STERIVALVE Installation and operation manual (Including welding guideline)

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1 STERIVALVE Installation and operation manual (Including welding guideline)

2 ---Table of Contents Introduction 1.1 Safety information 1.2 Scope and Purpose 1.3 Main Components Valve housing Actuators Diaphragms 2. Assembly 2.1 General Valve housing to actuator connection Diaphragm connection 2.2 Assembly Procedure Pneumatically operated valves Manually operated valves Additional procedures for installation of PTFE diaphragms Position Indicators Stainless Steel Pneumatic Actuators Plastic Pneumatic Actuators 3. Operation 3.1 Pneumatically operated valves 3.2 Manually operated valves 3.3 Position Indicators 3.4 Cleaning Internal cleaning External cleaning 4. Maintenance/Service 4.1 Special tools required 4.2 Preventive Maintenance Schedule 4.3 Actuators Manual Actuator Pneumatic Actuator 4.4 Diaphragms Interval of diaphragm inspection Inspection procedure 5. Troubleshooting 6. Technical specifications 7. Spare parts list 8. Traceability and Conformity information 9. Contact information APPENDIX A: Welding guide APPENDIX B: Indicator systems Page 2 / 45

3 1. INTRODUCTION 1.1 Safety information DANGER! The equipment may be operated and maintained only when this maintenance manual is thoroughly understood. Negligence to do so can result in personal injury and/or material damage. If the Sterivalve is part of a piping system, please note: DANGER! The system may be subject to overpressure, steam, hot water, vapors and chemicals. Incorrect handling of the system may result in electrical shock and burn injuries. DANGER! When opening a valve to atmosphere or to a non-pressure vessel, always make sure the pressure is 0 bar(g) (atmospheric pressure). DANGER! Operation, maintenance and adjustment of the equipment may be performed by authorized personnel only. CAUTION! The valve inner surface is manufactured to a high polish and WILL get damaged if tools are used improperly or without care. 1.2 Scope and Purpose This document provides information regarding installation, normal operation, maintenance, and troubleshooting of the valve, including safety aspects. 1.3 Main Components The Sterivalve is a diaphragm valve especially designed for use in aseptic processes. The valve consists of four major components: Housing Actuator manual or pneumatic* Diaphragm Clamp (Sterivalve 51 (2 ) and 76 (3 ) do not feature a clamp. Instead, the housing and actuator are bolted together). *The pneumatic actuator can be fitted with electrical position switches indicating open/closed position. Page 3 / 45

4 Figure 1: Main Components Sterivalve 12 (1/2 ) to 38 (1.5 ) Sterivalve 51(2 ) and 76 (3 ) Valve housing The valve housing is made as standard of stainless steel AISI 316L. Each valve housing is marked with a respective lot number that links it with a specific material mill certificate. Several housing configurations are available: Process valves: Standard process valves are available as shut-off, flow through, take-off, and divert. Refer to figure 2. Other custom configurations are available upon request. Bottom outlet valves: Standard bottom outlet valves are available as single or double outlet, and double outlet with steam integrated valve. Refer to figure 2. Outlet (s) can be provided as a straight weld-nose, or elbow (90 or 45 ) with or without TC connection. Other custom configurations are available upon request. Sampling valves: Standard sampling valves are available as single or double outlet, for welding direct into a vessel wall, or for mounting on a hygienic pad connection, such as Steriflange. Refer to figure 3. Page 4 / 45

5 Figure 2: Standard Valve Housing Configurations Figure 3: Standard Sample Valve Housing Configurations Page 5 / 45

6 1.3.2 Actuators The valve is provided with the following actuator types: Plastic Pneumatic Actuator 12 (1/2 ) to 76 (3 ) The plastic pneumatic actuator is made of PPE (polyphenylene ether) polymer. The actuators are sealed for life and are not serviceable. The actuator is provided as spring to close/air to open (normally closed). Figure 4: Plastic Pneumatic Actuators Stainless Steel Pneumatic Actuator 12 (1/2 ), 25 (1 ), and 38 (1 ½ ) The pneumatically operated actuator for Sterivalve has a stainless steel cover but it is not autoclavable. The actuator is mounted on the housing with a clamp. The stainless steel pneumatic actuator is available in two versions: S-A, where the designation S-A indicates: Spring closed, Air open A-A, where the designation A-A indicates: Air closed, Air open Figure 5: Stainless Steel Pneumatic Actuator 12 (1/2"), 25 (1"), & 38 (1-1/2") Page 6 / 45

7 Stainless Steel Pneumatic Actuator 51 (2 ) & 76 (3 ) The stainless steel pneumatic actuator for valves 51 (2 ) and 76 (3 ) is sealed and not serviceable. The actuator is bolted to the housing. The pneumatic actuator is provided already pre-assembled with the adapter and adapter plate (see figure 6). The pneumatic actuator is spring/air. The cylinder is reversible and can be set-up as either spring to close/air to open (normally closed), or spring to open/air to close (normally open). Figure 6: Stainless Steel Pneumatic Actuator 51 (2") & 76 (3") Manual Actuator 12 (1/2 ) to 76 (3 ) The manually operated actuator is manufactured in stainless steel and is autoclavable. The actuator is mounted in the same manner as with the pneumatic actuators. An extended handle manual actuator is also available for bottom outlet valves. This option makes the handle more accessible to the operator. See figure 8. Figure 7: Manual Actuator 12 (1/2") to 76 (3") Figure 8: Extended Manual Handle Page 7 / 45

