Gamma Wipe SuperSorb® Sterile
Manufacturer: Berkshire
Order number: CA-GWSS-ST.16
10 Sheets / Unit
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Delivery time appr. 2-4 workdays
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Gamma Wipe SuperSorb® Sterile
- ISO Class ISO 3, ISO 4, ISO 5 A/B
- Sterile sterile
- Material Polyester
Gamma Wipe SuperSorb® Sterile
Sealed Edge Cleanroom Laundered 100% Polyester
It's a high sorbency, ultrasonically sealed edge cleanroom laundered two-ply wiper recommended for ISO Class 3 and above environments 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 SuperSorb® with the highest level of cleanliness, abrasion resistance and chemical compatibility required for cleaning critical sterile processing environments.
Key Attributes
- 100% continuous filament polyester knit
- Two-ply pinsonic construction with unique knit structure and pattern
- Ultrasonically sealed edge for reduced fiber contamination
- Laundered and packaged in Berkshire’s 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
Benefits
- Critically low particles, fibers, ions and extractables
- High absorbency level available in a polyester knit reduces wiper usage
- Pinsonic design adds surface texture that aids in stubborn residue removal
- High abrasion resistance
- 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
Environmental
- Complies with RoHS 2002/05 and REACH requirements
Applications
- Designed for use in ISO Class 3 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. Excellent for spill control and aseptic processing areas where sorbency is of the greatest importance
Pre-Wetted Option
The same wiper 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. Pre-wetted options include WFI.
Validated Sterile ANSI/AAMI/ISO procedures have been followed for verification of irradiation dose with quarterly 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).
Size notice
30 x 30 cm (12 x 12") - 10 Sheets (Header Bag) / Unit
Other Sterile wipers
Gamma Wipe® VP
Gamma Wipe® 300
Gamma Wipe® 120
Gamma Wipe® 67