USER MANUAL
Contents
1. AO DI ES 00 Cleaning takes place with system disassembled a Detach bottle b Remove the filter unit and filter c Open valve head disassemble and remove from the aseptic system d Remove steel cap from inlet Wash all parts in washing machine or manually Assemble all parts again a Fasten the valve head in open position b Attach the filter unit with a new sterile filter c Loosely fasten a sampling bottle to the aseptic system d Add one drop of water to the inlet before the steel cap is closed Autoclave the assembled aseptic system Close the valve head while the aseptic system is still in the autoclave to avoid air contamination Connect the aseptic system to the sampling valve with the PTFE tube Open steam for sterilization of the valve The steam will also sterilize the connection tube and areas inside of the aseptic system that have come in contact with air The steam will be let through the pressure relief valve Close steam valve But do not remove steam tube until after the sample has been taken Ouanna e While steam sterilizing the steam will be let through the pressure relief valve Take care while operating It is pos sible to connect a drain hose to the pressure relief valve and lead the steam to a safe drainage e Do not open the valve head while sterilizing with steam That lets the steam in the bottle and will damage the sterile filter There is also a risk of the bottle exploding due to too high pressure2. Q mrortann e Assembling the valve head in closed position can damage and tear the membrane e Use saturated steam without condensation at max 2 bar At higher pressures the membrane can be damaged Split KEOFITT USER MANUAL PAGE 1 0 MAINTENANCE Keofitt recommends to change the PTFE membrane once a year or as needed The recommendation is based on 1 5 samples a day In the event of intensive sterilisation and cleaning it may be necessary to replace it more frequently HE EE JJ ee i Jeg A a D Bro N 5 bly Be P i y ed Sn MAIN PARTS Pressure relief valve Aseptic System A 260059 Valve Head W9 type Q Teflon er ilter Quick coupling st st plugtorwo _ 316L Siieone eooo Snap cuten secure fiter Aseptic o Filing tube complete for 500m _ 316L Siieene 200170 7 a rue compete engin 500mm PTFE 3161 Siicone 580002 fe 1 st st chaintorasepticSampingvane eos SPARE PARTS ha fa temonmugtorp Preem 2601r ao fi omezz2sx262 O fem EU 2a a membrane Tetontorwo erre qrwa esos a fe oringi03x24 seme soss Sterile fiter for Aseo System sore os omessa ETT RO E 770 gt eo fi Jo p pos KEOFITT USER MANUAL PAGE 11 VALVE HEAD FOR ASEPTIC SAMPLING SYSTEM ITEM NO 855543 TECHNICAL DATA Material process contact e Membrane PTFE Material without process contact e Steel part
3. aseptic system use gloves and eye protection e lt is important that the filter is changed after every use as there otherwise is the risk that the filter is blocked and pressure build up in the bottle ODimporranm e Itis recommended to use a sterile filter with a pore size of 0 45 um e The system is designed to be used with PP bottles type Krones or similar e f product is heat sensitive let the aseptic system cool down before sampling e Do not remove steam hose from the valve until after the sample has been taken e Assembling the valve head in closed position can damage and tear the membrane KEOFITT USER MANUAL PAGE 7 ITEM 260001 ASEPTIC SAMPLING SYSTEM TECHNICAL DATA Material Steel parts Membranes O rings Gasket Pressure Max steam pressure Max bottle pressure Net weight AISI 304 316 316L 1 4404 PTFE FDA approved Silicone EPDM PTFE Silicone 2 bar g 29 psi g 1 2 bar g 18 psi g 1 7 kg 3 75 Ib KEOFITT USER MANUAL PAGE 8 HOW TO USE SAMPLING oe OS Pt 1 Autoclave the bottle with the filling head 5 loosely mounted 2 After autoclavation and having closed the bottle hermetically the Aseptic System is connected to the sample valve by using the flexible tube 1 which is connected to the hose piece 2 Sample valve and valve head 4 are closed 3 Steam supply is connected to the upper hose piece of the sam ple valve ei 7 4 Adjust pressure relief va
4. KEOFITT WORLD LEADERS IN STERILE SAMPLING ASEPTIC SAMPLING SYSTEM item no 260001 sam 5 A UE a S va T W N Wi SOME PEOPLE WOULDN T GAMBLE WITH THEIR SAMPLE INTRODUCTION MANUFACTURER _Keofitt A S Lumbyvej 11H 5000 Odense C Denmark TYPE Aseptic system item no 260001 YEAR OF INTRODUCTION 1998 YEAR OF REVISED DESIGN 2009 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 Ne F TN Item 260001 Aseptic sampling system EE EN EE ER AR Pr 8 MN Pee 9 ANN 10 nn A EE TT 11 Valve head for Aseptic sampling system Item no 855543 nnvioioiminaniracan nr nennen nennen 12 ETEN ENN 13 PIFE membrane tem N0 S590055 ker volitinetaient 14 PRESENTATION The Keofitt Aseptic system enables the user to take a truly representative aseptic sample The aseptic system protects the sam ple against airborne contamination while taking the sample and in transportation The aseptic system is compatible with all small and medium sized sampling valves The Keofitt aseptic system is based on Keofitt s guarantied high quality microbiologically safe valve design The aseptic system is used in a wide range of industries such as breweries food and the pharmaceutical and biotechnological industries ASEPTIC SYSTEM FUNCTION The aseptic system is d
