Cleanroom Protocols
Documents used to establish cleanroom protocol and acceptable allowable particle counts are:
• ISO 14644-1 (formerly MIL STD 1246C): Details the specific cleanroom environment requirements for airborne particulate and personnel protocol, including the details for our cleanroom to meet the Class 5 designation. • IEST-STD-CC1246E (formerly Federal Standard 209E): Details the surface particle allowance, including Level 100 and Level 10,000. • NASA JPR 5322.1 Rev F: Details surface particulate as is allowed by NASA and Federal requirements. T E S T I NG Our cleanrooms are tested by an outside auditing agency. Liquid laser particle counting, Elmendorf tear, and tensile strength and elongation is performed onsite in our testing labs. NVR, F.T.I.R., SEMS, Chromatography and other related tests are conducted by an outside Lab. Test results for individual production lots are available upon request, at the customers cost.
MA T E R I A L S FCR-1000 Series Polyethylene Film
Orders received at Fruth Custom Packaging that call for a Level 10,000 or Level 100 specification are made with a proprietary blend of resin referred to as FCR-1000 and its subsequent variations. This resin compound consists of a virgin polyethylene resin base that is free of all additives including slip and anti-block. Elimination of these additives produces film that has a non-marring, non-scratching surface, perfect for the packaging of critical soft metal and plastic parts typically used in a cleanroom environment.
Our FCR-1000 cleanroom polyethylene is extruded in our cleanroom that meets or exceeds all requirements called for in ISO 14644, Class 5 (formerly Federal Standard 209E). Our blown film extrusion process uses clean, filtered, nitrogen purged air to avoid introducing airborne particulate to the interior surface of the film. Extruded film is wound on clean, plastic cores to avoid contamination with particulate from traditional spiral paper cores. Tubing rolls are individually wrapped and boxed. Every effort is made to handle the material with extreme care, as scraped or abraded film can generate particulate off of the surface of the material.
All raw cleanroom materials are purchased from our approved suppliers, in lot numbered gaylords for lot traceability and supplier accountability.
FCN-6000 Series Nylon Film In the processes for manufacturing our FCN-6000 Series Nylon bags, ultimate measures are taken to remove impurities from the film and to control environmental factors such as air cleanliness and atmospheric moisture vapor content. Every effort is made to ensure both the inside and outside of the film is clean, and our machinery is designed to eliminate any particulate or contaminants during the manufacturing process. Our FCN-6000 Series bags meet or exceed all requirements called for under IEST 1246E Level 100 specifications. This film is used in place of polyethylene in applications when a lower OTR and MVTR is necessary. This will protect from gas, aroma, chemicals, and moisture, and provides extra exterior strength and puncture resistance.
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