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Why Clean Room Is Important
For Medical Plastics Manufacturing ?
Unlike other industrial sectors,
Medical Device components manufacturing is highly specialized ,
carrying specific requirements for sterility and regulatory
accountability .This makes it essential for the Medical Device
Manufacturers to have clean room manufacturing for their molded
plastic parts/components.
Clean rooms are classified by
International Organization for Standardization (ISO). Clean rooms
are enclosed and environmentally-controlled spaces in which
temperature, humidity, pressure and contaminant levels are kept
within strict limits. It helps to ensure that products remain
under controlled contamination levels throughout the production
process, thereby reducing potential risks to patients. Therefore,
appropriate clean room designs, and the implementation of
personnel policies and procedures that control work within the
clean room environment, are critical for the production of safe
devices.
Particles found in the clean room
include those created by the manufacturing equipment, as well as
particles already in the room. In regards to plastics
manufacturing for medical devices, injection moulds are a source
of contaminants, especially if the moulds are not properly
maintained. Other clean room contamination sources specific to
plastics are dust that is released during production and
contaminated raw materials.
Basic clean room practices include :
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Developing a thorough clean room
gowning requirements and procedures.
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Ensuring the correct clean room
supplies are present and they are used properly.
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Instituting clean room housekeeping
procedures and schedules. Preventative maintenance is very useful,
especially for plastic mould injection equipment to reduce
contaminants that are produced during the process.
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Training personnel on behavioral
standards within the clean room environment.
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Continuously auditing and assessing
clean room procedures and making improvements as needed.
Micro-organisms, dust/smoke,
unapproved equipment, inadequate environmental controls and human
error are among leading causes of contamination in clean rooms.
Research has shown that clean room personnel contribute to
approximately 80% of all contamination that is found within the
clean room.
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