13.1 Checking and replacing the fuse 14 Control wiring Section 2 - Pump operation 15 Pump controls and interface 15.1 Keypad operation 15.2 USB keyboard operation 15.3 USB devices 15.3.1 Compatible devices 15.3.2 USB device troubleshooting PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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20.8 Deceleration 20.9 Anti-drip 20.10 Start delay 20.11 End delay 20.12 First fill delay 20.13 Between fill delay 20.14 Vial weight 20.15 Vial weight tolerance 20.16 Weigh check frequency 20.17 Fill tolerance PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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23.1 Batch size 23.2 Batch name 23.3 Start manual batch 23.3.1 Calibration whilst dispensing 23.3.2 Auto-recalibration 23.3.3 Pausing a batch 23.3.4 Calibration whilst paused 23.3.5 Add note to report 23.3.6 Fluid sample PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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25.10.1 Session timeout while pumping fluid 25.11 Password expiry duration 25.12 Users 25.12.1 Block user 25.13 Prime speeds 25.14 Calibration settings 25.14.1 First calibration fill amount 25.14.2 Recalibration averaging 25.14.3 Weigh check option PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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PF7+ 27 WMFTG NetTools — Installation and operation 27.1 Installation of NetTools 27.2 Launch NetTools 27.2.1 User Interface 27.3 Logging in to the pump 27.4 Changing the pump name PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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33.2 Exceptions 34 Returning pumps 35 Name and address of manufacturer 36 Trademarks 37 Version history Section 4 - List of figures and tables 38 List of figures 39 List of tables PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
11.1 Tube selection 11.2 Y-connector selection 11.3 Fluid path layout 12 Changing the tube 12.1 Maximising tube life 13 Connecting to a power supply 13.1 Checking and replacing the fuse 14 Control wiring PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
1 Disclaimers The information in this document is believed to be correct, but Watson- Marlow Flexicon A/S accepts no liability for any errors it contains, and reserves the right to alter specifications without notice. WARNING: This product must not be used for patient-connected applications.
TR11 4RU 3. This declaration of conformity is issued under the sole responsibility of the manufacturer. 4. All models and versions of the PF7/PF7+ series of peristaltic filler with all approved pumpheads, tubing and accessories. 5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:...
Falmouth TR11 4RU 3. All models and versions of the PF7/PF7+ series of peristaltic filler with all approved pumpheads, tubing and accessories. 4. The essential Health and Safety requirements (Annex 1) of the Directive have been applied and fulfilled and the relevant technical documentation has compiled in accordance with part B of Annex VII of the directive.
Dispose of the pump and packaging at an appropriate recycling centre for the recovery of electrical and electronic equipment. 4.2 Intended purpose The PF7/PF7+ is a peristaltic fluid dispensing pump suitable for viscous, shear- sensitive hygienic and aseptic applications. This pump must be used only for its intended purpose.
4.4 Shipping and handling The pump does not require special precautions to ship. The PF7 contains a non-replaceable Manganese Dioxide Lithium Battery (Li/MnO IEC CR2032, with a typical capacity of 225 mAh, containing 0.07 g of Lithium. The PF7+ contains a non- replaceable Manganese Dioxide Lithium Battery (Li/MnO ), IEC CR2016, with a typical capacity of 140 mAh, containing 0.0036 g of...
Peristaltic pumps are self-priming and self-sealing against backflow. No valves are required in infeed or discharge line, except those specified in "Table 3 - Tube sizes" on page 21. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Unpack all parts carefully, retaining the packaging. Make sure you have all components in "Supplied components" below: Table 1 - Supplied components PF7/PF7+ pump drive unit, fitted with a QC14 pumphead. QC14 pumphead tube lock set Power supply cable for country of use Safety information booklet Inspect components for damage.
