Custom Wire Technologies has been serving the medical field for over 20 years. We assemble medical devices for both large companies and small entrepreneurs. At our facility, we create custom medical and dental surgical components, custom guidewires, coil wires, and ultra-fine wire parts. When required manufacturing is done within our ISO class 7 cleanroom to ensure top-quality cleanliness of our products.
Let’s take a look at what a cleanroom is, how they’re maintained, and how we use them at Custom Wire Technologies Inc.
What is a cleanroom?
A cleanroom is a controlled environment used for a variety of industries. You may have also heard them called a “sterile environment”. Cleanrooms are used for research labs, pharmaceutical manufacturing, and medical device assembly. Within any cleanroom, airborne particulates are strictly controlled. In an ISO 7 cleanroom, air particulates are maintained at 352,000 particles per cubic meter (m³) maximum.
Cleanrooms are classified depending on the allowed number of particles per cubic meter. For comparison, ISO 1 cleanrooms are permitted only 0.35 particles of 0.5 microns in size per cubic meter, making it the “cleanest”. Class 8 is the least stringent. Room air is considered ISO 9 and can contain up to 35,200,000 particles of 0.5 microns (Data 14644-1 Cleanroom Standards)
Our cleanroom is Certified Class 7 and boasts 2,000 square feet of assembly space.
What do cleanroom technicians wear?
Cleanroom technicians must wear appropriate cleanroom attire. This attire is comprised of a blue gown, a bouffant, and disposable shoe covers, as proper procedures require that these pieces of clothing be worn in the environment at all times. Technicians and cleanroom occupants may also be required to wear a face covering, as well as 2 pairs of gloves or finger cots. This ensures cleanroom occupants are covered from top to bottom to prevent hair, skin, and other contaminants from entering the environment. The lower the ISO classification number the tighter the requirements are for gowning to prevent contamination.
“Gowning” (suiting up from head to toe) takes several detailed steps. It can take several minutes to ensure a successful gowning process. There is also a strict process for taking the garments off. The gowning protocol is perhaps the most important to maintaining the cleanliness of the cleanroom.
How is a cleanroom maintained?
Cleanrooms require regularly scheduled checks and maintenance. It’s extremely important that our cleanroom continuously falls under ISO Class 7 requirements. The goal is also to maintain positive air pressure within the room keeping particulates out. Unlike negative air pressure, which is used to keep biohazards inside the room.
Cleaning procedures are very strict and must be performed on a daily basis. There are specialty cleaning supplies specifically designed for cleanrooms including solutions, lint-free wipes, and specialty mops. The room must maintain the certified condition for assembly to continue.
How are cleanroom technicians trained?
Our cleanroom technicians are required to go through extensive on-the-job education and training including the daily “gowning” and “de-gowning” process. Attention to detail is certainly required for product assembly but it’s also important for room care and maintenance.
All of this is in compliance with ISO standards, we take pride in producing high-quality medical components.
What we do
Some of the services we perform under our operating procedures:
- Basic assembly of medical devices and other sensitive materials
- Product packaging
- Wire welding
- Ultrafine wire forming/coiling
- Pad printing, product inspection, sorting, and kit assembly
With all of these value-added services in one facility, you’ll save both time and money!