User Manual
Contents
1. dem ss be E 1 E CSL MS EPDM 400051 SCONE DC WS HF Ze OC MA 00084 MD AMM 00083 AC MINI TE SOE 400062 400070 4000595 ea0jd bao 104 55000 FIFE WO Oh 00071 OG M4 PTFE pang a 154 5503 da T PIFEW OC ADAPTOR KARCHER Soe Spa BAJA 101 SAINOSSAI99V F SLUHVAd Ce CLAP 1 S CKET AL 400073 FERRES Be SE jjj HOSE P 058 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 hose pieces in a vertical position with the arrow pointing upwards as shown on the figure Only with this orientation the valve will be self draining KU UC CENTER LINE s siaa om mg N ben 10 2 Before welding Remember to disassemble the valve body and head The valve body and head must be separated during welding Rubber plugs chain and 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 dr2. 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 sterilant disinfectant at the specific sterilisa
3. WORLD LEADERS IN STERILE SAMPLING M4 SAMPLING VALVE User MANUAL DON T GAMBLE W I YO U R SAMPLE nm 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 November 2015 Version Version date Major changes from previous versions 1 September 2015 Latest version without version log 2 113 November 2015 Various amendments to the text in 5 5 1 5 2 6 3 Major change in Viscosity range in 6 6 A new chapter 6 7 Flow Added Warning in 13 2 New chapter 13 3 about lubricating turn knob New illustration in 14 INTRODUCTION MANUFACTURER TYPE PATENTS YEAR OF INTRODUCTION YEAR OF REVISED DESIGN LAST UPDATED Keofitt A S Kullinggade 31 5700 Svendborg Denmark M4 SAMPLING VALVE U S PAT 5 246 204 E P 0468957 1998 2014 Nov 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 E 9 2 CLEANING DISINFECTION STERILISATION i nananannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnenenenennnnnnnnnnnnnnnnnnnn 10 2 1 Pre 10 PANNEN 10 SN NN 11 3 VALVE PONG TION rm 12 4 EVERYDAY USE OF THE VALVE wasssiitinistessansensncnsssavsnnasusanndvausesuntusnsaenuusa
4. Membrane Silicone acc to FDA amp BGA EPDM acc to FDA amp BGA 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 Working pressure 6 bar g 87 psi g Rubber plug 3 bar g 44 psi g Steel plug 15 bar g 218 psi g 6 4 Temperature max Sterilisation temp 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 finish Internal Electropolished Ra lt 0 5um 2Quinch Ra mean 0 2um 8uinch Ra std deviation 0 08um 3uinch Valves with internal electropolishing are identified by an E preceding the serial number e g E12345678 External Electropolished The surface roughness is measured for each valve at 4 critical places serial number identifies each valve body specific surface roughness certificate is supplied with every valve A general surface finish certificate copy is available on www keofitt dk 6 6 Viscosity Viscosity range O 100cP with particles up to 1 5 mm in diameter Higher viscosity liquids may be sampled only will the sampling take longer KEOFITT USER MANUAL PAGE 21 6 7 Flow The graphs below illustrate for water at 20 C
5. Sha 1043 Tensile strength MPa Min 8 5 Elongation at break 550 80 Density g cm3 1 19 0 01 Range of temperature in dry atmospheric air C F 60 200 C 140 392 Compression set DIN 53517 24h 175 C Max 25 Wear resistance Less suitable Tear resistance Very good Resistance to Weather and Ozone Excellent Resistance to Hydrolysis water and steam Good Resistance to Chemicals acids bases Suitable Resistance to mineral oil and gas Less suitable Air and gas density Not suitable Average service life of a Silicone membrane is 2 3 months actual life expectancy must be experimentally determined by the user Temp max 121 C 250 F Steam pressure O 2 bar g 0 29 psi g Process pressure O 6 bar g O 87 psi g CIP NaOH or similar Samplex 1 5 a day Net Weight Kg lbs 0 010 kg 0 02 Ibs For further information please visit keofitt dk Last updated 19 12 2014 KEOFITT USER MANUAL PAGE 37 16 2 EPDM membrane art no 400052 WORLD LEADERS IM STERILE SAMPLING 10 PACK MEMBRANE M4 EPDM BLACK GENERAL A KEOFITT has the widest selection of spare parts and accessories to complete your sampling system aq Compatible with all KEOFITT M4 valve heads for silicone amp EPDM membrane Ge ART 400052 Re The patented membrane design is an essential part of the hygienic design of the KEOFITT sampling valves amp FEATURES the use of tools
