ASEPTIMIX Agitator. Installation, Operation, and Maintenance Manual

Transcription

1 ASEPTIMIX Agitator Installation, Operation, and Maintenance Manual

2 ASEPCO Corporation 355 Pioneer Way Mountain View, CA USA Tel: or Fax: customer Copyright 2014 ASEPCO Corporation. All rights reserved. ASEPTIMIX is a trademark of ASEPCO Corporation. 3/31/2014 Page 2 of 61

3 Table of Contents 1. General Information Product Description Model Selection Guidelines About this Manual 7 Warning Designations in this Document Mixer Warranty Technical Service Return Procedure 9 2. Safety General Warnings for the ASEPTIMIX Mixer Checking for Safe Conditions for Mixer Operations Mixer Components Impeller Male Bearing Assembly Assembly Mounting Post Drive Unit RPM Sensor (optional) Impeller and Male Bearing Tool (optional) Drive Shaft Retractor (optional) Transport and Handling Transport Handling Dimensions and Weight Installation 22 Installation Checklist for the ASEPTIMIX Agitator 22 Step 1: Prepare the System 23 Step 2: Weld in the Assembly Mounting Post 23 Step 3: Install the Electrical Connection 23 Step 4: Install Male Bearing and Drive Mounting Hardware 24 Step 5: Verify the Correct Motor Direction 25 3/31/2014 Page 3 of 61

4 Step 6: Install the Drive Unit 25 Step 7: Install the RPM Sensor 27 Step 8: Commissioning the Drive Unit 28 Step 9: Installing the Impeller 29 Step 10: Start Up the System Operational Parameters Operating Limits 34 ph Limitations Principles of Operation 35 Optimal Mixing 35 Adding Solids to Media 35 Avoid Running When Dry Cleaning and Sterilization Procedures CIP Procedures for the AseptiMix Agitator 37 Cleaning from Inside the Vessel 37 Cleaning by Recirculation 38 Cleaning the Impeller Separately Sterilization Procedures for the ASEPTIMIX Mixer (SIP) 39 Sterilization by Injection of Pressurized Steam 40 Sterilization by Superheated Water 41 Sterilization Using a Steam Autoclave Service / Maintenance Inspection Checklist Summary Disassembling the Mixer Retracting the Drive Unit 43 Retracting the AS0040 Drive 43 Recoupling the AS0040 Drive 44 Retracting the AS0250 Drive 44 Recoupling the AS0250 Drive 46 Retracting the AS0400 and AS0700 Drives 46 Recoupling the AS0400 or AS Removing the Impeller Removing the Male Bearing from the AMP Inspecting the Impeller Inspecting the Male Bearing 53 3/31/2014 Page 4 of 61

5 8.8 Inspecting the Assembly Mounting Post (AMP) Inspecting the Drive Unit Reinstalling the Male Bearing onto the AMP Troubleshooting 56 Symptom: Impeller does not rotate 56 Symptom: Decoupling 56 Symptom: Impeller is spinning eccentrically 56 Symptom: Impeller scratches on vessel ID 57 Symptom: Magnetic drive unit rubbing against AMP 57 Symptom: Loss of speed 57 Symptom: Drive Unit or AMP Hot 58 Appendix A. ASEPTIMIX Parts List 59 A.1 Recommended Spare Parts On Hand 59 Index 60 3/31/2014 Page 5 of 61

6 1. General Information 1.1 Product Description The ASEPCO ASEPTIMIX magnetic mixer is an excellent solution for most common mixing applications, especially those that require a highly aseptic design. It is efficient, highly effective, and extremely robust. ASEPCO designed the ASEPTIMIX mixer to be used in liquid process vessels primarily in pharmaceutical/biotechnology applications and for liquid products. The ASEPTIMIX mixer is best designed for the following applications: General mixing Suspension Blending Immiscible liquids Miscible liquids Fluid motion Heat transfer 1.2 Model Selection Guidelines The ASEPTIMIX mixer comes in four sizes (Models 40, 250, 400, and 700). The following guidelines can help you select the most appropriate size for your application. If you have any questions about the best size for your application, call ASEPCO. Tank Size (liters) Mild 1-2 turnovers/min Moderate 3-4 turnovers/min Agitation Level Vigorous 5-6 turnovers/min Violent 7-10 turnovers/min 50 AS0040 AS0040 AS0040 AS AS0040 AS0040 AS0040 AS AS0040 AS0040 AS0250 AS AS0040 AS0040 AS0250 AS0250 3/31/2014 Page 6 of 61

7 Tank Size (liters) Mild 1-2 turnovers/min Moderate 3-4 turnovers/min Agitation Level Vigorous 5-6 turnovers/min Violent 7-10 turnovers/min 500 AS0250 AS0250 AS0250 AS AS0250 AS0250 AS0250 AS AS0250 AS0250 AS0400 AS AS0250 AS0400 AS0400 AS AS0400 AS0400 AS0400 AS AS0400 AS0400 AS0700 AS AS0700 AS0700 AS0700 AS AS0700 AS0700 Call ASEPCO Call ASEPCO 10,000 AS0700 Call ASEPCO Call ASEPCO Call ASEPCO 1.3 About this Manual This manual is the primary document available for installation, operation, and maintenance information for all ASEPTIMIX mixer models. All instructions, unless labeled otherwise, are applicable to all ASEPTIMIX models. This document does not contain details on how to weld the assembly mounting post (AMP) to your vessel. For this information, refer to the Welding Guidelines for the ASEPTIMIX AMP, which is included in your mixer package, and is also available online at _0306.pdf. Warning Designations in this Document Warnings and prohibitions are marked in this manual with one of symbols shown below. READ CAREFULLY: Possibility of equipment damage, malfunction, or incorrect process results if instructions are not followed. 3/31/2014 Page 7 of 61

