W15™ SAMPLING VALVE
Contents
1. P ARR Tr d Va E ug NE me In order to dissassemble and assemble the valve body and valve head please perform the following operations 1 DE T ae e de KEOFITT USER MANUAL Set the valve head at the OPEN position Release and remove the clamp ring Pull out the valve head from the valve body Perform whatever is required Refit the valve head in the OPEN position Attach and close clamp ring Close the valve head O vira During disassembly and reassembly of the valve unit set the valve head in the OPEN position before it is pushed in or pulled out of the valve body Omitting to do so may result in damaging the membrane and it will complicate the mounting of the clamp as you will work against the spring force Don t clean the valve head in an ultrasonic bath or by dipping it into a degreasing liquid as it will impeade proper functioning of the screw action When in doubt contact your local KEOFITT dealer PAGE 31 14 INSTRUCTIONS ON REPLACING PTFE MEMBRANE To remove old membrane from valve head Ek d ops 8 9 OPEN valve Release and remove the clamp ring Remove the valve head from the valve body Make sure valve is fully opened membrane fully compressed see illustration A below CLOSE valve head by which a gap will appear between the compressed membrane and the bushing see illustration B below If needed push the membrane upwards until the tool for membrane fi2. WORLD LEADERS IN STERILE SAMPLING W15 SAMPLING VALVE User MANUAL DON T GAMBLE W T H YO U R S AM PLE DOCUMENT VERSION LOG The table below lists previous versions of this User Manual and states the major changes between versions This version list is introduced in August 2015 Version Version date Major changes from previous versions 1 18 August 2015 Complete revision and new layout INTRODUCTION MANUFACTURER TYPE PATENTS YEAR OF INTRODUCTION YEAR OF REVISED DESIGN LAST UPDATED Keofitt A S Kullinggade 31 5 00 Svendborg Denmark W15 M SAMPLING VALVE U S PAT 5 246 204 E P 0468957 2002 2014 Aug 2015 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 1 PRESENTATION 7 TE PENT T L2 OUK S TE E E nae beau OE 9 2 CLEANING DISINFECTION STERILISATION i nananannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnenenenennnnnnnnnnnnnnnnnnnn 10 2 EPer 10 PENN 10 SUN 11 Jo VALVE FUNCTION rm 12 4 EVERYDAY USE OF THE 14 Al Pedersen 14 4 2 Chemical cleaning E 14 12 eiue aee mn 14 AA ENN 14 5 VALVE OP
3. 1 Pre rinse Flushing with water to mechanically remove product residues 2 Clean Applying a detergent to remove remaining visible product residues 3 Finalrinse Rinse with clean water to remove all traces of detergents Usually this procedure is followed by disinfection see below but for some application CIP might be sufficient It depends on your microbiological requirements the detergents applied and the process media to clean for Consult your supplier of CIP fluids In some cases where the process media is for instance water CIP might not even be necessary and you may go directly to disinfection 4 3 Chemical Disinfection Disinfection takes place with the valve closed and involves the following stages of which the first 3 are identical to CIP 1 Pre rinse Flushing with water to mechanically remove product residues 2 Clean Applying a detergent to remove remaining visible product residues 3 Intermediate rinse Rinse with clean water to remove all traces of detergents 4 Disinfection Apply an appropriate disinfectant targeting one or more or all microorganisms 5 Final rinse Rinse with cleaned water to remove all traces of the disinfectant 4 4 Steam sterilisation Steaming has the advantage that it does flushing cleaning and sterilisation in one operation However the heat from the steam will cause sugary substances to caramelise and substances containing protein to coagulate and burn see chapter 2 1 In this case flushing wi
4. lg Steam 1 Open the valve slowly and take the sample 2 Close the valve after the sample has been taken 3 Clean the valve by flushing with steam water or hot water If the process media is sticky viscous or aggressive or for any other appropriate reason do repeat a full CIP cycle after sampling in case steam is not available and flushing with water prove insufficient WARNING e When sampling at a high pressure and or with a low viscosity process media it may flow rapidly into the sample recipient Therefore open the valve slowly Special care must be taken with pneumatically operated valves as they open abruptly Always remember to wear safety goggles when steaming ClPping taking samples or any other operations of the sampling valve KEOFITT USER MANUAL PAGE 21 6 TECHNICAL DATA 6 1 Material Valve body AISI 316L 1 4404 Valve head AISI 316L 1 4404 Membrane PTFE white 6 2 Certificate Valve body SL Membrane PTFE acc to FDA amp BGA A 6 digit code is marked on the valve body This code refers to a 3 1 certificate which accompanies every consignment of valve bodies The 3 1 certificate is available at the Keofitt Online Service Center on www keofitt dk Click Certificates and then 3 1 6 3 Pressure max Rubber plug 3 bar g 44 psi g Steel plug 15 bar g 218 psi g If used with clamp to hose piece converters 6 4 Temperature max Sterilisation temp