6. 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 and Q must be cleaned before use Always remember to wear safety goggles when steaming CIPping taking samples or any other operations of the sampling valve i IMPORTANT Don t attach a steam trap to the hose from the valve steam outlet lower hose piece as it will impede the flow of steam and hence the flushing effect and make the sterilisation dependant on temperature only demanding a much longer sterilisation time If 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 e 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 hose piece KEOFITT USER MANUAL PAGE 19 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 Keofit
7. 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
8. 001 kg 0 00 Ibs 19 2 mm For further information please visit keofitt dk KEOFITT USER MANUAL Last updated 18 12 2014 PAGE 39 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 A m Fi KEOFITT A S Kullinggade 31 DK 5700 Svendborg Phone 45 6316 7080 info keofitt dk Denmark Fax 45 6316 7081 www keofitt dk
9. 68 F the following e Pressure drop across valve as a function of the flow for different positions of the turn knob e Pressure drop for flow between the inlet and outlet ports CIP ports Based on the tank pressure and the requested sample flow the graphs may be used to get an indication of to which degree the valve must be opened 1 400 1 200 Pressure drop Bar 0 200 0 000 1 000 7 0 800 0 600 0 400 1 M4 pressure drop 0 1000 2000 3000 4000 5000 6000 Flow ml min Fully open 1 5 turn 3 4 turn 1 2 turn 1 4 turn CIP ports The generally accepted sampling time is around 10 sec for small samples and around 30 sec for larg er samples As usual sample sizes are between 100 ml and 1000 ml the needed flow lies from 600 to 2000 ml min As the pressure on the sample side usually is O bar g the pressure drop across the valve equals the process pressure tank pressure or line pressure The volume flow through a valve is given by p E u CH 1000 x Ap Symbol Unit Description k m3 h Flow in m h through a valve at a pressure drop of 1 bar as defined in VDE VDI norm 2173 O m h Volume flow through the valve p kg dm Density of the fluid For Water it is 1 Ap bar Pressure drop across valve As the gauge pressure at the valve outlet usually is O bar g the pressure drop is often equal to the gauge pressure at the input
10. E 12 higher pressure the membrane may be damaged split Always remember to use safety goggles when steaming CIPping taking samples and all other operations of the sampling valve EP IMPORTANT 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 3 different qualities Silicone EPDM and PTFE The Silicone membrane has the advantage that it in general can withstand high temperatures but it cannot tolerate moisture condensation resulting from steam sterilisation e The EPDM membrane is better able to cope with the condensation in the steam and at the same time it can be used with a majority of CIP fluids and disinfectants in normal concentrations 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 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 surfa
11. It allows for optimal exposure to CIP and SIP media while also integrating the capacity to remove the membrane from the valve body without Compatible with all KEOFITT M4 valve heads for silicone amp EPDM gt membrane CERTIFICATION FDA USP EU 1935 2004 TECHNICAL DATA Type Hardness Sha Tensile strength MPa Elongation at break Density g cm3 Range of temperature in dry atmospheric air C F Compression set DIN 53517 24h 175 C Wear resistance Tear resistance Resistance to Weather and Ozone Resistance to Hydrolysis water and steam Resistance to Chemicals acids bases Resistance to mineral oil and gas Air and gas density SERVICE LIFE EPDM EPL 60 black 400 50 1 12 0 01 40 140 C 40 284 F Min 16 Very good Very good Excellent Excellent Very good Not suitable Less suitable Average service life of an EPDM membrane is 2 3 months actual life expectancy must be experimentally determined by the user Temp max Steam pressure Process pressure CIP Samplex Net Weight Kg Ibs For further information please visit keofitt dk KEOFITT USER MANUAL 121 C 250 F O 2 bar g O 29 psi g O 6 bar g O 87 psi g NaOH or similar 1 5 a day 0 010 kg 0 02 Ibs 17 0 mm Last updated 18 12 2014 PAGE 38 16 3 PTFE membrane art 400055 WORLD LEADERS IM STERILE SAMPLING MEMBRA
