Single-Use Filling System User Manual - Tecny Fluor
Contents
1. ASI 163 Research Lane Millersburg PA 17061 717 692 2104 1 800 724 4158 WWW aSISUS COM Additional Parts Should you require additional parts for your Filling System please refer to the part numbers listed Part Number Description OUZ S ANA Nozzle replacement assembly GO GS AA Ram carriage assembly COS ngana Micro switch 6070 ama Nozzle replacement kit System Repair Parts Kit GIO aa Disc spring set 4 pieces CO PAA Cam track roller Gf eee eee End position plunger CET a Home position spring CLO redne Gripper spring Aseptic Single Use Filling System Manual 19 20 Illustrations Illustration 1 Side View Item Number Part Number Description 1 Frame Base Table Handle Base Micro Switch Illustration 2 Alternate Side View Vp A WASHER Item Number Part Number i Cap Gripper and a Plunger Assembly an 6024 1 Nozzle Clamp www asisus com LA S 7 Illustrations Illustration 3 Motor View item Number Part Number OB 6064 1 6066 1 Motor Bracket Assembly Illustration 4 Detail View item Number Part Number C16 Disc Spring Set WASHER WASHER Aseptic Single Use Filling System Manual 21 22 Illustrations Illustration 5 Filling System Wiring Diagram IMS MOTOR PLUG FOOT PEDAL JUNCTION BOX START CYCLE GREEN GROUND GREEN YELLOW GROUND ae WHITE i WHITE GRAY I O BLACK FP o c PUMP START DOSE CYCLE A N aa WHITE HA SW WATSON MARLOW CONNECT2. Connect your Pump A pump is not included with the Filling System ASI recommends the use of a 620Di L WATSON MARLOW pump Any peristaltic pump can be used but the user will need to make sure that the selected pump can be adjusted to limit the maximum pressure and capable of reverse cycles to prevent drips www watson marlow com Plug the end of the Micro Start switch cord As shown in Figure 32 into the supplied main cable The Micro Start switch is shown on the right side of Figure 32 When the switch is depressed the internal contacts will be closed The switch is depressed contacts closed when the nozzle is engaged with connector in the fill position The user must select a pump and qualify the volumetric pump to be used in concert with the Filling System The Micro Start switch will activate the pump start of any pump of choice There is an adjustment for the Micro Start switch for making contact The Filling System has been tested with a WATSON MARLOW pump at fill pressures up to 6 PSI with the current bag closure design and Filling System nozzle Figure 32 Micro Start Switch 16 www asisus com Filling Procedure Figure 33 Load position of the connector retainer 3 E i Figure 35 Cap is disengaged and nozzle tip is moving into position Figure 36 Nozzle fully engaged into fill stem of bag Position Bag for a Fill To fill a new bag first verify that you have the correct pump settings for
3. Single Use Filling System User Manual Models 4MP6000 and 4MP6001 Manual and Motorized Versions ASI 163 Research Lane Millersburg PA 17601 1 800 724 4158 wwwaasisus com 4MP6001 Filling System Motorized Version with Pump WATSON MARLOW Warning The reset sequence begins when power Is supplied All safety precautions are the user s responsibility Table of Contents Safety Notes Failure to follow user instructions may cause personal harm ASI will not be held liable for personal injury caused by improper use of the Filling System e The system is designed to be used by only one individual at a time e Exceeding the pressure ratings or over filling the container will make any warranty claims to the supplier null and void e Please refer to this user manual for proper handling and for the use of the Filling System Filling System Shipping Crate Uncrating Filling System Remove the Lid Remove the Sides of the Crate Unbolt Filling System Flatten amp Store Crate System Setup Removal from Shipping Crate Lift Filling System to Upright Position Install Handle Cable Connections Gray Input Output Communication Cable Two Pin Twist Lock Connector 25 Pin Connector for Pump Three Pin Twist Lock for Foot Pedal Servo Motor Power Cable Install Tubing into Pump Install Nozzle Connect your Pump Filling Procedure Position Bag on Filler Plate Remove Cap for Filling Engage Filling Nozzle into Connect
4. ball detents for nozzle linkage lock Adjust 1 8 turn and cycle the Filling System 3 Nozzle misalignment a Adjust plastic nozzle to properly align with connector body b Check guide track for full travel of bag plate c Connector body not seated in receiver d Check the ball detents in receiver to hold connector body in place 4 Pump is not cycling Check the pump fill switch connection Check nozzle bracket engagement of the ball start switch Check the pump dose and setup status a0 o a Nozzle shutoff is not opening when inserted into connector body This is due to improper nozzle installation 5 System not cycling Check the power supply Check all of the electrical and communication connections Cycle power to reset home and load position If home cycle completes upon power up check foot pedal connection MON aT o If cycle begins but does not fill check ball start switch for pump If pump cycles and the system does not complete cycle check signal from pump to the system 24 www asisus com Appendix 3 Trouble Shooting Manual Filling System 1 Cap will not load into receiver a Filler is not in load position b Loose hardware or linkage Check set screws and key on drive shafts c Check cap stripper linkage and arm 2 Nozzle will not compress to fill connector a Nozzle is not installed in nozzle retaining bracket locator b Check nozzle set screw and key way at nozzle link
