Page 29 - Plastics News August 2018

FEATURES

value-added material production in the future and be used this time has the advantage of being able to selectively
to solve global warming problems and energy resource produce CO2 as a usable chemical element such as
depletion issues by selectively producing higher levels of methane or ethane. By conducting follow-up research
hydrocarbon materials using sunlight. that increases the conversation rate so that it can be
commercialized, we will contribute to the development
Professor In said, “The reduced titanium dioxide
photocatalyst with graphene that has been developed of technology for reducing carbon dioxide and turning it
into a resource.”

Getting Started with Medical Molding

Stephen Costa

Molders looking to take on medical-device manufacturing must be cognizant of the intrinsic challenges and
costs imposed by this industry. Four E’s represent more than evaluative criteria for medical molders.

lastics are pervasive in medical, from tiny extruded and qualify them for the rigorous demands of medical-
Pcatheters to tamper-evident medicine caps to huge device manufacture.
MRIs that are built using thermoformed parts. Plastics have Environment
made health care simpler and less painful and made new
techniques and prostheses possible. To compete in this Like the industry they serve, medical molders operate in
market, processors need to have commitment to quality a highly regulated, quality-intensive environment that
and consistency. often involves manufacturing products in cleanrooms that
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The competitive and regulatory demands on medical-
device OEMs require them to work with injection molders a cleanroom depends on the level of air cleanliness—a
that can bring the right environment, equipment, function of airborne particle sizes and quantities—required
engineering materials, and employees to the manufacture during manufacturing.
of their designs. These “Four E’s” encompass important 7R HQVXUH DLU FOHDQOLQHVV FOHDQURRPV UHO\ RQ +(3$ ÀOWHUV
evaluative criteria by which medical-device manufacturers installed in the ceiling, where air enters the room through
identify and measure with whom they partner among the ceiling and sweeps down to the base of the walls to
molders and other plastics processors. H[KDXVW GXFWV QHDU WKH ÁRRU 7KH DLU ÁRZ LV ODPLQDU WRS

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cleanrooms, and quality and regulatory requirements
such as cGMP, ISO 13485, ISO 9001, and lot traceability.

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molds, robotics and assembly automation.
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plastics with challenging process requirements. WR ERWWRP DQG NHHSV SDUWLFOHV IURP ÁRDWLQJ LQ WKH DLU
Includes supply lot controls, USP Class VI, BSE/TSE causing contamination.
and 10993 compliance.
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‡ (PSOR\HHV ,QFOXGHV KLJKO\ VNLOOHG SHRSOH ZKR ZRUN of which indicates the allowable size and amount of
with technically advanced molds, equipment and particulate matter in a cubic volume of air. A cleanroom’s
processes supporting complex mold and assembly FODVVLÀFDWLRQ DOVR GHWHUPLQHV WKH IUHTXHQF\ RI FRPSOHWH
validations. air changes. In a typical 25,000 ft2 ISO 8 cleanroom,

The Four E’s represent more than evaluative criteria the entire room volume of air is changed more than 20
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standards for performance that set these molders apart cleanrooms require periodic cleaning. Medical molders

29 August 2018 Plastics News