Make sure you have all components in "Supplied components" on the previous page. Inspect components for damage. Make sure that all parts of the pump work correctly. Tubing: Inspect for damage. Make sure tubing use-by-dates are not exceeded. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
(Refer to "Lifting point locations" below) DO NOT lift the pump by holding the pumphead as the access tray can disengage. Lifting points Figure 1 - Lifting point locations PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Rotates to produce smooth accurate flow. Removable tray for pumphead cleaning. (Note: Access tray* Access tray is consumable wearing part) *Pumphead safety—Pump will only operate when the integral safety switches are in the correct position. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
5 mm hex key to remove the bolts. The hex bolts are tightened to the pump using 3.6-4 Nm of torque. Figure 3 - Pumphead mounting and removal PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The pump's power input plug is the disconnecting device (for isolating the motor drive from the power supply in an emergency). PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Tubes must be selected according to the fluid and volume to be filled. Use the table shown below for choice of tubes according to minimum volume to be filled. PF7/PF7+ has been designed to provide optimal performance when used in combination with Flexicon Accusil and Asepticsu. Use Accusil and Aspeticsu to ensure the highest level of accuracy.
Before mounting the tubes in the pumphead, the tubes must be assembled with a Y- connector. Figure 5 - Y-connector selection When the Y-connector has been assembled, mount the tubes in the pumphead as shown in "Changing the tube" on page 25. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Minimum fluid level Position the pump at or just below the minimum level of the fluid to be pumped. This will ensure flooded suction and maximum pumping efficiency. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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It is recommended that the PF7+ is used in combination with the Flexicon Advanced Filling Kit that optimises the advanced features of the PF7+. For fluid path layout with Advanced Filling Kit, refer to "Start Zero waste batch" on page 91.
The pumphead features magnetic safety switches in both the tube bridge and access tray. If the tube bridge or access tray are opened the pump will not operate and a warning screen is displayed. Figure 7 - Opening the pumphead PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Figure 8 - Removing the tube from the pumphead PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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(Note: Tube locks are consumable wearing parts) If using a twin infeed, secure the tube with the correctly sized tube lock. Pumping performance can be affected. Figure 9 - Loading the tube into the pumphead PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
To maximise the performance of the tube, avoid leaving tubes mounted in the pumphead with the tube bridge locked down, when not in use (for example overnight). Lift the locking lever up in order to relieve the pressure in the tube. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
WARNING: Only connect to an earthed single phase power supply of either 100-120 VAC 60 Hz or 200-240 VAC 50 Hz via either a Ground Fault Circuit Interrupter (GFCI) or Residual Current Device (RCD) or Branch Circuit Protection Device. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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In some cases an adaptor (not supplied) may be required to ensure a fully earthed connection. Power supply inlet IEC socket. Image shows PF7+. PF7 rear panel looks slightly different. Power supply inlet is located in the same place.
Figure 13 - How to remove the fuse holder Front Rear A - Fit both fuses in the rear position Figure 14 - Fuse position PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Figure 15 - The rear of the pump. Image shows PF7+. PF7 rear panel looks slightly different. M12 connectors are located in the same place. There are two M12 connectors on the rear of the PF7/PF7+ for control wiring. Plugs and cables for these connectors should be: M12, female, 8-Pin A coded, shielded.
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General error Paused Return (0 VDC) Control return Control return Table 5 - M12 connector pin signals Input/ Function Pin number Signal response Output Discrete Output (Open Drain) Voltage Output (24 Input PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Table 5 - M12 connector pin signals Input/ Function Pin number Signal response Output Relay (Normally Closed) Relay (Common) Relay (Normally Open) Signal and Power Return PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
20.1 Load recipe 20.2 Create new recipe 20.3 Volume 20.4 Density 20.5 Tube size 20.6 Speed 20.7 Acceleration 20.8 Deceleration 20.9 Anti-drip 20.10 Start delay 20.11 End delay 20.12 First fill delay PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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23.4 Start Zero waste batch 23.5 Test fill 23.6 Index filling machine 24 Reports mode 24.1 View batch report 24.2 Print batch report 24.3 Delete batch report 24.4 Export reports to USB flash drive PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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27.1 Installation of NetTools 27.2 Launch NetTools 27.3 Logging in to the pump 27.4 Changing the pump name 27.5 Saving a recipe 27.6 Saving a report 27.7 Saving an audit trail log PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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27.8 Saving a batch report without a network using USB flash drive 27.9 Export as PDF PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
If the pump is stopped part way through a fill, a message stating this will be displayed. Keyboard operation is recommended for PF7+. Refer to "USB devices" on page 41 to connect a keyboard. Refer to "Keypad operation" above for keyboard mapping. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Use the letter keys ( ), number keys and symbols to input text. Full functionality is only guaranteed for devices on the list of compatible devices. For list of compatible devices: www.wmftg.com/softwareanddevices PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Screen info bar. Successful connection of another compatible balance indicated by a grey icon on the Screen info bar. Connect a compatible balance to PF7+ to enable the following: • "Start Zero waste batch" on page 91 •...