5. O DO DO WO CO Ww O O N N N N P pal Co D e e e ae BS Bae RS BS RH Ro BS BeBe BeBe BE HKB H u uaan A A BR WwW W N N FP FP KH FP O O O Oo Table of Figures Figure 32 33 34 35 36 37 38 39 Description Pump Start Switch Load Position of the Connector Receiver Fill Connector in the Load Position Ready for a Fill Cycle Cap is Disengaged and Nozzle Tip is Moving into Position Nozzle Fully Engaged into Fill Stem of Bag Micro Switch in Free Position Micro Switch Depressed Pull Back Handle to Re engage Cap onto Bag Continue to Pull Back on Handle Remove Bag Table of Illustrations Illustration 1 2 Description Side view Alternate Side View Motor View Detail View Filling System Wiring Diagram Table of Appendices Appendix il 2 3 Description Preventative Maintenance Troubleshooting Motorized Filling System Troubleshooting Manual Filling System Aseptic Single Use Filling System Manual Page 16 17 17 17 17 18 18 18 Page 20 20 21 21 22 Page 23 24 25 5 6 Introduction Thank you for purchasing the 4MP6000 or 4MP6001 Filling System In addition to the Filling System you will need a fluid pump and a single use flexible container bag with an ASI interface connector The Filling System is available in both manual 4MP6000 and motorized 4MP6001 versions Both versions include the Filling System only and do not include the pump ASI has tested the fill rates and p
6. OR DP25 PIN WHITE PUMP START lt HG DOSE CYCLE PIN 9 gt BLACK O GROUND WHITE GRAY PIN 14 5 RED I O CYCLE COMPLETE PIN 11 www asisus com PINK I O 4 Appendix 1 General Cleaning Using Isopropyl or Denatured alcohol spray and wipe all parts of 4MP6000 4MP6001 Preventative Maintenance Suggested every 10 000 cycles or it problem occurs 1 Inspect Filling System for any loose components Be sure to check a Nozzle brackets b Cap stripper assembly c Moving linkage 2 Tighten all hardware for proper system operation a Check nozzle bracket b Check stripper bracket c Set screws on couplers and moving linkage 3 When cap cover is removed for cleaning count the number of ball bearings in the slide assembly a There should be 48 ball bearings per liner Replacement ball bearings can be installed into the cover and liner assembly Aseptic Single Use Filling System Manual 23 Appendix 2 Trouble Shooting Motorized Filling System 1 Cap will not load into receiver Filler is not in load stand by position Loose hardware or linkage Check set screws and key on drive shafts Check cap stripper linkage and arm Oo 90 T Motorized Filling System is not homed Cycle power to reset home and load position 2 Nozzle will not compress to fill connector a Nozzle is not installed in nozzle retaining bracket locator b Check nozzle arm set screw and key way at nozzle linkage c Check
7. age c Check ball detents for nozzle linkage lock Adjust 1 8 turn and cycle the Filling System 3 Nozzle misalignment Adjust the plastic nozzle to properly align with connector body Check the guide track for full travel of bag plate Connector body not seated in receiver Check the ball detents in receiver to hold connector body in place O NT Y 4 Pump is not cycling Check the pump fill switch connection Check the nozzle bracket engagement of ball start switch Check the pump dose and setup status Nozzle shutoff is not opening when inserted into connector body This is due to improper nozzle installation OO O If any additional trouble shooting assistance is required please call Customer Service 1 800 724 4158 Aseptic Single Use Filling System Manual 25 Instructional Video m 2 5 m Life Sciences ASI 163 Research Lane Millersburg PA 717 692 2104 800 724 4158 www asisus com ASI is an FDA Registered ISO 13485 2003 Certified Manufacturer PK 01317 REVF 12 31 12 Life Sciences ASI ASEPTIC SINGLE USE FILLING SYSTEM ASI s Filling System when used in conjunction with good technique and a laminar flow hood yields an aseptic bag fill The filling system utilizes a fixture and cap assembly developed and manufactured by ASI and fully controls the filling interface with no user interaction required with the fill port What is left after completion is a tamper evident dispensin