5. 121 C 250 F It is important that the steam is saturated but dry as condensation can damage the membrane Dry steam at max 1 bar g 6 5 Surface treatment Inside Electropolished Ra lt 0 8um 32uinch Outside Electropolished Ra lt 1 2um Process connection Electropolished Ra lt 0 8um 32yinch Valves with internal electropolishing are identified by an E preceding the serial number e g E12345678 The surface roughness is measured for each valve at 4 critical places A serial number identifies each valve body A specific surface roughness certificate for each valve body is available on www keofitt dk If surface roughness lower than Ra 0 8um is required please contact your KEOFITT dealer 6 6 Viscosity Viscosity range 0 5OOOOCP with particles up to 8mm in diameter KEOFITT USER MANUAL PAGE 22 T VALVE BODIES CONNECTION BODIES Pipe Welding 20 d O80 UM S tX9TIA produ 31g008 STM For further product information material dimensions etc please refer to the specific datasheet at www keofitt dk KEOFITT CLASSIC W15 SAMPLING VALVE BODIES KEOFITT USER MANUAL PAGE 23 8 VALVE HEADS g a u efi T 8 2 e ml D z un Mi ri e BZ z ii o eg D e S 5 5 Wdda 34d For further product information material dimensions etc please refer to the specific datasheet at www keofitt dk KEOFITT USER MANUAL PAGE
6. The gas remains in the system until the item is lukewarm after which the set up can be dismantled 11 2 Guideline welding values W15 valve welded onto a 2 mm 3 dairy pipe 50 60 Amp It should be noted that Keofitt can supply all P type valves welded onto a pipe section according to customer specifications Flaring is thus avoided and only a girth weld is required KEOFITT USER MANUAL PAGE 27 12 BLOCK DIAGRAMS 12 1 Keofitt valve type T tank WELDED TO PIPE KEOFITT USER MANUAL PAGE 28 12 3 Keofitt valve type clamp connection KEOFITT USER MANUAL PAGE 29 13 MAINTENANCE The PTFE membranes should be replaced every 12 months In the event of intensive sterilisation and cleaning it may be necessary to replace it more frequently The appropriate replacement frequency should be determined by the user by starting with short intervals and continuously extend the time in use intil one reaches the limit of the membrane s durability Based on the desired safety margin the user then decides on the replacement interval to adapt In each individual case a standard operating procedure including maintance intervals should be endorsed based on experience For disassembly of valve body and valve head see instructions 13 1 Spare parts list Valve body Membrane PTFE White Lower stem Spring except type B Steel bushing prac t KEOFITT USER MANUAL PAGE 30 13 2 Disassembly and assembly of valve body and head
7. 0 mm Last updated 06 01 2015 PAGE 33 Keofitt reserves the right to change technical data without notice For complete set of updated data sheets and manuals for Keofitt products please refer to our web page www keofitt dk WORLD LEADERS IN STERILE SAMPLING m n d KEOFITT A S Kullinggade 31 DK 5700 Svendborg Phone 45 6316 7080 info keofitt dk Denmark Fax 45 6316 7081 www keofitt dk
8. 24 9 PARTS amp ACCESSORIES E os d i Ris AR PING ELSO X 22 X 325 Baek ADAPTER T 00 0 V n uz ul 3 E ERE DE o lt p WE aj a if e Be BI TA Be cb SE hg i 1 Lm T ef H ei z m o E e gO 1 qu Wi SE M3 Lid e sut I WIG Aj duuira 4 juju iog Spat GA UA 103 S8 Al SIINOSSAIDDV BF SLUVd mTM For further product information material dimensions etc please refer to the specific datasheet at www keofitt dk KEOFITT USER MANUAL PAGE 25 10 MOUNTING INSTRUCTIONS 10 1 Location The valve should always be located with its centre line in a horizontal position and with the two mini Tri clamp connections in a vertical position with the arrow pointing upwards as shown on the figure Only with this orientation the valve will be self draining CENTER LINE 10 2 Before welding Remember to disassemble the valve body and head The valve body and head must be separated during welding The membrane must be removed from the valve body as otherwise heat from the welding process will damage them KEOFITT USER MANUAL PAGE 26 11 WELDING INSTRUCTIONS Valves for welding are available in two types T tank and P pipe 1 For type T tank it is necessary to drill a hole 50 mm into the tank wall and then fit the valve into this hole flush with the inside of the tank Welding should be car
