Clean Room Environment For Medical Device Manufacturers
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December 03, 2009 | Category: Product Information
With over 6 billion people on the planet and at least 3 billion of them using some form of health care system, the need for all types of medical devices continues to grow. From medical devices products as simple as syringes to complicated and life saving Stents, the need for these products continues to explode and the manufacturing techniques are becoming much more sophisticated.
One of the main challenges facing most hospitals, clinics and out patient facilities that use these numerous medical devices is the constant threat of infection especially post-operative infections. The advent of the newer, more drug resistant strains of bacteria, or MRSA, have made the medical community more aware of the need for reducing any possibility for infection from outside sources.
To ensure these medical devices and products are bacteria free they are manufactured in clean room environments and then sterilized prior to being encased in an air tight enclosure or special wrap.
The technicians that assemble these devices are often gowned and wear latex gloves and masks. This ensure no contamination from the technicians to the devices during the assembly process.
To ensure the entire environment where the materials, parts and final assembly take place is totally free of microscopic airborne contaminants, high efficiency particulate air filters ( HEPA) are used. The entire assembly areas are constantly washed with the HEPA filtered air to ensure a clean room type of environment and to reduce the possibility of shipping a medical device that could be contaminated and thus create a problem for the patient on which the product is used.
HEPA filters by design have a minimum efficiency of removing 99.97% of all particles 0.3 microns or larger. Many of the HEPA systems today use even more efficient HEPA media that can remove up to 99.9995% of all particles 0.12 microns and larger.
Pure Air Systems has been producing HEPA based air filtration systems since 1985 and has hundreds of units in operation in the medical market including; hospitals, clincs, surgery rooms, pharmaceutical manufacturing, post-operative recovery rooms, medical device manufacturers and doctor’s offices.
Pure Air Systems offers a line of fan powered, HEPA based (99.99% at 0.3 microns) systems that range from 300 CFM to 2000 CFM using variable speed drive motors for finite control of air flow. These units can be used as a portable system or attached to existing HVAC units and ductwork. The flexibility and high performance capabilities of the PAS HEPA product line make it one of the most effective line of HEPA filtration systems on the market today.
For more information on the complete line of HEPA based and media based filtration products please go to our website at: www.pureairsystems.com
Post Tags: clean room HEPA Filters medica devices medical manufacturing
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About the Author: Don Musilli
My name is Don Musilli. I started Pure Air Systems in 1985 and then sold it in 2006. I continue to consult for PAS and write their blog and control their Twitter account. I also, on occasion, make changes to the website. The company is now almost 26 years old and has been a major player in offering commercial grade, high performance HEPA and Carbon based filtration systems for the commercial, institutional, industrial and residential markets.
I currently reside in Englewood, Florida where I write blogs and do social media marketing for a number of clients.
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