8 1.3.3 Diaphragms The valve has three different diaphragm material options. Consult Steridose for availability of each material for any particular valve size. Diaphragm material selection is a function of chemical compatibility with the process fluid (s), including CIP solutions/steam, operational temperature and number of cycles. The following materials are offered: -Platinum cured Silicone, USP <88> Class VI. -EPDM, USP <88> Class VI. -Modified PTFE (TFM), USP <88> Class VI. All diaphragms can be traced by their lot number. The lot number is marked in the packaging. Additionally, silicone and EPDM diaphragms have markings on the back providing the manufacturing date. See section 10 for more details. Figure 9: Diaphragm Materials Page 8 / 45

9 2. Assembly 2.1 General When installing the valve sufficient clearance to remove/assemble the actuator must be considered. The amount of space required depends on valve size and actuator configuration. In order to ensure self draining, the valve must be installed in the correct position. See figures 10 and 11: Figure 10: Self draining positions for process valves The housing is self draining in these positions, but NOT in this position. Figure 11: Self draining position for bottom outlet valves Page 9 / 45

10 2.1.1 Valve housing to actuator connection The valve housing and actuator are connected with either a hygienic clamp union or bolts, as indicated below: Size 12 (1/2 ): TC CLAMP 1"/ 1.5" Size 25 (1 ): TC CLAMP 2.5" Size 38 (1 ½ ): TC CLAMP 2.5" Size 51 (2 ): M8x16mm. ( 4pcs.) Size 76 (3 ): M8x16mm. ( 4pcs.) Diaphragm connection The diaphragm connection to the actuator stem is made by means of a pressure plate or threaded connection depending on valve size and diaphragm material. For valves 12 (1/2 ), 25 (1 ), and 38 (1 1/2 ), with EPDM and Silicone diaphragms, the diaphragm is attached by means of a pressure plate installed in the stem, type 1 or 2. As a standard, the actuators are supplied with a type 1 pressure plate. When using type 1, the diaphragm is pressed into the plate. The type 2 pressure plate is provided as an option and recommended when it is expected that the valve would remain in the closed position for prolong periods of time and would also be subject to steaming. The diaphragm screws into the type 2 pressure plate. The pressure plates are interchangeable. Refer to Figure 13 for details on how to replace a type 1 for a type 2. Figure 12: Diaphragm Connection Types No Pressure Plate Pressure Plate Type 1 Pressure Plate Type 2 Page 10 / 45

11 Figure 13: Replacement of pressure plate type 1 for type 2 For valves 12 (1/2 ) to 76 (3 ), with PTFE diaphragm, no pressure plate is required in the valve stem. The PTFE diaphragm is provided with a threaded stud that will screw direct to the valve stem. In the event of replacing a silicone or EPDM diaphragm for a PTFE diaphragm on an existing installation, the pressure plate type 1 or 2 must be removed from the stem. The pressure plates are glued to the stem. Caution should be taken that all residual glue is carefully removed from the threads in the stem, so that the PTFE diaphragm can screw all the way into the stem. Failure to do so may result in diaphragm damage. A tap can be run on the stem threads to ensure removal of all residual glue. NOTE: When replacing silicone or EPDM diaphragms for PTFE diaphragms on valves that have been in operation for some years, ensure that the valve is tested for leaking prior to put back into service. Small scratches, misaligments, etc that may be present in the valve housing may not affect the sealing capability of silicone or EPDM, but may affect PTFE. For valves 51 (2 ) and 76 (3 ), the diaphragm is provided with a threaded insert that screws directly into the valve stem. Page 11 / 45

12 2.2 Assembly Procedure Pneumatically operated valves In order to install the pneumatic actuator to the valve, follow these steps: 1-Attach diaphragm to actuator stem, or screw the valve diaphragm to the actuator stem. Refer to section Actuate the actuator to the open position. If the actuator is set-up as normally closed, actuate the actuator to the open position. If the actuator is set-up as normally open, continue to step 3. 3-Insert actuator with diaphragm into valve housing. 4-Secure clamp around actuator and valve body. For 51 (2 ) and 76 (3 ) secure the 4 bolts that attach the actuator to the valve body. Tighten the bolts. 5-Actuate the actuator to the closed position. 6- For valves with PTFE diaphragms make sure support gasket/o-rings are installed with the diaphragm. See figure 14. See additional installation procedures for PTFE diaphragms in section O-ring Support gasket Figure 14: PTFE diaphragm o-rings (left) and support gasket (right) Manually operated valves In order to install the manual actuator to the valve, follow these steps: 1- Turn the actuator hand wheel clockwise (closed). 2- Attach diaphragm to actuator stem or, screw the valve diaphragm to the actuator stem. Refer to section Turn the actuator hand wheel counterclockwise (open). 4- Insert actuator with diaphragm into valve body. Page 12 / 45

