single-use recirculation mixer - saint-gobain · 8.1 tote preparation 8.1.1 obtain the appropriate...

Single-Use Recirculation Mixer

OPERATIONS MANUAL

www.biopharm.saint-gobain.com

Single-Use Recirculation Mixer: Operations Manual

www.biopharm.saint-gobain.com2 SOP0049-C

Table of Contents

1.0 Important Notice 3

2.0 General Description 4

3.0 Warnings and Safety Labels 4

3.1 Warnings 4

3.2 Safety Labels 4

4.0 Definitions 5

5.0 Equipment 5

5.1 Configuration and Features 5

5.2 SURM Diagram 6

5.3 SURM Mixing Bag Assembly Diagram 6

5.4 Equipment Ratings 7

6.0 Chemical Compatibility 7

7.0 General Environment Conditions 7

8.0 Procedures 8

8.1 Tote Preparation 8

8.2 SU Bag Assembly Installation 8

8.3 Filling the Bag Assembly 11

8.4 Pump, Flow Meter, and Console Setup and Use 11

8.5 Component Addition 16

8.6 Temperature Control Unit (TCU) Operation and Temperature Monitoring 17

8.7 Handling and Movement 18

8.8 Removing Final Mixed Solution 18

8.9 Shut Down Operations 19

9.0 Specifications and Parameters 20

10.0 Troubleshooting 21

11.0 Preventive Maintenance/Calibration/Cleaning 21

11.1 Console 21

11.2 Load Cells (if applicable) 21

12.0 Warranty Information 22

13.0 Ordering Information 23

14.0 Support Documents 24


www.biopharm.saint-gobain.com 3SOP0049-C

Read this manual before using the Single-Use Recirculation Mixer

All users must read the entire Single-Use Recirculation Mixer Operations Manual (“Operations Manual”) before installing, using or maintaining the Single-Use Recirculation Mixer (“SURM”). Always keep the Operations Manual on hand when using the SURM.

IMPORTANT: It is the user’s responsibility to ensure the suitability and safety of Saint-Gobain Performance Plastics (“SGPPL”) products for all intended uses and that the materials to be used comply with all applicable medical regulatory requirements. SGPPL assumes no responsibility for any product failures that occur due to misuse arising out of the design, fabrication or application of the products into which the materials are incorporated. SGPPL cannot assume liability if the SURM is subjected to improper use or operation. SGPPL is not liable for any damages resulting therefrom. The operator bears the sole risk. Proper use also includes compliance with operating, inspection, and maintenance conditions prescribed by SGPPL. Noncompliance with the warnings in the operating instructions constitutes improper use of the SURM. Any user modifications made to the SURM without the consent of SGPPL, beyond any cleaning or maintenance as described in the “Preventive Maintenance/Calibration /Cleaning” section of this Operations Manual, may void the warranty. Contact SGPPL if the product fails to operate correctly. Do not continue to use the SURM if it is not operating correctly, as this could result in injury to the operator or others, or damage to the product. Intended Use The SURM was exclusively designed for the industrial and commercial purpose of mixing a wide variety of solutions, from process intermediates to final drug components, commonly used in the biopharmaceutical industry. Due to its cuboidal design and patented recirculation mixing technique, the SURM is suitable for liquid-liquid and solid-liquid mixing operations that require moderate to high mixing intensity such as:

• Buffer and media preparation

• Product formulation and reformulation

• Hydration and dissolution of hydrophobic powders

• Bulk intermediate resuspension

• Final formulation

1.0 Important Notice



Cat. No.

Serial No. #######-##

###### Date of Manuf. Date

15301 HIGHWAY 55, PLYMOUTH, MN 55447 Made in the USA

Product Description

2.0 General Description

The SURM has been developed to simply and effectively handle a range of mixing needs for biopharmaceutical applications. The innovative design utilizes an externally mounted pump that recirculates and mixes fluid in a single-use bag assembly. The SURM’s pump is electromagnetically driven and has no bearings to wear out or seals to break. Utilizing magnetic levitation, the pump’s impeller is levitated, contact-free, inside a sealed casing and driven by the magnetic field of the motor — resulting in zero particle generation.

This document provides a consistent methodology for the operation of the SURM to mix solid or liquid components into a homogeneous solution. This includes SURM setup requirements, a sequence of operations to perform optimum mixing, and the methodology for adding components via the top port of the mixing bag or via the optional Venturi valve.

3.0 Warnings and Safety Labels

3.1 Warnings This Operations Manual contains WARNINGS concerning the safe use of the SURM. See definitions below.

3.1.1 WARNING indicates a hazardous situation which, if not avoided, could result in serious injury to the user or bystanders, or damage to the SURM. It is important not to proceed until all stated conditions are met and clearly understood.