9. ERATIONS je 16 TDN 16 oase es tege e EE Te Ed 17 NN 19 sm 21 5 TECHNICAL DATA NAG 22 BITS ST E Tm 22 db AE i ERIT EE 22 SE NNN 22 PTE er 22 ES MEN 22 VALVE HEADS 24 9 PARIS 25 10 MOUNTING INSTRUCTIONS nnnnnnnnnnnnnnnnnnnnnunenenenenenennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 26 VNR 26 10 2 BEE VP arien 26 LL WELDING INS RUC HO 27 ILL WV CIOS EE 21 TFL GGT EP En 21 12 28 t21 Keolittvale ype T tank EE 28 L2 2 TONLE valve Ype P DIDE ae 28 12 9 Keofitt valve type clamp 29 2 4 Keofiit valve type 29 13 MAINTENANCE 30 13 2 Disassembly and assembly of valve body and head eere nne 31 14 INSTRUCTIONS ON REPLACING PTFE MEMBRANE s nnnannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 15 MEMBRANES 15 1 PTFE membrane art no 860055 wvewvcescccevenscosevocecesovewesscs Yeesdecedevevevetaestededevecdcevesstasetewsveresesetes 1 PRESENTATION The Keofitt W15 sampling valve can be readily cleaned and disinfected sterilised as it meets both hygienic and process design requirements Effective cleaning and disinfection sterilisation of the sampling valve can be carried out between random samples independen
10. a the initial microbial load distribution b the required hygienic level and c the type exposure time and concentration of the chemicals used if using a chemical disinfectant By steaming in a continued process after steam cleaning By applying one or more suitable liquid chemical disinfectants There are a number of chemical disinfectants It is important to choose the right one the right concentration and contact time and the right method for your current application Your usual supplier of chemical disinfectants can support you in choosing the right disinfectant for your process media and the specific group of microorganisms you are aiming at The company Novadan ApS Kolding Denmark has supplied the table below as a preliminary indication of which type of disinfectant to use KEOFITT USER MANUAL PAGE 10 Disinfectant Halogenes Peroxides Alcohol 70 Clorine hydrogenperoxid amp peracetic acid Microbes to inactivate Gram neg bacteria Salmonella Campylobacter E Coli and others Gram pos bacteria Listeria Bacillus cereus Clostridium and others Bacteria spores Bacillus cereus and others Bacteriophage Yeast Fungi Virus NOTE The final choice of detergent disinfectant and method lies with the user supported by the supplier of the CIP fluids and disinfectants as it is very much dependant on individual concerns and circumstances 2 3 Sterilisation Sterilisati
11. aturated steam without condensation at max 1 bar g At higher pressure the membrane may be damaged split e Always remember to use safety goggles when steaming ClPping taking samples and all other operations of the sampling valve P IMPORTANT e The valve cannot be used for vacuum since the membrane will be sucked hard into the seat and the valve will not function properly e The membrane is available in PTFE e The PTFE membrane resists all CIP fluids and disinfectants except highly oxidising acids in high concentrations KEOFITT USER MANUAL PAGE 13 4 EVERYDAY USE OF THE VALVE This chapter gives an introduction to how the sampling valve works in different operating conditions For specific operator instructions please refer to the chapter VALVE OPERATIONS 4 1 Pre production treatment Before every new production batch the sampling valve is cleaned and disinfected sterilised together with the tank or vessel or the entire production line Make sure the valve is in its open position during the initial line CIP to allow cleaning of the valve seat and the membrane contact surface Also allow CIP fluid disinfectant or steam to flow through the inlet and outlet mini Tri clamp connections Remember to close the valve after the final rinse and prior to starting up the next production batch 4 2 Chemical cleaning CIP During production and prior to sampling cleaning takes place with the valve closed and involves the following stages
12. ct a hose to the lower mini Tri clamp connection and let it go to drain 4 Open the steam supply and let it flow through the valve for sterilisation Allow 1 minute at 121 C 1 bar g 5 Close the steam supply but leave the hose in place to prevent contamination from the ambient during sampling If removal of steam hose is required fit a sterile rubber or stainless steel plug onto the upper mini Tri clamp connection The valve is now ready to take a sample The sampling must be performed immediately after steaming to avoid any contamination of the sample WARNING During sterilisation with steam the valve will become hot and care should thus be taken when operating the valve The valve is designed for use in working conditions of up to 6 bar g pressure and temperatures of up to 121 C It is therefore important to be aware that the rubber plug designed for max 3 bar g or the steel plug designed for 10 bar g may be forced out at high speed if not seated properly e For valve heads allowed under ATEX for Group IIGD Category 2 zone 1 both handle and top of valve heads N must be cleaned before use Always remember to wear safety goggles when steaming ClPping taking samples or any other operations of the sampling valve KEOFITT USER MANUAL PAGE 19 i IMPORTANT e Don t attach a steam trap to the hose from the valve steam outlet lower mini Tri clamp connection as it will impede the flow of steam a
