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KEOFITT W9 USER MANUAL V.4 

PAGE 11

The company Novadan ApS, Kolding, Denmark has supplied the table below, as a preliminary indication 

of which type of disinfectant to use:

Disinfectant

Microbes to inactivate

Halogenes

(Clorine)

Peroxides

(hydrogenperoxid & 

peracetic acid)

Alcohol

 (70%)

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

Legend:

Efficient

Limited effect

Little/No effect

 

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

Sterilisation 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.

Содержание W9

Страница 1: ...DON T GAMBLE WITH YOUR SAMPLE W9 SAMPLING VALVE User Manual ...

Страница 2: ...5 Various amendments to the text in 5 5 1 5 2 6 3 6 4 A new chapter 6 7 Flow Added Warning in 13 2 New chapter 13 3 New illustration in 14 Updated data sheets in 16 x 3 September 2017 Chapter 3 rewritten and extended Rubber cap and steel cap instructions added to chapter 5 Expanded temperature ranges in chapter 6 4 Chapter 13 MAINTENACE extended and more detailed A new chapter 14 FAILURE MODES add...

Страница 3: ...ING VALVE PATENTS U S PAT 5 246 204 E P 0468957 YEAR OF INTRODUCTION 1998 YEAR OF REVISED DESIGN 2014 MANUAL LAST UPDATED Nov 2017 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 ...

Страница 4: ...KEOFITT W9 USER MANUAL V 4 PAGE 4 ...

Страница 5: ...7 Membranes 14 3 8 Parts and Accessories 15 3 9 Pressure and vacuum 15 3 10 Valve cleaning disinfection sterilisation 16 4 EVERYDAY USE OF THE VALVE 17 4 1 Batch change cleaning 17 4 2 Chemical cleaning CIP 17 4 3 Chemical Disinfection 17 4 4 Steam sterilisation 18 4 5 Sampling 18 5 VALVE OPERATIONS 19 5 1 Chemical CIP 20 5 2 Chemical disinfection 21 5 3 Steam sterilisation 23 5 4 Sampling 24 6 TE...

Страница 6: ...ance 37 13 2 Spare parts list 37 13 3 Disassembly and assembly of valve body and head 38 13 4 Replacing a rubber membrane 39 13 5 Replacing a PTFE membrane 40 13 6 Regrease the head spindle 41 14 FAILURE MODES 42 14 1 Broken membrane tip 42 14 2 Broken membrane side 42 14 3 Cleaning the valve after a failure 42 15 CHANGE FROM SILICONE EPDM FFKM TO PTFE MEMBRANE 43 16 MEMBRANES 44 16 1 Silicone mem...

Страница 7: ...al 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 7 A lower pH means a higher acidity and thus a higher concentration of positive hydrogen ions in the solution Removes limestone and most mineral deposits Alkali Alkalis are all bases which form hyd...

Страница 8: ...process during which the item is exposed to the sterilant 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...

Страница 9: ...f 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 Level The probability of a viable microorganism being present on an item after sterilisation Usually expressed as 10 n a SAL of 10 6 means 1 1 million cha...

Страница 10: ...ater is usually sufficient as the product is water soluble Sugar caramelises when heated 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 possibly Enzymes Biofilm is an accumulated mass of microorganisms that is tightly adhered to a surface and cannot be easily removed Starch Alkali...

Страница 11: ...inty 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...

Страница 12: ...upling Mini Tri clamp Thread M16x1 5 Welding ends to weld steel tubing on All welding connector options are available with Hose Piece ports For the other port configurations only some combinations are standard but all non standard combinations are likely to be available On request All valve bodies with their various ports are machined in one piece of steel thus avoiding all crevices and fissures f...

Страница 13: ... and depends on the actual operating conditions pressure temperature viscosity etc If a sample is taken using a needle it is highly recommended to replace the membrane before launching the next production batch For further information please consult www keofitt dk 3 5 Rubber caps and steel caps The hose piece version of the valve bodies all come with a set of rubber caps EPDM connected to the body...

Страница 14: ...ndensation in the steam and at the same time it can be used with a majority of CIP fluids and disinfectants in normal concentrations The PTFE membrane resists all CIP fluids and disinfectants except highly oxidising acids in high concentrations The FFKM covers the highest temperature range and has excellent chemical resistance to virtually any chemical compound Membranes in rubber materials like E...

Страница 15: ...type B valve head the closing pressure is exerted by turning the knob firmly by hand it closes like an ordinary water tap In this way this valve may be used in equipment with a nominal max pressure of 12 bar Vacuum ratings On installations where vacuum may occur temporarily rubber membranes EPDM FFKM Silicone are at risk of being sucked hard into the valve seat whereby the valve might not open pro...

Страница 16: ... 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 Acc...

Страница 17: ...he valve is fitted to a pipe there will usually be enough pressure and flow during the CIP process for the CIP fluid to flow through the valve PIPE TANK 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 P...

Страница 18: ...ase 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 an adapter for a Kärcher steam generator as well as other mobile steam supply systems The steaming process with a Keofitt sampling valve has been validated to obtain steril...

Страница 19: ... of high pressure flow To place a rubber cap simply press it axially against the hose piece until it clicks in Remove it by pulling it outwards axially Caps in stainless steel are available as accessories part no 800061 They are mechanically more robust withstand higher pressure and may be autoclaved To fit the steel cap compress the spring loaded lock pin place the cap over the hose piece and rel...

Страница 20: ...rain circulate it or collect it in a suitable container and dispose of correctly 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 st...

Страница 21: ...hose piece This bottle or similar recipient is to collect the disinfectant step 3 and the rinsing water step 6 2 Fill a flexible bottle with the defined amount of disinfectant 3 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 5 Disconnect the h...

