Sterile SatPax® 670 from Berkshire
Manufacturer: Berkshire
Order number: CA-SSP670.001.24
30 pcs. / Unit
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Delivery time appr. 2-4 workdays
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Sterile SatPax® 670 from Berkshire
- ISO Class ISO 5 A/B, ISO 6, ISO 8 D
- Sterile sterile
- Material Polyester, Cellulose
Sterile SatPax® 670 from Berkshire
combines Durx® 670 nonwoven wipers composed of a hydroentangled nonwoven blend of 55% cellulose and 45% polyester with a high saturation level of 70% IPA and 30% DI water.
This pre-wetted format provides a cost effective and easy to use solution versus traditional bulk handling of solvents, maintenance of squirt bottles and inconsistent wetting and cleaning associated with wetting a dry wiper. Each package is then gamma irradiated sterile to a 10-6 Sterility Assurance Level making the product ideal for cleaning critical sterile processing environments.
Key Attributes
- 55% cellulose / 45% polyester hydroentangled nonwoven blend
- No chemical binders in base material
- Pre-wetted with consistent 70% IPA/ 30% DI Water to a high saturation level
- Re-sealable solvent resistant packaging
- Wipers in c-folded configuration for single withdrawal
- Gamma irradiated and sterile validated to a 10-6 Sterility Assurance Level per AAMI guidelines
- Certificate of Sterility with each case and available on the web by lot number 24/7. Details: Expiration Date, Ra-diation Dosage, Lot Information, Meets cGMP requirements for traceability
Benefits
- Low extractables and fiber and particle counts
- Smooth and durable with good wet strength
- Passes LAL test for endotoxins <20 EU/device
- Reduces alcohol usage and preparation / handling costs
- Reduces VOC emissions
- Increases cleaning efficiency
- Increases cleaning protocol consistency
Environmental
- Reduces VOC (Volatile Organic Compound) emissions
- 55% cellulose fiber content is biodegradable
- Complies with RoHS 2002/05 and pre-registered under REACH
Applications
- Designed for use in ISO Class 5 and higher sterile cleanroom environments and USP <797> applications
- Designed for use in wet cleaning of critical surfaces where control of flammable solvents and flammable solvent concentrations is required
- Final cleaning of surfaces or products prior to manufacturing or packaging
- High saturation level is ideal for removing cleaning and disinfecting residues in sterile environments
Saturation Levels
The amount of solution contained in each wiper can be varied according to customer requirements. Higher saturation levels apply more solution to the surface during cleaning.
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: 23 x 23 cm (9 x 9")