13. e parts and accessories to complete your sampling system P Compatible with KEOFITT W15 valve head ES The patented membrane design is an essential part of the hygienic design of the KEOFITT sampling valves es It allows for optimal exposure to CIP and SIP media while also integrating the capacity to remove the membrane from the valve body without the use of tools FEATURES C Compatible with KEOFITT W15 valve head ur CERTIFICATION FDA USP EU 1935 2004 TECHNICAL DATA Material Range of temperature in dry atmospheric air Ball hardness N mm2 Tensile strength DIN53455 N mm2 Elongation at break DIN53455 96 Density DIN 53479 g cm3 Shore D DIN 53505 Thermal conductivity W m k DIN 52612 Expansion coefficient DIN 53752 K 1 Flammability Chemical resistance SERVICE LIFE Ge ART NO 860055 PTFE TFM 1600 white 200 200 C 328 392 0 22 12 17x10 5 Inflammable UL 94 Is not attacked by common chemicals with the exception of strongly oxidising acids Average service life of a PTFE membrane is 12 months actual life expectancy must be experimentally determined by the user Temp max Steam pressure Process pressure CIP Net Weight Kg lbs For further information please visit keofitt dk KEOFITT USER MANUAL 1 150 C 34 302 F O 2 bar g 0 29 psi g O 6 bar g O 87 psi g NaOH or similar 0 017 kg 0 04 Ibs 51
14. he cleaning properties of a detergent Contact time The time span during which the item is in contact with the detergent or the disinfectant Enzymes Molecules which are added to cleaning agents to ease the removal of specific organic material Assures same cleaning effect at a lower temperature Disinfectant Usually a chemical agent that destroys harmful microorganisms but might not kill bacterial spores Disinfection Detergent Thermal or chemical destruction of microorganisms Disinfection is less lethal than sterilisation because it destroys most recognised microorganisms but not necessarily all microbial forms e g bacterial spores A cleaning agent that has no antimicrobial effect but in diluted solutions good cleaning properties EHEDG Abbreviation for the European Hygiene Engineering and Design Group EHEDG is a consortium of equipment manufacturers food industries research institutes as well as public health authorities promoting safe food by improving hygienic engineering and design in all aspects of food manufacture Electro polishing Exposure time Electro polishing is an electrochemical process by which the high points within the microscopic surface texture are removed and the corners rounded This results in Reduced Product Adhesion Ease of Cleaning and Improved Corrosion Resistance Period in a sterilisation disinfection process during which the item is exposed to the sterila
15. ide is a surfactant that reduces the surface tension of water and 1 2 Quick start The table below gives you an overview of the relevant chapters to read depending on the operations you want to perform to obtain the required hygienic level assures a faster and better contact between the detergent and the soil Required sa OE ak ieni LEGO amp c 9 o e mnc 1 25 1588 18 S S8 188 level GER O SL n O og Q2 Se 4998 NO o x 10 ND mo x SEE Se ek 65 LO Cleaning Y X X X Disinfection X X X X Sterilisation X X X X KEOFITT USER MANUAL PAGE 9 2 CLEANING DISINFECTION STERILISATION 2 1 Clean In Place CIP Thorough cleaning of the valve is a prerequisite for proper disinfection or sterilisation Cleaning of the valve is the removal of any visible residual product it be organic or inorganic It may be done using either steam continuous steam will eventually lead to sterility SIP Sterilise In Place or a suitable liquid detergent Cleaning is the removal of adhering soil from the environment and from the previous sample to the extent it has not been removed by the recommended post sample cleaning Cleaning is usually performed by flushing with water followed by a thorough washing with an appropriate detergent and finished off with a thorough rinsing with water Depending on the actual process media the proper detergent must be deter
16. lve s two mini Tri clamp connections results in cleaning the valve CIP It is the perfect hygienic design and surface finish of the inner part of the valve which enables easy efficient and reliable cleaning in a closed state of the valve Supplying steam through the upper of the valve s two mini Tri clamp connections results in cleaning and sterilisation It is the perfect hygienic design and surface finish of the inner part of the valve which enables sterilisation in a closed state According to an EHEDG based test conducted by the Biotechnological Institute in Denmark the valve is sterile after just 1 minute s supply of steam at a pressure of 1 bar g 121 C Steaming is therefore a SIP process Sterilise In Place Following CIP or SIP but prior to sampling a sterile plug of rubber or stainless steel is fitted to the top mini Tri clamp connection When the valve is opened the process product will run out of the lower mini Tri clamp connection WARNING During sterilisation with steam the valve will become hot and care should thus be taken when operating the valve The valve is designed for use in working conditions of up to 6 bar g pressure and temperatures of up to 121 C It is therefore important to be aware that the rubber plug designed for max 3 bar g or the steel plug designed for max 10 bar g may be forced out at high speed if not KEOFITT USER MANUAL PAGE 12 seated properly e When steaming always use dry s