3.2 Safety Labels There are 3 adhesive labels attached to the outside surfaces of the SURM. The labels are presented and described in this section.

3.2.1 Low Head Room Indicates a space with limited clearance that may require users to lower their head in order to access. Users must be wary to avoid accidental injury when operating the SURM in this area.

3.2.2 System ID Provides identification information for the specific SURM unit you have purchased. The illustration below is a generic representation of this label which is placed on the lower right of the door face of the mixing tote.

Label Text Description

1. Product Description Description of the unit

2. Category Number Product configuration number

3. Date of Manufacture Month and year the system was built

4. Serial Number Serial number of the system

5. CE Mark Indicates SURM has met rigorous performance and safety testing requirements

6. Saint-Gobain Logo Logo indicating Saint-Gobain product

7. Saint-Gobain Location Saint-Gobain office managing this product

8. Made in the USA Indicates product was constructed in USA

132

4

5

7 8

6

3.2.3 System ID Provides identification information for the specific SURM unit you have purchased. The illustration below (see image 3.2.4) is a generic representation of this label which is placed on the lower right of the door face of the mixing tote.

Image 3.2.4



4.0 Definitions

4.1 SGPPL (Saint-Gobain Performance Plastics): An abbreviation for Saint-Gobain Performance Plastics

4.2 SU (Single-Use): An industry designation for disposable equipment used in bioprocessing.

4.3 SURM (Single-Use Recirculation Mixer): This abbreviation is used throughout this document to reference the Single-Use Recirculation Mixer.

4.4 Venturi Valve: An optional apparatus used to add solid and liquid components to the system upstream of the pump inlet at a comfortable ergonomic height. It operates based on the “Venturi effect” of fluid dynamics whereby a vacuum effect is created by the fluid velocity of the recirculation loop.

5.0 Equipment

5.1 Configuration and features 5.1.1 Base frame and mixing tote (200L, 500L, 1,000L, 2,000L, and 3,000L sizes available). 5.1.2 Mixing bag assembly (standard and custom sizes available).

5.1.3 Levitronix centrifugal pump drive and motor.

5.1.4 Levitronix clip-on flow meter.

5.1.5 Levitronix control console.

5.1.6 Venturi ball valve and funnel (optional).

5.1.7 Load cells (optional).

5.1.8 Jacketed tote (optional).

5.1.9 Appropriate personal protective equipment (supplied by user and based on user’s facility requirements).



5.2 SURM diagram (500L system shown without jacketed tote or load cells)

5.0 Equipment Continued

Console

Flow Meter(not visible)

Pump motor

Venturi ball valve(optional)

Base frame

Venturi funnel (optional)

Tote

5.3 SURM mixing bag assembly diagram (500L bag shown)

2” filling port

Recirculation mixing bag inlet

Discharge/ outlet line

Venturi addition port (optional)

Single-use pump head

Sample port

Recirculation mixing bag outlet

4” component addition port

Image 5.2

Image 5.3



It is the user’s responsibility to determine the compatibility and safety of chemicals and substances to be mixed in the SURM prior to actual use in the SURM. As a base reference, SGPPL’s single-use bag assemblies are designed to contain commonly-used biopharmaceutical solutions and are generally resistant to most acids, bases, and salts but are likely not resistant to organic solvents.

5.0 Equipment Continued

Power Supply 100-240Vac

Console for bearingless pump system (for 200L, 500L, and 1000L SURM's), Model: PuraLev® Console LCO-600.1

100-240VAC, 50/60Hz, 650 W max

Console (for 2000L and 3000L SURM's), Model: PuraLev® Console LCO-i100.1 24 VDC, 6 A

Console for bearingless pump system. Model: PuraLev® Console LCO-2000.1 (Drive Unit)

L/N/PE 200-240 VAC, 13.5-11 A L1/L2/L3/PE 200-240 VAC, 8.5-8 A 50/60 Hz, 2100 W max

Bearingless pump system Model: BPS-600 (for 200L, 500L, and 1000L SURM's) 48 VDC, 300/600 W (Max 600 W)

Bearingless pump system (for 2000L and 3000L SURM's), Model: BPS-2000 1 x 200-240 VAC / 13.3 – 11.1 A

5.4 Equipment Ratings

WARNING: – Hazardous voltage may be present.

In case of the usage of an inadequate AC/DC power supply, mains voltages may be present. The usage of a galvanic separated power supply, which is certified by a 3rd party (UL or CE), is highly recommended.