3. Turn the pump on using the power switch on the rear of the pump. 15.4 Glossary of icons Table 7 - Smart key icons BACK TO PREVIOUS PAUSE SCREEN NO / MODE STOP CANCEL EDIT NEXT YES/CONTINUE PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Supported keyboard (Unverified compatibility) connected Supported USB memory stick Reporting off connected Unsupported USB device Recipe is connected Fill activation by time Operator delay Fill activation by Administrator external input Supervisor User blocked PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Screen info icons Recalibration reminder Fill activation by keypad PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Danger of damage to pump. Make sure the voltage is set correctly before connecting to a power supply. Refer to "Connecting to a power supply" on page 29 Keyboard operation is recommended for PF7+. Refer to "USB devices" on page 41. Keypad operation: •...
• German • Portuguese • Italian • Dutch • Chinese • Korean • Japanese • Danish • Swedish • Spanish Batch reports and notes are English only. Keyboard input is English only. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The option to enable or disable FDA 21CFR Part 11 compliance is only available during initial setup. To change FDA 21CFR Part 11 compliance between enabled or disabled, factory reset the pump. (Refer to "Backup and reset" on page 116). PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The time format is hh/mm/ss and the date format is yyyy/mm/dd. The time is 24hr format. Once the time is correct, press . Pressing at any point returns to the previous screen. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
External input to start each fill— Remote controlled filling. Refer to "Control wiring" on page 32. The Filling method icon displays on the Screen info bar. The filling method can be reset in settings mode. Refer to "Filling method" on page 104. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Refer to "Users" on page 110. Enter a username for the pump administrator. The default username is USER1. If you have multiple PF7+ pumps, set up a common administrator username and password for every pump. This will allow importing and exporting of data from a USB flash drive for faster configuration of multiple pumps.
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The password is: • 4 characters minimum • 16 characters maximum Press to confirm. Re-enter the password when requested and press If the entry’s don’t match, the following screen will be displayed. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Set the power switch on the rear of the pump to the 'I' position. The pump displays the start-up screen with the Flexicon logo. Follow the on screen instructions. For more information refer to "Log in" on the next page. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
18.1 Select a user Select the desired username. The icon by the username indicates the type of user. Refer to "Glossary of icons" on page 42. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
171 for service and recovery. The option to block the service user is only available if FDA 21CFR Part 11 compliance is enabled. If you lose your password contact your local WMFTG or Flexicon representative. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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If FDA 21CFR Part 11 compliance is enabled, a password is required. Refer to "Enable United States Food and Drug Administration (FDA) 21CFR Part 11 Compliance" on page 47. Enter the password using the numeric keypad or keyboard. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Smart key functions are indicated by the smart key icon bar. Whenever the icon is displayed, press to scroll through the MODE tabs. The active MODE tab is highlighted. Keyboard operation—Refer to "USB keyboard operation" on page 40. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
119 to import/export saved recipes to other PF7+. 20.1 Load recipe Load a recipe from a list of stored recipes. Recipe is restored to the parameters that were saved in that recipe. Recipe name displays in white. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
20.5 Tube size Defines the default value used for the first calibration and the limits applied to a calibration. Only compatible Accusil tubing sizes are listed. Refer to "Tube selection" on page 21. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
If dripping occurs after the fill has completed, increase anti- drip to create "suck back" by momentarily reversing the direction of pumphead. Anti-drip is measured by the number of reverse steps 0-10. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Allows time to position filling needle manually. Only available if filling method is 'time delay between fills 20.13 Between fill delay Time delay between each fill. Only available if filling method is 'time delay between fills PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
It is recommended to set vial weight tolerance less than "Volume" on page 1 if possible to prevent accidental filling of a previously filled vial. Zero waste filling only. Refer to "Start Zero waste batch" on page 91. Requires a connected balance. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Table 11 - Example weigh check frequencies Fill number Weigh check frequency = Checked fill PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