8 WARNING: Possibility of severe personal injury, loss of life, or equipment damage in indicated situation. ELECTRICAL HAZARD: Possibility of severe personal injury or loss of life due to electrical exposure. FIRE OR HEAT HAZARD: Possibility of severe personal injury, loss of life, or equipment damage associated with extreme heat or fire exposure. ROTATING PARTS HAZARD: Possibility of severe personal injury, loss of life, or equipment damage due to parts rotating at high speed. 1.4 Mixer Warranty ASEPCO offers a two-year warranty on workmanship for our mixers. Modifying the mixer voids any warranty. 1.5 Technical Service ASEPCO offers comprehensive after-sales service. If any adverse issue (such as material defect or mixer function) with your mixer develops, contact ASEPCO immediately to determine the most effective resolution for the issue. For spare parts and advice regarding operation of your ASEPCO ASEPTIMIX mixer, contact ASEPCO at (customerservice@asepco.com). Support is available Monday throughpsw Friday, from 7 a.m. to 5 p.m. Pacific Time, except for holidays. 3/31/2014 Page 8 of 61

9 1.6 Return Procedure When returning a mixer, contact ASEPCO for a Return Material Authorization (RMA) number. Package the mixer carefully to prevent damage in transit. Please label boxes, packing slips, and all correspondence with the RMA number provided by ASEPCO. 3/31/2014 Page 9 of 61

10 2. Safety Anyone who installs or operates this equipment must carefully read and understand this manual before using or installing this equipment. Failure to follow operating and installation instructions could result in operator injury or damage to the equipment. All ASEPCO mixers are supplied as components and must be mounted onto process vessels before use. Do not modify the mixer in any way or run it beyond the limits specified by ASEPCO. 2.1 General Warnings for the ASEPTIMIX Mixer Anyone using any electrically controlled medical devices (such as pacemakers) should not be in close proximity to magnetic mixers. When operating the mixer, it must be fully installed in a vessel. On a routine basis, check the magnetic items (impeller and magnetic drive unit) for foreign material that can get magnetically stuck to their surfaces. Protect the drive unit against dust. Handle the bearings carefully; the material is hard and brittle. Verify that all components of a complete unit are of the same size. Always ensure that the impeller is submerged during operation. Do not run with an empty vessel. Do not perform mixer maintenance unless the vessel and piping system where the mixer is installed is at atmospheric pressure, cooled down to max 25 C, completely drained of liquids or gases, and not showing any traces of dangerous products. To avoid burns, stay away from all heated parts as well as the drive unit. Do not use motors in explosion-prone environments unless the motor plate and documentation state motor is explosion proof. Properly ground the assembly before operation. 3/31/2014 Page 10 of 61

11 Never install any components (such as dip-tubes and sensors) in the immediate vicinity of rotating parts. Do not insert fingers into rotating equipment pinching may occur. 2.3 Checking for Safe Conditions for Mixer Operations It is the customer s responsibility to check the safety of the mixer each time it is used in a new application. Perform the following operating checks relatively frequently: Check for potential external loads and collisions due to movement of heavy equipment, seismic activity, or other situations that might affect stability. Check for equipment supports, attachments, or modifications to the mixer that might result in reaction forces, moments, and adverse torquing that could affect stability. Check for exposure to corrosive agents or unstable fluids that could cause erosion, decomposition, or fatigue of the mixer components, such as the following: Chlorine gas and chlorine liquid Ferric chloride Hydrochloric acid Sulfuric acid 3/31/2014 Page 11 of 61

12 3. Mixer Components Figure 3-1: ASEPTIMIX components Your mixer should have arrived as four major components, shown in Figure 3-1. In addition, you may have also ordered the following optional items: RPM indicator Drive shaft retractor Impeller puller These components are introduced in this chapter. Model numbers for these components are listed in Appendix A. ASEPTIMIX Parts List. 3.1 Impeller The ASEPTIMIX mixer comes with only one type of impeller design, which is sized specifically for each model. The impeller consists of the following parts: Magnetic hub containing the magnets Female bearing hub containing the female bearing Four impeller blades in a unique design, providing simultaneous up and down pumping action for more efficient mixing 3/31/2014 Page 12 of 61

13 Figure 3-2: Impeller features ASEPTIMIX impellers are designed to operate in aseptic pharmaceutical/ biotechnology processes. They are constructed to be free from pits, crevices, cavities, and hidden areas, and are polished to a smooth finish (25 Ra or less, depending on customer specifications). Keep the mixer s magnetic forces away from any contaminating magnetically attractive particles that interfere with the magnetic fields. Avoid operating at temperatures >135 C. To retain the high-quality surface finish and prevent damage to the impeller, handle it with great care. 3.2 Male Bearing Assembly All male bearings are designed according to the following features: The bearing is slotted to fit over the anti-rotation key on the assembly mounting post (AMP). The bearing is a single piece unit made of tungsten carbide or silicon carbide. The bearing is sealed with FEP-encapsulated silicone O-rings. The bearing and seals are held in place by the bearing nut that threads into the AMP. 3/31/2014 Page 13 of 61

14 Figure 3.3: Male bearing components Do not handle the bearing carelessly. Hard impacts can damage the bearing surface. 3.3 Assembly Mounting Post The assembly mounting post (AMP) is made from one uniform piece of material and includes: Threaded hole for the male bearing assembly Connection flange for the drive unit The AMP is an integrated part of the vessel on which it is mounted, so it must meet or exceed any and all valid pressure vessel codes. Each AMP is marked with a heat and serial number. 3/31/2014 Page 14 of 61