12. NE M4 PTFE GENERAL A KEOFITT has the widest selection of spare parts and accessories to complete your sampling system aq Compatible with all KEOFITT M4 valve heads for PTFE membrane Re The patented membrane design is an essential part of the hygienic design of the KEOFITT sampling valves 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 a Compatible with all KEOFITT M4 valve heads for PTFE membrane 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 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 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 Ge ART 400055 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 Ibs 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
13. ce Also allow CIP fluid disinfectant or steam to flow through the inlet and outlet hose pieces 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 1 Pre rinse Flushing with water to mechanically remove product residues 2 Clean Applying a detergent to remove remaining visible product residues 3 Final rinse 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 c
14. ce 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 OD el Required sa Se OE ak ieni E E 9 EO Q hygiene 1 35 1988 E g 198 188 f level ase og OS O 2 1908 o 2 10 ND mo Ss NE ek O o LO Cleaning vo ov S Disinfection ov S S S Sterilisation ov S S 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 determine
15. d 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 a
16. emaining in its closed position Perform the following steps fl PROCESS MEDIA fl Cp LIQUID CLEAN WATER fl STEAM 1 Remove the plugs In the case of 8 valve with clamp connections there are no plugs supplied 2 Connect a water hose to the upper hose piece 3 Connect a hose to the lower hose piece and let the hose go toa drain 4 Flush with clean water 5 Remove the water hose and let the CIP liquid flow through the upper hose piece If the CIP liquid must not go to drain circulate it or collect it in a Suitable container and dispose of correctly KEOFITT USER MANUAL PAGE 15 6 Reconnect the water hose to the upper hose piece 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 WARNING e Carefully follow the guidelines given for the chemicals involved Always remember to use safety goggles when steaming CIPping 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 remai
17. erformed by skilled personnel only e Use vice with aluminium grips to avoid scratching and damaging the valve head Do not use hammer or other tool that might scratch the surface of the membrane Upgrade kit 404755 consisting of ident no Part name Material Je q tat Une 400347 Lower stem for PTFE AISI 316L 1 4404 400055 Membrane for M4 PTFE 15 3 For pneumatically operated valve heads type N 1 Put the actuator in open position Dismount the actuator by turning it anti clockwise and pull it out Pull off the silicone EPDM membrane and the membrane bushing holding it Dismount Lever Q handle Use a special tool in the two holes on the end cap and turn it anti clockwise Be aware of the pressure released from the spring Pull out all parts Inspect interior of actuator for loose parts or particles Install new valve stem for Teflon Before mounting make sure to grease the seal on the entire surface only use mineral grease While mounting the valve stem turn it while pushing it down to avoid damaging the seal Remount the spring Remount the end cap by pushing it down turning it clockwise Tighten it by use of the special tool Care should be taken not to damage the threads Mount the air connection KEOFITT USER MANUAL PAGE 35 9 Mount the bushing with the new teflon membrane installed by pressing the membrane with your hand until it clicks in place 10 Remount the lever Q