4 - Lower fill tolerance Denoted in batch report with: • Within limits: True/False An unacceptable fill can be removed from the batch if "Remove from batch option" on page 113 is turned on and selected. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Enter the value specified in the table as a percentage of the fill volume defined in the recipe Table 12 - Guideline fill tolerance limits Tube size (mm) Recommended tolerance in (ml) ±0.0099 ±0.0149 ±0.0149 ±0.0209 ±0.0407 ±0.0594 ±0.0792 ±0.1100 PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Sets the number of fills or time before a recalibration pause. The batch is paused and the pump beeps three times when reached. The batch cannot resume until a recalibration is performed. Manual batch only Refer to "Dispense mode" on page 81. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Prints the current recipe parameters. 20.24 Delete recipe Deletes a saved recipe. As a best practice for cGMP, apply user restrictions to disallow this function. Refer to "Operator access restrictions" on page 105. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The pump will run forwards at the set speed until Continuous pumping the stop key is pressed The pump will run the slowly, in reverse at a fixed Fluid recovery speed to allow recovery of fluid from the fluid path. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
21.2 Continuous pumping When using continuous pumping: • Adjust the pump speed using the up and down keys ( • Press to Start pumping. • Press or the Stop key to stop pumping. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Using fingers, squeeze the tube and push air bubbles along the tube and back into the fluid container or towards the pumphead and nozzle Repeat until no air is visible inside the tube PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
2 and 99 fills). For best results use Multi-fill calibration. If Multi-fill calibration is selected, a screen will be displayed to enter the number of fills that will be used to create an average fill calibration value. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Place the container under the filling nozzle. Press or use the external input to start the calibration fill. 22.1.1 Calibration value entry Place the filled vial(s) on the balance. The balance value will be automatically displayed. Press PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The following are added to the report, for each calibration since the last recipe change or since the pump was powered on: • Data/time of calibration • Calibration volume • Active username when calibration was done PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Check the tube size is as per the recipe. • Check the fluid path is set up correctly. Calibration with fill tolerance limits Refer to "Fill tolerance" on page 63 to enable fill tolerance limits. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The following are added to the report, for each calibration since the last recipe change or since the pump was powered on: • Data/time of calibration • Calibration volume • Active username when calibration was done PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Any further fills will start automatically after the Between fill delay has elapsed. Keypad to start each fill - Press to start each fill. External input start each fill - Press or use the external input to start each fill. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Check the tube size is as per the recipe. • Check the fluid path is set up correctly. Calibration with fill tolerance limits Refer to "Fill tolerance" on page 63 to enable fill tolerance limits. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The following are added to the report, for each calibration since the last recipe change or since the pump was powered on: • Data/time of calibration • Calibration volume • Active username when calibration was done PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Any further fills will start automatically after the Between fill delay has elapsed. Keypad to start each fill - Press to start each fill. External input start each fill - Press or use the external input to start each fill. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Check the tube size is as per the recipe. • Check the fluid path is set up correctly. Calibration with fill tolerance limits Refer to "Fill tolerance" on page 63 to enable fill tolerance limits. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The following are added to the report, for each calibration since the last recipe change or since the pump was powered on: • Data/time of calibration • Calibration volume • Active username when calibration was done PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
23 Dispense mode To start a batch on a PF7 refer to "Start manual batch" on the next page. To start a batch on a PF7+: • Refer to "Start manual batch" on the next page. • Refer to "Start Zero waste batch" on page 91.
23.3 Start manual batch For instructions for filling directly onto a balance using the PF7+ with Flexicon Advanced filling kit refer to "Start Zero waste batch" on page 91. Start manual batch is for all other types of filling. Before a batch is dispensed, ensure your recipe...