13 5- Secure clamp around actuator and valve body. For 51 (2 ) and 76 (3 ) secure the 4 bolts that attach the actuator to the valve body. Tighten the bolts by using a wrench. 6-Actuate the manual actuator to the closed position by turning the wheel in the opposite direction. 7- For valves with PTFE diaphragms make sure support gasket/o-rings are installed with the diaphragm. See figure 14. See additional installation procedures for PTFE diaphragms in section Additional Procedure for Installation of PTFE Diaphragms In order to ensure proper sealing of PTFE diaphragms, it is recommended to heat-treat them before use. Follow these steps for the heat-treatment procedure: 1- Expose the installed diaphragm to steam at around 121 C for approximately 30 minutes. The valve should be in the closed position, or closed directly after exposure. Alternatively, the installed diaphragm can be exposed to hot air at around 100 C for approximately one hour. 2- Re-tighten the clamp (1/2-1.5 sizes) or bolts (2 and 3 sizes), after the valve has cooled down to ambient temperature. 3- Repeat this process each time the valve insert (actuator and diaphragm) is disassembled and reassembled Position Indicators An assortment of models and styles of instrumentation are available to sense the actuator position. Listed below are some of the most common. Please consult Steridose to determine the best solution to your particular application Stainless Steel Pneumatic Actuators For valves 12 (1/2 ), 25 (1 ), and 38 (1-1/2 ) To accommodate a wide variety of position indicator solutions various adapters may need to be used on particular assemblies. Please consult with Steridose representatives to determine overall dimensions and specifications. The sensors available are: Open, micro-switch Open/Close, micro-switch Open, inductive proximity switch Page 13 / 45

14 In order to assemble open micro-switches follow these steps: 1. Add/remove any required adapters or sensors from top of actuator. 2. Screw the electrical position indicator in and adjust so that when the actuator is open the sensor switch is activated. 3. Wire the sensor per manufacturer recommendations. In order to assemble open/close micro-switches follow these steps: 1. Set the actuator open. 2. Screw in/remove adapters as necessary. 3. Screw in instrumentation bushing. 4. Set stroke limiter. 5. Fix nut against actuator top. 6. Unscrew screw on actuator top lid and remove. 7. Loosen set screw on body. 8. Slip on instrumentation body into correct position. 9. Lock into place with set screw. 10. Reassemble to lid with screw. In order to assemble open, inductive proximity switches follow these steps: 1. Set the actuator open. 2. Screw the indicator into the tapped hole on top of the actuator, until it stops. 3. Loosen the indicator one turn and fix the indicator against the actuator by screwing the locknut down against the top of the actuator. 4. Compare the measurement A against the chart. Check that measurement A and B are achieved during operation. The switch can be adjusted by turning it. 5. Secure the switch with the lock-nut. Chart Sterivalve 12 (1/2 ), 25 (1 ), and 38 (1 ½ ) Size / Measures A B Sterivalve Sterivlave Sterivlave Figure 15: Installation of position indicators for valves 12 (1/2"), 25 (1"), and 38 (1.5") Page 14 / 45

15 For valves 51 (2 ) and 76 (3 ) The stainless steel pneumatic actuator for 51(2 ) and 76 (3 ) valves can be provided with inductive switches for sensing open and closed position. The same actuator is used with or without switches. A plastic sensor holder is added to the actuator and the sensors are screwed to each mounting bracket as shown on figure 16. The sensors available are: Open, inductive proximity switch Open/close, inductive proximity switch In order to adjust the sensor position, follow these steps: 1. Place the actuator in either the open or closed position. 2. Loosen the vertical adjustment screw on the corresponding mounting bracket and adjust the position until the switch LED signal light is activated. By carefully moving the mounting bracket up and down vertically, position the switch in the middle of the sensor range and then tighten down. 3. Move the actuator to the other position and repeat step 2 for the remaining switch. Figure 16: Installation of position switches for valves 51 (2") and 76 (3") Page 15 / 45

16 Plastic Pneumatic Actuators For valves 12 (1/2 ), 25 (1 ), 38 (1-1/2 ), 51 (2 ), and 76 (3 ) The sensors available are: Open, micro-switch Open/Close, micro-switch Open, inductive proximity switch Open/close, inductive proximity switch In order to assemble switches follow these steps: 1. Loosen set screw on instrumentation body. 2. Remove duplication system from instrumentation body. 3. Check that seals are properly seated and undamaged. 4. Unscrew and remove transparent plastic cap on top of actuator. 5. Apply air to position actuator rod to the top position. 6. Unscrew and remove yellow visual indicator. 7. Screw duplication system into actuator rod. 8. Tighten adapter until contact is made with top of the actuator. 9. Fully tighten duplication system rod on actuator rod with screwdriver. 10. Depressurize actuator to return to default position. 11. Insert instrumentation body onto duplication system, making sure not to damage contact levers on switches. 12. Tighten set screw on instrumentation body 13. Wire according to manufacturer instructions. Page 16 / 45

