Cleanroom manufacturing and sterilization
NovoSci Corp. manufactures, packages, sterilizes, and distributes single-use, disposable medical products that are used in inpatient and outpatient surgical procedures. In addition to commercializing its own product lines, the firm provides contract supply-chain services to other companies, including OEM component manufacturing, kit assembly, ethylene oxide (EtO) sterilization, climate-controlled warehousing and global distribution. The FDA-registered and ISO-certified company offers manufacturing software that provides streaming and real-time inventory tracking.
Cleanroom manufacturing services
Coastline International Inc. provides manufacturing services to the medical device community. It operates several Class 100,000 cleanrooms in its FDA-registered and ISO 13485–certified facilities. Capabilities offered by the firm include manual assembly of components and subassemblies, secondary manufacturing processes, and ultrasonic welding. In addition, services such as gluing and solvent bonding, packaging and bagging, and private labeling are available. The firm handles logistics for transporting raw materials and components to its manufacturing facility in Tijuana, Mexico.
Coastline International Inc.
SAN DIEGO, CA
Providing Class 10,000 and Class 1000 cleanroom environments, Hutchinson Technology Inc. assembles intricate medical microassemblies. Core assembly operations include laser welding, polymer stamping and attaching, die bonding, and automated material handling and packaging. Certified to ISO 9001 and ISO 13485 standards, the company has also introduced production capabilities for chemically sharpened medical blades.
Hutchinson Technology Inc.
CleanCut Technologies operates an ISO 13845–certified and FDA-compliant facility dedicated to stringent process control—from initial design input through product realization. All products are manufactured in a Class 100,000 cleanroom and then completed in a Class 10,000 cleanroom for additional assembly, cleaning, inspection, double poly bagging, and labeling. Offering more than 320,000 sq-ft of cleanroom space dedicated to medical device packaging, the company provides die-cutting, the production of catheter/guidewire dispensers, pad-printing, vibe welding, chevron pouch manufacture, tube-flaring, and assembly services.
Full-service medical device contract manufacturer Precision Tool & Die has added a new Class 10,000 and Class 100,000 fixed hard-wall cleanroom, providing molding, assembly, and packaging services. The company’s cleanroom presses perform both horizontal and vertical molding dedicated to the production of Class I, II, and III medical devices. Applications span cardiac care, gastroenterology, infusion therapy, oncology, orthopedics, and vascular surgery. Viable and nonviable testing is certified to ISO 14644-1 standards. The company also offers validation IQ-OQ-PQ in-process, engineering materials and elastomerics, bioabsorbable molding, prototyping, short- and long-run molding, ultrasonic welding, hot stamping, and pad-printing in a cleanroom environment.
Precision Tool & Die
- Michael P. Driscoll, operation manager at Precision Tool & Die (Derry, NH) shares advice related to cleanroom manufacturing and assembly services