Chuck Brewer III, CEO, C. Brewer Co., Anaheim, CA
Leading healthcare companies can grow by strategically leveraging the outsourcing of their molding projects. It is important for them to choose the correct partner, since these contract molders will become an extension of their manufacturing capabilities. In turn, medical molders must become their OEM partners’ molding “alter ego.”
Successful contract molders have seamlessly assimilated a scientific approach to international product realization planning requirements in their validation, quality, and manufacturing disciplines. They recognize that medical device manufacturers need partners that apply technology and have a team of expert operators that can advance their systems.
Lean manufacturing, six sigma, VMI, kanban, and online auctions are all aggressive business practices. But chasing these solutions without a vigilant commitment to a quality policy leaves companies and people at risk. As OEM partners, our systems must rival those whom we serve; therefore complying with the ISO 13485 standard is the new benchmark. The regulation emphasizes software and process validation, demands a formal containment procedure for product recalls, and has a keener focus on product realization than the 9000 standard.
This commitment to quality translates into a molding partner that has implemented scientific molding practices and has procedures to demonstrate it—in short becoming the OEM’s alter ego.
Contract Firm Offers Cleanroom Injection Molding
A company offers injection molding in a cleanroom environment. Mold design and fabrication capabilities include low-cost rapid tooling and high-speed, multicavity hot-runner tooling. Cleanroom molding is performed on all-electric, servo-driven machines. Precision production tolerances of ±0.0005 in. are standard. The company specializes in making Teflon, PEEK, and biosorbable polymer medical products.
Infinity Plastics LLC, Ventura, CA
Cleanroom Injection and Insert Molding Available
A Class 100,000 cleanroom is used for custom and high-precision injection molding. The company’s molding facility provides high-speed material-handling equipment. Closed-loop processes ensure that products are molded in a controlled environment. Injection molding services include mold tool design, building, and prototyping. The company molds medical components such as fitments, exit ports, and tubing connections.
Advanced Scientifics Inc., Millersburg, PA
Reaction Injection Molding Available from Foam Converter
Reaction injection molding (RIM) services are available from a polyurethane-processing company. The RIM process takes two liquid components, a polymer resin blend and a modified diisocyanate, and blends them via a high-pressure mixing system. The blend is then injected into a closed mold at low pressure. The reaction yields a polymer that takes on the details of the mold cavity with high degrees of accuracy and repeatability. Chemicals can be used to adjust the polymer’s pliability, density, and design. Other services available include vacuum forming, fabrication, casting, foam in place, and specialty and polyurethane molding.
Foam Molders & Specialties, Cerritos, CA
Molding Service Focuses on Thermoplastic Materials
With a specialty in molding engineering-grade thermoplastic and elastomeric materials, a supplier also offers micromolding, machined-metal component fabrication, and liquid silicone injection molding. The company’s capabilities include complete design and engineering services, in-house CAD- and CAM-based tooling design and fabrication, insert molding, overmolding, and white-room molding. In addition to Class 10,000 and Class 100,000 cleanroom assembly, contract manufacturing services can include machining, welding, and packaging.
Donatelle, New Brighton, MN
A Company Specializes in Silicone Molding
A medical device manufacturer’s molding division offers OEMs expertise in injection, transfer, and compression molding of silicone. As a maker of custom-extruded and injection-molded silicone rubber products, the company offers a variety of custom-fabricated components. Custom profiles, tubing, valves, and other finished parts can be produced. Customers’ designs can be converted into finished products using the company’s CAD system.
Axiom, Torrance, CA
UK-Based Company Provides Advanced Metal-Injection Molding
A metal-injection molding firm makes custom components for the medical device industry. The company offers advanced metal-injection molding (AMIM) at its UK production facility. The AMIM process can reduce the cost of metal components and also allows for complex designs to be manufactured to a net shape. The firm can produce low or high part volumes. Materials available include 300- and 400-series stainless steel, Hastelloy, tungsten carbide, copper, and ceramic.
Egide UK Ltd., Rendlesham, Suffolk, UK
Injection Molder Provides Plasma Treatment Services
A supplier of injection molding offers plasma technologies for surface modification. A variety of value-added processes, including plasma treatment, are applied on an assortment of in vitro cell culture kits for various customers. The treatment enhances surfaces to promote cell adhesion and protein binding. Processes, procedures, production, and assemblies are accomplished in conjunction with validation and verification studies, IQ-OQ-PQ protocols, and all other appropriate requirements found in 21 CFR Part 820. Multishot insert molding, postmold decorating, and overmolding are available. The company also offers full-service contract manufacturing and total logistics and supply-chain management.
Moll Medical, Dallas, TX
Micromolding System Used for Component Manufacturing
A company uses a micromolding system to produce parts with a shot weight of 1 g or less. Specifically designed for micromolding, the self-contained system offers fast injection speeds, simultaneous injection and ejection of parts, and optical inspection of all finished parts. The system is certified to Class 10,000 cleanroom standards. Additionally, the company can produce dedicated molds in four-, six-, or eight-up sets, or make customized inserts for use with generic mold sets. Tool design, fabrication, and contract assembly are also available.
Rapidwerks Inc., Pleasanton, CA
Injection Molding Process Defines Parameters
A proprietary injection molding process defines time, heat, cooling, and pressure variables for each mold before production. Molded products can be consistently replicated to tolerances of 0.001 in. The company offers a Class 100,000 cleanroom for mission-critical, precision production. Other manufacturing capabilities include electric molding machines, PC-linked pressure transducers, integrated design and process software, robotics, in-house mold making, assembly services, and supply-chain management.
C. Brewer Co., Anaheim, CA