Cleanroom Injection Molding for the Medical Industry

injection_moldingOne of the fastest growing injection molding market segments is medical.  This is a coveted market by many because it seems to be relatively isolated from economic downturns.  One of the biggest tickets to entry for this market is cleanroom molding.  But many ask “What is cleanroom molding and what does that mean?”

Let’s start with the basics.  Per GlobalSpec, “Cleanliness class is a standard determined by the contamination control industry. They currently use a government specification known as Federal Standard 209D to provide a qualified and standardized method for measuring how clean the air is in a cleanroom. Six classes have been established to designate cleanroom cleanliness. The class number refers to the maximum number of particles bigger than one-half of a micron that would be allowed in one cubic foot of cleanroom air. A Class 100 cleanroom, for example, would not contain more than 100 particles bigger than half a micron in a cubic foot of air. The six classes are Class 1 (ISO 3), Class 10 (ISO4), Class 100 (ISO 5), Class 1,000 (ISO 6), Class 10,000 (ISO 7), and Class 100,000 (ISO 8).”

So from a molding standpoint this means that manufacturers must adapt their manufacturing areas to meet the cleanliness standards covered above.  In addition, many of the various medical product development companies will have their own set of standards that must be met.  So the next questions is “How are these standards met?” 

For medical molding, a HEPA Filter System is used to filter the air and they need to be checked periodically.   In addition, hoods can be installed over the molding machines to help filter the air.  Next, the operator running the press typically wears gloves, gowns, masks and booties to protect from contaminants coming in contact with the parts.  Furthermore, quality plans and procedures must be created and followed during the manufacturing of cleanroom molded parts. 

Above is just a small snapshot of what needs to happen for cleanroom molding.  As you can see, it becomes somewhat of a barrier of entry for injection molding companies to easily want to jump into the medical molding segment.  Cleanroom molding capabilities also become an attractive marketing tool for injection molding companies trying to grow their business. 

To learn more about injection molding, visit www.quickparts.com and to learn more about cleanroom injection molding you can check out this piece from Moldmaking Technology: http://www.moldmakingtechnology.com/articles/060604.html

Source : http://injectionmolding.blog.quickparts.com/2009/07/23/cleanroom-injection-molding-for-the-medical-industry/

4 Comments

  1. I agree, it does seem as if the medical injection molding market is protected from the ebbs and flows of the economy — and that makes it attractive to investors. The key, as you stated, is to adhere to stringent manufacturing processes. It isn’t an easy market to enter, but it can be worth it when done right.

  2. I think it’s really good up to Class 1000. It should be “Must” for all manufacturers.

  3. Amy

    it does seem as if the medical injection molding market is protected from the ebbs and flows of the economy.

  4. ayman

    Nice tips for the Medical Industry ~

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