With the steady increased adoption of bioabsorbable polymers and sensitive materials for micro medical device components, temperature controlled environments for manufacturing and storing these critical pieces has become essential. Due to the sensitivity of bioabsorbable materials and the criticality of the molded products they create, cleanroom manufacturing and handling have proven to be the only option for success and a key component bioabsorbable micromolding expertise.
100% Cleanroom Manufacturing
Many molding vendors offer clean room molding as an option to their customers. At MTD, 100% of injection molding manufacturing occurs in environmentally controlled ISO Class 8 cleanrooms. These specialized molding cells are equipped with customized robotics,vision systems, packaging automation, and run “lights out” for optimized efficiency. Validation activities, process development, short- and long-run molding all take place in a cleanroom environment.
Shipping and Storage Controls
In addition to temperature controlled manufacturing of these sensitive materials, all molded parts are handled, inspected, tested, stored, and packaged cleanrooms at MTD. Temperature of storage conditions for these materials is constantly monitored and logged, with alert limits created to notify personnel if critical settings are exceeded. This applies to raw resin storage as well as molded inventory. Specialized shipping procedures are also utilized for sensitive materials—for both high and low volume shipments—where temperature is closely controlled and monitored.
Cleanroom Expansion Plans
MTD currently performs all manufacturing in the 3,500 sq.ft of dedicated cleanroom space. Next year’s building expansion plan, which will result in a 12,000 sq. ft. addition to the existing building, will effectively double the existing cleanroom space and molding capacity in the Charlton facility,