15 Figure 3-4: AMP and associated parts Before the AMP is welded into the vessel make sure that the welder reads and understands the ASEPTIMIX Agitator Welding Guidelines. Ignoring these guidelines might cause deformation of the post and further malfunction of the entire mixing unit. If the vessel and AMP are to be electropolished, ensure that the inside of the entire vessel is equally grounded and manually polished before performing electropolishing. 3/31/2014 Page 15 of 61

16 3.4 Drive Unit Figure 3-5: Drive unit components The drive unit consists of a four parts: Drive magnet assembly Adapter plate to attach the drive assembly to the assembly mounting post Gear reducer Motor Model RPM Current (A) Power (hp) Weight (lb) 40 Slow / Fast / Slow / Fast / Slow / /31/2014 Page 16 of 61

17 Model RPM Current (A) Power (hp) Weight (lb) 400 Fast / Slow / Fast / For further motor data (such as noise level and vibrations). see the individual motor and applied standards, as noted in the motor manual supplied with your mixer. Protect the drive magnet assembly and shaft from impact damage. If this part becomes misaligned, the mixer might malfunction. 3.5 RPM Sensor (optional) The RPM sensor shows the true rotational speed of the impeller unit. The indicator connects to the drive unit through an included bracket and hardware. Our standard model is a PNP sensor with a picofast connector. Figure 3.6: 8-mm Picofast RPM barrel sensor and sensor bracket RPM Sensor Specifications Operating Voltage VDA Ripple <=10% Differential Travel (Hysteresis) 5% TYP. Voltage Drop Across Conducting Sensor 200 ma Output Function Normally open 3-wire self-contained 3/31/2014 Page 17 of 61

18 Short-circuit Protection Yes Trigger Current for Overload Protection >=220 ma Continuous Load Current <=200 ma Off-state (leakage) Current <=1.0 ma No Load Current <=10.0 ma Maximum Approach Velocity <= 1 ms Time Delay Before Availability <=5 ms Reverse Polarity Protection Incorporated Wire-break Protection Incorporated Power-on Effect Protection Per IEC Protection Against Transients Per EN Operating Temperature -25 to +70 C (-13 to +158 F) Enclosure Meets NEMA 1,3,4,6,13 and IEC IP67 Shock 30 g. 11ms Vibration 655Hz, 1mm amplitude (in all 3 planes) LED Function Yellow: output energized Rated Operating Distance Magnet dependant Switching Frequency 1000 Hz Temperature Drift <=-.1mm (constant temp & voltage) Magnetic Actuation Strength 7.5 gauss typ. Repeatability <=0.1 mm (constant temp & Voltage) Embeddable (shielded) Yes Connection 3-wire picofast, 8mm Along with the RPM indicator is a sensor bracket. The size and shape of the mixer bracket varies slightly depending on the size of the mixer model. Installation information can be found in Step 7: Install the RPM Sensor on page Impeller and Male Bearing Tool (optional) The ASEPTIMIX mixer comes with a tool used to install and remove both the impeller and male bearing assembly from a tank. This tool is available as an option from ASEPCO. 3/31/2014 Page 18 of 61

19 The following instructions apply for all ASEPTIMIX sizes. The tool is comprised of four main components: the bearing removal housing, the impeller holder, the main body, and the push/pull lever and handles. Figure 3.7: Impeller and bearing installation and removal tool for AS0250, AS0400, and AS0700 models 3.7 Drive Shaft Retractor (optional) The drive shaft retractor is used to safely couple (push up) and decouple (push down) the drive shaft. This enables the operator to remove the impeller from the assembly. The ASEPTIMIX AS0040 does not require a drive shaft retractor. The operator can retract the drive shaft by hand. The ASEPTIMIX AS0250 requires the use of the retractor shown in Figure 3.7 (to the right). Figure 3.7: Drive retractor for AS004 3/31/2014 Page 19 of 61

20 The ASEPTIMIX AS0400 and AS0700 come with the retractor shown below. This retractor is more robust and is designed to handle the larger magnetic forces associated with these models. Figure 3.8: Drive retractor for AS0400/AS0700 with cover (left) and without cover (right) Detailed instructions on how to use the retractors to install and remove the male bearings and impellers can be found in section 5. Installation and section 7. Cleaning and Sterilization Procedures. 3/31/2014 Page 20 of 61

21 4. Transport and Handling 4.1 Transport ASEPTIMIX Installation, Operation, and Maintenance Manual To avoid damage, pack the ASEPTIMIX agitator securely prior to transport or storage. Keep the impeller, male bearing, AMP, and drive unit in their packaging as long as possible to protect them from dirt and impact. 4.2 Handling When you receive and unpack the mixer, take precautions to prevent scratching the polished surfaces of the impeller or AMP. Be aware that any contact between the stainless material and other non-stainless materials causes material contamination that can lead to corrosion spots. To retain the surface finish and prevent damage to the impeller, handle it with great care. When the impeller is removed from the vessel and is not in use, place it on a table or store it in its original packing materials. To avoid damaging the adapter when it is not installed in the vessel, position the adapter so that there is no risk of the drive unit flipping over and damaging the adapter. Because the impeller and the drive magnet assembly are highly magnetized, avoid contact with magnetically attractive particles and other magnetized material. 4.3 Dimensions and Weight Model Impeller Diameter Height Impeller Weight w/o Motor Weight w/ 175-rpm Motor Weight w/ 350-rpm Motor in. 4.8 in. 5 lb. 18 lb. 18 lb in. 6.5 in. 19 lb. 55 lb. 80 lb in. 6.4 in. 29 lb. 104 lb. 127 lb in. 6.6 in. 34 lb. 132 lb. 222 lb. 3/31/2014 Page 21 of 61

