Tijuana Manufacturing Facilities

Manufacturing with Confidence:

Our Tijuana manufacturing facilities, production standards, and dedication to quality means our clients can confidently rely on us to produce the highest quality products on their behalf.

Location

• Coastline's Tijuana, Mexico facilities are a short drive from San Diego, California
• Access to large low-cost labor market trained in medical device and electronics manufacturing sector
• Well established supply chain and shipping infrastructure
• Quick access to California-Mexico border crossing and international seaports
• Easy travel destination for visitors

Capacity and Qualification

• Operational capacity includes 3 buildings totaling more than 50,000 square feet
• 4 separate ISO Class 8 (Class 100,000) cleanrooms
• Various controlled manufacturing environments (HEPA & non-HEPA filtered conditions)
• Antistatic mats and flooring
• RoHS compliant
• ISO 13485 certified (NEMKO ISO 13485:2016)
• ISO 9001 certified (NEMKO ISO 9001:2015)
• FDA registered
• Lean Manufacturing principles
• Well-versed in manufacturing transfers
• Program Management
• Established IQ, OQ, PQ protocols

Safety and Security

• Excellent work safety record
• Facilities built to U.S. standards
• On-site security systems
• Controlled access to manufacturing facilities
• Controlled access to business park

Facilities Background:

With more than 40 years of experience in the medical device manufacturing sector, Coastline International Inc. has manufactured a wide variety of medical devices for our client companies and specializes in finished device assembly and cleanroom & sterilization services. Coastline International is registered with the FDA and our facilities have produced sterile and non-sterile, single-use disposables, consumables, subassemblies, and finished medical devices for clients across the USA & internationally.

Coastline has manufactured electronic and electrical products for the OEM community since its inception in 1982. We have always been committed to meeting the demanding quality standards and aggressive lead times associated with OEM manufacturing.

The strategic location of our manufacturing operations in Tijuana Mexico offers several important advantages that benefit our client companies. First and foremost, we have direct access to a large, motivated, and inexpensive labor pool associated with the medical device, electronics, & aerospace industries. Our clients also benefit from duty-free movement of goods under the North American Free Trade Agreement (NAFTA) and other location-related cost advantages.

In addition, our close proximity to the California border and international seaports allows us to utilize the highly developed cross-border transportation network and ports of entry that serve the greater San Diego and Tijuana area. This proximity to the US-Mexico border eases transportation schedules and costs to anywhere in the USA or overseas. Client company visits are convenient since our facilities are less than 30 miles from the San Diego International Airport.

Capacity and Qualification

Our manufacturing facilities of over 50,000 sq. ft. are FDA registered and ISO 13485 & 9001 certified. We have several Class 100,000 (ISO Class 8) cleanrooms and other controlled environments dedicated to medical manufacturing. Our cleanroom capacity is among the largest of any contract medical manufacturer in the border region of Mexico.

Productive Work Environment

We are committed to maintaining an excellent safety record and work environment in our manufacturing facilities. We are proud of our safety programs and working conditions, and provide clean work areas with air-conditioning, an on-site on-staff nurse, and an on-site cafeteria. We pay attention to ergonomics, monthly health awareness campaigns, and employee appreciation events. Our employees are also well served by the convenient public transportation that serves our business area.

Safety and Security

Our client's products are manufactured in facilities that are constructed and maintained in accordance with U.S. building standards, and equipped with modern security systems. We monitor and control visitor and employee access to our premises. In addition, pedestrian and vehicular traffic into and out of the business park of our manufacturing facility is controlled by a guard station and entrance gate.

 

Frequently Asked Questions About Tijuana Manufacturing Facilities

What makes Coastline's Tijuana manufacturing facilities ideal for U.S. manufacturers?

Our Tijuana manufacturing facilities span over 50,000 square feet with several hundred skilled employees trained in medical device and electronics manufacturing. Located a short drive from San Diego, California, we provide easy access to California-Mexico border crossings and international seaports with convenient travel for facility visits.

What cleanroom assembly capabilities are available at your Tijuana manufacturing facilities?

Our facilities feature 4 separate ISO Class 8 (Class 100,000) cleanrooms with various controlled manufacturing environments including HEPA and non-HEPA filtered conditions. We offer cleanroom assembly & packaging, sterile-barrier packaging, and manual assembly of components, subassemblies, and finished devices.

Are your Tijuana manufacturing facilities ISO 13485 cleanroom certified?

Yes, our facilities are ISO 13485:2016 certified by NEMKO and ISO 9001:2015 certified, with FDA registration. Our ISO 13485 cleanroom operations include established IQ, OQ, PQ protocols and specialize in manufacturing sterile and non-sterile single-use disposables and finished medical devices.

How does Tijuana manufacturing benefit U.S. companies compared to other locations?

Tijuana manufacturing offers direct access to a large, motivated labor pool with free trade cost benefits under USMCA (formerly NAFTA). Our proximity to the California border and international seaports provides highly developed cross-border transportation networks and reduced shipping costs compared to offshore alternatives.

What industries do your Tijuana manufacturing facilities serve?

Our facilities serve medical device, biotech/pharmaceutical, electronics, aerospace, commercial construction, and consumer product sectors. We have over 40 years of experience manufacturing medical devices and have served the electronics OEM community since 1982 with demanding quality standards and aggressive lead times.

What cleanroom assembly processes can you perform in your Tijuana manufacturing facilities?

Our cleanroom assembly capabilities include ultrasonic and RF welding, solvent bonding, UV curing, friction fit/press-fit assembly, and sterile-barrier packaging. We also offer validation & process qualification activities and quality assurance testing per ISO standards to ensure products meet exact specifications.

How secure and compliant are your Tijuana manufacturing facilities?

Our facilities are built to U.S. standards with controlled access to manufacturing areas and the surrounding business park through guard stations and entrance gates. We maintain FDA registration, RoHS compliance, and operate with antistatic mats and flooring in controlled manufacturing environments.

How do I learn more about manufacturing in Tijuana?

Contact Coastline International at 888-748-7177. If you prefer, you may send us a message.