USER MANUAL
Contents
1. PART DRAWING KEOFITT ASEPTIC SAMPLING BAG ITEM 120500TC 121000TC 122000TC i E N rm M KK M SO v E ise Y ze gt ceol m mm ee 3 way valve piston PP TPE ES Sampling Bag PE PA KEOFITT USER MANUAL PAGE 10 HOW TO OPERATE Remove the Keofitt Aseptic Sampling Bag from the sealed pouch Optional Place heat indicator on 3 way valve ATTACH TO VALVE OUTLET CLAMP AND SEAL NOT INCLUDED Attach the Keofitt Aseptic Sampling Bag to the closed sampling valve by closing the clamp ring The 3 way valve steam outlet is designed with a standard Keofitt W9 connector allowing the connection of tubing pressure relief valve steam trap etc O STEAM OR FLUSH STERILISATION WARNING HOT Steam supply is connected to the upper connection of the sampling valve and the assembly is sterilised for 1 minute 1 bar g 121 C Ona e Hot Wear goggles and gloves remove SEAL After sterilization Break and remove the protective plastic seal preventing the valve piston from being activated unintentionally O PUSH PISTON TO OPEN VALVE Press down the piston to open the 3 way valve open SAMPLE VALVE To extract the sample the sampling valve is opened slowly KEOFITT USER MANUAL PAGE 11 F Take sample om e Do not remove steam connection from sampling valve until after sample has been extracted O CLOSE2. the steam flow through the 3 way valve for sterilization for 1 minute 3 Close the steam supply Ona e The Keofitt 3 way valve and silicone hose are designed to withstand system pressure of 1 bar g at 121 C for 1 minute DO NOT AT ANY TIME APPLY SYSTEM PRESSURE ABOVE 1 5 BAR g Ona e During steam sterilization the system becomes hot and emits steam Care should be taken when handling the system Use protection goggles and gloves KEOFITT USER MANUAL PAGE 8 ACCESSORY Optional It is possible to apply a heat indicator onto the 3 way valve The heat indicator will change colour as a function to heat vs time When the second dot on the heat indicator changes to black the indicator measures approx 77 C and the corresponding steam temperature inside has been approx 121 C for approx 1 minute The difference in time and temperature is due to slow heat transfer in the plastic valve material The heat indicator can be purchased separately at Keofitt A S Item nr 120055 It is very important to place the heat indicator correctly see illustration SS Oma e The heat indicator will indicate a significant lower temperature on the outside of the valve than the actual temperature inside the valve Beware of hot surface Use protection gloves cc e Using a heat indicator is convenient when assessing steam temperature but should be used based on test and experience only KEOFITT USER MANUAL PAGE 9
3. KESFITT WORLD LEADERS IN STERILE SAMPLING KEOFITT ASEPTIC SAMPLING BAG PAT PE Item no 120500TC 121000TC 122000TC SOME PEOPLE WOULDN T GAMBLE WITH THEIR SAMPLE INTRODUGTION MANUFACTURER Keofitt Sampling Bags ApS Industriveenget 6 8 5700 Svendborg Denmark TYPE Keofitt Aseptic Sampling Bag item no 120500TC 121000TC amp 122000TC YEAR OF INTRODUCTION 2010 YEAR OF REVISED DESIGN Manufacturer retains the right to change technical specifications and the contents of this User manual without prior notice The English version of this Manual is the governing version and it is the only authorized version Consequently KEOFITT cannot be held liable for other versions including translations of this Manual CONTENTS Presentato srian OE ea pakse DU eee a A ai EA ede eee 7 Aseptic Sampling Bag function manere nene ame nn nana ana manea EKO K ERA a nana nn 8 SteriliZati O zace ete aaa ceea doi note male DMT T SD o 8 ACCESSOIY insisi nissen TT 9 Part drawi ng Keofitt Aseptic Sampling Bag Item 120500TC 121000TC 122000TC 10 PRESENTATION The Keofitt Aseptic Sampling Bag is a single use product The Keofitt Aseptic Sampling Bag is a sterile pre irradiated product supplied in a sealed PE bag The product is to be removed from its sterile bag immediately before use The sterile condition enables the user to extract a truly representative aseptic sample from a ligui
4. SAMPLE VALVE Close the sampling valve 4 8 PULL PISTON TO CLOSE VALVE li a IE Pull the valve piston back up to close the 3 way valve PUSH PINCH CLAMP TO SEAL BAG y Push down the pinch clamp to make the Keofitt Aseptic Sampling Bag airtight T PULL CLAMP TO RELEASE Disconnect clamp ring and remove the Keofitt Aseptic Sampling Bag To extract test samples from the Keofitt Aseptic Sampling Bag either penetrate the Luer lock Septum by a needle connect a syringe to the male or female adaptor or simply dismount the Luer lock to pour KEOFITT USER MANUAL PAGE 12 KEOFITT USER MANUAL PAGE 13 KEOFITT USER MANUAL PAGE 14 For complete set of updated data sheets and manuals for Keofitt products please refer to our web page www keofitt dk KESFITT WORLD LEADERS IN STERILE SAMPLING
5. d process line sampling point in a convenient way The Keofitt Aseptic Sampling Bag is the ultimate sampling bag solution based on Keofitt s renowned high guality and ultra hygienic sampling valve design The Keofitt Aseptic Sampling Bag protects the sample against airborne contamination while extracting the sample during transportation and storage The standard operating procedure involves steaming the sampling valve with the Keofitt Aseptic Sampling Bag connected in order to sterilize the sampling valve and the connection between the sampling valve and the Keofitt Aseptic Sampling Bag The 3 way valve is designed to seal off sample and ensure sterility even after valve closure The valve sealing part is never in contact with non sterile area 3 The valve is closed and the sample is 1 Valve is steam sterilized 2 Sample is taken sealed and sterile During sampling the sealing area is never in contact with non sterile areas The Keofitt Aseptic Sampling Bag with tri clamp connector is a universal sampling bag system that can be used with all small and medium sized Keofitt sampling valves as well as all other sampling valves that have a tri clamp connector outlet en e Mini Tri Clamp and O ring for connection are not included Please purchase Item 900074 and 900075 separately The Keofitt Aseptic Sampling Bag is used in a wide range of industries such as breweries dairie
6. s and the pharmaceutical and biotechnological industries Oma e During sterilization with steam the system will become hot and emits steam care should be taken when handling the system Use protection goggles and gloves KEOFITT USER MANUAL PAGE 7 ASEPTIC SAMPLING BAG FUNCTION The Keofitt Aseptic Sampling Bag is designed for extracting one single product sample The design as a single use Aseptic Sampling Bag greatly reduces the risk of sample contamination occurring due to insufficient sterilization of the sample container The Keofitt Aseptic Sampling Bag is available in 3 different sizes 500 ml 1000 ml and 2000 ml It is important to choose the adeguate Aseptic Sampling Bag size in order not to overfill the bag Ona e An overfilled or over pressurized Aseptic Sampling Bag may result in material burst Pay attention to sampling process at all times STERILIZATION Sterilization is carried out by supplying steam through the sampling valve Steam flushes through the hose piece and through the 3 way valve The Keofitt Aseptic Sampling Bag is based on the Keofitt steam sterilizable sampling valve design According to a test carried out by DB Lab in Denmark steam sterilizing the connection to the Aseptic Sampling Bag becomes effective after just 1 minute s supply of steam at a pressure of 2 bar a 1 bar g 121 C Damon e Sterilization takes place with 3 way valve closed 1 Open the steam supply 121 C 1 bar g Let
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