18. etween the membrane and the bushing illustration B 6 OPEN valve head illustration T Now the membrane is loosened from the valve head and can be replaced To attach a new membrane to the valve head 8 Set the valve head to CLOSED position lever position as in illustration B 9 Place the new membrane on valve head 10 Mount the membrane bushing with the new Teflon membrane by pressing the membrane with your hand until it clicks 11 Set the valve head in OPEN position 12 Insert the valve head into the valve body 13 CLOSE valve head i 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 KEOFITT USER MANUAL PAGE 33 15 UPGRADE FROM SILICONE EPDM PTFE MEMBRANE 15 1 For manually operated valve heads type H K and Q Close valve Pull off the silicone EPDM membrane Take the bushing off page 30 pos 5 Put the valve head in vice Turn the hex nut counter clockwice until the membrane seat and spring are loose Put the new lower stem for PTFE membrane in the vice Fit the spring on the new lower stem Insert the rest of the valve head in the pin and press firmly 8 Turn the hex nut clockwise until the lower stem is firmly in place Care should be ta
19. from the system and welding can commence Welding may take place only with the purge gas continually flowing in the system The gas remains in the system until the item is lukewarm after which the set up can be dismantled 11 2 Guideline welding values M4 valve welded onto 8 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 OD WELDED PIPE KEOFITT USER MANUAL PAGE 28 12 3 Keofitt valve type P pipe connection vertical Inline WELDED TO PIPE KEOFITT USER MANUAL PAGE 29 12 5 Keofitt valve type Varivent KEOFITT USER MANUAL PAGE 30 13 MAINTENANCE The rubber membrane should be replaced every other month 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 The rubber plug must be replaced at least once every six months In each individual case a standard operatin
20. g procedure including maintance intervals should be endorsed based on experience For disassembly of valve body and valve head see instructions SO SNK 13 1 Spare parts list Valve body Membrane Silicone grey Membrane EPDM black Membrane PTFE White Lower stem slightly different shape for PTFE membrane Spring except type B Steel bushing ae SN am KEOFITT USER MANUAL PAGE 31 19 2 Disassembly and assembly of valve body and head Ww e E 2 NEA OS NN GU GK KSE A gt 5355 KS AA AA In order to dissassemble and assemble the valve body and valve head please perform the following operations 1 Setthe valve head at the OPEN position For types H and K this is done by turning pos 6 clockwise 2 Remove the valve head pos 5 DON T use a wrench A tommy bar pos 8 should be used for disassembly and assembly This is carried out by turning pos 5 anti clockwise until loose and then pulling the valve head off 3 Refit the valve head in the OPEN position once the necessary parts have been replaced Care should be taken not to damage the threads Use suitable lubricant When replacing the membrane set the valve head in the OPEN position before it is unscrewed and pulled out of the valve body Omitting to do so may result in twisting and cutting of the membrane e Don t clean the valve head in an ultrasonic bath or by immersing it in a degreasing liquid as i
21. handle on the actuator and put it in open position Remount the actuator on the valve body pushing while turning clockwise Dismount lever Q handle Tighten actuator by use of the tommytttt 11 Re connect the air hose to air fitting on actuator EP IMPORTANT e Do not use a hammer or any other hard material to mount the membrane This can damage the membrane seal Upgrade kit 404455 consisting of ident no Part name Material 400348 Stem for M4 AISI 316L 1 4404 400055 Membrane for M4 PTFE w pe 600825 O ring 7 1x1 6 Silicone 400820 O ring 15 6x2 4 EPDM KEOFITT USER MANUAL PAGE 36 16 MEMBRANES 16 1 Silicone membrane art no 400051 WORLD LEADERS IN STERILE SAMPLING 10 PACK MEMBRANE M4 SILICONE GREY ART NO 400051 GENERAL ey KEOFITT has the widest selection of spare parts and accessories to complete your sampling system EI Compatible with all KEOFITT M4 valve heads for silicone amp EPDM membrane The patented membrane design is an essential part of the hygienic design of the KEOFITT sampling valves 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 a Compatible with all KEOFITT M4 valve heads for silicone amp EPDM gt membrane CERTIFICATION FDA USP EU 1935 2004 Type Silicone QBF 65 grey Hardness
