can have peace of mind knowing we are taking every step we can to ensure they’re components arrive the way they want them to.
Specializing in various high-performance medical cables and components, HPMS manufactures everything from fine wire for medical devices to braided tubing as well as wide ranging options in medical tubing and cabling customization.
OE manufacturers turn to HPMS because we offer custom parts that are reliable, durable and affordable. On top of all of that, our Class 8 and Class 9 rooms provide controlled environments necessary to reduce risk of contamination and confirm that our components are free of particles.
The PCA-HPMS team understands that quality and cleanliness are vital in the medical field and we know how to maintain both principals. Our ISO-cleanrooms ensure that all of our products, from braided tubing to custom medical cables are manufactured and packaged with the highest standards in mind.
HPMS is a prime choice for customers seeking an extra layer of assurance or a partner to keep the best standards as policy. If you’re looking for a manufacturing partner committed to cleanliness and quality standards, contact us today. Learn how our ISO-certified cleanrooms can meet your medical solutions needs.