22 5. Installation Keep the impeller and male bearing in the plastic transport wrapping until you are ready to install them in the process vessel. If they have become dirty during handling, clean them using one of the procedures described in section 7. Cleaning and Sterilization Procedures. Installation Checklist for the ASEPTIMIX Agitator Check off during start-up: Everyone involved in the installation of the ASEPTIMIX mixer manual has carefully read and understood this manual, especially Chapter 2. Safety. Make sure all surfaces of the male bearing, impeller, and drive unit are clean as described in Step 1: Prepare the System. Check that the ASEPTIMIX AMP is properly welded in the vessel as described in Step 2: Weld in the Assembly Mounting Post. Check that the electric source is connected to the ASEPTIMIX drive unit as described in Step 3: Install the Electrical Connection. Install the male bearing and drive mounting hardware according to the installation instructions in Step 4: Install Male Bearing and Drive Mounting Hardware. Install the drive unit according to the installation instructions in Step 6: Install the Drive Unit. If you ordered a RMP Sensor, install it and check that the pickup is connected Step 7: Install the RPM Sensor. Perform commissioning on the drive unit as described in Step 8: Commissioning the Drive Unit Install the impeller according to the installation instructions in Step 9: Installing the Impeller. Fill the vessel in which the mixer is installed with a preferred liquid media before running the mixer on then start it up as described in Step 10: Start Up the System. 3/31/2014 Page 22 of 61

23 Step 1: Prepare the System ASEPTIMIX Installation, Operation, and Maintenance Manual 1. Before installing the male bearing, impeller, or the drive unit into a new process system, make sure the system has been properly cleaned. New process systems always carry a heavy burden of foreign material that must be removed before the system can be put into use. These materials could contain magnetically attractive particles that will be caught by the magnetic fields of the impeller. Before performing any kind of maintenance work, make sure the vessel is cooled down, emptied, and depressurized and that any gases or dangerous products are ventilated. Disconnect all media during maintenance work. Step 2: Weld in the Assembly Mounting Post 1. Use then directions in AseptiMix Agitator Welding Guidelines to install the mounting post. Ensure that the welder carefully follows all instructions. An authorized welder must perform all welding work. 2. Ensure that all necessary material certificates and approvals have been received from ASEPCO and documented. Step 3: Install the Electrical Connection Electrical installations for these products are regulated in EN Note the following electrical connection guidelines: Verify that all incoming power is equipped with an emergency stop (installed near the controller) and an on/off switch with locking capabilities. Use only cables with correct voltage and current ratings. ASEPCO recommends the use of shielded cables. Check that the electrical equipment is well grounded. Make sure that the electric cables between the drive unit and connecting cabinet are long enough to allow maintenance personnel to easily disconnect and remove the drive unit from the vessel. 3/31/2014 Page 23 of 61

24 Step 4: Install Male Bearing and Drive Mounting Hardware The vessel must be clean and completely dry inside before installing the male bearing. Ignoring this warning can result in material damage. Before installing the drive unit, install the male bearing and the mounting hardware: 1. Clean the AMP and male bearing assembly threads to ensure that foreign material is not on the threads. 2. Thread the male bearing assembly onto AMP and tighten clockwise by hand. The male bearing assembly threads onto the top of the AMP; drive mounting hardware threads in from bottom on the outside of the vessel, as shown in the figure. Figure 5-1: Male bearing assembly components 3. Using a torque wrench, tighten the bearing to the recommended torque values in the following table. Model # AS0040 AS0250, AS0400, or AS0700 Recommended Torque 60 in-lbs (6.78 Nm) 120 in-lbs (13.56 Nm) 3/31/2014 Page 24 of 61

25 Step 5: Verify the Correct Motor Direction Before installing the motor, check that the motor is rotating in a CLOCKWISE direction, as seen from above. If it is not, the impeller can come off the bearing and cause damage in the vessel or the bearing can become unscrewed. 1. Place the drive unit on the floor or on a table. 2. Run it quickly for a second or two. 3. Verify that the motor is turning CLOCKWISE, as viewed from above. Motor showing clockwise rotation Step 6: Install the Drive Unit Never install the impeller while the driveshaft is engaged. Ensure that the driveshaft is completely retracted; otherwise, the powerful magnetic forces can cause severe damage to the bearing and the operator. To prevent damage to equipment or personnel, use the appropriate lifting equipment when handling the drive unit. 1. Thread the four, five, or six nuts onto the studs protruding from the AMP. Only thread them on until the nut is flush with the end of the studs. 3/31/2014 Page 25 of 61

26 2. Ensure that the impeller is not on the weld post. If it is, the driveshaft will be engaged by the magnetic force from the impeller and certain injury will result. 3. Line up the large holes on the drive unit with the studs. 4. Slide the large holes over the nuts on the studs. 5. Twist the drive unit until the nuts are over the elongated slots. 6. Tighten the bolts evenly to 50 ft-lbs (5.65 Nm) each. 3/31/2014 Page 26 of 61

27 Step 7: Install the RPM Sensor If you purchased a RPM Sensor, this is an excellent time to install it. The following instructions are valid for all ASEPTIMIX agitator models; however, the size and shape of the brackets will vary depending on the model. The sensor bracket is design to be inserted at the interface between the drive unit mounting hardware and the AMP, as shown in Figure 5-2. It is held onto the unit by two of the mounting drive bolts. Figure 5-2: Location for inserting sensor bracket 1. While insuring that the drive unit is in a stable position and will not fall, loosen two of the drive mounting bolts where you want to locate the bracket. 2. Slide the bracket slots onto the two mounting bolts. 3. Tighten the bolts. You can no install the sensor. 4. Move the sensor into the desired position in the bracket and tighten the nuts on the sensor until the desired height is reached (see Figure 5-3). We recommend that you install a lock washer in between the nuts and the sensor bracket to prevent loosening due to vibration. 3/31/2014 Page 27 of 61

