What criteria should an OEM consider when selecting an outsourcing partner with cleanroom capabilities? Bob Lord, sales and marketing director at Quality Tech Services (Bloomington, MN), provides some insights.
MPMN: What advantages do medical device OEMs gain by partnering with contract manufacturers that offer cleanroom services?
Lord: There is less risk of contamination if the OEM’s devices are fabricated in a cleanroom because of the lower bioburden and reduced foreign-material contamination potential. The OEM can also enjoy better-quality products, since cleanroom-trained personnel often have higher skill levels than other workers and take better care of customers’ products in the process. The OEM also gains the ability to focus on strategic activities and core competencies, while the contract manufacturer uses its industry knowledge and relationships to create the best products possible.
MPMN: What capabilities should OEMs demand of contract manufacturers that provide cleanroom services?
Lord: ISO certifications are crucial. The OEM should ensure that the contract manufacturer is certified to ISO 13485 and is compliant with both ISO 14644 and ISO 14698 standards for cleanrooms. In addition, the outsourcing facility should maintain cleanrooms that are rated Class 10,000 or better and be equipped with Class 100 laminar-flow workstations for fabricating and assembling devices requiring high levels of cleanliness. The vendor should also maintain quality control systems, comply with regulatory requirements, demonstrate device and component cleaning capabilities, operate separate gowning areas to reduce the potential for contamination, and maintain systems for delivering ultrapure water, clean dry air, and filtered nitrogen. And to ensure a smooth working relationship with its contract manufacturer, the OEM should select a partner with dedicated production and customer teams to guarantee quality control for each project.
MPMN: What cleanroom manufacturing and assembly trends should OEMs be looking out for?
Lord: Built-in redundancy at the contract manufacturing site is becoming increasingly important, along with the maintenance of a supply plan. Also, OEMs should ensure that a potential outsourcing partner is able to offer unique device identification compliance services for labeling products.
Molding and assembly capabilities
In addition to its existing eight cleanrooms, a contract manufacturer has added a 420-sq-ft Class 100,000 cleanroom that will be used for molding and packaging medical device parts. The company uses its cleanroom facilities to mold and assemble a surgical tool and an accompanying device used for hearing-loss correction, for example. Its cleanrooms can handle production runs of as few as 10 or as many as 1,000,000 parts.
Plastics One Inc.
Medical device and electronics assembly services
Featuring two Class 100,000 cleanrooms totaling 1700 sq ft, a contract manufacturer focuses on medical part and electronics assembly operations. The ISO 13485– and ISO 9001–certified company also plans to double its Class 100,000 cleanroom capacity this spring. Equipped with SMT and through-hole wave-soldering equipment, the facility provides RoHS-compliant and surface-mount manufacturing services, in addition to such full-contract manufacturing services as parts procurement.
Coastline International Inc.
Imaging, orthopedic, radiological, and surgical device components
Located in a 50,000-sq-ft facility, a contract manufacturer provides the medical device industry with complete cleanroom manufacturing services. The company uses its cleanroom to fabricate and assemble components and products such as lens devices for fluoroscopy and endoscopy equipment, orthopedic implant parts and instruments, radiology equipment, and general surgery devices. With more than 1600 sq ft of space designated in its facility for cleanroom and assembly activities, the company specializes in a range of capabilities that include prototyping, packaging, and logistics. The FDA-compliant manufacturing facility has multiple certifications, including ISO 13485:2003 and ISO 14644-1 for cleanrooms and associated controlled environments.
3D Medical Manufacturing Inc.
Riviera Beach, FL
Molded parts for laparoscopic, handheld, and respiratory devices
Specializing in the engineering of thermoplastic and liquid silicone rubber (LSR), a medical device contract manufacturer provides plastic injection, double injection, insert, LSR injection, and overmolding services in a Class 100,000 cleanroom. These molded plastic parts are used in laparoscopic applications such as tissue-retrieval bags, handheld instruments, trocars, and silicone valves used in respiratory devices. In addition to its molding services, the company offers ultrasonic welding, assembly, and packaging services. Certified to ISO 13485 standards and compliant with QSR and FDA requirements, the company concentrates on vertically integrated contract manufacturing services, from small preproduction runs to large-scale full-production runs manufacturing millions of parts.
Cleanroom assembly, packaging, and sterilization services
Offering Class 7 cleanroom assembly services to the medical device industry, a manufacturer provides multicomponent kitting, solvent welding, silicone coating, suture tying, and liquid-nitrogen processing for services involving nitinol component assembly. In addition, the ISO 13485:2003–certified and FDA-registered manufacturer offers detailed inspection of customers’ components to ensure that they adhere to specifications. Concentrating on orthopedic, spine, urology, neurology, and cardiovascular applications, the company offers package design expertise, cleaning and passivation, label development and printing, contract sterilization, and material sourcing and inventory management services.
Quality Tech Services Inc.
Published in MPMN, January/February 2011, Volume 27, No. 1
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