3. Enter the calibration value i. No connected balance— Use the numeric keypad. Press confirm. ii. Connected balance— Place the filled vial on the balance. The value automatically displays. Press to confirm. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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A rolling average of previous fill weights can be used for calibration. Refer to "Calibration settings" on page 112. Calibration with fill tolerance limits Refer to "Fill tolerance" on page 63 to enable fill tolerance limits. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
23.3.2 Auto-recalibration Option only displayed when a USB balance is detected. Refer to "USB devices" on page 41. Option only displayed when Auto-recalibration tolerance is set. Refer to "Auto-recalibration tolerance" on page 65. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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The balance must achieve a stable weight for a calibration value to be entered. If the balance is taking too long to stabilise or not stabilising at all, refer to the balance manufacturers instructions. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Add note to report—"Add note to report" on page 89 • End batch—"End batch" on page 90 • Batch size—"Batch size" on page 81 • Fluid sample—"Fluid sample" on page 90 To resume filling press PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Dispense a calibration fill —dispense a calibration fill before the calibration value is entered. A rolling average of previous fill weights can be used for calibration. Refer to "Calibration settings" on page 112. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
23.3.5 Add note to report Pause the batch. Select Add note to report. Type the text. Maximum 63 characters. Keyboard operation is recommended for PF7+. Refer to "USB devices" on page 41. Keypad operation: • Scroll characters using keypad up/down keys ( Wait 1 second to enter next character.
If a Batch size is unlimited or to end a batch early, press . Once the current fill has been completed, the batch will pause. 2. Select End batch and press If reporting is On, the batch report will be completed. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Option only displayed when a USB balance is detected. Refer to "USB devices" on page 41. Ensure balance is connected and powered on for the duration of the batch. The Flexicon Advanced Filling Kit is recommended for Zero waste batch. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Using fingers, squeeze the tube and push air bubbles along the tube and back into the fluid container or towards the pumphead and nozzle Repeat until no air is visible inside the tube PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Figure 28 - Setup with PF7+, Asepticsu and the Flexicon Advanced Filling Before Zero waste batch: Set Vial weight and Vial weight tolerance in the Recipe. Refer to "Vial weight tolerance" on page 61. Set the height of the filling needle with enough clearance to be able to remove the vial if there is a drop of fluid hanging on the nozzle.
Ensure the balance is empty before pressing Press to confirm. The balance is zeroed by the pump. The fill will be weigh checked or non weigh checked as determined by the"Weigh check frequency " on page 62 PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The balance must achieve a stable weight for a calibration value to be entered. If the balance is taking too long to stabilise or not stabilising at all, refer to the balance manufacturers instructions. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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The measured weight of this fill will be included in the batch report if this is turned on. (Refer to "Reports mode" on page 100). The measured weight will be used to update the calibration value. (Refer to "Recalibration averaging " on page 113). PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
If the filling method is set to keypad to start each fill, the icon is displayed once an empty vial is placed on the balance. Press to start filling. A single fill will complete. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Batch size—"Batch size" on page 81 • Fluid sample—"Fluid sample" on page 90 23.4.5 Resuming a Zero waste batch To resume filling press When a Zero waste batch is resumed the balance is zeroed by the pump. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
As a best practice for cGMP, apply user restrictions to disallow this function. Refer to "Operator access restrictions" on page 105. 23.6 Index filling machine For use only with a Flexicon FlexFeed system. Will index one vial. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Batch reports can be viewed, printed, deleted or exported to USB flash drive from the reports tab. This information is related to reports. For Audit trail logs refer to "Saving an audit trail log" on page 152. Example is PF7+. PF7 may vary. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The report data stored and output by the PF7 are the values for the following: Table 15 - Report data Software Version Tube size Batch number - unique ID Acceleration Start time and date Deceleration User name Anti-drip Batch name...
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Figure 29 - Example PF7+ batch report (Printed from NetTools not a USB thermal printer.) These report values will be shown if FDA 21CFR Part 11 compliance was enabled when the report was created. Example is PF7+. PF7 may vary.