5. esigned to regularly take representative samples in the production process The aseptic system is there fore designed so that effective cleaning sterilisation and sampling can be carried out regularly without interrupting the produc tion process Sterilisation is carried out by supplying steam through the aseptic systems hose piece It is the perfect hygienic design of the aseptic system that enables absolute sterilisation The Keofitt aseptic system is based on the Keofitt valve design and accord ing to an EHEDG based test carried out by the Biotechnological Institute in Denmark the valve is sterilised after just 1 minute s supply of steam at a pressure of 2 bar 121 C Onenna e The Aseptic system will become hot and emits steam while sterilizing Use gloves and eye protection while operat ing e While steam sterilizing the steam will be let trough the pressure relief valve Take care while operating It is pos sible to connect a drain hose to the pressure relief valve and lead the steam to a safe drainage e Do not open the valve head while sterilizing with steam As it lets the steam in the bottle and will damage the sterile filter There is also a risk of the bottle exploding due to too high pressure e The aseptic system is designed for use in working conditions of up to 1 bar and temperatures of up to 121 C It is therefore important to be aware that the glass bottle will explode at higher pressure Take care while operating the
6. lve 3 until the required temperature pressure is reached 5 After finished sterilisation of the sample valve the connecting tubing 1 and the valve head on the bottle 4 the steam is turned off 6 To sample the sampling valve and the valve head 4 are opened The valve head 4 is opened before the sampling valve 7 After sampling sampling valve and valve head 4 are closed The sampling valve is closed before the valve head 4 8 Repeat steps 3 5 The Aseptic System now containing the sample is ready for transport to the laboratory 9 Place the aseptic system in a sterile bench detach the bottle and remove it from the aseptic system Now there is access to the sample ODimrorran e Do not remove steam hose from valve until after the sample has been taken e If the product is heat sensitive let the aseptic system cool down before sampling One e The Aseptic system becomes hot and emits steam while sterilizing Use gloves and eye protection while operating e The aseptic system is designed for use in working conditions of up to 1 bar and temperatures of up to 121 C It is therefore important to be aware that the glass bottle will explode at higher pressure Take care while operating the aseptic system and use gloves and eye protection e Do not use a filter that has been used before as this may cause pressure build up in the bottle and possible explosion KEOFITT USER MANUAL PAGE 9 STERILISATION 1
7. r White e Temperature range 200 200 C e Ball hardness 29 N mm2 e Tensile strength DIN53455 35 N mm2 e Elongation at break DIN53455 350 e Density DIN 53479 2 17 g cm3 e Shore D DIN 53505 57 e Thermal conductivity W m k DIN 57572 0 25 0 5 mm e Expansion coefficient DIN 52612 9 12 x 10 K e Friction coefficient very low lt 0 1 e Flammability Inflammable UL 94V0 e Chemical resistance e Food safe Yes FDA e Temp max 150 C e Steam pressure max 2 bar 29 psi e Process pressure 1 6 bar 14 87 psi Keofitt recommends to change the PTFE membrane once a year or as needed The recommendation is based on 1 5 samples a day Is not attacked by common chemicals with the exception of strongly oxidising acids FDA approved compound according to Code of Federal Regulations Title 21 8 177 1550 109mm 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 KEOFITT WORLD LEADERS IN STERILE SAMPLING
8. s AISI 316L 1 4404 AISI 304 1 4301 Temperature process 1 C 150 C 34 F 302 E Pressure process 6 bar 87 psi Net weight e 0 295 kg 0 65 Ib PARTS Go nom Trate Tidentne Remark PTFE TFMA600 fa screw ormaywowneaa Joos KEOFITT USER MANUAL PAGE 12 INSTRUCTIONS ON REPLACING PTFE MEMBRANE Open valve Remove the valve head from the valve body Push the membrane upwards until the tool for membrane fits under it Insert tool for membrane between the membrane and the bushing Close valve head Now the membrane is loosened from the valve head and can be replaced Ole 2h gt To attach new membrane to valve head 7 Set the valve head to closed position 8 Place the new membrane on valve head 9 Mount the membrane bushing with the new Teflon membrane by pressing the membrane with your hand until it clicks 10 Set the valve head in open position 11 Insert the valve head into the valve body 12 Close valve head ODimrorran e Once the membrane has been removed from the valve head the click system in the membrane might be damaged Therefore the membrane might be unsafe for further use and it is recommended not to use the membrane again e Do not use hammer or other tool that might scratch the surface of the membrane a 300255 140 152 and W15 400255 KEOFITT USER MANUAL PAGE 13 PTFE MEMBRANE ITEM NO 850055 e Technical Specification e Type AF1012 PTFE e Colou
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