Description
Berkshire Gamma Wipe® 120 is a knife-cut, high-sorbency, cleanroom laundered wipe recommended for use in environments rated ISO Class 4 and above. It is composed of 100% continuous filament polyester knit fabric. Each package is gamma irradiated sterile to a 10-6 Sterility Assurance Level. This combination of properties provides Gamma Wipe® 120 with the high level of cleanliness, abrasion resistance and chemical compatibility required for cleaning critical sterile processing environments.
ANSI/AAMI/ISO procedures have been followed for verification of irradiation dose with audits being performed to monitor bioburden levels and dose. The Sterility Assurance Level (SAL) or the probability of a viable organism being present on a product unit after sterilization is a SAL of 10-6 (which is the chance of 1 non-sterile unit in 1,000,000.
• 100% continuous filament polyester knit
• Knife cut edge
• Laundered and packaged in Berkshires ISO Class 4 cleanroom with Lot Number on each pack
• Gamma irradiated and sterile validated to a 10-6 Sterility Assurance Level per AAMI guidelines
• Header style packaging with Package Integrity testing
• Certificate of Sterility with each case and available on the web by lot number 24/7. Details: Expiration Date, Radiation Dosage, Lot Information, Meets cGMP requirements for traceability
• Low particles, fibers, ions and extractables
• High absorbency
• High abrasion resistance
• Soft hand and edge for sensitive surfaces
• Chemically compatible with common cleaning and disinfecting solutions including isopropyl alcohol, phenols, bleaches and quarternary ammonium compounds
• Passes LAL test for endotoxins <20 EU/device
• Designed for use in ISO Class 4 and higher sterile environments where microbial exclusion is demanded
• Designed for cleaning sterile surfaces and equipment during aseptic processing
• Excellent for cleaning sterile laminar air flow units, barrier isolators and bio-containment units
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