Option only displayed when a USB flash drive is detected. "USB devices" on page 41. Reports can also be exported by Ethernet using NetTools. Refer to "Saving a report" on page 151. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Keypad to start each fill—Manual filling. Press to start each fill. External input to start each fill— Remote controlled filling. Refer to "Control wiring" on page 32. The Filling method icon displays on the Screen info bar. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
As a best practice for cGMP, apply user restrictions to disallow this function. Refer to "Operator access restrictions" below. 25.6 Operator access restrictions Customise the Active/Hidden/View only options for all operator level users. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Active End delay / Between fill Active/view only/hidden Active delay Vial weight Active/view only/hidden Active Vial weight tolerance Active/view only/hidden Active Weigh check frequency Active/view only/hidden Active Fill tolerance Active/view only/hidden Active PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Table 19 - Access restrictions - Dispense Dispense tab item Description Default Start manual batch Active/hidden Active Start Zero waste batch Active/hidden Active Test fill Active/hidden Active Index filling machine Active/hidden Active Protected recipes only Yes/No PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Refer to "Units" on page 105. On the Screen info bar—auto-recalibration tolerance is set. Refer to "Auto- recalibration tolerance" on page 65. 25.9 Default recipe Sets the default values for when a new recipe is created. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The pump cannot be operated until a new password is set. New passwords must be different from the previous 5 passwords. A setting of 0 weeks will ask the user to reset the password at every login. This feature is for testing purposes. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The active user cannot delete their own user account. For further information about FDA 21CFR Part 11 compliance including deleting users and duplication of user names refer to the whitepaper available on request. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The administrator has blocked the account. Blocking or unblocking a user Log in as the administrator. Refer to "Log in" on page 53. On the settings menu, select 'Users'. Select the desired user. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Prime slow / Prime fast PF7+ Fluid recovery PF7+ 25.14 Calibration settings 25.14.1 First calibration fill amount Reduce the volume dispensed in the first calibration fill to 90% or 80% of the recipe fill volume. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Refer to "Remove from batch option" on page 84. Off—Every fill is included in batch. 25.15 Reporting 25.15.1 Batch reports On—Batch report generated when new batch starts. Off—No report generated. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
As a best practice for cGMP, apply user restrictions to disallow this function. Refer to "Operator access restrictions" on page 105. 25.16 Time and date Refer to "Setting the time zone" on page 48. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Bootloader version is factory set and will not change. Refer to "Backup and reset" on the next page. 25.18 Sound level Sets sound volumes for: • keypad beep • recalibration • start fill • end fill tones PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Option only displayed when a USB flash drive is detected. Table 25 - Required equipment - Import all data USB flash drive with PF7+ files. (Refer to "Export all data" on page 119) PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Importing a settings.pf7 file will replace all pump setting, including the FDA 21CFR Part 11 selection. Importing a users.pf7 file will replace all users currently saved on the pump. Keep a record of the administrator username and password at the time of export.
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USB flash drive. • Log in to that administrator account. 3. Select import all data. Press to confirm. 4. After importing data, the pump will restart. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
USB flash drive. Exporting a settings.pf7 file will replace settings.pf7 currently saved on the USB flash drive. Exporting a users.pf7 file will replace users.pf7 currently saved on the USB flash drive. Table 26 - Required equipment - Export all data USB flash drive (Refer to "USB devices"...
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Figure 31 - Top level folder of USB flash drive The exported .pf7 files are encrypted to protect the information contained. Batch reports will not be exported, refer to "Export reports to USB flash drive" on page 103. Audit trail data will not be exported, refer to "Saving an audit trail log"...
"Export reports to USB flash drive" on page 103 • "Export as PDF" on page 155 PF7+ Audit trail data is NOT erased. Audit trail data is stored to an internal backup SD card. The unit must be returned to a WMFTG approved service centre for access to SD card.
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Figure 32 - Top level folder of USB flash drive 2. Insert the USB flash drive into the USB port on the rear of the pump. 3. Select Start USB firmware update. 4. Follow the on screen instructions. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
"Export reports to USB flash drive" on page 103 • "Export as PDF" on page 155 PF7+ Audit trail data is NOT erased. Audit trail data is stored to an internal backup SD card. The unit must be returned to a WMFTG approved service centre for access to SD card.
Refer to "Network" on page 116 to set your pump to the following IP Configuration. 1. On the pump display, select Settings > Network. 2. Set DHCP to off to allow manual configuration. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
4 (TCP/IPv4) Properties window, select the Use the following IP address button. Enter the required IP Address, Subnet Mask and Default Gateway (example below). Select OK (outlined in red). Close all open windows. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Anybus Certificate Generator software (Optional for full SSL certificate compliance) see "Generate a security certificate (Optional)" on page 131 1. Connect the PF7+ to your router or network using the Ethernet port on the rear of the pump and a standard Ethernet cable.