22. he valve s two hose pieces 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 hose pieces 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 hose piece When the valve is opened the process product will run out of the lower hose piece 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 seated properly e When steaming always use dry saturated steam without condensation at max 1 bar g At KEOFITT USER MANUAL PAG
23. ill a hole 625 mm into the tank wall and then fit the valve into this hole flush with the inside of the tank Welding should be carried 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 2 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 1 5mm material thickness as in the pipe wall This machined shoulder can be modified according to the customer s wishes L IMPORTANT e 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 e The pipe section and the valve s hose pieces are sealed with sponge rubber or similar e 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 O is thus expelled
24. ken not to damage the threads 9 Put the bushing over the spring then place PTFE membrane on the lower stem and press firmly until it clicks in place 10 Put the valve head in open position 11 Put valve head in valve body and tighten L IMPORTANT e This is a delicate procedure to be performed by skilled personnel only e Use vice with aluminium grips to avoid scratching and damaging the valve head Do not use hammer or other tool that might scratch the surface of the membrane L 0 9 1 N O Upgrade kit 404155 consisting of ident no Part name Material 400340 Lower stem for PTFE AISI 316L 1 4404 400055 Membrane for M4 PTFE KEOFITT USER MANUAL PAGE 34 15 2 For manually operated valve heads type B SE SD 10 Close valve Pull off the silicone EPDM membrane Take the bushing off page 31 pos 5 Put the valve head in vice Turn the hex nut counter clockwice until the membrane seat is loose Put the new lower stem for PTFE membrane in the vice Insert the rest of the valve head in the pin and press firmly Turn the hex nut clockwise until the lower stem is firmly in place Care should be taken not to damage the threads Put the bushing over the lower stem then place PTFE membrane and press firmly until it clicks in place Put the valve head in open position Put valve head in valve body and tighten L IMPORTANT e This is a delicate procedure to be p
25. leaned 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 with 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 Karcher steam generator The steaming process with a Keofitt sampling valve has been validated to obtain sterility after 1 minute of steaming at 121 C 1 bar g Documentation is available at the Keofitt Online Service Center on www keofitt dk KEOFITT USER MANUAL PAGE 14 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 For the initial cleaning before a new batch please refer to chapter 4 1 Pre production treatment L IMPORTANT All illustrations show a sampling valve with Keofitt hose piece connections All instructions also apply to valve versions with clamp connections only make sure to use the corresponding fittings 5 1 Chemical CIP The CIP takes place with the valve r
26. lve 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 tenside is a surfactant that reduces the surfa
27. 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 soores 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 the cleaning properties of a detergent
28. ning 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 fil Cp LIQUID L CLEAN WATER fl STEAM 1 Connect a hose with an empty bottle to the lower hose piece This bottle or similar recipient is to collect the disinfectant step 3 and the rinsing water step 6 Fill a flexible bottle with the defined amount of disinfectant Connect the flexible bottle via a hose to the upper hose piece and press the disinfectant slowly through the valve to wet the interior of the valve 4 Allow the disinfectant to act for the prescribed time KEOFITT USER MANUAL PAGE 16 5 Disconnect the hose from the upper hose piece and connect a flexible bottle with cleaned water to the upper hose piece 6 Rinse through the upper hose piece by squeezing the bottle thus pressing the water through the valve chamber 7 Leave the squeezed bottle connected to the hose piece and clamp the hose to avoid contamination from air being sucked in through the valve Steps to perform when adopting B fl PROCESS MEDIA fil Cp LIQUID L CLEAN WATER fl STEAM 1 Plug the lower hose piece with a rubber plug o