17 3. OPERATION 3.1 Pneumatically operated Valve The pneumatically operated actuator type S-A is opened when pressurized and closed otherwise. The pneumatically operated actuator type A-A is opened when the lower connection is pressurized and closed when the upper connection is pressurized. DANGER! Always make sure that the surrounding system is de-pressurized before opening a valve to atmosphere or non-pressure vessels. Negligence can result in personal injuries or material damages. 3.2 Manually operated Valve The handle is turned counterclockwise to open the valve and clockwise to close. The valve is not suitable as a regulating valve, and should therefore not be set half-way open. Degree of opening is visually displayed on the side of the handle. When closing the valve be sure not to over tighten the handle. The manually actuator with extension handled is opened by turning the handle counter-clockwise and closed by turning it clockwise. DANGER! Always make sure that surrounding system is de-pressurized before opening a valve to atmosphere or non-pressure vessels. Negligence can result in personal injuries or material damages. WARNING! The handle will become hot if the valve is cleaned with hot liquid or sterilized with steam or water. Use glove if the valve must be opened when the valve is hot. 3.3 Position indicators When installed, the position indicators will indicate if the valve is closed or open by means of sending an electric signal to a control panel. In some models, a red LED light will also provide a visual indication that the valve is in the open position. 3.4 Cleaning Internal cleaning The valve is designed for Cleaning In Place (CIP) but can also be cleaned manually by disassembling the parts and manually cleaning housing and diaphragm External cleaning External cleaning is made according the customers standard procedures, designed for the selected materials of the equipment. Page 17 / 45

18 4. MAINTENANCE / SERVICE 4.1 Special tools required No special tools are required for operation and ordinary maintenance of the valve. For maintenance of the pneumatic actuator 12 (1/2 ), 25 (1 ) and 38 (1 ½ ) a special tool and instruction are needed. It is recommended that the pneumatic actuators 12 (1/2 ), 25 (1 ) and 38 (1 ½ ) are returned to Steridose for repair. Pneumatic actuators 51 (2 ) and 76 (3 ) are sealed and not serviceable. All plastic Pneumatic actuators and manual stainless steel actuators are also sealed and not serviceable. 4.2 Preventive Maintenance Schedule Table 1 shows the recommended intervals for inspection of the valve components: Preventive maintenance Table 1: Intervals of inspection Section in manual for reference Interval Leakage inspection 4.2 Daily Sterivalve diaphragm inspection 4.4 see Sterivalve pneumatic actuator inspection months Sterivalve housing inspection months Pneumatic tubing months Electrical cables months Clamps frequently opened should be greased at the thread with Molykote 111 regularly. Negligence may result in damage to threads. The wetted surfaces of the valve housing should be checked for signs of corrosion and discoloration. Page 18 / 45

19 4.3 Actuators Manual Actuator The manual actuator does not need any maintenance or service. Visual inspection every 12 months is recommended Pneumatic Actuator General The pneumatic actuator requires inspection every 12 months. The following components shall be inspected: 1- Inspect pneumatic tubing and replace if damaged. Assure that the pneumatic hose is not in contact with hot piping etc. 2- Inspect electrical cables and replace if damaged. Assure that the electric cable is not in contact with hot piping etc. 3- Inspect overall function of the actuator. Any noises that may indicate air leakage would result in loss of pressure and could result in an inoperative actuator. Additional service procedures for stainless steel actuators 12 (1/2 ), 25 (1 ) and 38 (1.5 ) The stainless steel pneumatic actuators 12 through 38 are serviceable and a repair kit is available for each size. Refer to tables 2-4. The repair kits include all O-rings and gaskets in the actuator assembly. Special tools are required. See section 4.1. Page 19 / 45

20 STERIVALVE 12 Table 2: Sterivalve 12 (1/2") S-A STERIVALVE 12 (1/2 ) S-A Part # Pos: Qty: Description: Material: Dimension: Note: 1 1 O-ring Viton 16.1x X-ring Viton 9.25x Compact seal Nitril O-ring Viton 34.65x O-ring Viton 3.1x Pressure plate 316 L STERIVALVE 25 Table 3: Sterivalve 25 (1") S-A STERIVALVE 25 (1 ) S-A Part # Pos: Qty: Description: Material: Dimension: Note: 1 1 O-ring Viton 17.17x X-ring Viton 9.25x X-ring Viton 56.75x O-ring Viton 59.2x O-ring Viton 12x2 6 1 O-ring Nitril 4.3x2.4 STERIVALVE 38 Table 4: Sterivalve 38 (1-1/2") S-A STERIVALVE 38 (1 ½ ) S-A Part # Pos: Qty: Description: Material: Dimension: Note: 1 1 O-ring Viton 17.17x X-ring Viton 9.25x Compact seal Nitril O-ring Viton 74.2x O-ring Nitril 4.3x2.4 Page 20 / 45

21 4.4 Diaphragms Interval of diaphragm inspection The service life to the valve diaphragm depends on its working conditions. Important factors with regard to the service life are temperature and the type of process and CIP fluid (s). In general, inspection should be made at every 50 hours of sterilization (e.g. exposure to steam or superheated water) or 1000 hours of operation, whichever occurs first. The interval may however vary between different installations, depending on the diaphragm material, chemicals and utilities used, and temperature during SIP. NOTE: Once the diaphragm has been replaced, please make sure that the actuator is in open position before mounting the actuator to the valve Inspection procedure Any leakage from the diaphragm will be indicated by fluid seeping from a telltale hole at the bottom of the actuator. DANGER! The inspection must be carried out while the valve is free from harmful chemicals, cold, and not pressurized. Negligence may result in personal injuries. When inspecting the diaphragm: Shut down the system (pumps etc) and purge all pressure. Secure that the system is clean, drained, ventilated and below 55 C. Follow the instructions shown below: Page 21 / 45