Enter the pump IP address into the PC web browser (For example Microsoft Edge or Google Chrome) Configure your pump name and IP address in the PF7+ Network Settings menu. Refer to "Settings mode" on page 104. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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A similar principle is used to validate the identity of IoT (Internet of Things) devices, such as the PF7+ and the computer it is connecting to. The connection between the PF7+ and the computer is a peer-to-peer connection over Ethernet, with no cloud based, web based or other external aspects.
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Enter a new username and password to create a Network Administrator. The administrator account is now configured. Use this username and password to log in when prompted. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Connection via Ethernet network can be reinstated after the first time setup has completed. The Device Certificates will be tied to specific IP Addresses. Assign your PF7+ a valid static IP address. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Run the Anybus certificate generator software. The software displays PF7+ discovered on the network. Figure 34 - The software displays PF7+ discovered on the network. Click the Manage… button to open the Manage CA certificates dialogue. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Click Generate CA Certificate. The certificate is generated and can now be used to issue device certificates for PF7+. 26.4.2 Install CA certificate in Windows Go to the Manage CA certificates dialogue of the Anybus Certificate Generator software. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Type 'Manage computer certificates' into the start menu to run the Windows Certificate Manager. Right click on Trusted Root Certification and click All Tasks > Import... Figure 37 - Windows Certificate Manager PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Figure 38 - Certificate Import Wizard Click Next in the Certificate Import Wizard dialogue. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Paste the file path from the clipboard or browse to the location of the CA certificate. Figure 39 - File to import Select the certificate. Figure 40 - Select the certificate PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Figure 41 - Certificate store Click Next. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Figure 42 - Finish Click Finish. Figure 43 - Import successful Click OK. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
26.4.3 Use the CA certificate to generate a Device Certificate which is installed on the PF7+ Go to the Anybus Certificate Generator software. Figure 44 - The software displays PF7+ discovered on the network. Click the icon to access settings.
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In the main window, select the PF7+, then the root certificate and click Assign Certificate..Figure 46 - Assign Certificate... Type the IP address of the PF7+ in the Common Name (CN) and Alternative Name fields. Figure 47 - Configure Certificate Make sure the PF7+ is still connected to the network.
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Type the details for the first administrator account Click Continue. Figure 48 - Create administrator account Click OK. Figure 49 - Install successful Restart the PF7+. Click the rescan icon in the Anybus Certificate Generator. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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PF7+. Close all Chrome browser windows. Click the icon. Figure 51 - You can now log in to the PF7+ and assign network users for use with NetTools. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
512 MB RAM • 0.5 GB free hard drive space 1. Check the PF7+ Software version: "Pump info" on page 115 2. Download the software corresponding to your PF7+ software version from www.wmftg.com/softwareanddevices 3. Extract the files from the .zip folder.
Pumps panel—Displays a list of connected pumps and the data stored on that pump. Save as PDF—Saves the selected report or audit as a PDF file on your Tabs—Files that are open, but not selected. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Edit—Opens the edit pump info box where the Host name can be edited. 27.3 Logging in to the pump Click refresh to find PF7+ pumps connected to the network. The pump IP address identifies it on the network. Refer to "Network" on page 116 to view the IP address.
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Double click pump name to open login window. Log into pump using credentials created in initial set-up. Refer to "Initial pump set-up" on page 127. Double click to access Info, Recipes, Reports or Audit. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
27.4 Changing the pump name If there are multiple PF7+ pumps on the network, changing the pump name can help identify individual pumps. Log in to the pump Right click on the pump name and selecting configure networking. Enter pump name in the box Host name. Spaces are not allowed.