17. mined in cooperation with your usual supplier of detergents The company Novadan ApS Kolding Denmark www novadan dk has supplied the generic table below for your convenience What to clean for Generic cleaning agents Comments Fat Alkali and Tensides Heat will facilitate the cleaning process as the fat melts Protein Alkali Acids Tensides and Chlorine Coagulation and burning when heated which makes the product hard to remove Sugar Salt Water is usually sufficient as the Sugar caramelises when heated product is water soluble turning into a hard sticky substance which is difficult to remove Minerals Acids Complexing agent Often seen as lime scale Biofilm Alkali and Chlorine Peracetic acid Biofilm is an accumulated mass of possibly Enzymes microorganisms that is tightly adhered to a surface and cannot be easily removed Starch Alkali and Chlorine 2 2 Disinfection Although CIP removes all visible residues of the process media the valve surfaces will still be contaminated on a microscopic level Depending on your actual process media it will be necessary to carry out a disinfection operation in order to a reduce the microbial load to an acceptable level also referred to as Sanitization or b destroy critical microorganisms but not necessarily all microbial forms e g bacterial spores The disinfection process may be carried out in one of two ways and to different levels of disinfection depending on
18. nd hence the flushing effect and make the sterilisation dependant on temperature only demanding a much longer sterilisation time f the steam capacity is low and or the outlet hose from the valve is short and or with a large diameter the temperature will drop and condensation may occur in the valve chamber In this case a counter pressure must be established using a pressure relief valve or a needle valve at the outlet Leave the steam hose in place to prevent contamination from the ambient during sampling If removal of steam hose is required fit a sterile rubber or stainless steel plug onto the upper mini Tri clamp connection KEOFITT USER MANUAL PAGE 20 5 4 Sampling Prepare a recipient for your sample For aseptic sampling use steam and a Keofitt Aseptic Sampling Bag available in different sizes please see datasheet on www keofitt dk Leave the steam hose in place to prevent contamination from the ambient during sampling For all other sampling use a Keofitt Sterile Sampling Bag or a Spike Bag which provides a closed flow path for your sample protected against the ambient Alternatives are bottles with a screw cap jars or any other available container If removal of steam CIP hose is required fit a sterile rubber or stainless steel plug onto the upper mini Tri clamp connection Take the sample immediately after cleaning disinfection sterilisation performing the following steps ll PROCESS MEDIA ll Cp LIQUID CLEAN WATER
19. nt disinfectant at the specific sterilisation disinfection parameters Flow path The path the sample flows from the tank or process equipment to the sample recipient Germicidal The property of an agent to destroy microorganisms Microbial load The number and types of viable microorganisms with which an item is contaminated also called bioload or bioburden Microorganisms Animals or plants of microscopic size As used in food and pharmaceutical industries generally refers to bacteria fungi viruses and bacterial spores Peracetic acid A commonly used disinfectant which is efficient at low temperature and short contact time Relatively harmless as it decomposes into carbon dioxide CO2 and water H20 Process media The product in the process equipment and the product from which a sample is taken Representative sample A sample which when it reaches the laboratory is still identical to the process media A sample which is in no way contaminated or altered during neither the sampling process nor the transport to the laboratory Sanitization The application of a chemical agent that reduces the number of bacterial contaminants to a safe level as judged by the public health authorities The official sanitizer protocol indicates that 99 999 of the specific test bacteria be killed in 30 seconds under the conditions of the test SIP Abbreviation for Sterilise In Place The process of rendering a pr