22 Sterivalve 12 (1/2 ), 25 (1 ) and 38 (1 ½ ) Sterivalve 51 (2 ) and 76 (3 ) 1. Open the valve, manually or pneumatically. 1. Open the valve, manually or pneumatically. 2. Unscrew the clamp with the wing-nut and separate the valve housing from the actuator. 3. Set the actuator to the closed position. 4. Inspect diaphragm. The purpose of the inspection is to detect visible signs of wear, cracks, significant deformation or discoloration. Replace the diaphragm immediately if any fault is detected. Remove the diaphragm and fit the new one in place. Some force may be needed to push the diaphragm over the bottom plate on the piston rod (refer to section 2.1.2) 5. Set the actuator to the open position. 6. Fit the valve housing and actuator together with the clamp. Tighten the clamp manually. Do not use tools. The diaphragm may be damaged if the clamp is over tightened. 7. Close the valve. The valve is now ready for use. 2. Unscrew the four screws and separate the valve housing from the actuator. 3. Set the actuator to the closed position. 4. Inspect diaphragm. The purpose of the inspection is to detect visible signs of wear, cracks, significant deformation or discoloration. Replace the diaphragm immediately if any fault is detected. Remove the old diaphragm, by turning it counterclockwise. It is recommended to exchange the rubber gasket. Fit the new diaphragm by turning it clockwise. 5. Set the actuator to the open position. 6. Fit the valve housing and actuator together with the four screws. 7. Close the valve. The valve is now ready for use. Page 22 / 45

23 5. TROUBLESHOOTING Trouble Description Possible cause Remedial action Manual valve does not open when actuator is turned counterclockwise Manual valve does not close when actuator is turned clockwise Pneumatic valve does not open Pneumatic valve does not close Cleaning in CIP is not satisfactorily Rouging or similar effects on inner surface Diaphragm has short lifespan 1. Diaphragm is stuck on valve seat. 2. Diaphragm is not mounted properly on the actuator. 3. Actuator is not functioning correctly. 4. Incorrect flow direction in combination with high fluid pressure. 1. Incorrect flow direction in combination with high fluid pressure. 1. Diaphragm is stuck on valve seat. 2. Diaphragm is not mounted properly on the actuator. 3. Actuator is not functioning correctly. 4. Compressed air supply is too low. 5. Pneumatic hose is damaged. 6. Solenoid valve, if supplied, faulted or in wrong position. 7. Incorrect flow direction in combination with high fluid pressure. 1. Actuator is not functioning correctly. 2. Solenoid valve electrical cable, if supplied, is damaged. 3. Pneumatic system does not ventilate. 4. Incorrect flow direction in combination with high fluid pressure. 1. Cleaning chemicals wrong type or too low concentration. 2. Flow too low. 3. Valve not installed in drainable position, refer to figure Flow obstructed. 5. Diaphragm is damaged. 1. No acid used in CIP. 2. Poor WFI or PW quality. 3. Incorrect chemicals used in CIP. 1. Incorrect diaphragm material for the application. 2. Media has too high temperature. 1. Inspect diaphragm and replace if required. 2. Correct mounting. Some force must be used to push the diaphragm onto the actuator stem. 3. Inspect and replace if required. 4. Correct flow direction or lower fluid pressure. 1. Correct flow direction or lower fluid pressure. 1. Inspect diaphragm and replace it if required. 2. Correct mounting. Some force must be used to push the diaphragm onto the actuator stem. 3. Inspect and replace if required. 4. Check compressed air supply pressure. 5. Replace pneumatic hose. 6. Check that the solenoid valve is in the correct position and operating normally. Replace solenoid valve if required. 7. Correct flow direction or lower fluid pressure. 1. Inspect and replace if required. 2. Replace electrical cable. 3. Check ventilation of pneumatic system 4. Correct flow direction or lower fluid pressure. 1. Use correct chemicals and concentration. 2. Increase flow. 3. Check valve orientation and change if required. 4. Check flow path. 5. Replace diaphragm. 1. Perform passivation regularly. 2. Check quality of WFI and PW. 3. Use compatible chemicals to valve housing material. 1. Check material compatibility. 2. Lower temperature or use alternate material. Telltale hole is leaking 1. Diaphragm is damaged. 1. Replace diaphragm. Valve is leaking 1. Clamp is not properly mounted. 2. Diaphragm is damaged. 3. Fluid pressure is too high. 1. Mount clamp or replace if broken. 2. Replace diaphragm. 3. Check that pressure does not exceed design pressure. Actuator is leaking air 1. Actuator seals are worn out. 1. Replace seals if applicable, or actuator. Page 23 / 45

24 6. TECHNICAL SPECIFICATIONS Design data for complete valve Design temperature Sterivalve 12, 25 & 38 Sterivalve 51 & 76 (1/2 ), (1 ) & (1 ½ ) (2 ) & (3 ) Sterilization In Place (SIP) Max 135 C (at 1 hour) Max 135 C (at 1 hour) Autoclave Max 135 C (at 1 hour) Max 135 C (at 1 hour) (manual valves only) Design pressure Minimum working pressure -1 bar(g) -1 bar(g) Maximum working pressure +7 bar(g) +5 bar(g) (At +121 C max pressure 3 bar(g))(at +121 C max pressure 3 bar(g)) Other design data ph range Viscosity cp cp Material Housing (valve body) For all types and sizes AISI 316L (ASTM 316L, EN ) Actuator covers AISI 316 or better AISI 316 or better Plastic Plastic Diaphragm Silicone EPDM TFM (Ultra High Density PTFE) USP <88> Class VI. According to FDA specification of approved material (FDA 21 CFR ) USP <88> Class VI According to FDA specification of approved material (FDA 21 CFR ) USP <88> Class VI. According to FDA specification of approved material (FDA 21 CFR ) Page 24 / 45

