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.
The same wipe material can be provided in pre-wetted formats for reduced VOC emissions, increased convenience, increased productivity, improved solvent control and cleaning protocol repeatability and reduced costs.
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.
- Wipes laundered and packaged in Berkshire’s ISO Class 4 cleanroom with Lot Number on each pack.
- Gamma irradiated wipers and sterile validated to a 10-6 Sterility Assurance Level per AAMI guidelines.
- Header style packaging with Package Integrity testing.
- Radiation Dosage, Lot Information, Meets cGMP requirements for traceability.
- Chemically compatible with common cleaning and disinfecting solutions including isopropyl alcohol, phenols, bleaches and quarternary ammonium compounds.
- Designed for cleaning sterile surfaces and equipment during aseptic processing.
- Excellent for cleaning Medical Device.
- Applying and removing cleaning and disinfecting solutions.
- Excellent wipe for cleaning sterile laminar air flow units, barrier isolators and bio-containment units.