Cleanliness in Medical Device Manufacturing

Jul 2, 2012

Over the last couple of decades, “hi-tech” industries have learned that “particulate” creates major problems in the manufacturing process.  As a result, many operations are performed in “Clean Rooms”.  The medical device industry has similar requirements but for different reasons. 


Particulate represents a foreign substance, which in most cases, presents a safety issue in the medical device itself.  Many devices including needles and cannulas are sterilized but not washed after the manufacturing process.  Therefore, the manufacturing automation system or process has to be “clean”.  This is different from the aseptic processes that are concerned with biological issues in that particulate is created or infiltrate into the device during the manufacturing process.  Medical device manufacturers are now seeking professionals in the automation industry to help with the design and build of complex automated manufacturing systems.  “It is imperative for these companies to choose an automation partner that understands the issues surrounding particulates and has the technologies to remove them during the manufacturing process”, Bob Rice; ATC Automation applications team leader.  ATC recently added on to its “clean facility” that is utilized to produce automation systems for these types of applications.


“The environment controls provided by the manufacturer is a good place to start when designing a system”, Ben Webster; ATC Automation validation manager.  A laminar air flow significantly assists in the control of particulates.  If it exists, the automation manufacturer can design the equipment to utilize this feature to help control unwanted particulates.  If a laminar flow does not exist, other techniques can be utilized such as enclosures.  At this point, every influence of air flow should be examined to understand each mechanism that moves air within the automated equipment.  A good example of this was recently discovered when a robot in an automation system began to experience erratic failures.  It was determined that the cooling fan was pulling the conductive dust from the assembly in and exposing the control board causing shorts in the circuit. 


“‘Clean-ability’ is another area that is critical in the designing of automation systems”, said Rice.  Machines should be designed to reduce pockets or crevices that can harbor foreign substances or even stray piece parts.  Good plastic or stainless steel shielding can make a machine easy to clean.  If parts or materials exit the normal product flow, they can be easily identified and removed.  Special consideration should be given to the area where “accepted” parts and materials are presented.  Every precaution should be made to avoid the contamination of “approved” materials.  Advancements in vision systems can now help with these issues.


The effort of cleanliness starts with the automation equipment.  The ability to provide a clean workspace with environmental controls to minimize the ambient particulate is crucial.  The automation designer must consider every mechanism on the machinery.  If the air flow is typically down, the mechanisms above the product should be minimized or correct mechanisms for “clean” applications should be used.  It is also recommended during the design phase to use surface finishes that are easily wiped down.  Nothing is more important than having experience with these issues when designing automation equipment.  Trying to correct “cleanliness” errors once the equipment is on the production floor is too costly.  Therefore, a device manufacturer should seek a reputable automation professional that can discuss these issues during the design phase of a project; not during the installation phase.


With today’s standards and economic pressures, medical device manufacturers are turning more and more toward automation.  Unwanted particulates can create havoc and unplanned costs in an automation system.  However, a strong understanding of the issues presented and upfront planning can help keep particulates out and provide a system that will produce effectively for many years.


Contact ATC Automation for additional information;

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