6.0 Chemical Compatibility

7.0 General Environmental Conditions

Usage Indoor (laboratory, industrial environments. Motor with pump head can be placed outdoor)

Altitude Up to 2000 m

Operating ambient temperature 10 to 40 °C (50–104 ⁰F)

Storage ambient temperature (extremes for transportation)

-20 to 70 °C (-4–158 ⁰F)

Operating humidity range (relative humidity) 15 – 95% (non-condensing)

Fluid Temperature 10–60 ⁰C (50–140 ⁰F)

Storage humidity range (relative humidity) (transportation extremes)

15 – 95% (non-condensing)

Normal storage conditions Ambient temp.: 20 to 30 °C (50–86 ⁰F) Relative humidity: 50% (non-condensing

Mains supply fluctuations ± 10% of nominal voltage

Transient over-voltages typically present in mains supply

Surge immunity according to EN 61000-4-5 (tested together with certified AC/DC power supply)

Pollution degree 2

Ingress Protection Flowmeter IP65

Ingress Protection Pump System IP67

Ingress Protection Console IP54



8.0 Procedures

8.1 Tote Preparation 8.1.1 Obtain the appropriate tote, bag assembly, and associated tri-clamps, gaskets, pinch clamps and other necessary hardware. 8.1.2 Position the tote in the proper location and lock the casters. 8.1.3 If the tote is positioned on a scale, power on the scale. If the tote has intrinsic load cells, then ensure load cell transmitter is plugged in and the system has been standardized. 8.1.4 Ensure all electrical connections underneath the control console are hand tight. 8.1.5 Connect the console to a 110V power supply (220V power supply, if in Europe). 8.2 SU Bag Assembly Installation 8.2.1 Remove the contents of the box carefully and check the Certificate of Conformance for the intended bag assembly part number. 8.2.2 Remove the mixing bag from its heat-sealed packaging bag and discard the packaging bag. 8.2.3 After unpacking the bag assembly, unfold the bag film carefully. 8.2.4 If any flaws or damage is discovered, please immediately contact your Saint-Gobain sales representative to discuss remediation.

8.2.5 To install SU bag assemblies, perform the following steps:

8.2.5.1 Lift handle on door and pull to open (see images 8.2.5.1 A & B).

Image 8.25.1 A

Image 8.25.1 B



8.0 Procedures Continued

8.2.5.2 Remove the false bottom rectangular plastic sheet from the tote (see image 8.2.5.2 A & B). Set it aside to reinsert once bag assembly is installed. 8.2.5.3 Place the SU bag assembly inside the tote such that the tubing assembly is inserted through the openings in the bottom of the tote. Ensure that the pump head part of the tubing assembly is entered directly above the pump. Note: Ensure the tubing is completely fed through the bottom of the tote (see image 8.2 Note).

8.2.5.4 Unfold SU bag assembly as much as possible to allow proper filling. 8.2.5.5 Replace the false bottom by sliding back into place below the bag.

8.2.5.6 Close the door on the tote and lower handle to lock.

8.2.6 Locate the SU pump head on the bag assembly packaging.

8.2.7 To insert the SU pump head into the pump motor, follow these instructions: 8.2.7.1 Remove the pump head’s protective magnetic cover from the back of the pump head. Discard the protective cover. 8.2.7.2 Insert the SU pump head into the blue pump drive motor at a slight counterclockwise angle so the pump head outlet is over the green marking (see below).

Image 8.2.5.1 A

Image 8.2.5.1 B

Image 8.2 Note



8.2.7.3 Lift the black locking pin on the pump drive motor. 8.2.7.4 Turn the pump head clockwise so that the pump outlet is positioned over the red marking.


Colored markings

SU pump headLocking pin

8.2.7.5 Release the locking pin to lock the pump head into position. 8.2.7.6 If a Venturi valve is being used continue to Step 8.2.8. If no Venturi valve is used, proceed to Step 8.3. Note: All connections are assumed to be tri-clamp connections that require a gasket and clamp. 8.2.8 To install the Venturi valve assembly, follow these steps: 8.2.8.1 Obtain Venturi valve and funnel (these items are sold separately and come in their own packaging). 8.2.8.2 Ensure bag assembly is fully installed into tote before continuing. 8.2.8.3 The Venturi valve is installed into a bracket on the lower front of the SURM (see image 8.2.8.3). 8.2.8.4 Install Venturi valve on mixing tote by removing the locking pins, placing valve into supporting bracket, then reinserting the locking pins through each hole on the front of the valve (see image 8.2.8.4).

8.2.8.5 Attach Venturi valve to the bag assembly by inserting a gasket between the rigid tee and the valve. Secure by fastening a tri-clamp.

8.2.8.6 Install flat-back funnel on top of valve by placing a gasket between the valve and the funnel. Secure by fastening a tri-clamp.

Image 8.2.8.3

Image 8.2.7.2




NOTE: The tote door cannot be opened when the funnel is installed on the valve.

