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Cleanrooms can be found in almost every industry that performs scientific research or manufactures and packages Critical components. Typical industries that use cleanrooms are: Bio Tech, Military, Pharmaceutical, Semiconductor Manufacturers, Aerospace and Medical Device manufacturing. A cleanroom is a contained and controlled area specifically designed to Limit the amount of airborne particulates. HEPA Filters are used to filter out particulates larger than 0.5 microns in size. Humidity, Temperature and pressure are also tightly regulated.
Contaminants that are filtered or controlled are dust, airborne microbes, aerosol particles and chemical vapors. The controlled level of contaminants within a cleanroom is specified by the number and size of allowed particles within a cubic meter of air. The allowable number and size of particulates is determined by the cleanroom classification.
A TRUE cleanroom bag begins with the resin. Many companies use a commercial grade resin for the extrusion and conversion process. Often this commercial grade resin will contain reground material i.e: Recycled material and unwanted contaminants, such as slip agents, release agents and manufacturing aids.
To eliminate any potential resin contaminants only a Virgin Barefoot resin should be used. This is a specialized resin that does not contain any regrind i.e: Recycled material, No SLIP agents, No Anti Block additives and no manufacturing aids, such as ungofos.
Slip agents are normally an amide and are used as a manufacturing aid. Amides can leach from the film on to your critical components and cause contamination through out-gassing.
Organic Anti-block is an additive that is used to assist in the ease of opening of a polyethylene bag. Organic Anti Block can migrate onto your critical components and cause contamination also through out-gassing.
Often many “Cleanroom” packaging manufacturers extrude and convert their commercial grade resin in an open warehouse. Then the material is moved into a cleanroom and run through a web cleaner then blown with nitrogen to clean the inside of the converted materials. This does not make a CLEAN bag, tube or sheet of material. A true cleanroom bag, tube or sheet will not only use a Virgin barefoot resin but will also be extruded and converted within the confines of a cleanroom. This will keep the complete manufacturing process from resin to end product within the confines of a controlled environment.
Even though Virgin Barefoot Resin is being extruded and converted within the confines of a certified cleanroom it still takes testing. At the beginning and end of every conversion process samples of the material are taken and tested using a liquid laser particle tester. The liquid laser particle counter measures and counts the amount of particulates on a given material by size count of the particulation. This ensures that the end product will meet the cleanliness of a given classification. Once material has made it through the conversion and testing process it needs to be prepped for shipment. All material, whether it is bags sheeting or tubing, should be double vacuum packed for shipment. Bags or pouches will be grouped into lots of 50 or 100 pcs, depending on bag size and weight, then placed into a sub pack bag and vacuum sealed. This pack will then be placed into another bag and vacuum packed again providing a double layer of protection during shipping and receiving. At this time each sub pack should be labeled with a label of certification to the determined cleanliness level. Tubing or sheeting is wound on a 3” pvc molded core, then double vacuum packed and labeled.