500 ml - Keofitt

KEOFITT ® STERILE SPIKE SAMPLING BAG (PE)GENERALThe Keofitt Sterile Spike Sampling Bag (PE) is a cost-effective single-use sampling bag to be used where aseptic (closedsystem) sampling is not required. It features a unique auto-sealing septum allowing very thick needles for fast andconvenient sampling of most liquids including viscous products.The Keofitt Sterile Spike Sampling Bag (PE) is a single-layer sampling bag made from medical grade polyethylene andmanufactured under cleanroom conditions (class D). The bags are supplied sterilized by Gamma irradiation.NB! It is also available in a similar version made from medical grade polypropylene (PP), where the sterile condition isnot mandatory.The Spike Sampling Bag features a unique sealed septum, which accepts very large needles (spikes) with 2-3 mminternal diameter. This assures a much faster sampling process than otherwise experienced with hypodermic needles.Despite the large needle the unique septum design assures a secure and sterile auto-sealing effect after collection ofthe sample.It works with the Keofitt Quick Coupling Spikes that fit the standard Simplex, M4 and W9 Keofitt Sampling valves witheither Keofitt Hose Piece connection or Mini Clamp connection (see Accessories).The Spike Sampling Bag system will also work with all sampling valves foreseen with a Mini Clamp connector.The Spike Sampling Bag is intended for collection of samples to be analyzed within hours or days after sampling.For prolonged storage time consider the Keofitt Sterile Sampling Bag.For lower gas permeability values choose the multi-layer Keofitt Sterile Sampling Bag.For the need of sterilizing the flow path prior to sampling use the Keofitt Aseptic Sampling Bag.The product to be sampled should have a maximum viscosity of 1000 cP and should not contain particles larger thanapprox. 1 mm. in diameter. Products with somewhat higher viscosities may be sampled, only will it take longer.The Spike Sampling Bag is a single use product.FEATURES• Single Use product• Supplied sterilized by Gamma-irradiation• Septum area protected by an aluminium foil seal to be ripped off prior to use• Septum allowing 2-3 mm needles for fast sampling• Auto-sealing septum to prevent contamination of the sample• Thick walled (0.3 - 0.5 mm.) bag wall for mechanical strength and relatively low water vapor and gaspermeability• Outlet port to be cut open for easy emptying of the sampling bag• Possibility to extract, partly or fully, the sample through the septum using a needle or a spikeTECHNICAL DATASAMPLING/FILLING:The Spike Sampling Bags are fitted with a protective aluminium foil covering the septum to assuresterility of septum surface. Immediately prior to sampling rip off the foil to access the septum; noneed for further cleaning with alcohol or similar.Mount the steel Spike fitting (accessory) on the valve. Perform your usual cleaning/steamingprocedure. After having removed the protective aluminium foil press the bag septum against thespike to penetrate into the sampling bag.Allow the bag to be filled by slowly opening the sampling valve and leave it open until requiredsample volume is obtained. Do never exceed the nominal volume of the bag, as the bag willeventually be pushed off the spike due to pressure building up.STERILITY:The sampling bags have been manufactured under cleanroom conditions (class D or100,000) to assure cleanliness of the septum and the interior of the bag and packaging isdone under Laminar Air Flow (LAF).Prior to final packaging the Keofitt Sterile Spike Bag (PE) has been sterilized by Gammairradiation.The Products are subject to bacteriological tests and particle counts according to Ph.Eur.DATA SHEET FROM KEOFITT.DK LAST UPDATED 09. Sep. 2014

SAMPLE TEMPERATURE:Up to 90°C (194°F) sample temperature provided delicate handling. Support in a tray or similar and leave for cooling tobelow 60°C (140°F) before further handling.STORAGE AND SHELF LIFE:The Spike Sampling Bags are fitted with a protective aluminium foil covering the septum to protect it during storage andhandling. Immediately prior to sampling rip off the foil to access the septum; no need for further cleaning.The sampling bags are packed and delivered in a carton box with a PE liner containing 50 pieces. Shelf life is 3 yearsfollowing product date printed on the carton box. Store in original packaging at 50 – 94°F (10 – 34°C) and less than 80%humidity.CERTIFICATES:Each delivery is accompanied with an irradiation certificate.A Certficate of Conformity (CoC) is available upon request.SIZES:The sampling bags are available in the following sizes (part number): 500 ml (130500PE) & 1000 ml (131000PE).MATERIAL:The bag is made from medical grade polyethylene.The membrane is made from pharmaceutical polyisoprene based rubber with a fluorocarbon film and sits in a housing madefrom medical grade polyethylene.PERMEABILITY:The permeability of gasses is given by the approximate values below:Water Vapour Transmission rate: 0,13 g/m2/dayCarbon Dioxide Transmission rate: 1500 cm3/m2/dayOxygene Transmission rate: 400 cm3/m2/dayFor lower transmission rates choose the multi-layer Keofitt Sterile Sampling Bag.DATA SHEET FROM KEOFITT.DK LAST UPDATED 09. Sep. 2014