Venturi valve locking pins

Venturi valve mounting bracket

Venturi funnel attached to the Venturi valve

8.2.8.7 Ensure that valve is closed (blue handle should be horizontal) 8.2.8.8 Ensure that the outlet line (located at tee above pump outlet) has clamp installed and engaged before starting pump recirculation 8.3 Filling the Bag Assembly

8.3.1 If using load cells, attach the clean water line to the fill port on top of the mixing bag before setting the tare weight.

8.3.2 Look over the bag assembly to ensure all connections have been made and are well-attached. 8.3.3 If applicable, press tare on the load cell interface. 8.3.4 For 200-1000L totes, fill the bag to 50% of the desired final volume. For 2000L and 3000L totes, fill to 25% of the desired final volume. 8.3.5 As necessary, manipulate the bag film to seat the seams in the corners and along the bottom of the tote as the bag begins to fill. 8.4 Pump, Flow Meter, and Control Console Setup and Use 8.4.1 Flow meter installation 8.4.1.1 Locate the flow meter and the interconnect cable. Make sure the interconnect cable is attached to the sensor and the SURM console (see Image 8.4.1.1).

Image 8.4.1.1

Image 8.2.8.4



8.4.1.2 For a proper and accurate flow measurement, it is very important that the ultrasonic beam is not disturbed by particles, dust and air in the measurement path, which would result in reflections and lead to an imprecise flow measurement. Specifically the clamp-area between tubing and sensor must not squeeze in and trap particles or dust during the clamp-on process.

8.4.1.3 Check the cleanliness of the inside surface area of the sensor and, if necessary, clean it with alcohol (see Image 8.4.1.3). WARNING: Do not use aggressive cleaning agents, which could attack the sensor surface and its parts. Alcohol has been tested and approved as an adequate cleaning agent.

8.4.1.4 Check the tubing surface area, which will be clamped into the sensor, for cleanliness and inertness. Ensure that no particles or dust is present. If necessary, clean the tubing with alcohol.

8.4.1.5 Properly align the tubing with the clamp area of the sensor and avoid bending or squeezing the clamp area. 8.4.1.6 Clamp the flow meter to the tubing with the black arrow pointing up and away from the pump head (see Image 8.4.1.6). WARNING: Be careful not to pinch fingers during the clamp-on process.

8.4.1.7 For a stable and repeatable measurement, it is very important that the tube is properly clamped into the square shape of the transducer area of the sensor. Check to make sure that the tubing is not being squeezed in the sensor (see Image 8.4.1.7). 8.4.1.8 Visually check the tubing for air pockets. If any air is still in the system, refer to Step 8.4.5 to turn the pump on which will purge the line of air.

Image 8.4.1.3

Tubing squeezed in poor sensor attachment

Image 8.4.1.1 Image 8.4.1.7




8.4.2 Power on the console 8.4.2.1 Power on the SURM by pressing the blue power button on the controller. The screen will turn on and show the loading screen (see Image 8.4.2.1) before showing the home screen. 8.4.3 Zero adjust the flow meter 8.4.3.1 The SURM bag assembly must be filled for his procedure to complete. 8.4.3.2 Turn off the pump, if it is running.

8.4.3.3 From the main screen of the console, press “Zero Adjustment” (see Image 8.4.3.3) 8.4.3.4 A configuration wizard will begin that takes you through the zero adjustment process. Follow the steps given (see Image 8.4.3.4)

Image 8.4.2.1

Image 8.4.3.3

Image 8.4.3.3




8.4.3.5 A message on the console screen will tell you if the zero adjustment process was successful. If you see this message, press “OK” on the console screen to complete.

8.4.3.6 If a message appears on the console screen indicating that the zero adjustment procedure was NOT successful, follow the instructions given in the message, press “OK”, and perform the procedure again. NOTE: The process to zero the flow meter should be performed whenever the flow meter is clamped into place over the tubing. In most cases, this will only occur when installing a new mixing bag assembly into the SURM. 8.4.4 Pump activation and flow control: 8.4.4.1 Return to the main screen by pressing the home icon on the lower right portion of the console screen (see Image 8.4.4.1).

8.4.4.2 Specify flow control in pump speed (RPM) or flow rate (LPM) by pressing “Speed” or “Flow”. 8.4.4.3 Adjust the set point using the “+” and “-” buttons or click the number pad symbol to select a specific number.