25 Surface treatment Sterivalve 12, 25 & 38 Sterivalve 51 & 76 (1/2 ), (1 ) & (1 ½ ) (2 ) & (3 ) Internally High grade polished High grade polished Ra 0.5 μm or better Ra 0.5 μm or better Externally Ra 0.8 μm Ra 0.8 μm Operating data for pneumatic actuator Control air Dry, free from particles Dry, free from particles (<10 μm) and oil (<10 μm) and oil Supply pressure, recommended 6.0 bar(g) 6.0 bar(g) Supply pressure, minimum 4.5 bar(g) 6.0 bar(g) Supply pressure, maximum 7.0 bar(g) 8.0 bar(g) Air consumption 12 (1/2 ) Air consumption 25 (1 ) Air consumption 38 (1-1/2 ) Air consumption 51 (2 ) Air consumption 76 (3 ) 0.03 Nl / stroke at 4 bar 0.12 Nl / stroke at 4 bar 0.30 Nl / stroke at 4 bar 2.1 Nl / stroke at 4 bar 4.5 Nl / stroke at 4 bar Air connection M5 thread 1/8 BSPP thread Hose, quick connection For 4 mm hose fitted For 6 mm hose fitted into the M5 thread into the 1/8 thread Page 25 / 45

26 7. STERIVALVE PARTS LIST 7.1 Sterivalve 12 (½ ) Diaphragms Part # Designation Description Picture NP EPDM diaphragm - FDA EPDM diaphragm USP Class VI NP Silicone diaphragm USP Class VI PTFE diaphragm USP Class VI Actuators Part # Designation Description Picture NP Manual handle, SS NP Pneumatic actuator, spring/air SS NP Pneumatic actuator, air/air SS Pneumatic actuator, spring/air - plastic Repair kit actuator spring/air Clamp light duty NP A Pressure plate type Pressure plate type 2 Page 26 / 45

27 Valve Housings Part # Designation Description Picture ASTM shut off body w/tc connect new style ASTM shut off body w/tc connect old style ASTM flow-thru body w/tc connect new style ASTM flow-thru body w/tc connect old style ASTM TC connectable, double outlet ASTM bottom outlet, 45 TC, single outlet ASTM bottom outlet, 45 TC, double outlet Page 27 / 45

28 7.2 Sterivalve 25 (1 ) Diaphragms Part # Designation Description Picture NP EPDM diaphragm FDA EPDM diaphragm USP Class VI NP Silicone diaphragm USP Class VI PTFE diaphragm USP Class VI Actuators Part # Designation Description Picture NP Manual handle, SS NP Pneumatic actuator, spring/air SS NP Pneumatic actuator, air/air SS Pneumatic actuator, spring/air - plastic Repair kit actuator spring/air NP Pressure plate type NP Pressure plate type Clamp light duty Page 28 / 45

29 Valve Housings Part # Designation Description Picture ASTM shut off body w/tc connect new style ASTM flow-thru body w/tc connect new style ASTM bottom outlet, 45 TC, single outlet ASTM bottom outlet, 45 TC, double outlet ASTM bottom outlet w/1/2 satellite valve Page 29 / 45

30 7.3 Sterivalve 38 (1-1/2 ) Diaphragms Part # Designation Description Picture NP EPDM diaphragm FDA EPDM diaphragm USP Class VI NP Silicone diaphragm USP Class VI PTFE1.5 PTFE diaphragm USP Class VI Actuators Part # Designation Description Picture NP Manual handle, SS NP Pneumatic actuator, spring/air SS Pneumatic actuator, air/air SS Pneumatic actuator, spring/air - plastic Clamp light duty Repair kit actuator spring/air NP Pressure plate type NP Pressure plate type 2 Page 30 / 45

31 Valve Housings Part # Designation Description Picture ASTM shut off body w/tc connect ASTM flow-thru body w/tc connect new style ASTM bottom outlet, 45 TC, single outlet ASTM bottom outlet, 45 TC, double outlet Page 31 / 45

32 7.4 Sterivalve 51 (2 ) Diaphragms Part # Designation Description Picture NP Teflon diaphragm, including support gasket Actuators Part # Designation Description Picture NP Manual handle, SS Pneumatic actuator, spring/air SS Pneumatic actuator, spring/air - plastic NP Pneumatic actuator spring/air (cylinder only) - SS Valve Housings Part # Designation Description Picture ASTM shut off body w/tc connect ASTM flow-thru body w/tc connect ASTM bottom outlet, 45 TC, single outlet ASTM bottom outlet, 45 TC, double outlet Page 32 / 45

33 7.5 Sterivalve 76 (3 ) Diaphragms Part # Designation Description Picture NP Teflon diaphragm, including support gasket Actuators Part # Designation Description Picture NP Manual handle, SS NP Pneumatic actuator, spring/air SS Pneumatic actuator, spring/air - plastic NP Pneumatic actuator spring/air (cylinder only) - SS Valve Housings Part # Designation Description Picture ASTM shut off body w/tc connect ASTM flow-thru body w/tc connect ASTM bottom outlet, 45 TC, single outlet ASTM bottom outlet, 45 TC, double outlet Page 33 / 45