8. com Activate Pump When the nozzle is fully engaged the micro switch will be depressed activating your pump The motorized version 4MP6001 will do this automatically As shown in Figure 37 Fill Bag to Desired Level Your volumetric pump when setup properly will stop filling automatically when the set level is reached Fully Close Cap Now that the bag is filled the cap must be re seated and locked onto the connector body Pull back on the handle of the manual version Filling System until the cap engages the connector and engages to the fully closed position As shown in Figure 38 The motorized version 4MP6001 will do this automatically for you Note The bag is now sealed and tamper resistant Once the cap is locked it cannot be refilled nor can its contents be altered Remove Bag Remove the bag and store appropriately As shown in Figure 39 You may fill another bag of the same specification If you wish to fill a different bag specification adjust your pump to the new volume Warranty and Customer Service Warranty The product warranty includes part replacement for worn and broken components The warranty excludes any physical damage abuse or improper use of the Filling System The warranty applies for six 6 months from the date of purchase When contacting Customer Service Representatives please have your serial number ready The serial number is located on the bottom of the base Customer Service
9. en twist the connector until it is firmly seated in place As shown in Figure 21 Figure 20 Gray input output Figure 21 Align notches insert cable and twist the connector until firmly in place communication cable Aseptic Single Use Filling System Manual 11 System Setup Cable Connections Two Pin Twist Lock Connector Locate and connect the two pin twist lock connector for the pump start switch Connect the two ends Then twist to lock the connection As shown in Figure 22 is ip o wae LA Figure 22 Locate the two pin twist lock connector Twist to lock the connection Cable Connections 25 Pin Connector for the 620Di L Watson Marlow Pump Locate the 25 pin connector for the 620 Di L Watson Marlow pump and plug it into the back of the pump Then twist the screws to tighten the cable to the pump As shown in Figure 23 a HU Figure 23 Locate the 25 pin connector and twist the screws to tighten the cable to pump 12 www asisus com System Setup Cable Connections Three Pin Twist Lock Connector for the Foot Pedal Locate the three pin twist lock connector for the foot pedal Plug the ends together and twist to secure the connection As shown in Figure 24 af TIBA M ma pa Wi Figure 24 Locate the three pin twist lock and plug and test to secure connection Cable Connections Servo Motor Power Cable Connect the power cable to the servo motor by inserting it into the power input and tw
10. g port This results in a cleaner more efficient and cost effective method of filling ee at AMP6000 Manual Filling System AMP6001 Semi Automatic Filling System B100787 I 1 Liter Bag with Fill Connector 3 000 count Watson Marlow 620Di L Peristaltic Pump AMP6065 Ram Carriage Assembly ASI Catalog x f i Port 1 Co Ex Tube ASI Filling Connector N z r B i Port 1 Co Ex Tube ASI Filling Connector Port 2 1 8 ID x 1 4 OD Clear C Flex 374 16 LL Female Cap Slide Clamp h ie 2 B100792 1 ASI 163 Research Lane Millersburg PA 717 692 2104 800 724 4158 www asisus com ASI is an FDA Registered ISO 13485 2003 Certified Manufacturer Rev 01 16 13 MK 00044
11. in this position Figure 16 Pin in shipping position Figure 17 Pin in vertical position 10 www asisus com System Setup Install the Handle on Manual Version 4MP6000 A handle is included in both versions but has been removed for shipping If you have the motorized version 4MP6001 do not install handle while the motor is connected The handle can be attached and used when the motor is disconnected if you prefer to operate the system manually To install Insert the end of the handle into the hole on shaft As shown in Figure 18 Tighten set screws on both sides using 1 8 Allen wrench As shown in Figure 19 Allen wrench not included NOTE There are two handle orientation options to choose from To change the handle orientation remove the one Allen head set screw from the receiver on the end of the shaft You may move the handle to a desired position to ease the filler operation Pivot the handle up or down to preferred orientation and tighten the three Allen screws Figure 18 Install handle Figure 19 Tighten set screw on handle Cable Connections Gray Input Output Communication Cable Instructional Video To set up the Filling System and the pump first locate the gray input output communication cable used to connect the pump to the motor As shown in Figure 20 Note the notch located on the cable s end and motor connector Align the notches and insert the gray input output cable into the motor Th
