Based on a strategic alliance it has formed with the package design and engineering consultancy firm Spartan Design Group, Thermoform Engineered Quality is able to provide customers with a full range of services from concept to completion of the medical package. The contract supplier of sterile medical device packaging is equipped to offer package thermoforming in Class 100,000 and Class 10,000 cleanroom environments; gamma, E-beam radiation, EtO, or steam sterilization services; and package testing and validation in CGMP facilities that are compliant with ISO 11607 standards and certified for quality management to ISO 13485 standards. In addition, it works with the customer throughout a project to undertake packaging system design and engineering, material selection, stability testing, and manufacturing process validation.
Thermoform Engineered Quality
Injection Molding Services
Contract-manufactured components employed in medical devices and custom kits can be supplied by a company offering capabilities in injection molding, insert molding, and overmolding. Specializing in the tight-tolerance fabrication and customization of medical device components, the B. Braun OEM division of B. Braun Medical Inc. is equipped with 80 injection molding machines with presses ranging in clamping force from 55 to 330 tn. The contract manufacturer also operates nine insert molding machines and ultrasonic welding systems. Many of the presses, which are standardized to allow easy mold changeouts, are operated in an ISO Class 8 molding facility. The FDA-registered, ISO 13485–certified company’s manufacturing capabilities are complemented by an in-house tool and machine shop that maintains production molds. Providing design and prototyping, validation, assembly, packaging, private labeling, regulatory guidance, sterilization, and quality control services, the service provider manufactures such high-volume components as check valves, stopcocks, clamps, caps, and fittings.
B. Braun OEM Div., B. Braun Medical Inc.
Injection Molding and Tooling Services
Matrix Tooling and Matrix Plastic Products, an enterprise offering services in precision plastic injection molding and tool building, is equipped with a 45-tn vertical injection molding press acquired specifically to meet the needs of medical device molding projects. The press has a vertical injection unit and clamp and a two-station rotary table. It also features a servo-controlled injection system to maximize accuracy and repeatability, a high-temperature barrel package, and dual core pulls. The vertical machine is expected to help the company carry out projects that require the overmolding of machined inserts, stampings, and metal-injection-molded components in accordance with tight tolerance requirements. Specializing in the molding of intricate and tolerance-critical components, the ISO 13485:2003– and ISO 9001:2008–certified service provider offers design consultation and mold design services, construction capabilities, and inspection reporting. It processes such medical polymers as PEEK, liquid-crystal polymers, and resorbable materials in cleanroom facilities.
Matrix Tooling Inc., Matrix Plastic Products
WOOD DALE, IL