20. ocess component like a sampling valve sterile without removing it from the production line KEOFITT USER MANUAL PAGE 8 Spores Relatively water poor resting cells surrounded by an impervious cell wall which makes them relatively resistant to disinfectants and sterilants They are dangerous as they can survive in adverse conditions and re emerge as live bacteria at a later stage Sporicidal The property of an agent that kills spores Steaming The process of using saturated steam under pressure as the sterilising agent Sterile State of being free from all living microorganisms In practice usually described as a probability function e g as the probability of any microorganism surviving sterilisation being one in one million Sterilant A few disinfectants will kill spores with prolonged exposure times 3 12 hours these are called chemical sterilants Sterilisation Validated process used to render an item free of all forms of viable microorganisms In a sterilisation process the presence of microorganisms is expressed in terms of probability Although this probability can be reduced to a very low number it can never be reduced to zero Sterility Assurance The probability of a viable microorganism being present on an item after Level sterilisation Usually expressed as 10 n a SAL of 10 6 means 1 1 million chance that a single viable microorganism is present on a sterilised item Tensides A tens
21. ogen ions in the solution Removes limestone and most mineral deposits Alkali Alkalis are all bases which form hydroxide ions OH when dissolved in water The terms base and alkali are often used interchangeably Alkalis have a pH value above 7 Alkalis dissolves fat and oil destroys protein and attacks light metal Aseptic sampling The process of withdrawing a sample from the production equipment through a closed circuit which has been sterilised and kept sterile with no exposure to the ambient during the sampling process Bioload See Microbial load Bioburden See Microbial load Chemical Sterilant A few disinfectants will kill spores with prolonged exposure times 3 12 hours these are called chemical sterilants Chlorine Chlorine is a chemical element with symbol Cl and atomic number 17 It belongs to the halogen group together with for instance iodine It is a strong oxidizing agent and reacts with many substances These properties make chlorine compounds efficient disinfectants CIP Abbreviation of Clean In Place The process of cleaning a process component like a sampling valve without removing it from the production line Cleaning Removal usually with detergent and water or enzyme cleaner and water of adherent visible soil on a surface KEOFITT USER MANUAL PAGE 7 Complexing agent A substance capable of forming a complex compound with another material in solution Improves t
22. on is a high level disinfection designed to render the valve free of all forms of viable microorganisms incl bacterial spores to a high level of certainty the so called Sterility Assurance Level or SAL A SAL value of 10 6 means that the probability or risk of a single viable microorganism being present on the valve interior afterwards is only 1 in 1 000 000 which is a generally accepted level for calling an item sterile Although the probability can be reduced to a very low number it can never be reduced to zero Sterility may in practise only be obtained by steaming Disinfectants exist that in high concentrations and for a prolonged exposure time will be able to inactivate all forms of microorganisms and render the valve interior sterile with a high probability these disinfectants are called chemical sterilants However the application of chemical sterilants is most often problematic due to a a required high concentration which causes an operator hazard and b the several hours of exposure time NOTE Furthermore sterilisation with a chemical sterilant may not convey the same sterility as surance as sterilisation with steam because the germicidal and sporicidal kinetics are much less investigated and documented for chemical sterilants compared to steam KEOFITT USER MANUAL PAGE 11 3 VALVE FUNCTION The valve is designed to regularly take representative samples in the production process The valve is therefore designed such that effec
23. onnect the water hose to the upper mini Tri clamp connection and rinse with clean water If disinfection is not needed the valve is now ready for taking a sample If disinfection is required proceed with the steps mentioned in the section Chemical disinfection below Flush with clean water after sampling If the process media is sticky viscous or aggressive or for any other appropriate reason do repeat the full CIP cycle after sampling KEOFITT USER MANUAL PAGE 16 WARNING Carefully follow the guidelines given for the chemicals involved e Always remember to use safety goggles when steaming ClPping taking samples and all other operations of the sampling valve 5 2 Chemical disinfection Immediately following the CIP perform the disinfection if required The disinfection takes place with the valve remaining in its closed position There are 2 recommended ways to carry out the disinfection A by letting the disinfectant flow through the valve chamber B by filling the valve chamber with the disinfectant advantage smaller volume of disinfectant needed and quicker and more reliable disinfection Steps to perform when adopting A fl PROCESS MEDIA ES CiP LIQUID CLEAN WATER lg steam 1 Connect a hose with an empty bottle to the lower mini Tri clamp connection This bottle or similar recipient is to collect the disinfectant step 3 and the rinsing water step 6 Fill a flexible bottle with