28 Figure 5-3: Installation position of the sensor in the bracket Make sure the sensor is rigid and not loose. The desired location depends entirely on the tank thickness. The thicker the tank, the closer the sensor needs to be to the tank to pick up the moving magnetic fields. Step 8: Commissioning the Drive Unit To check that the AMP is correctly welded into the vessel and has not been altered connect and run the drive unit per these instructions: 1. Run the drive unit and its drive magnet assembly inside the AMP at a low speed and listen for any interference noises. Do not run the drive unit in excess of the recommended speeds. The impeller must not be installed in the vessel when this test is performed. 2. After testing the drive unit according to the instructions, retract the drive shaft from the drive unit. 3/31/2014 Page 28 of 61

29 Step 9: Installing the Impeller ASEPTIMIX Installation, Operation, and Maintenance Manual Before installing the impeller, make sure that the drive shaft is retracted. Mount the impeller after the drive shaft has been retracted to prevent damage to the bearing surfaces. This ensures that no bearing damage can occur by the significant magnetic forces drawing the impeller to the magnets of the drive unit. 1. Clean and inspect the impeller to ensure that it does not contain any foreign particles, especially on the internal surface below the bearing. 2. Retract the driveshaft from the drive unit and hold it in this position using the motor retracting tool, described in section 8.3 Retracting the Drive Unit. 3. Engage the lever so that there is no space between the bearing housing and the impeller holder. 3/31/2014 Page 29 of 61

30 4. Position the tool over the impeller and move it downward over the hub until it sits flush with the top. Make sure that the two prongs are in between the blades when the tool is sitting flush. 5. Rotate the tool counter-clockwise so that the tops of the two blades fit in the grooves on the prongs. 6. Engage the lever to lock the impeller in place on the tool. You should see a gap between the bearing housing and impeller holder. The impeller is now ready to be installed into the tank. 3/31/2014 Page 30 of 61

31 7. Carefully lift the impeller without butting against any objects. When the impeller is inside the tank, align the impeller with the male bearing assembly. Gently slide the impeller s female bearing over the male bearing assembly on the AMP. Do not let the two bearings hit each other, as the collision could cause significant damage. 8. When the impeller is resting on the AMP, engage the lever, rotate the tool, and lift the tool off the impeller and out of the tank. 3/31/2014 Page 31 of 61

32 Step 10: Start Up the System Before start-up, you must complete all previous installation procedures described in this chapter, otherwise damage to the mixer may occur. 1. Before starting up the mixer, fill the vessel with enough liquid to cover the impeller. Dry or low water operation will immediately damage the bearings! 2. Connect the drive unit to the controller. 3. Adjust the min/max speed to be within the recommended speed range for the mixer, and to a speed that is applicable to the actual product and volume in the vessel. 4. Start the mixer for a few seconds and then stop it. Ensure that the impeller is rotating clockwise (as seen from above inside the vessel). 3/31/2014 Page 32 of 61

33 Keep away from moving parts. Make sure that nobody is working inside the vessel when the mixer is operating. Never work close to the drive unit while it is connected to power and is running. 5. Start the mixer again, and if there are no issues, slowly increase the speed to its full rpm. If there are signs of malfunction, abnormal noise, or abnormal smells stop the mixer immediately. Do not start the mixer again until you have determined the cause and make the necessary adjustments. To avoid magnetic decoupling during start-up and continuous production, adjust acceleration, deceleration time, and speed level appropriately. ASEPCO recommends a period of 30 seconds for acceleration and deceleration settings. If the mixer runs without issues, the assembly is ready for full operation. 3/31/2014 Page 33 of 61

34 6. Operational Parameters 6.1 Operating Limits Media Newtonian liquids Must not contain magnetic particles Viscosity up to 300 cps Specific gravity from 1.0 to 1.2 Acceptable Vessel size ratio 1:1-1:2 (diameter:height) Temperatures Impeller assembly, male bearing, and mounting post 31 F (0 C) to 275 F (135 C) Mounting post -112 F (-80 C) to 275 F (135 C) Drive unit Ambient temperature less than 104 F (40 C) Media and operating temp Up to 135 C Internal Vessel Pressure psi to 145 psi ph Limitations Most of the mixer parts are quite tolerant of harsh environments; however, carefully consider the bearings (both male and female) with respect to operating ph. ph Ranges Tungsten Carbide Silicon Carbide < 2 Avoid Any contact 2 3 Max 15 minute continuous contact Any contact 3 10 Any contact Any contact Max 15 minute continuous contact Any contact > 12 Avoid Any contact 3/31/2014 Page 34 of 61

35 6.2 Principles of Operation Optimal Mixing The optimal mixing effect is obtained when the liquid movement in the vessel shows turbulence and begins to vortex slightly. Adding Solids to Media Always fill the vessel with up significant liquid and run the mixer before adding solid material to the media. Add the solids according to your specific process parameters. Avoid the build-up of a large quantity of solids in the bottom of the vessel, as this might cause magnetic decoupling of the impeller. Avoid Running When Dry In this manual, we repeatedly emphasize that the mixer should not be run unless the impeller is submerged in liquid. A more exact definition of a physically dry surface is that it is completely clean and free from any liquid film that can act as lubrication for the bearing. Completely dry surfaces can rapidly develop between the male and female part due to sudden liquid boiling or cavitation. A physically dry bearing surface will shear, start screaming, and eventually break. 3/31/2014 Page 35 of 61

36 Dry running conditions can develop during certain processes, and you need to take precautions to avoid this. Carefully monitor and control these situations during process validation work, so that significant damage does not occur. At high speed In hot WFI At atmospheric pressure During and after steam sterilization Running when dry is easy to recognize. It usually starts with a high frequency noise, which progresses to rumbling. Soon afterward, the system magnetically decouples, which can cause bearing damage. If you notice signs of dry running, proceed as follows: 1. Stop the mixer immediately and inspect the male bearing to ensure that it is tight. 2. Make certain that the impeller is not hitting any tank surfaces. 3. Check the bearings for cracks and damage. 3/31/2014 Page 36 of 61

