Cleanroom Manufacturing and Assembly 15912

Originally Published MPMN June 2009

OUTSOURCING OUTLOOK

Cleanroom Manufacturing and Assembly

OEM customers and patients expect and demand particulate-free devices, including devices that are free of paper, hair, minute fragments, or foreign materials. To that end, OEMs should choose contract manufacturers that fabricate medical device components in strictly controlled, monitored, and certified cleanrooms. However, because particulate-free manufacturing environments are difficult to maintain, the OEM should ensure that the contractor’s facilities have all protocols, validations, and certifications in place.

Outsourcing manufacturing to controlled facilities that are constructed according to clean-build protocols is important for medical device OEMs. They should select outsourcing partners that maintain cleanroom facilities rated to at least Class 100,000 or better, depending on the classifications of the medical devices they make.
A growing trend in cleanroom manufacturing and assembly is the move toward turnkey manufacturing. As a result of this development, OEMs are choosing outsourcers that can perform a range of services under a single roof, including metalworking, injection molding, and assembly.
Part of what it means to be a turnkey manufacturing source for an OEM partner is the ability to provide full packaging and sterilization services. This is an especially valuable asset because over the past 20 years, there has been a transition in the hospital setting from reusable devices to disposable products, requiring that device manufacturers choose outsourcing firms that can deliver cleanroom packaging. And with the heightened importance of infection control in the hospital environment, the growing trend is for OEMs to partner with contract manufacturers that are also qualified to perform sterilization services.

Medical Products Provider Specializes in Cleanroom Services
With four Class 10,000 cleanrooms in two ISO 13485–certified facilities, a medical device development and manufacturing firm specializes in the production of Class II and Class III medical devices, including custom catheter systems and components, disposables, and implantables for the vascular, surgical, and urology markets. The company’s cleanrooms have injection molding machines, braiders, custom catheter-forming equipment, and bonding, sealing, packaging, and inspection machines. In addition to providing ongoing routine volume production services, the provider offers short-run production services for clinical and animal testing. The company also maintains a development facility that supports production with product engineering, custom manufacturing equipment, and fixture design.
Medical Murray Inc.
North Barrington, IL
www.medicalmurray.com

Contractor Provides Medical, Electronic Assemblies
Providing full-contract manufacturing services, including components procurement and assembly, a supplier specializes in cleanroom manufacturing services. FDA registered and ISO 13485 certified for subcontracting manufacturing of medical, electrical, and mechanical parts and assemblies, the company maintains a 1700-sq-ft Class 100,000 cleanroom that is equipped with SMT and through-hole wave-soldering equipment. It also manufactures both RoHs- and non-RoHs-compliant products.
Coastline International
San Diego
www.coastlineintl.com

Supplier Offers Cleanroom Medical Device Manufacturing Services
A contract manufacturer of such medical devices as bone-marrow collection systems and halos maintains a 370-sq-ft HEPA-filtered controlled-environment cleanroom equipped with a supplemental HEPA downdraft hood. The full-service contract manufacturer provides manual, automated, and semiautomated assembly; custom and kit packaging; and printing. To complement its cleanroom operations, the company is adding a 640-sq-ft Class 10,000 cleanroom containing a softwall gowning area and a softwall partition for the transition from the assembly area to the sealing and packaging areas. In addition to offering product-marking capabilities such as hot stamping, screen printing, pad printing, and laser engraving on both flat and 3-D items, the manufacturer provides prototyping, start-up manufacturing, and full production services.
HPC Medx
Hanover, PA
www.hpcmedx.com

Vendor Offers Class II and Class III Medical Device Manufacturing
Equipped with a 56,000-sq-ft facility consisting of 10,000 sq ft of Class 10,000 cleanroom space, a contract manufacturer offers a variety of turnkey outsourcing services, including manufacturing, assembly, sterilization, sterilization validation, and laboratory testing. The manufacturer of Class II and Class III medical devices is qualified to produce nonactive, invasive and noninvasive surgical devices, diagnostic equipment, and active electromechanical devices. The FDA-registered and ISO 13488- and ISO 9002-certified vendor also offers a range of packaging and packaging validation services, including protocol development, conditioning studies, transportation simulation, package-integrity testing, package-strength testing, and microbial-barrier testing.
Life Science Outsourcing Inc.
Brea, CA
www.lso-inc.com

Manufacturer Maintains Class 100,000 to Class 10,000 Cleanrooms
A contract manufacturer of medical devices operates Class 100,000 down to Class 10,000 cleanrooms that have been constructed according to a five-step clean-build protocol. The ISO 13485:2003-certified and FDA-registered facility manufactures and packages CE-marked medical devices using a variety of technologies. In addition to its certified cleanroom manufacturing area, the company has a certified mobile Class 10,000 softwall facility for clean injection molding. It also employs a reverse-osmosis pyrogen-free water system to meet the washing requirements of components and assembled products. A manufacturer of devices and needles for cardiovascular, orthopedic, drug-delivery, ophthalmology, and general hospital products, the supplier provides a range of services, including insert molding, metal processing, plastic processing of catheters, and in-house lab testing.
Precision Medical Products Inc.
Denver, PA
www.pmp.net
For more features on such contract manufacturing services as cleanroom manufacturing and assembly, go to www.devicelink.com/mpmn/cm
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