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Contec™ Amplitude™ Kappa™ Sterile LE Wipes
Designed for wiping in ISO Class 5 environments. Contec™ Amplitude™ Kappa™ Sterile LE Wipes are low endotoxin wipes that meet the FDA standard for bacterial endotoxins using Limulus Amoebocyte Lysate at the endotoxin limit for medical devices at <20 EU/device.
Supplier: Contec™ NWPZ0002
Includes: Certificate of Sterility and Certificate of Irradiation with each case.
Description
- Sterile, nonpyrogenic nonwoven wiper made of cellulose-free lyocell (rayon) and polyester material
- Ideal for product wipe down and cleaning the exterior surfaces of equipment in the biotech, pharmaceutical, and medical device industries
- Unique surface texture provides effective cleaning and particle removal
- Low levels of particles and extractables
- High water and solvent sorbent capacity and rate
- Gamma-irradiated to a Sterility Assurance Level (SAL) of 10-6
Order Info
Sterile packaging features peelable outer bag and linear tear inner bag; embossed lot numbers on both bag seals for lot traceability. Basis weight, 65g/m2.
Compliance
Passes LAL test for endotoxins (<20 EU/device). Validated to a 10-6 SAL per AAMI/ISO 11137 Method 1 Guidelines for sterilization of medical devices.
Specifications
Wipes | |
30 cm | |
30 cm | |
ISO Class 5 | |
Cleanroom |
12 in. | |
12 in. | |
Lyocell, Polyester | |
12 in. x 12 in. (30.48 cm x 30.48 cm) | |
Sterile |
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