37 7. Cleaning and Sterilization Procedures ASEPTIMIX Installation, Operation, and Maintenance Manual ASEPTIMIX mixers are designed with an open structure that makes it easy to clean the impeller, male bearing, and the AMP while they are installed in the processing vessel. This procedure is generally called cleaning in place (CIP). The CIP procedure described below clean the parts adequately on a routine basis. However, you must also routinely remove the impeller from the vessel to check if magnetically attractive particles from the raw materials have collected on the inside of the impeller. This accumulation of magnetically attractive particles can cause corrosion and damage the impeller. A large number of particles can cause higher torque, which can cause the impeller to come off and damage the vessel. You can perform CIP procedures in several different ways depending on the application and processing conditions as described in the following sections. 7.1 CIP Procedures for the AseptiMix Agitator Cleaning from Inside the Vessel Spray balls internally clean vessel with wash and rinse solutions. Systems with spray balls have different capabilities and fall into three major categories. If the spray ball can cover all the surfaces including the impeller, total CIP can be accomplished. This is due to the open structure of the impeller. The spray balls clean the impeller to the same level of cleanliness as the inner surfaces of the vessel. 1. Leave the bottom outlet valve open to allow the wash and rinse solutions to drain continuously. 2. Run the mixer between 50 and 100 rpm during the CIP process. 3/31/2014 Page 37 of 61

38 If the spray ball only covers the upper part and sidewalls of the vessel: 1. Close the bottom outlet valve. 2. Fill the vessel with wash or rinse solution until the impeller is completely submerged. 3. Run the impeller at approximately 100 rpm for 10 minutes. 4. Drain the vessel. Repeat this process until the equipment is adequately cleaned according to your residuals requirements (usually 1 wash and 2 rinse sequences). The impeller can run continuously during and between the sequences, if they are performed without interruptions. Cleaning by Recirculation When pumps are involved, the vessel must keep a certain liquid volume to feed the pumps. This liquid volume should also cover the impeller. 1. Close the bottom outlet valve. 2. Fill up the vessel through the spray ball to cover the impeller and the dead volume in the external piping. 3. Run the mixer at approximately 100 rpm. 4. Start the circulation pump, then open the bottom outlet valve and let it run according to your standard procedures. 5. Repeat this process until the equipment is adequately cleaned according to your residuals requirement (normally 1 wash and 2 rinse cycles). 3/31/2014 Page 38 of 61

39 The impeller can run continuously during and between the sequences, if they are performed without interruptions. Cleaning the Impeller Separately The spray ball cleaning methods are good to clean the impeller, the male bearing, and the AMP on a day-to-day basis. However, if any of the raw materials used in the formulation contain magnetically attractive particles, the particles are caught in the magnetic field on the inside surfaces of the impeller and are not removed by the normal CIP procedure. To remove these particles, you must remove the impeller from the vessel and clean it manually. Use the appropriate method for retracting the drive for your ASEPTIMIX model. To Remove the Impeller To avoid the risk of personal injury or damage to the bearing, retract the drive shaft before removing the impeller from the AMP. 1. Verify that the power is off and locked before attempting to retract the drive shaft. 2. Retract the driveshaft by following the instructions for your model, as described in section 8.3 Retracting the Drive Unit. 3. Carefully lift the impeller out of the vessel by using the impeller removal tool. To Clean the Impeller 1. Spray the impeller with a high-velocity jet cleaner. 2. Clean with a soft brush or a sponge and a standard detergent (soap). 3. Clean off the magnetically charged particles with an ultrasonic cleaner. 4. After a thorough cleaning, replace the impeller in the vessel, connect the drive unit, and run a standard CIP procedure as described in your SOPs. 7.2 Sterilization Procedures for the ASEPTIMIX Mixer (SIP) All ASEPCO mixers of are designed with an open structure that enables you to sterilize the impeller, male bearing, and AMP while they are installed in the processing vessels. This procedure is generally called sterilization in place (SIP). 3/31/2014 Page 39 of 61

40 The three most common methods for SIP are: ASEPTIMIX Installation, Operation, and Maintenance Manual Injection of pressurized steam into the processing vessels to achieve a steam temperature of at least 121 C. Recirculation of superheated water that has been heated up to at least 121 C and kept under pressure. Dry heat (air) obtained in an oven. When performing sterilization procedures, place the equipment to be sterilized in a steam autoclave into which pressurized steam is injected. Normally, use a minimum temperature of 121 C. You must remove the drive unit from the vessel and keep the vessel in an upright position during sterilization in an autoclave or oven. If the drive unit is unattached during transportation and sterilization in an autoclave or oven, the drive magnet assembly must remain mounted to ensure safe handling of the male and female bearing. Sterilization by Injection of Pressurized Steam You can sterilize the ASEPTIMIX mixer in place with the drive unit connected to the vessel using these steps: 1. Before injecting steam, initiate a pre-vacuum period to remove most of the air inside the system. 2. Blow live steam into the vessel at ambient pressure for 3 to 5 minutes. 3. Optionally, bump the mixer to no more than 75 rpm for no longer than 30 seconds. This step serves to eliminate any air pockets between the two bearing surfaces. 4. After this bump, keep the mixer off for the rest of the SIP cycle. After a completed sterilization cycle the impeller, its male and female bearing are completely dry and can be damaged if you run the mixer. Therefore, avoid running the mixer before liquid has wetted the impeller. 3/31/2014 Page 40 of 61