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The entered name is now used to identify the pump rather than the IP address. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
27.5 Saving a recipe Recipes are viewed and saved on NetTools. Recipes are created on the pump. Double click Recipes to retrieve saved recipe data. This may take several minutes. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Double click on a recipe to view. Click save as PDF. Select a location, enter a name and click save. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
"Users" on page 110) rather than the username and password used to log into NetTools. The second approver of a batch report must be a different user than the one who approved the batch when it was created. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
27.7 Saving an audit trail log Each audit trail log is created automatically when the log gets to a set size. It is identified by the time and date that the log was created. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
The batch report must first be exported from the pump to a USB flash drive, refer to "Export reports to USB flash drive" on page 103. In NetTools, select File > Open and then locate the saved batch report. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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"Users" on page 110) rather than the username and password used to log into NetTools. The second approver of a batch report must be a different user than the one who approved the batch when it was created. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Enter a username and password that is different from the user that completed the first approval. (Refer to "First user batch approval" on page 91). PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Figure 54 - Save the file to the desired location when requested. PDF format including watermark cannot be changed. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Figure 55 - Example PF7+ batch report (Printed from NetTools not a USB thermal printer.) These report values will be shown if FDA 21CFR Part 11 compliance was enabled when the report was created. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
30 Spares and accessories 31 Pump maintenance (including cleaning) 31.1 Service 31.2 Cleaning 32 Troubleshooting 33 Warranty 33.1 Conditions 33.2 Exceptions 34 Returning pumps 35 Name and address of manufacturer 36 Trademarks 37 Version history PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Maximum speed PF7 400 rpm, PF7+ 600 rpm Weight PF7 12.5 kg (27 lb 10 oz), PF7+ 10.9kg (24 lb) USB (PF7+) 4 x Type A USB 2.0 High Speed 500 mA PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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2 x Type A USB 2.0 High Speed 500 mA RJ45 10/100 Mbps (For export capability from pump only, not control use. Ethernet (PF7+) Not designed for use with EtherNet/IP™. Not designed for use with PROFINET). PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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QC14 complete tubelock set 87-068-500 QC14 replacement access tray 87-068-055 Weigh pan set for Advanced Filling Kit up to 30R 87-208-100 *X represents one of the plug options from "Plug options" on the next page. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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E: EU mains plug A: American mains plug K: Australia mains plug R: Argentina mains plug C: Swiss mains plug D: India/South Africa mains plug B: Brazilian mains plug J: Israel mains plug PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Make sure the access tray is correctly refitted before putting the pumphead back in service or the pump will not operate. The tube locks and access tray are gamma irradiateble and autoclavable PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
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Follow all the Safety Data Sheet (SDS) precautions when using cleaning agents. Table 39 - Compatible cleaning agents Ethyl Alcohol 70% Surface disinfectant containing Formaldehyde 6% concentration of hydrogen peroxide in water for injection (WFI) PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Check that the correct wall-thickness tube is being used. • Check the direction of rotation. • Check that the correct tube bridge is fitted for the selected tube • Check the tubes are not overlapping in the rotor channels PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
33 Warranty Watson- Marlow Limited ("Watson- Marlow") warrants this product on behalf of Flexicon to be free from defects in materials and workmanship for five years from the date of shipment, under normal use and service. Watson-Marlow's sole responsibility and the customer's exclusive remedy for any claim arising out of the purchase of any product from Watson-Marlow is, at Watson- Marlow's option: repair, replacement or credit, where applicable.
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Failure caused by UV light or direct sunlight. Any attempt to disassemble a Watson-Marlow product will invalidate the product warranty. Watson-Marlow reserves the right to amend these terms and conditions at any time. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Inform us if software or hardware changes or replacement would impact your validation. • Export any recipes or records—Pumps returned after repair or inspection will be at factory default. We cannot take responsibility for any lost data. PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
37 Version history Table 40 - Version history Document number Date Notes m-pf7-pf7+-en-00 06/2021 First release as Draft PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual...
Figure 13 - How to remove the fuse holder Figure 14 - Fuse position Figure 15 - The rear of the pump. Image shows PF7+. PF7 rear panel looks slightly different. M12 connectors are located in the same place. Figure 16 - Keypad...
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Figure 50 - The Anybus Certificate Generator shows an https certificate has been assigned to the PF7+. Figure 51 - You can now log in to the PF7+ and assign network users for use with NetTools. Figure 52 - NetTools User Interface Figure 53 - save as PDF Figure 54 - Save the file to the desired location when requested.
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