8.4.4.4 To start the pump, press the blue button to the left of “Zero Adjustment” (see Image 8.4.4.4). While the pump is off, there a gray “OFF” indicator in the button field. Once pressed, the button will slide to the right revealing a green “ON” indicator. 8.4.4.5 Once activated, a green bar will also appear at the bottom of the screen indicating that the pump is running. 8.4.5 Recording and logging mixing data:

8.4.5.1 Insert a USB drive

8.4.5.1.1 A USB drive must be inserted into the USB portal on the console to record and log mixing data.

8.4.5.1.2 Above the console’s power button, unplug the rubber stopper and insert a USB drive.

8.4.5.2 Record a screenshot 8.4.5.2.1 Press the Saint-Gobain logo in the upper right corner of the console screen to capture a screenshot of the information currently displayed on the console screen.

8.4.5.2.2 A countdown begins and after 3 seconds the screenshot will be stored to the USB drive in a folder named “/screenshots”

8.4.5.2.3 The screenshot file will be saved as “LCO_Screenshotxx.png” where “xx” represents a consecutive number.


Image 8.4.4.1

Image 8.4.4.4



8.4.5.3 Enable data logging 8.4.5.3.1 Press “Settings” > “System” > “Appearance” 8.4.5.3.2 On this menu page press the down arrow to scroll down and reveal additional menu options.

8.4.5.3.3 Press the box next to the option “Show Logging Activation in Main Screen.” A checkmark will appear and now “Data Logging” will appear in the upper right corner of the console screen, underneath the logo (see Image 8.4.5.3.3). 8.4.5.3.4 Press the box next to “Data Logging” to enable data logging.

8.4.5.4 Set data log file properties 8.4.5.4.1 From the main screen, press “Settings” > “System” > “Data Logging” to access the data logging screen (see Image 8.4.5.4.1). 8.4.5.4.2 Log filename: By adding a log filename the leading part of the log filename can be defined. The ending part of the log filename is fixed and is named with the date followed by the time when the log file was generated. For example, in the above figure, the log filename would be: “2017_04_25_18-59-00.csv” 8.4.5.4.3 Log interval: Set the time interval at which a data entry will be logged. 8.4.5.4.4 Log file size: Specify the maximum number of lines of data you would like the log to contain


Image 8.4.5.3.3

Image 8.4.5.4.1




Image 8.4.5.5.3

8.4.5.5 Log mixing data 8.4.5.5.1 A USB drive needs to be inserted into the console in order to perform data logging. (See 8.4.5.1 for instructions to insert a USB drive.)

8.4.5.5.2 From the main screen, press “Info” > “System Data” 8.4.5.5.3 The System Data screen (see Image 8.4.5.5.3) contains all the relevant real-time data available to the console. Press the up or down arrows to navigate between the first and second screens showing this data. 8.4.5.5.4 This data will be logged into the log file when data logging is enabled (see 8.4.5.3 above for instructions on enabling data logging). 8.5 Component Addition 8.5.1 Obtain component(s) for addition. 8.5.2 Components can be added in two ways: through the component addition port on the SU mixing bag, or through the optional Venturi valve and funnel. 8.5.3 If component addition is through the component addition port, follow these steps: 8.5.3.1 Start pump and specify desired RPM or flow rate per steps 8.4.2 and 8.4.3. 8.5.3.2 Begin adding the components at the proper rate of addition and consider this time zero. Proceed to Step 8.5.5. 8.5.4 If the Venturi is the method for component addition follow these steps: 8.5.4.1 Start pump and set to desired set point per steps 8.4.2 and 8.4.3.

8.5.4.2 Confirm the Venturi valve and funnel is secure. 8.5.4.3 Ensure that pump is running at >70 LPM for Venturi component addition. This flow rate is needed for proper Venturi effect.

8.5.4.4 Add the component (no larger than 6mm in diameter) to the funnel.

8.5.4.5 Open the Venturi valve to allow the material to be pulled into the tubing. 8.5.4.6 Once the funnel is empty, close the valve immediately to maintain flow. 8.5.4.7 Repeat this process (steps 8.5.4.1 to 8.5.4.6) as many times as necessary to complete the component addition. When the component addition is complete, proceed to

step 8.5.5.



NOTE: Process water or buffer is recommended to clear Venturi funnel and tubing of trace components. 8.5.5 Recirculate as detailed on batch record and then fill to final volume. 8.6 Temperature Control Unit (TCU) Operation and Temperature Monitoring NOTE: The SURM unit does not come equipped with a native TCU to provide temperature control of a jacketed mixing tote. End users must each purchase their own TCU. Saint-Gobain recommends the Mokon Full Range Pro-cess Heating and Chilling System with a temperature range of -20°F to 300°F. The steps below have been crafted with this unit in mind. If using another TCU, these instructions may not be compatible.

