Page 30 - Plastics News August 2018

FEATURES

operate according to strictly documented procedures Class III medical devices are the most complex,
that describe these and other requirements.For instance, carry the highest risk and, consequently, impose the
HPSOR\HHV PXVW IROORZ VSHFLÀF SURFHGXUHV IRU JRZQLQJ most stringent regulatory controls. Examples include
Donning is done from top to bottom, starting with a implantable pacemakers, continuous glucose monitors,
hair/beard net and followed by a coat, pants and shoe and other implants, all of which are usually molded and
covers. A bench separates “clean” and “dirty” sides so assembled in cleanrooms to minimize the potential for
WKDW DQ HPSOR\HH·V VKRHV ZRQ·W FRQWDPLQDWH WKH ÁRRU contamination from airborne particulate.Together, the
Jewelry must be covered or removed completely. Hearing costs and procedures required to maintain these highly
protection, safety glasses and gloves are also mandatory. regulated and quality-intensive environments can pose
0RVW PROGLQJ FOHDQURRPV DUH FHUWLÀHG WR ,62 VWDQGDUGV a major barrier to entry to medical molding and set the
1\SUR·V PROGLQJ FOHDQURRPV DUH DOO ,62 FHUWLÀHG ZKLOH practice apart from conventional industrial molders.
its cleanrooms for assembly are ISO 8 or ISO 7—a more Establishing a quality-management system (QMS) to meet
stringent standard. If cleanroom manufacturing is required FDA requirements for 21 CFR 820 compliance, cGMPs, and
for a project, the customer’s quality specs will indicate ,62 FHUWLÀFDWLRQ LV H[SHQVLYH ,W PD\ DOVR UHTXLUH
the ISO level. In medical molding, it’s especially critical hiring additional quality personnel.
to follow written documentation and procedures.
Maintaining certifications and compliance can be
:KHQ D PHGLFDO GHYLFH GHVLJQHU LV XQVXUH ZKHWKHU D challenging as well. There are regular audits by ISO
molded product requires cleanroom manufacturing, registrars, continuous audits by customers, and periodic
many a times the U.S. Food and Drug Administration’s audits by the FDA. Quality documentation begins at
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for materials is captured as part of the device history
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and must provide complete traceability. Medical molders
also need statistical process-control (SPC) charting and
the validated inspection of critical and process-sensitive
dimensions. All molds and assembly automation must be
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(IQ/OQ/PQ) process. Fully documented reports include
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that require customer approval for production readiness.
Equipment

)'$ GHYLFH FODVVLÀFDWLRQ FDQ EH KHOSIXO ,GHDOO\ PRVW RI Not surprisingly, medical-molding equipment must undergo
them follow the international norms. For example, Class VWULFW LQVWDOODWLRQ TXDOLÀFDWLRQ SURFHGXUHV &RQÀUPLQJ WKH
I medical devices may not require cleanroom molding correct setup is essential for compliance, quality, safety
because they carry the lowest level of risk and must and cost control. Most injection molding machines are
comply with the lowest amount of regulatory control. housed entirely inside ISO 8 cleanrooms. Medical molders
Examples of these simple devices include elastic bandages, must also identify and document their equipment to
GHQWDO ÁRVV ÁRVV ER[HV DQG WRRWKEUXVKHV &ODVV ,, PHGLFDO support daily process audits. Most of Nypro’s presses are
devices have medium complexity but pose a higher risk. HTXLSSHG ZLWK URERWV WKDW DXWRPDWLFDOO\ UHPRYH ÀQLVKHG
Therefore, they carry more stringent regulatory controls parts to ensure they remain clean and undamaged. The
to ensure they are safe and effective. machine-mounted robots also provide mold protection by
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Most, but not all, Class II medical devices are molded or
assembled in ISO Class 8 cleanrooms. Among the medical closing on parts.Molding machines can be either electric
parts molded in cleanrooms are asthma inhalers and or hydraulic. Electric molding machines use approximately
auto-injector pens. Class II devices that do not require 40-50% of the electricity of hydraulic equipment, which
cleanroom manufacture include condoms and pregnancy explains their favor for lowering manufacturing costs.
testing kits. +RZHYHU K\GUDXOLF HTXLSPHQW LV VWLOO D EHWWHU ÀW IRU

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