29. nnnnannnnnnnnnnnunennnnennnnenen 29 12 4 Keofitt valve type clamp connection NEE 29 NNN 30 Vorren NO 30 eV 31 16 Ms EI NN 31 13 2 Disassembly and assembly of Valve body and head asurusavuvnvnnnnnnnnnnnnnnnnnnnnnnnnnnnnunnnnnnnnnnvuvnrnnn 32 13 3 Disassembly NN 32 14 INSTRUCTIONS ON REPLACING PTFE MEMBRANE si nnannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnenenennnnnansnnnnnnnnn 33 15 UPGRADE FROM SILICONE EPDM TO PTFE MEMBRANE 2 0scssssescssesesesensnseseseesesenensesenens 34 15 1 For manually operated valve heads type H Kand Q ee 34 15 2 For manually operated valve heads type B nunvnnnunnnnnnnnrnnnnnnnnnnnnnnvunnvnnnnnnnnnnnnnnvnnnvnnnnnnnnnnsnnnnnnne 35 15 3 For pneumatically operated valve heads type N i r amrevanunvananrnnannnnnnnnannnnnnnnnnnunrnnnnnnnnnnnannnnnnunnnnne 35 ENER Eege 37 16 1 Silicone MEMDANE Ail J0005 vans caiincdaientiadaduasiudacnaaeidelsgudodeewteadsnceddabooswbanaedanidoiaeneuradeaees 37 16 2 EPDM membrane art NO400022 a a E a Rri 38 16 3 PTFE membrane art no ZOO 39 1 PRESENTATION The Keofitt M4 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 independently of the course of the production process with
30. 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
31. out compromising the same The coaxial design and the electro polished valve interior ensure absolute cleanability The M4 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 ASSI 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 T A lower pH means a higher acidity and thus a higher concentration of positive hydrogen ions in the solution Removes limestone and
32. r a steel plug In case of 8 valve with mini clamp connections the closing of the outlet may be obtained by using a tri clamp blind cap or by squeezing an attached piece of tubing or by any other appropriate means 2 Fill the valve chamber with the disinfectant through the upper hose piece 3 Leave to act for the prescribed time 4 Empty the valve chamber by unplugging the lower hose piece while holding a recipient under the valve allowing the disinfectant to flow out 5 Connect a flexible bottle with cleaned water to the upper hose piece and rinse through the upper hose piece 6 Leave the squeezed bottle connected to the upper hose piece and clamp the hose 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 KEOFITT USER MANUAL PAGE 17 appropriate reason do repeat the full CIP cycle after sampling WARNING e Carefully follow the guidelines given for the chemicals involved Always remember to use safety goggles when steaming CIPping taking samples and all other operations of the sampling valve 5 3 Steam sterilisation Chemical CIP and chemical disinfection are not needed when using steam as steam does it all An e
33. svinadusuwunusudesuanidenieususausiann 14 Al FCO TENNENE 14 42 Chemical cleaning E 14 12 TENNENE 14 AA ENN 14 5 VALVE OPERATIONS gedet 15 FTP 15 ones ege e ET 16 To EEE EEE EE 18 SA STN 20 6 TECHNICAL DATA NA 21 SMR E vote ann EE E EEE P E E AE E E E 21 SK Gade EE 21 PENN 21 SNE GO MAK EE EE NE 21 MENN 21 21 Er FOW E A A E E 22 Ta VALVE BODIES EE aA AA AA 23 S VALVE HEADS rinin E A 24 9 PARTS amp ACCESSORIES iiiiicacniinnccnsedenenedetenkscnesscieeesusussussudnsesvasuuntsubisedusauaWunsuewduebennduusicusasansesuuusuus 25 LO MOUNTING 5 26 VL 26 VP MP vr 26 11 WELDING INSTRUC dl LE 27 ILL WSN DC tence beatae 2 e Guideline wedn 27 12 BLOCK DIAGRAMS ssss11010010200220100 5 5 55555151551515551510501000nnnnnnnnnnnnn 28 Te gt CONG GE T E 258 12 2 IC valve type P DIDE E 28 12 3 Keofitt valve type P pipe connection vertical Inline anarranananannnnannnrnnunnnn