41 Sterilization by Superheated Water ASEPTIMIX Installation, Operation, and Maintenance Manual You can sterilize the ASEPTIMIX mixer in place with the drive unit connected to the vessel. With this method, you fill the process vessel part way with WFI that is heated to the designated sterilization temperature. In some cases the sterilization is limited to the vessel only, while in other cases the heated water is pumped through the entire process system. In this sterilization process, you do not take any action with the mixer; in fact, do not turn on the mixer at any time during this process. 1. Fill the vessel with superheated water (at least 121 C) to the level determined to be adequate by your staff. This level must be high enough to cover the impeller. 2. Soak the system for the entire sterilization period. 3. Drain when the sterilization period is complete. Sterilization Using a Steam Autoclave When sterilizing using an autoclave, you place the entire process vessel including the impeller inside a steam autoclave and you set the temperature to the actual sterilization temperature, normally 121 C. 1. Turn off the power to the mixer. 2. Retract the drive and then detach the motor and gearbox from the vessel (see section 8.3 Retracting the Drive Unit). 3. Put the vessel (with the impeller inside the vessel) into the autoclave. Keep the vessel in an upright position during sterilization in autoclave/oven to prevent the impeller from getting dislodged and damaged. 4. Initiate a pre-vacuum period to remove most of the air inside the equipment. 5. Autoclave the assembly per your system requirements. The drive magnet assembly should remain in the vessel to prevent damage to the bearings during transportation. After an autoclaving process the impeller and its male and female bearings are completely dry and can be damaged if you run the mixer. Therefore, avoid running the mixer before any liquid has wetted the impeller. 3/31/2014 Page 41 of 61

42 8. Service / Maintenance Your operations team should perform routine inspections to ensure trouble-free operation of the mixing system. Every 6 months is a common interval, however, if your process uses abrasives or has high solid contents, inspect the bearings more frequently. Rumbling, de-coupling, high pitch noise, or other unfamiliar noises can indicate that the bearings are worn out. This section describes the maintenance procedures that you should perform, as well as how to do it. Before performing maintenance and service ensure that the following things are true: The impeller and vessel are fully cleaned from any processed media. No processed media can enter the vessel during maintenance. The vessel is fully vented from any possible gases. The vessel is depressurized. The main power is switched off and cannot be accidentally switched on during the maintenance process. The vessel temperature is below 50 C/122 F (or another limit set by local regulations). 8.1 Inspection Checklist Summary At least once a year (or more frequently, depending on the application) perform the following inspections: Inspect the internal and external surfaces of the impeller for foreign particles, scratches, and surface damage. Inspect the male bearing assembly for tolerance, damage to threads, damage to external surfaces, and seal discoloration. Inspect the assembly mounting post (AMP) for damage to threads and damage to the outer surface. Inspect the drive unit for foreign particles, leaks, noises, and power cable issues. 3/31/2014 Page 42 of 61

43 8.2 Disassembling the Mixer Each of the inspection procedures requires disassembling the mixer. You must follow these steps in the order listed. 1. Turn off the electricity to the motor and make sure it is locked in the off position. 2. Retract the driveshaft using the tool that came with your mixer (as described in section 8.3 Retracting the Drive Unit). 3. Remove the impeller using the impeller removal tool. 4. Loosen the nuts that connect the motor to the AMP. 5. Turn the motor CLOCKWISE in the slots so that the nuts can come out the larger holes, and then carefully let the motor down. 6. Remove the male bearing from the top of the AMP using the impeller removal tool as described in section 8.5 Removing the Male Bearing from the AMP. 8.3 Retracting the Drive Unit When removing or installing the impeller, fully retract the drive shaft. Drive retractors are specifically designed for the mixer model. Refer to the appropriate section for the instructions for your model. Retracting the AS0040 Drive 1. Grab the bottom ball knob and pull down until it stops to completely decouple the drive shaft from the impeller. 2. When the impeller is decoupled from the drive, remove it from the AMP. 3/31/2014 Page 43 of 61

44 Recoupling the AS0040 Drive To recouple the impeller and drive, install the impeller on the AMP while the drive is down and then push the ball knob upward. Retracting the AS0250 Drive To safely retract the drive shaft for the AS0250 series agitator, use the drive retractor tool provided by ASEPCO. Use the drive shaft retractor to safely couple (push up) and decouple (push down) the drive shaft. The shoulder screw on the drive shaft is used to mount the drive shaft retractor. 1. Slide the drive shaft retractor onto the shoulder screw though the larger hole. 2. Move the retractor laterally and down so that the head of the shoulder screw sits securely in the inner flange of the smaller hole. 3/31/2014 Page 44 of 61

45 3. With a simple hand motion, pull down the drive shaft so that the drive and driven magnets become decoupled. Pull down the drive shaft until it stops. 4. Rotate the handle into position as shown below. Make sure that the drive shaft does not interfere with the alignment of the pinholes. 5. Place the locking safety pin into the pinholes. Do this while holding down the button on the pin. When the pin is in place, let go of the button and the pin will be captured in place. The pin and handle prevent the drive from accidently being pushed upward (known as the lockout position). You can now remove the impeller. 3/31/2014 Page 45 of 61

46 Recoupling the AS0250 Drive To push the drive shaft up, remove the pin, rotate the handle back down, and gently push up on the retractor tool. Keep your hands and fingers on the handle and away from the bottom of the gearbox. Retracting the AS0400 and AS0700 Drives The AS0400 and AS0700 series use a special drive shaft retractor mechanism that bolts directly onto the gear motor. This mechanism uses a wheel and thread system to disengage and reengage the drive shaft. The drive shaft retractor is shipped separately from the mixer and must be installed onto the gear motor on site. Before attaching the retractor onto the gear motor, remove the cover as described below. AS0400/AS0700 retracting tool with cover on 3/31/2014 Page 46 of 61

