When it comes to medical facilities, it is critically important to the health and safety of the occupants that all medical devices and equipment are void of foreign materials and fragments. The most effective way to achieve this level of sterility is by outsourcing the manufacturing of medical equipment to a clean room manufacturing company. There, devices are assembled in a controlled environment and monitored by a team of experts to ensure all equipment is free of particles and meets all necessary protocols.
What is a Clean Room Facility?
A clean room is a lab, production, or assembly facility that is specially designed to maintain low levels of airborne particulates. Dust, pollen, microorganisms, and vapor particles can affect areas that require high levels of sterilization and sanitation control. Clean rooms are an essential part of manufacturing and assembly for products that are sensitive to environmental contamination.
Clean rooms are measured on the basis of standard cleanliness levels. In the US, clean room air quality uses a scale established by the federal government called the Federal Standard 209E (FS 209E). This scale measures the average quantity of particulates 0.5 mm and smaller, per square foot. It divides these into several classes which can be equivalenced with the International Standards Organization (ISO) classifications.
At Coastline International Inc. we operate several ISO Class 8 rooms. ISO Class 8 rooms can be equivalenced to the FS 209E Class 100,000. We maintain consistently monitored air change rates (the number of times that all the air in the room changes, per hour) in our clean rooms. We use about 9,000 of our 50,000 square foot facility for clean rooms.
Is Clean Room Assembly Suitable for Medical Grade Products?
Yes, our ISO Class 8 clean rooms are perfect for assembling a range of medical supplies, tools, and instruments. We assemble a wide range of medical products in our facilities. These include:
- Catheter sets
- Infusion therapy, IV & extension sets
- Laparoscopic suture devices
- Blood collection / phlebotomy devices
- Ophthalmology devices
- Enteral feeding tubes assemblies
- Surgical devices and kits
- Wound treatment devices
- Finished device assembly
Over the years we have built strong relationships with medical institutions, suppliers, and professionals in San Francisco and the Bay Area. Having medical grade production and assembly so close by is a huge advantage for many businesses. You can visit our facility and see firsthand the professionalism with which we run our business.
We are an FDA registered and an ISO 13485:2016 & ISO 9001:2015 certified manufacturer.
Professionally Trained Workers
All of our staff at Coastline International Inc. are professionally trained in precision manufacturing and production. With years of experience operating clean rooms, our employees form a cohort of skilled labor that is unmatched in the region.
We’ve served a range of well-known organizations in the medical, electronics, aerospace, and consumer goods industries. These industries require exceptional compliance standards. There is no room for error. That’s why we hire the most skilled technicians from across the country to work in our state-of-the-art manufacturing and assembly facilities.
Innovation and Affordability
Drawing on 35 years of manufacturing experience, we work hard to continually optimize our assembly services. Coastline International Inc. doesn’t simply make the most of recent innovations in technology. We also use innovative technologies in our assembly process.
Our ISO Class 8 clean rooms are part of this strategy. Clean rooms allow us to assemble supplies, tools, and products that require exceptionally high levels of environmental control. By combining this with the import-export component of our services, we’re able to ship our products around the world with ease. If your business is in San Francisco, that’s not much more than a drive down the road!
Experienced Clean Room Manufacturers
At Coastline International Inc., we are a premier clean room assembly and manufacturing company committed to manufacturing equipment in a clean and controlled environment. As an FDA registered facility, we strive to provide each our clients with the highest level of professionalism and efficiency. Our technicians are highly experienced and participate in ongoing training to ensure assembly meets stringent protocols. If you have a blueprint, we are here to take that design and transform it into a useable product. Our skill and years of experience means that we possess the capabilities to assembly a wide range of equipment, including surgical clip guns, feeding tube sets, esoteric diagnostic pouches, electrophoresis devices, and more.
Timely Medical Device Delivery
Ask anyone who works in the medical field and they’ll tell you how important timely delivery is when it comes to medical equipment. At Coastline International Inc., we strive to get you what you need when you need it, and because we are a nearshore manufacturer, transit time is greatly reduced. For us, this is much more than a job. We are passionate about becoming partners in the success of your facility. What’s more is that our clients can benefit from duty-free movement of goods under the North American Free Trade Agreement (NAFTA) because we are a nearshore company. What this means is that our products are manufactured in neighboring Mexico and then transported to the United States. In general, our manufacturing services are 30 percent lower than other clean room assembly companies.
Medical Clean Room Supplies
OEMs in North America choose us because we have the capabilities to perform each aspect of medical manufacturing under one roof. For three decades, we have offered:
- Assembly of components
- Ultrasonic welding
- Laser beam welding
- Gluing and solvent bonding
- Packaging and bonding
- Private labeling
- Soft good sewing
- …and more
When you partner with Coastline International Inc, you are working with a company that is committed to providing you with exceptional service from beginning to end. We handle all the logistics to ensure all raw materials are transported in an efficient and safe manner. This allows you to focus on what you do best. If you have any questions or would like to schedule an appointment to discuss your needs, then we encourage you to get in touch with us today. A member of our seasoned staff will gladly answer any questions that you have and provide you with a quote. We are looking forward to working with you.