12. ist the connector until firmly seated in place As shown in Figure 25 Figure 25 Locate the servo motor power cable insert into power input and twist in place NOTE DO NOT PLUG IN THE POWER CABLE INTO A WALL RECEPTACLE AT THIS TIME Aseptic Single Use Filling System Manual 13 System Setup Installing Tubing into the Pump To install the pump tubing first remove the pump roller cover As shown in Figure 26 Next install the pump tubing over the rollers and stretch to the retention pin As shown in Figure 27 Now Re install the roller cover As shown in Figure 28 NOTE See the Watson Marlow pump setup guide for more information Li zh Figure 28 Re install the roller cover 14 www asisus com System Setup Install Nozzle To install the nozzle assembly open the clamp collar on the Filling System by turning the adjustment nut towards you As shown in Figure 29 Note the adjustment ridges in the clamping jaws and nozzle As shown in Figure 30 Figure 29 Opening the clamping Jaws Figure 30 Adjustment ridges on the clamping jaws and nozzle Place nozzle into the collar engaging the slot of the nozzle with the ridges in the clamping jaws Tighten clamping collar by turning adjustment nut away from you This will secure the nozzle As shown in Figure 31 Figure 31 Nozzle clamped in place and twist clamping collar to secure nozzle Aseptic Single Use Filling System Manual 15 System Setup
13. nel pairs As shown in Figures 5 6 N N Figure 5 Unfold the vertical edge tabs Shown Figure 6 Flattening the tabs with channel locks will here using a flat blade screwdriver allow the wall panel pairs to uncouple more easily and facilitates the eventual reuse of the crate Note that the lower edge of each wall panel has two tabs attaching the side walls to the base pallet These will typically be folded under and almost unnoticeable Locate these eight tabs unfold them and lift the side walls away As shown in Figures 7 8 Aa Figure 7 Note that the lower edge of the wall has two Figure 8 With all the tabs unfolded lift away the side walls to tabs Go around the base of the crate and expose the Filling System on the bottom base pallet Remove unfold the eight base tabs as shown here using any padding or protective wrap from the Filling System a flat blade screwdriver 8 www asisus com Filling System Shipping Crate Step 3 Unbolt the Filling System from the Base Pallet There are four mounting points on the base of the Filling System Use the appropriate tool Either a crescent wrench or a screwdriver to remove the fasteners which secure the Filling System to the base pallet As shown in Figure 9 10 After all four fasteners are removed lift away the Filling System Figure 9 Unscrew base mounting hardware Figure 10 Unbolt base mounting hardware using using a screwdriver a crescent wrench Step 4 Flat
14. or Activate Pump Fill Bag to Desired Level Fully Close Cap Remove Bag Warranty and Customer Service Warranty Customer Service Additional Parts Aseptic Single Use Filling System Manual O WO CO N N 10 10 11 11 11 12 12 IK 13 14 io 16 17 17 17 18 18 18 18 19 19 KO 3 Table of Figures Figure O 00 N DB WH A W N F amp F w W N N N NH NH NH NHB NH NY HY FPP RP RP RP RP ha ha pa pa PH O ON DA WT KR W N FP CO oO WN DO WN KR W NHB O Description Filling System Crate Unfold Cover Tabs of Crate Flatten Cover Tabs of Crate Removing Cover of Crate Unfold Vertical Edge Tabs of Crate Flatten Vertical Edge Tabs of Crate Unfold Lower Edge Tabs of Crate Lift Side Walls of Crate Unscrew Base Mounting Hardware Screwdriver Unbolt Mounting Hardware Crescent Wrench Walls of Crate Folded Walls of Crate Folded Crate 4MP6000 Handle 4MP6000 Filling System Pin in Shipping Position Raise System and Re insert Pin into Desired Position Install Handle Tighten Set Screws on Handle Gray Input Output Communication Cable Align Notches Insert and Twist Connector Two Pin Twist Lock Connector 25 Pin Connector Cable to Pump Three Pin Twist Lock Foot Pedal Cable Servo Motor Power Cable Connection Remove Pump Roller Lid Install Tubing Over Rollers Re Install Roller Cover Opening the Clamping Jaws Adjustment Ridges on Clamping Jaws and Nozzle Nozzle Clamped In place www asisus com O D
15. ressure ratings with a WATSON MARLOW 620Di L pump Any peristaltic pump can be used but the user will need to make sure that the selected pump can be adjusted to limit the maximum pressure and capable of reverse cycles to prevent drips The Filling System has been tested with a WATSON MARLOW pump to fill pressures up to 6 PSI with the current bag closure design and filler nozzle ASI cannot guarantee the accuracy of the fill volume as this is controlled by the pump Please consult the user manual provided with your pump or consult the manufacturer regarding volume or pressure adjustments Operations outside of the scope of this Filling System manual may void the warranty Please consult with ASI on bag specifications Life Sciences www asisus com Filling System Shipping Crate Your new Filling System may have shipped to you in a ULine wooden shipping crate As shown in Figure 1 These wooden crates offer vault like protection for your Filling System The crate is made of 1 4 thick plywood and includes a 5 base pallet After unpacking your Filling System the crate breaks down for essentially flat storage and can be stored for eventual reuse Should you ever need to store move or ship your Filling System the crate can be easily reassembled Theses crates are export certified allowing your Filling System to be shipped globally Uncrating the Filling System To uncrate your Filling System follow these simple s