47 1. To remove the cover, remove the four hold down screws. 2. Mount the retractor to the gear motor using the four 5/16-18 x 1-inch screws provided with the retractor. ASEPCO recommends using blue Loctite or a similar product on each screw. 3. Use a maximum of 130 in-lbs of torque when installing the screws. 4. Extract the red-handled set screw from the back of the retractor. 5. Swing the fork into place on the shoulder screw with the fork in between the two rubber pads. 6. Screw the red-handled screw back into the fork. 7. Reinstall the cover. The retractor is now ready to be used. 3/31/2014 Page 47 of 61

48 8. Spin the wheel counter-clockwise until the fork reaches the stop at the bottom. The shaft is held in place until the wheel is turned back in a clockwise fashion. Recoupling the AS0400 or AS0700 To re-engage the drive, spin the wheel in a clockwise motion until the fork reaches the stop at the top. Drive in fully retracted position (without cover) 3/31/2014 Page 48 of 61

49 8.4 Removing the Impeller 1. Ensure that the drive shaft of the mixer is in the lower or disengaged position. 2. Engage the lever so that there is no space between the bearing housing and the impeller holder. 3. Position the tool over the impeller and move it downward over the hub until it sits flush with the top. Make sure that the two prongs are in between the blades when the tool is sitting flush. 3/31/2014 Page 49 of 61

50 4. Rotate the tool counter-clockwise so that the tops of the two blades fit in the grooves on the prongs. 5. Engage the lever to lock the impeller in place on the tool. There is now a gap between the bearing housing and impeller holder. 6. Carefully lift the impeller out of the tank without hitting against any objects. 7. When the impeller is safely out of the tank and on a secure surface, engage the lever, rotate the tool, and lift the tool from the impeller. 3/31/2014 Page 50 of 61

51 8.5 Removing the Male Bearing from the AMP ASEPTIMIX Installation, Operation, and Maintenance Manual 1. Engage the lever on the tool so that there is no gap between the bearing housing and the impeller holder. 2. Carefully align the bearing housing with the male bearing assembly inside the tank. 3. Slide the bearing housing over the bearing assembly so that the male bearing assembly is totally enclosed in the bearing house and the tool cannot slide down any further. Note that a little extra force may be necessary to slide the o-rings past the male bearing assembly. 4. While keeping a constant downward force, rotate the tool counterclockwise until the hex head of the bearing assembly locks with the flats inside the bearing housing. 5. Rotate back and forth to seat the hex head into the tool. 3/31/2014 Page 51 of 61

52 6. Rotate the tool counter-clockwise until the threads are disengaged. 7. Remove the tool from the tank and remove the bearing assembly from inside the bearing housing. 8.6 Inspecting the Impeller Inspect the impeller carefully. Your onsite operations staff can perform some of the impeller inspection and maintenance, but some tasks require special tools and must be performed by ASEPCO. 1. Make a visual inspection of the magnet of the impeller to see if there is foreign material adhering to the magnet. If so, carefully clean off the magnet. 2. Perform a careful visual inspection of the internal and external surfaces of the impeller. If you have the capability, polish the surfaces if there are scratches. If you don t have the capability, send the impeller to ASEPCO for polishing. 3. Visually check the surfaces of the bearings for any damage. If it appears that there is any damage, send the impeller to ASEPCO to replace the bearing. The impeller bearing cannot be replaced in the field. 4. If you have the capability, measure the tolerance of the female bearing with a bore gauge/micrometer with three points. Many of our customers don t have this capability; in this case, send the impeller to ASEPCO to adjust the tolerances. 3/31/2014 Page 52 of 61

53 8.7 Inspecting the Male Bearing ASEPTIMIX Installation, Operation, and Maintenance Manual Most of the male bearing can be inspected and maintained by the operations staff. 1. Visually inspect the male bearing seal (O-ring) for discoloration, cracks, and other damage. If found, replace the seal. 2. Inspect the outer surface of the male bearing for scratches and dings. If found, replace the bearing. 3. Inspect the threads of the bearing nut. The gauge should easily thread onto the nut. If there is an issue, we suggest that you send the male bearing assembly to ASEPCO for rethreading. 4. Check the tolerance of the male bearing with the no-go gauge. If the bearing is out of tolerance, replace the bearing immediately. 8.8 Inspecting the Assembly Mounting Post (AMP) 1. Visually inspect the outer surface of the AMP for scratches and dings. If found, polish or electropolish the surface. 2. Screw the gauge into the mounting post. If the go gauge doesn t easily screw, on rethread the AMP or call ASEPCO for assistance. 8.9 Inspecting the Drive Unit 1. Visually inspect the magnet drive shaft for adherence of foreign particles. If found, carefully clean the shaft. 2. Visually inspect the power cable for any damage. If found, replace the cable. 3. Carefully examine the gearbox for dripping oil, or noisy or uncharacteristic sounds. If there are problems, contact ASEPCO to repair or exchange the gearbox/motor Reinstalling the Male Bearing onto the AMP 1. Ensure that the drive shaft of the mixer is in the lowest or disengaged position. 3/31/2014 Page 53 of 61

54 2. Engage the lever so that there is no space between the bearing housing and the impeller holder. 3. Position the bearing assembly as shown to the right. 4. Slide the bearing assembly into the bearing holder until the bottom surface passes the first O-ring completely. The bearing assembly is now ready to be installed inside the tank. 3/31/2014 Page 54 of 61

55 5. Align the bearing and tool to the AMP (post) on the inside of the tank. 6. Slowly place the tool over the post and engage the thread of the bearing assembly to the thread of the post. Maintain a constant downward force on the tool assembly while installing. This ensures that the hex head of the bearing assembly engages the tool correctly. 7. When the threads are engaged, rotate the tool clockwise to at least 100 in-lbs of torque to secure the bearing assembly in place. 8. Remove the tool from the tank by pulling upwards on the tool. You can now install the impeller. 3/31/2014 Page 55 of 61