8.6.1 If using a jacketed tote, ensure power supply is connected and the Mokon TCU has been turned on. 8.6.2 If using a jacketed tote, ensure both Supply and Return lines to and from the TCU are attached and the valves are open. 8.6.3 If Heating, enter Temperature set point into the Eurotherm control interface (Image 8.6.3) from the front of the Mokon TCU. 8.6.4 If Cooling, enter Temperature set point into the Eurotherm control interface from the right hand side of the Mokon TCU. (see picture above)

8.6.5 If Heating, press Start Button on the Supply pump interface on the front of the TCU. Allow the temperature to reach internal set point. Once the internal recirculation temperature has reached the set point, press Start Button on the Process Pump and allow the temperature control solution to distribute out to the tote being controlled.

8.6.6 If Cooling, press Start Button on the Supply pump interface on the front of the TCU and then Press the Compressor button. Allow the temperature to reach internal set point. Once the internal recirculation has reached the set point, press Start Button on the Process Pump and allow the temperature control solution to distribute out to the tote being controlled. 8.6.7 For all other Mokon TCU operational guidance in terms of initial setup, maintenance and troubleshooting, please refer to Reference Document 9.4 Mokon Duratherm-Hydro therm-Minitherm-Manual-2016 8.6.8 If the temperature sensor is intrinsic to the SU bag design, then upon installation into the tote, connect the transmitter leads to the sensor and ensure there is temperature feedback once the connection has been made. 8.6.9 If using an in-process temperature sensor and transmitter for process material, ensure that the temperature sensing device is free of air pockets and is completely flooded prior to monitoring.


Image 8.6.3




8.7 Handling and Movement

8.7.1 For protection of the SURM, facility environment, and operations personnel, always have two operators to handle and move the SURM.

8.7.2 Before moving the SURM, release the foot brakes on the caster wheels.

8.7.3 Never attempt to move the SURM by pulling on the handles of the console.

8.7.4 See suggested methods for moving the SURM in Image 8.7.4. 8.8 Removing Final Mixed Solution

8.8.1 Stop the mixing pump (refer to step 8.4.4). 8.8.2 Ensure that a tube clamp is still installed on the discharge/outlet tubing section of the mixing bag assembly (see Image 8.8.2.).

8.8.3 If required per batch record, connect any necessary filter to the capped 1.5” TC connection at the end of the outlet line.

8.8.4 Install tubing assembly or bag assembly to the outlet side of the filter and ensure connection with receiving vessel. 8.8.5 Remove tubing clamp on the discharge/outlet line.

Image 8.7.4

Location of the tube clamp during operation of the SURM and prior to removing the final mixed solution

Image 8.8.2




8.8.6 Install and engage a tubing clamp on the discharge/outlet tubing on the bag assembly, immediately above the tee and below the mixing bag inlet (see Image 8.8.6).

8.8.7 Activate the pump to transfer the mixed material from the mixing tote to the storage vessel. NOTE: Transfer mixed solution at < 50 LPM.

8.9 Shut Down Operations

8.9.1 To power down the SURM, press the power button on the console. 8.9.2 A confirmation pop-up will appear depending on whether or not the pump is running when the power button is pressed (see Images 8.9.2). 8.9.3 Press “No” to cancel the shutdown process. Press “Yes” to complete the shutdown process and turn off the SURM.

8.9.4 After “Yes” is pressed, the pop-up message will confirm by displaying “Shutting down…” and the SURM will shut down momentarily after that.

NOTE: If the power button is pressed and held for more than 4 seconds, the pump is turned off and the SURM is shut down immediately.

Location of the tube clamp once ready for removing the final mixed solution

Image 8.8.6

Image 8.9.2



9.0 Specifications and Operating Parameters

Weight - working (w/o jacket) lb (kg)

200L 1050 (476)

500L 1740 (790)

1,000L 3020 (1370)

2,000L 5570 (2527)

3,000L 8090 (3670)

Weight - working (w/jacket) lb (kg)

200L 1090 (494)

500L 2000 (907)

1,000L 3440 (1560)

2,000L 5970 (2708)

3,000L 8680 (3937)

Jacket fluid volume (approximate) gal (L)

200L 1.6 (6)

500L 2.6 (10)

1,000L 5.3 (20)

2,000L 5.3 (20)

3,000L 10.8 (41)

Maximum working pressure

150 psi @ 150°F

ASME U-1 code stamped Included on jacketed units

Load cells (optional)

Mettler Toledo SWB505 MultiMount™ Model #0745A

Ingress protection rating IP68

Load cell readout display (optional)

Mettler Toledo IND 331 part #: 33H100000A00A00

Materials of construction

Frame 304 stainless steel

Tank (internal body) 304L stainless steel

Tank (external body) 304 stainless steel

Casters Polyurethane 75D

Overall Dimensions H x L x W in (cm)

200L 50 (125) x 61 (153) x 34 (85)

500L 57 (143) x 61 (153) x 40 (100)