24. ried out as a penetration welding Material thickness less than 4 mm Weld from inside Material thickness greater than 4 mm Weld from both outside and inside Since type T has a solid end piece the valve will not be damaged by penetration welding However the use of purge gas in the form of either Argon or Formier gas is recommended in order to give the best result For type P pipe penetration welding must be carried out from outside The valve is machined with a recess like shoulder on the outside of the end piece which gives approximately the same material thickness 2mm material thickness as in the pipe wall This machined shoulder can be modified according to the customer s wishes P IMPORTANT When grinding polishing the internal weld the valve seat must not be touched 11 1 Welding method The welding result will be best if the following method is used A collar is made on the pipe section so that the valve has a flat contact face This flaring must look like a T piece as shown in the example below The pipe section and the valve s mini Tri clamp connections are sealed with sponge rubber or similar Purge gas such as Argon or Formier gas is fed through the valve body into the pipe section and the system is now filled with 6 times the estimated volume of the pipe section All O2 is thus expelled from the system and welding can commence Welding must take place only with the purge gas continually flowing in the system
25. rough the upper mini connection 6 Leave the squeezed bottle connected to the upper mini connection and if possible pinch the tube to avoid contamination from air being sucked in through the valve The valve is now ready to take a sample The sampling must be performed immediately after disinfection to avoid any contamination of the sample Flush with water after sampling If the process media is sticky viscous or aggressive or for any other appropriate reason do repeat the full CIP cycle after sampling WARNING Carefully follow the guidelines given for the chemicals involved e Always remember to use safety goggles when steaming ClPping taking samples and all other operations of the sampling valve KEOFITT USER MANUAL PAGE 18 5 3 Steam sterilisation Chemical CIP and chemical disinfection are not needed when using steam as steam does it all An exception from this is with sugary substances which caramelise and with substances containing protein which coagulate and burn see chapter 2 1 In this case flushing with an appropriate fluid must precede post sampling steaming Steam sterilisation takes place with the valve remaining in its closed position Perform the following steps Jl PROCESS MEDIA fl Cp LIQUID CLEAN WATER RB Steam 1 Remove any plugs or blinds from the mini Tri clamp connections 2 Connect the steam hose to the valve s upper mini Tri clamp connection 3 Conne
26. th an appropriate fluid must precede post sampling steaming If steaming is the preferred procedure but no steam is installed near the sampling point an option is to use a portable steam generator Keofitt supplies fittings for a K rcher steam generator The steaming process with a Keofitt sampling valve has been validated to obtain sterility after 1 minute of steaming at KEOFITT USER MANUAL PAGE 14 121 C 1 bar g Documentation is available at the Keofitt Online Service Center on www keofitt dk KEOFITT USER MANUAL PAGE 15 5 VALVE OPERATIONS This chapter provides clear instructions on how to operate the sampling valve in different situations Before sampling the valve must be cleaned followed by disinfection or sterilisation depending on your requirements 5 1 Chemical CIP The CIP takes place with the valve remaining in its closed position Perform the following steps fl PROCESS MEDIA ES Cp LIQUID L3 CLEAN WATER Nl steam 1 Remove any plugs or blinds that might cover the mini clamp ports 2 Connect a water hose to the upper mini Tri clamp connection 3 Connect a hose to the lower mini Tri clamp connection and let the hose go to a drain 4 Flush with clean water 5 Remove the water hose and let the CIP liquid flow through the upper mini Tri clamp connection If the CIP liquid must not go to drain circulate it or collect it in a suitable container and dispose of correctly 6 Rec