Страница 22: ...t 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 ...

Страница 23: ... 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 ...

Страница 24: ... 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 hose piece 5 4 Sampling Prepare a recipient for...

Страница 25: ... 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 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 If pr...

Страница 26: ...FKM acc to FDA USP Class IV EC1935 EC2023 6 3 Pressure max Working pressure 6 bar g 87 psi g valve head type B 12 bar g 174 psi g Rubber plug 3 bar g 44 psi g Steel plug 12 bar g 174 psi g 6 4 Temperature Steam Sterilisation using dry saturated steam at 121 C 250 F and 1 bar g Dry saturated steam at temperatures up to 134 C 272 F and 2 bar g is possible but might reduce the service life of the mem...

Страница 27: ...umber e g E12345678 External Electropolished The surface roughness is measured for each valve at 4 critical places the valve body process surface the valve chamber and each of the two ports A serial number identifies each valve body A 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 ...

Страница 28: ...mall samples and around 30 sec for larger 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 0 bar g the pressure drop across the valve equals the pro cess pressure tank pressure or line pressure The volume flow through a valve is given by kv Q 1000x p ρ Symbol Unit Description kv m3 h Flow in m3 h...

Страница 29: ...KEOFITT W9 USER MANUAL V 4 PAGE 29 7 VALVE BODIES For further product information material dimensions etc please refer to the specific datasheet at www keofitt dk ...

Страница 30: ...KEOFITT W9 USER MANUAL V 4 PAGE 30 8 VALVE HEADS For further product information material dimensions etc please refer to the specific datasheet at www keofitt dk ...

Страница 31: ...KEOFITT W9 USER MANUAL V 4 PAGE 31 9 PARTS ACCESSORIES For further product information material dimensions etc please refer to the specific datasheet at www keofitt dk ...

Страница 32: ...igure Only with this orientation the valve will be self draining IMPORTANT The tank side of the valve body must be positioned flush with the inside of the tank or the pipe in order to avoid any dead space 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...

Страница 33: ...n be modified according to the customer s wishes 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 ...

Страница 34: ...KEOFITT W9 USER MANUAL V 4 PAGE 34 12 BLOCK DIAGRAMS 12 1 Keofitt valve type T tank 12 2 Keofitt valve type P pipe ...

Страница 35: ...KEOFITT W9 USER MANUAL V 4 PAGE 35 12 3 Keofitt valve type P pipe connection vertical Inline 12 4 Keofitt valve type clamp connection ...

Страница 36: ...KEOFITT W9 USER MANUAL V 4 PAGE 36 12 5 Keofitt valve type Varivent 12 6 Keofitt valve type thread ...

Страница 37: ...ability Based on the desired safety margin the user then decides on the replacement interval to adapt For valve heads with Micro Port approx 5 10 samples may be drawn off per membrane at 5 2 bar g respectively more piercings are acceptable at lower pressure See chapter 3 5 Membranes for more information The rubber plug must be replaced at least once every six months In each individual case a stand...

Страница 38: ...is carried out by unscrewing pos 7 until loose and then pulling the valve head off 4 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 5 Tighten with tommy bar 6 Fit and tighten the set screw if wanted needed it prevents the valve head from being inadvertently unscrewed applies only to type K ...

Страница 39: ...cing a rubber membrane The membrane must be replaced a regular intervals determined by the operating conditions of the sampling valve As each application is different the customers must establish their own replacement scheme Start with very short replacement intervals keep the used membranes for refrence and extend the intervals until the condition of the the used membrane is such that it cannot s...

Страница 40: ...ttach 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 tip of the membrane with your hand until it clicks 11 Set the valve head in OPEN position lever position as in illustration A 12 Insert the valve head into the valve body ...

Страница 41: ...f the membrane Remove the bushing Fix the lower stem in a vice using soft jaws Unscrew the valve head top using the tommy bar hold it back when it gets loose as the spring will push it out Pull by the knob to separate it from the union nut Unscrew the upper stem from the turn knob Lubricate the upper stem s threaded part in contact with the turn knob Assembly is the same in reverse order but pleas...

Страница 42: ...ery low pressure on the external side of the membrane The valve is not foreseen with a leakage hole in the valve head as the risk of building up of dirt inside the valve head from such a hole does not outweigh the manageable consequences of a broken membrane side The effect of such a failure will be an accumulation of a small quantity of product which cannot be removed during the ordinary post sam...

Страница 43: ...AGE 43 15 CHANGE FROM SILICONE EPDM FFKM TO PTFE MEMBRANE All rubber membranes Silicone EPDM FFKM are interchangeable To change from a rubber membrane to a PTFE membrane please contact your local Keofitt dealer or Keofitt directly ...

Страница 44: ...KEOFITT W9 USER MANUAL V 4 PAGE 44 16 MEMBRANES 16 1 Silicone membrane art no 600051 ...

Страница 45: ...KEOFITT W9 USER MANUAL V 4 PAGE 45 16 2 Silicone membrane for Micro Port art no 600251 ...

Страница 46: ...KEOFITT W9 USER MANUAL V 4 PAGE 46 16 3 EPDM membrane art no 600052 ...

Страница 47: ...KEOFITT W9 USER MANUAL V 4 PAGE 47 16 4 EPDM membrane for Micro Port art no 600252 ...

Страница 48: ...KEOFITT W9 USER MANUAL V 4 PAGE 48 16 5 FFKM membrane art no 600053 ...

Страница 49: ...KEOFITT W9 USER MANUAL V 4 PAGE 49 16 6 PTFE membrane art no 850055 ...

Страница 50: ... 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 KEOFITT A S Kullinggade 31 DK 5700 Svendborg Denmark Phone 45 6316 7080 Fax 45 6316 7081 info keofitt dk www keofitt dk ...

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