34. t will impede the proper functioning of the screw action When in doubt contact your local Keofitt dealer 13 3 Disassembly of valve head Over time the turn knob may become harder to turn which may be remedies by regreasing the threaded part of the turn knob Perform the following steps to take the valve head apart after having separated it for the valve body as explained in chapter 13 2 e Set the valve head in closed position e Pull off the membrane Remove the bushing Fix the lower stem in a vice using soft jaws e Unscrew the valve head top using the tommy bar hold it back when it gets loose as the spring will push it out e Pull by the knob to separate it from the union nut e Unscrew the upper stem from the turn knob e Lubricate the upper stem s threaded part in contact with the turn knob Assembly is the same in reverse order but please note e Discard the membrane and replace with a new one e Push the membrane and the bushing together so that the membrane is situated against the shoulder of the bushing KEOFITT USER MANUAL PAGE 32 14 INSTRUCTIONS ON REPLACING PTFE MEMBRANE To remove an old membrane from the valve head 1 OPEN the valve lever position as in illustration A 2 Unscrew the valve head from the valve body as described in chapter 13 2 3 CLOSE valve head illustration A 4 Push the membrane and bushing apart illustration B until the tool for membrane fits under it 5 Insert tool for membrane b
35. t 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 hose piece Take the sample immediately after cleaning disinfection sterilisation performing the following steps fl PROCESS MEDIA E Cp LIQUID CLEAN WATER fl 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 CIPping taking samples or any other operations of the sampling valve KEOFITT USER MANUAL PAGE 20 6 TECHNICAL DATA 6 1 Material Valve body AISI 316L 1 4404 Valve head AISI 316L 1 4404 Membrane Silicone grey EPDM black PTFE white 6 2 Certificate Valve body 3 1
36. the process side KEOFITT USER MANUAL PAGE 22 7 VALVE BODIES D Diamp 17 CONNECTION BODIES Clamp 2 Varirent 558 Vateerg 250 WELDING BODIES e NW25 Pipe Welding 1 KEOFITT CLASSIC M4 SAMPLING VALVE BODIES 6580 4 G80 400022 Ed re Ze due D j4L mum PAN Vi 4 i gh de e L Da id rt Le Z 1 GP L De De d s F LA 6 j PPF ie Ke Ais A Wes fa 12 5 ay d G Je a a E 15 i di j I Tex La i GL OYETIA Daul DM REQUEST OSL For further product information material dimensions etc please refer to the specific datasheet at www keofitt dk KEOFITT USER MANUAL PAGE 23 8 VALVE HEADS Type b ae 0 12 bar auesjiis JAER KEOFITT CLASSIC M4 SAMPLING VALVE HEADS For further product information material dimensions etc please refer to the specific datasheet at www keofitt dk KEOFITT USER MANUAL PAGE 24 9 PARTS amp ACCESSORIES KEOFITT CLASSIC M4 PARTS amp ACCESSORIES DOES 5 001 6 SILICONE 2144 EPDM E a DAS Sie 152 5 SEL 00825 SKK TAKLE FOM SWELLS TANG FESTO EE SSO 400205 4000 URNI 65 ESOM 2200 FDA EPUM 1S 6X2 4 FDA S r 5 3524 FDA 5 32 4 EPDM Zug ON GASKET 32 WU 400055 PTFE aunque om
37. tion 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 002 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 process component like a sampling va
38. 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 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 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 z operation e Steaming is not suitable with heat Ka sensitive products Steaming entails the risk of burns Flushing with water followed by the supply of a chemical detergent through the upper of t
39. xception 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 fl PROCESS MEDIA fl Cp LIQUID L CLEAN WATER fl STEAM 1 Remove the plugs from the hose pieces 2 Connect the steam hose to the valve s upper hose piece 3 Connect a hose to the lower hose piece 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 hose piece The valve is now ready to take a sample The sampling must be performed immediately after steaming to avoid any contamination of the sample KEOFITT USER MANUAL PAGE 18 WARNING During sterilisation with steam the valve will become hot and care should thus be taken when operating the valve e 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
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