16. ten and Store the Crate You may store the ULine crate in a relatively flat compact fashion Fold each of the two side wall pairs as if closing a book Place each pair on the base pallet Place the cover on top of the stack As shown in Figures 11 13 Store the flattened and condensed crate in a dry location for eventual reuse Figure 11 Two side wall pairs after Figure 12 Fold each of the pairs flat Figure 13 Place the two folded side walls removal from base pallet almost like closing a book and then the lid on top of the base pallet Aseptic Single Use Filling System Manual 9 System Setup Removal From Shipping Crate Locate the following items the handle which is used with the manual version As shown in Figure 14 and Filling System As shown in Figure 15 Figure 14 4MP6000 Handle Figure 15 4MP6000 Filling System Lift Filling System to Upright Position The Filling System is shipped in the folded down position Raise the system into operation position by pulling the inclination pin lifting the system to the desired position and re inserting the pin As shown in Figure 16 1 Pull inclination pin from shipping position 2 Lift system to upright position 3 Place pin in desired hole dictating table angle NOTE ASI recommends the vertical position shown in Figure 17 This is the last hole for inclination pin This position supports the best filling angle The motorized version 4MP6001 can only be used
17. teps No special tools Figure 1 Filling System in a ULine shipping or skills are required A few basic hand tools are all that is required crate Model S 13371 approximately 24 x 24 x 28 34 including base pallet e A flat blade screwdriver or small pry bar e Asmall rubber mallet e Pliers or channel locks e Crescent wrench Step 1 Remove the Lid Note that the lid is secured by eight fold over tabs There are two along each edge of the lid Use a flat blade screwdriver or similar flat prying tool to unfold the eight cover tabs Make the tabs as flat as possible to allow the lid to be easily removed As shown in Figures 2 4 Figure 2 Unfold the cover tabs and Figure 3 Flattening the tabs with pliers Figure 4 Removing the lid It may bend them to vertical as shown here will allow the lid to lift off easily and it help to tap the SONEN of the lid to using a flat blade screwdriver facilitates the eventual reuse of the crate break it free of the side wall tabs Then lift off cover Aseptic Single Use Filling System Manual 7 Filling System Shipping Crate Step 2 Remove the Sides of the Crate The walls of the crate are two pairs of side panels Note that two vertical opposite edges of the crate are tabbed Unfold and straighten the two vertical edge tabs on the vertical edge Then unfold and straighten the two vertical edge tabs on the opposing vertical edge Straightening the tabs makes is easier to separate the wall pa
18. the bag volume you will fill Connector retainer and cap gripper has to be in the load stand by position As shown in Figure 33 Insert the connector flange into the connector retainer The cap gripper needs to be engaged under the cap As shown in Figure 34 Figure 34 Fill connector in the load position ready for fill cycle Remove Cap for Filling If you are using the manual Filling System 4MP6000 remove the cap by pushing the handle forward to disengage the cap from the connector body As shown in Figure 35 For the motorized version 4MP6001 depress the foot pedal actuator and the cap will be removed from the connector body The cap is opened and ready for filling Engage the Filling Nozzle into Connector In the case of the manual Filling System 4MP6000 continue to push handle forward to complete the docking of the nozzle into the fill connector of the bag As shown in Figure 36 If you have a motorized version this will occur automatically The Motorized Filling System 4MP6001 takes care of all necessary alignments positioning and engagement Aseptic Single Use Filling System Manual 17 Filling Procedure Figure 37 Micro Switch in free position switch contacts open Micro Switch depressed contacts closed 18 Figure 38 Pull back handle to re engage cap onto bag Continue to pull back on handle until cap is engaged into the fully closed and sealed position Figure 39 Remove Bag www asisus
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