Cleanroom Assembly and Packaging Services
Primo Medical Group is an ISO 13485:2016 certified facility offering comprehensive assembly and testing of medical devices in Class 7 cleanrooms, designed to meet specific application requirements. Our cleanroom environments ensure that the assembly and packaging of medical products maintain controlled conditions throughout the production process.
Spanning over 30,000 square feet, our ISO Class 7 cleanrooms are highly effective at preventing product contamination, leading to significant savings in time, energy, and costs. We specialize in the precision assembly and testing of a wide range of medical devices, each with varying complexities. Our capabilities include the assembly, cleaning, testing, and packaging of medical implants, instruments, surgical tools, electro-mechanical devices, catheters, and infusion ports, among others.
Our cleanroom staff, trained extensively in processing both disposable and reusable medical devices, perform all assembly operations. Each assembly process is governed by product- and client-specific documentation. Clients approve all processes before initial production begins, and any changes to assembly procedures are pre-approved.
Primo Medical Group offers a broad array of cleanroom services, including:
- Complete device assembly or component/sub-assembly level work
- Adhesive and solvent bonding
- Ultrasonic welding
- Laser marking and welding
- Dielectric and heat shrink coatings
- In-line tensile, leak, and burst testing
- Anionic washing
- Tyvek pouching and lid sealing of thermoformed trays
- Customized labeling solutions
With our extensive expertise in medical device assembly, we strive to meet or exceed industry and customer expectations. We are committed to maintaining the highest quality control standards using the latest ISO procedures. Whether you are launching a new product or managing an established medical business, our team is dedicated to supporting your growth and success. For top-quality device assembly and manufacturing services, turn to Primo Medical Group.