27. the defined amount of disinfectant Connect the flexible bottle via a hose to the upper mini Tri clamp connection and press the disinfectant slowly through the valve to wet the interior of the valve Allow the disinfectant to act for the prescribed time Disconnect the hose from the upper mini Tri clamp connection and connect a flexible bottle with cleaned water to the upper mini Tri clamp connection 6 Rinse through the upper mini Tri clamp connection by squeezing the bottle thus pressing the water through the valve chamber f Leave the squeezed bottle connected to the mini Tri clamp connection and clamp the hose to avoid contamination from air being sucked in through the valve KEOFITT USER MANUAL PAGE 17 Steps to perform when adopting B lj PROCESS MEDIA ES Cp LIQUID P CLEAN WATER lg steam 1 Shut off the lower mini Tri clamp connection by means of a Tri clamp to hose piece connecter filled with a rubber plug or steel plug or by means of pinching an attached piece of flexible tubing 2 Fill the valve chamber with the disinfectant through the upper mini Tri clamp connection 3 Leave to act for the prescribed time 4 Empty the valve chamber through the lower mini Tri clamp connection while holding a recipient under the valve allowing the disinfectant to flow out 5 Connect a flexible bottle with cleaned water to the upper mini connection and rinse th
28. tive cleaning disinfection sterilisation and sampling can be carried out regularly without interrupting the production process NOTE The membrane functions as a dynamic seal in the valve seat as well as a hygienic static sealing against the valve head The table below describes the two fundamentally different ways of preparing the valve for sampling 1 Chemical cleaning disinfection and 2 Steaming Method Description Pros amp Cons Chemical Liquid detergents are used to clean the This process is adopted where steam cleaning valve is not available or where the product CIP 7 Clean In Place cannot withstand the exposure to heat Involves several stages with flushing 9 cleaning and rinsing between batches 5 Chemical A disinfection process using an It adds 2 more stages to the CIP S disinfection appropriate chemical liquid disinfectant application of disinfectant and final usually follows the cleaning process rinse The valve interior is wetted soaked Involves handling of potentially or flushed with an appropriate hazardous chemicals disinfectant Sterilisation Steam is supplied for 1 minute just Steaming does flushing cleaning e before and immediately after sampling rinsing and sterilisation in one operation E Steaming is not suitable with heat L3 sensitive products Steaming entails the risk of burns Flushing with water followed by the supply of a chemical detergent through the upper of the va
29. tly of the course of the production process without compromising the same The coaxial design and the electro polished valve interior ensure absolute cleanability The W15 valve is 3 A authorised and EHEDG Type EL Class certified The American 3 A Sanitary Standard is normative for the component s ease of cleaning and sterilisation and ensures optimum conditions for food products which comes in contact with the component in question The European EHEDG Type EL certificate is issued based on the cleanability of the valve and the test method is an indicator of good inherent hygienic equipment design Keofitt valves are used in a wide range of processing industries such as breweries dairies juice soft drinks and the biotechnological and pharmaceutical industries 1 1 Definition of terms In order to ease the reading of this manual and to avoid any misunderstanding please refer to the definition of terms in the table below TERM DEFINITION 3 A Sanitary Standard 3 A SSI is an independent not for profit US corporation dedicated to advancing hygienic equipment design for the food beverage and pharmaceutical industries Acids An acid is a chemical substance whose aqueous solutions are characterized by a sour taste and the ability to react with bases and certain metals like calcium to form salts Aqueous solutions of acids have a pH of less than f A lower pH means a higher acidity and thus a higher concentration of positive hydr
30. ts in the gap see illustration C below Insert tool for membrane between the membrane and the bushing see illustration C below OPEN valve head Now the membrane is loosened from the valve head and can be replaced To attach new membrane to valve head 10 11 12 15 14 15 16 Set the valve head to closed position Place the new membrane on valve head Mount the membrane bushing with the new Teflon membrane by pressing the membrane with your hand until it clicks Set the valve head in open position Insert the valve head into the valve body Attach and close clamp ring Close valve head L IMPORTANT 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 Do not use hammer or other tool that might scratch the surface of the membrane During disassembly and reassembly of the valve unit set the valve head in the OPEN position before it is pushed in or pulled out of the valve body Omitting to do so may result in damaging the membrane and it will complicate the mounting of the clamp as you will work against the spring force KEOFITT USER MANUAL PAGE 32 15 MEMBRANES 15 1 PTFE membrane art no 860055 WORLD LEADERS IN STERILE SAMPLING MEMBRANE W15 PTFE GENERAL e KEOFITT has the widest selection of spar
Download Pdf Manuals
Related Search