34 8. Traceability & Conformity information All wetted components in the Sterivalve are traceable and marked with a batch number. All wetted components are provided with certificates of compliance with regards of the materials of constructions. Valve housing All valve housings are provided with the part number and batch number etched to the outside of the valve housing. Figure 17: Part number & batch number etchings A Certificate of Compliance is included showing the part number, batch number and heat numbers for all components (this could include the housing, fittings and connections). Mill certificates are provided for each different heat number shown in the Certificate of Compliance. Diaphragms All diaphragms are traceable. Each diaphragm is provided with a Certificate of Compliance indicating the material, compliance requirements (e.g.usp<88> Class VI), part number, batch number, and date of manufacturing. EPDM and Silicone diaphragms have the batch number molded on the non product contact side. A code is used to determine the batch number and date of manufacturing Figure 18: Batch number molded location Page 34 / 45

35 Declaration of EC Conformity We herewith declare, the Pneumatic actuators used on different Bürkert types meet the requirements given in the European Directives for ATEX Directive (94/9/EG) Pressure Directive (97/23/EG) For the assessment of the products according to the ATEX the European Standard was used. EN :2002 Non electrical equipment for the use in Hazardous Locations With these results the pneumatic activated process valves may be used as Category 2 units in Zone 1 or 21. These units are supposed to be used in Temperature Code T4 applications. The fluid temperature has to be less than 120 C. The grounding of a metal body has to be realized with the complete pipeline. For the assessment of the products according to the pressure directive the European Standards: were used. EN : 01/02 EN : 10/95 According to this directive the CE mark is valid in case the valves control - gases of group 1 or steam and the orifice size is larger than 25 mm or - gases of group 2 and the product rated pressure x orifice size is > 1000 and < This declaration was issued for the manufacturer by Sonja Drolshagen Ingelfingen, Page 35 / 45

36 Declaration of EC Conformity Herewith we declare, that the supplied products meet all requirements laid down in the following European Directives: Low voltage installations with rated voltage V/AC respective V/DC (Directive 73/23 EEC) Electromagnetic compatibility (Directive 89/336 EEC) Pressure Equipment Directive (97/23/EG) Specification of products: Type: 1062 Applied harmonized standards for low voltage installation: EN 50178: 04/98 Electronic equipment for use in power installations EN : 01/96 Automatic electrical controls for household and similar use; Part1: General requirements DIN VDE : 04/97 Insulation coordination for equipment within low-voltage systems; Part 1: Principles, requirements and tests EN 60529: 09/00 Degrees of protection provided by enclosures (IP-Code) DIN VDE : 06/93 Safety of machinery - Electrical equipment of machines; Part 1: General requirements Additional for solenoid valves: VDE 0580: 10/94 Electromagnetic devices; General specifications Applied harmonized standards for electromagnetic compatibility (EMC): EN : 08/02 EMC-Generic emission standard; Industrial environment EN : 08/02 EMC-Generic immunity standard; Industrial environment EN : 12/01 Harmonic Current EN : 05/02 Voltage Variation Applied harmonized standards for pressure equipment directive (PED): EN : 01/02 Automatic electrical controls for household and similar use Part 1: General requirements EN : 10/95 Automatic electrical controls for household and similar use Part 2: Particular requirements for electrically operated water valves, including mechanical requirements The CE mark is valid according to this directive in case the valves control gases of group 1 or steam and the orifice size is larger than 25 mm or control gases of group 2 and the product rated pressure multiplied with the orifice size is larger than This declaration is given responsible for the producer Bürkert + Cie. S.a.r.l. Established by Triembach-au-Val Thouvenin, Bruno F Villé Quality Inspector Triembach-Au-Val, Page 36 / 45

37 9. CONTACT INFORMATION Steridose is a Swedish company highly specialized in the design, development and manufacturing of Mag Drive Mixers. Steridose and Sterivalve are registered trademarks for Steridose Sales AB. Since its beginning Steridose has progressed to be a highly respected global supplier, partnering many multinational companies. We have operational centers throughout the world to best service our customers. Through experience in the industry we have earned an enviable reputation in our market areas; Sterimixer and Sterivalver applications. Our mission is to enable our customers to achieve a market leading position by being the most competent Mag Drive Mixing solution partner. Steridose is known for its client s integrity and proactive approach with involvement stretching beyond our customer s expectations. Steridose Head Office STERIDOSE HIMMELSBODAVÄGEN 7 SE TUMBA SWEDEN Phone: Fax: info@steridose.com Home Page: Steridose Regional Office STERIDOSE 5020 WORLD DAIRY DRIVE MADISON, WI USA Phone: Fax: info@steridose.com Home Page: Page 37 / 45