1,000L 74 (185) x 61 (153) x 47 (118)

2,000L 101 (254) x 64 (162) x 52 (130)

3,000L 133 (333) x 64 (162) x 52 (130)

Weight - empty (w/o jacket) lb (kg)

200L 610 (277)

500L 630 (286)

1,000L 820 (372)

2,000L 1160 (526)

3,000L 1480 (671)

Weight - empty (w/jacket) lb (kg)

200L 650 (295)

500L 900 (408)

1,000L 1240 (563)

2,000L 1560 (708)

3,000L 2070 (939)

SURM Frames/Tanks



10.0 Troubleshooting

In case of problems or failures while operating the SURM, the console provides various notifications with back-ground information and potential mitigation actions to the user, which should be self-explanatory. More details to the notification concept and its configuration can be found in the LCO Console Software Manual PL-4067-00. If problems or failures cannot be solved with the help of the notification on the console screen, it is recommended to capture a data log during operation, as described in LCO Console Software Manual PL- 4067-00 (support document referenced in Section 14), until the failure appears and then send the data log file to your designated SGPPL representative who will work with you to resolve the issue.

For all other issues that cannot be solved by referring to the applicable section of this manual or the support docu-ments referenced in Section 14, please contact your designated SGPPL representative for assistance.

11.0 Preventive Maintenance/Calibration

11.1 Console Cleaning

WARNING: Hazardous voltage may be present. Always isolate the console from the mains power supply before performing any cleaning procedure. Furthermore, assure that all connections are sealed either with an attached connector or a protective cover.

The console can be cleaned by wiping off the housing with a soft cloth using either isopropanol or water. Wash down with water jets of up to 40 L/min is possible. In any case the console must be isolated from the mains power and all connections shall be sealed by an attached connector or by the protective covers, which is assembled on all connectors. The console is designed and tested to meet IP66.

For more information on proper care and maintenance of the SURM console, please refer to Section 14 which will direct you to applicable reference documents that are provided to you. 11.2 Load Cells (if applicable) 11.2.1 Load Cell Readout Display 11.2.1.1 Cleaning Clean the terminal’s keypad and cover with a clean, soft cloth that has been dampened with a mild glass cleaner. Do not use any type of industrial solvent such as toluene or isopropanol (IPA) that could damage the terminal’s finish. Do not spray cleaner direct ly on the terminal. 11.2.1.2 Maintenance Regular maintenance inspections and calibration by a qualified service technician are recommended by the load cell manufacturer, Mettler Toledo. The Mettler Toledo IND131 and IND331 terminals are rugged instruments; however, the front panel is a relatively thin covering over sensitive electronic switches and a lighted display. Care should be taken to avoid any punctures to this surface or any vibrations or shocks to the instrument. Should the front panel become punctured, ensure that steps are taken to prevent dust and moisture from entering the unit until the terminal can be repaired. 11.2.1.3 Service Mettler Toledo recommends periodic preventative maintenance to the terminal and scale system to ensure reliability and to maximize service life. Please refer to Section 14 which will direct you to applicable support documents regarding the servicing of these components.

11.2.2 Load Cells Calibration For detailed calibration instructions, please refer to Section 14 which will direct you to applicable reference documents that are provided to you.



12.0 Warranty Information

ONE YEAR LIMITED WARRANTY WHO AND WHAT ARE COVERED AND FOR HOW LONGSaint-Gobain Performance Plastics Corporation (“SGPPL”) warrants to the original purchaser (the “Purchaser”) that its Single-Use Recirculation Mixer (the “Product”) will be free of manufacturing defects for a period of one (1) year from the date of original purchase. Should SGPPL determine that the Product has a manufacturing defect, it will, at its sole discretion, repair, replace or refund the original purchase price of the Product.

LIMITATIONSThis limited warranty is not transferable. This limited warranty does not provide coverage for any failure, defect or damage caused by matters not the result of a manufacturing defect, including but not limited to: • Repairs made or attempted by unauthorized persons. • Operation of the Product not in accordance with SGPPL’s written user instructions. • Damage or breakage due to carelessness, accidents, improper use, misuse, abuse, negligence or accidents. • Normal wear and tear or failure to properly maintain the Product. • Electrical surges or other matters beyond the control of SGPPL. WHAT THE PURCHASER MUST DOIf the Purchaser believes that the Product has a manufacturing defect, the Purchaser must provide such notice to SGPPL within one (1) year of the original purchase date in order for coverage under this limited warranty to apply. You may contact SGPPL by telephone at 763-398-1560 or by email at [email protected]. The Purchaser must obtain a Return Material Authorization (RMA) number from SGPPL before returning the Product. If the Product must be returned to the Company, all shipping costs shall be the Purchaser’s responsibility. SGPPL will return a repaired or replaced Product at its own expense, but if it determines there is no manufacturing defect or that the defect resulted from causes not within the scope of the limited warranty, then the Purchaser bears the cost of returning the Product. The original proof of purchase and an explanation of the defect must accompany the Product. SGPPL reserves the right to discontinue or modify any Product. If SGPPL replaces any Product under this limited warranty it may substitute a product that SGPPL determines is of comparable quality or price if, for whatever reason, the Product is no longer available. EXCLUSIVE WARRANTY AND LIMITATION OF REMEDIESTHIS DOCUMENT CONSTITUTES THE EXCLUSIVE WARRANTY AND SOLE REMEDIES PROVIDED BY SGPPL. THE WARRANTY AND REMEDIES CONTAINED IN THIS DOCUMENT ARE EXPRESSLY IN LIEU OF ANY AND ALL OTHER OBLIGATIONS, GUARANTEES, WARRANTIES AND REPRESENTATIONS, WHETHER WRITTEN, ORAL, IMPLIED BY STATUTE, AT LAW OR IN EQUITY, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANT-ABILITY, FITNESS FOR USE AND FITNESS FOR A PARTICULAR PURPOSE. SOME STATES OR JURISDICTIONS MAY NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES OR MAY DETERMINE THE PERIOD OF TIME FOLLOWING THE SALE THAT A PURCHASER MAY SEEK A REMEDY UNDER IMPLIED WARRANTIES, SO THE ABOVE EXCLUSION MAY NOT APPLY TO YOU.

SGPPL’S OBLIGATIONS, RESPONSIBILITIES AND LIABILITY SHALL BE LIMITED TO REPAIRING, REPLACING OR REFUNDING THE DEFECTIVE PRODUCT AS SET FORTH IN THIS LIMITED WARRANTY. IN NO EVENT SHALL SGPPL BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING LOSS OF PROFITS, REVENUE, OR LOSS OF EQUIPMENT USE, ANY DAMAGE TO ANY PROPERTY, BUILDING OR ITS CONTENTS, FOR INJURY TO ANY PERSONS, OR FOR ANY CLAIM AGAINST THE PURCHASER BY ANY OTHER PARTY THAT MAY OCCUR AS A RESULT OF THE USE OF THE PRODUCT OR AS A RESULT OF THE BREACH OF THIS WARRANTY. IN NO EVENT SHALL SGPPL’S TOTAL LIABILITY ARISING OUT OF OR RELATED TO THE PRODUCT COVERED UNDER THIS WARRANTY EXCEED THE ORIGINAL PURCHASE PRICE OF THE PRODUCT. This limited warranty may not be modified, altered or expanded by anyone, including product distributors, dealers, sellers and/or SGPPL representatives. This limited warranty gives you specific legal rights, and you may also have other rights which vary from state to state. Saint-Gobain Performance Plastics Corporation15301 Highway 55Plymouth, MN 55447biopharm.saint-gobain.com



13.0 Ordering Information

SURM Hardware

Part Number Description

SURM System Configurations

RXCARTR0200 200L SURM system

RXCARTR0200-J 200L SURM system w/jacketed bin

RXCARTR0200-LC 200L SURM system w/load cells

RXCARTR0200-JLC 200L SURM system w/jacketed bin and load cells

















SURM Mixing Bag Assemblies

RX0200LR 200L mixing bag

RX0200LR-V 200L mixing bag w/Venturi port

RX0500LR 500L mixing bag

RX0500LR-V 500L mixing bag w/Venturi port

RX1000LR 1,000L mixing bag

RX1000LR-V 1,000L mixing bag w/Venturi port

RX1001LR 1,000L mixing bag (for use in larger systems)



Venturi Port Accessories

RX-VENTURIBV-G (Optional) Venturi Valve, gamma irradiated

RX-FBFUNNEL-G (Optional) Polypropylene Venturi funnel, gamma-irradiated

RX-FBFUNNEL-SS (Optional) Stainless steel Venturi funnel

Standard Component Addition Funnel

RX-FUNNEL4-G (Optional) Polypropylene component addition funnel w/4” neck, gamma-irradiated

For ordering or pricing information on these parts, please contact your Saint-Gobain sales representative



14.0 Support Documents

14.1 Levitronix PuraLev® Console LCO-600 (600 W) User Manual [PL-4049-00]

14.2 Levitronix LCO Console Software Manual [PL-4067-00] 14.3 Levitronix LEVIFLOW® Clamp-On Flow Meters User Manual [PL-4507-00] 14.4 Mettler Toledo IND131, IND131xx, IND331, IND331xx Terminals User’s Guide

14.5 Mettler Toledo SWB505 MultiMount™ Weigh Module Service Manual