38 APPENDIX A: Welding Guide 1. Placement of the valve housing The valve housing is usually placed according to the figure below, but other locations may exist. Therefore the relevant vessel drawings should be checked in order to determine the desired location. Position the outlet of the valve housing according to the relevant drawing. The distance from the valve housing weld seam to any other weld seam shall comply with the local relevant standards regarding pressure vessels, if applicable. As an example, Figure 1 shows the required distance according to the 1987 Swedish standards for pressure vessels, TKN 87 (minimum of three times for the thickness of the material of the dished end, 3 x t.) Figure 1: distance between welds Welding (TIG) Cut a hole for the valve housing in the dished end. Grind the edge of the hole to prepare a suitable weld gap. Position the valve housing in the hole in the dished end. Make sure that the valve housing outlet is correctly oriented. Valve size Sterivalve 12 Sterivalve 25 Sterivalve 38 Sterivalve 51 Sterivalve 76 Diameter of weld flange (hole) ø 48 mm ø 79 mm ø 84 mm ø115 mm ø148 mm Page 38 / 45

39 Tack weld the valve housing with a TIG-welder from the outside. The correct filler depends on the material in the dished end and valve housing. For a dished end and valve housing of 316L filler Avesta 316L (SKR), 316L-Si/SKR-Si or similar type may be used. Seal off between the bench and the dished end with the aid of tape etc. Fill the dished end with an inert protective gas. Starting from the outside, weld the valve housing to the lower dished end in one operation. Make sure that the weld is well burned-through and that it is free from pores and cracks. Use as low heat as possible (low current). High heat can deform the valve housing. Continue welding until the weld opening is completely filled. Turn over the dished end and weld from the inside in order to smooth out the weld seam. If it is considered necessary some filler material may be used. 2. After Welding On completion of welding, the dished end and the bottom outlet valve house shall be allowed to cool slowly. No cooling medium other than air is required. The inside and outside of the weld is ground and polished to the required finish. Page 39 / 45

40 APPENDIX B: Indicator systems 1. Position Indicators for Stainless Steel actuator size 12 (1/2 ) to 38 (1½ ) 1.1 Single induction switch The electrical position indicator indicates open position of the valve. It is threaded to the top of the pneumatic actuator. Technical specifications Model IFB3002-BPKG/V4A/US Type Inductive sensor Connection size Metal thread M12 x 1 Sensing range [mm] 2 [f] Mounting Flush mountormally open Operating voltage [V] DC Current rating [ma] 250 Short-circuit protection pulsed Reverse polarity protection yes Overload protection yes Voltage drop [V] < 2.5 Current consumption [ma] <15 (25V) Real sensing range [mm] 2 ± 10 % Operating distance [mm] Switch-point drift [% of Sr] Hysteresis [% of Sr] Switching frequency [Hz] 1200 Correction factors: mild steel = 1 / stainless steel approx. 0.7 / brass approx. 0.5 / Al approx. 0.4 / Cu approx. 0.3 Ambient temperature [ C] Protection IP 67, II EMC EN EN 55011: class B Housing material Stainless Steel 316Ti/1,4571 Function display Yellow Connection M12 connector Accessories (included) 2 lock nuts Page 40 / 45

41 1.2 Single micro switch The electrical position indicator indicates open position of the valve. It is threaded to the top of the pneumatic actuator. This indicator contains a micro switch with snap action contact mechanism designed for up to 10 6 switching operations. The silver contacts are gold plated. The housing can be rotated through 360. In addition to the electrical position signal there is also visual indication from a red cam via the transparent section. Technical specifications Ambient temperature [ C] Protection IP 65 Operating voltage [V] 250AC/24DC Current rating [A] 4 Protection Class EX II 2G IIB T6 X Dimensions [mm] Page 41 / 45

42 1.3 Double micro switch The electrical position has two micro switches that indicate both open and close position. It is threaded to the top of the pneumatic actuator. Both micro switches can be continuously and precisely adjusted, independent of each other, via thread spindles. The housing can be rotated 360 Technical specifications Setting range of limit switch 2-20 mm continuous Ambient temperature [ C] Protection IP65 Operating voltage [V] 250AC/24DC Current rating [A] 4/2,5 Approvals UL 508/ CSA, C22.2 Dimensions [mm] Page 42 / 45

43 2. Position indicators for Plastic Pneumatic actuators (all sizes) The electrical position feedback is installed on the valve actuator. Valve positions are remotely reported electrically according to switch type: - open, closed (version with a limit switch) or - open and closed (version with two switches or a double limit switch) LEDs provide optical position indication (except with the inductive 2-wires version). Mechanical or inductive switches are housed in a compact splash-proof enclosure. The position indicator can be rotated 360 and is easily fitted to the valve. Technical specifications Material Protection Plastic IP65 Mechanical limit switch (per limit switch) Ambient temperature [ C] -20 to +60 Operating voltage [V] AC/DC AC/DC Current rating [ma] < 8 /< 35 Approval VDE, IEC, UL, CSA ATEX versions II 2 GD EEx ia II C T6, T5 or T4-T1 Inductive limit switch with 3-wire technology Output version PNP Ambient temperature [ C] -20 to +60 Operating voltage [V] DC Current rating [ma] 150 Approval VDE, IEC, UL, CSA ATEX versions II 2 GD EEx ia II C T6, T5 or T4-T1 Page 43 / 45

44 Dimensions [mm] Page 44 / 45

45 3. Inductive switches for Stainless Steel actuator size 51 (2 ) and 76 (3 ) The inductive switches are mounted on a plastic holder mounted on the actuator. Technical Specifications Diameter [mm] 11 Length [mm] 32 Operating voltage [V] VDC Connection type [ma] pnp-l Sensing range [mm] 5 Thread M12 Weight (each) [kg] 0.07 Cable length [m] 5 Page 45 / 45

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