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How to use this guide

Scope of this publication

This user's guide contains information about the standard Thermo
Scientific

™

HyPerforma

™

DS 300 S.U.M. systems, including hardware,

components, product design verification methods, installation,
operation and specifications. It is intended for use by people who may
or may not have experience with Thermo Scientific systems, but who
have some knowledge of bioproduction processes and large-scale
mixing systems.

Document change information

Rev.

Date

Section

Change made

Author

A

03/2013

--

Initial release

G. Brau

B

02/2018

--

Updated formatting to current brand
standards

E. Hale

B

02/2018

Ch. 4

Removed hardware and BPC part
numbers

E. Hale

Input into Thermo Scientific publications

The accuracy of the information in this publication and your
satisfaction with the scope and content of this publication are
important to us. Please send any corrections or suggestions you
have for this user's guide (or for any other Thermo Scientific technical
publication) to [email protected].

Related publications

Please contact your local sales representative for information about
the related publications listed below.

Publication

Description

Thermo Scientific HyPerforma DS 300 S.U.M.

Unpacking Guide (DOC0010)

Information about validation

procedures

Thermo Scientific HyPerforma DS 300 S.U.M.

Data Sheets

Product descriptions and

ordering information

Thermo Scientific

How to use this guide

HyPerforma DS 300 Single‑Use Mixer User's Guide

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Содержание Thermo Scientific HyPerforma DS 300

Страница 1: ...Thermo Scientific HyPerforma DS 300 Single Use Mixer S U M User s Guide DOC0011 Revision B February 2018 ...

Страница 2: ...and operating information 15 2 1 Site preparation 16 2 1 1 Electrical connections 16 2 1 2 Protective earth grounding 16 2 2 Initial setup 16 2 3 Docking station preparation 21 2 4 BPC preparation and setup 23 2 4 1 BPC handling instructions 23 2 4 2 Working volume 24 2 4 3 Liquid transfer 24 2 4 4 Dispensing 24 2 5 BPC loading 24 2 5 1 Open top liner loading 24 2 5 2 Closed top BPC loading 27 2 6...

Страница 3: ... specifications 42 4 2 BPC specifications 42 4 2 1 Closed top BPC for 50 L 100 L and 200 L drums 43 4 2 2 Open top liners for 50 L 100 L 200 L and 300 L drums 44 4 3 General mixing specifications 44 4 4 Part numbers for components parts and accessories 45 4 5 Part numbers for replacement and spare parts 48 Chapter 5 General ordering information 49 5 1 Ordering instructions 50 5 2 Ordering support ...

Страница 4: ... are designed into the DS 300 S U M and required for the unit to function properly The mixing motor motor controller electronic lift mechanism and hand held control device all have electrical components Modification replacement by passing and or adding any electrical component without the written consent of Thermo Scientific voids any all warranties ETL CE certification s and liabilities WARNING S...

Страница 5: ...h as Safety Data Sheets labels and pictograms to communicate any hazards WARNING Burst hazard air under pressure Under normal operating conditions the closed top mixing BPC chamber is under slight pressure Normal passive venting prevents any excess of pressure building up within the chamber Chamber pressure and inlet line pressure should be monitored for proper settings Contents are under pressure...

Страница 6: ... of a second at currents well below those that are considered dangerous Due to the sensitivity of GFCIs to electrical leakage a few mA it is recommended that the S U B NOT be plugged into a GFCI outlet Main power 20 A 108 240 VAC or 208 250 VAC 1 Phase 50 60 Hz circuit Warranty information Any warranties if applicable covering this equipment exclude a normal wear and tear b accident disaster or ev...

Страница 7: ...MENT PERFORMED BY ANY PERSON OR ENTITY OTHER THAN US WITHOUT OUR PRIOR WRITTEN APPROVAL OR ANY USE OF REPLACEMENT PARTS WE HAVE NOT SUPPLIED WILL IMMEDIATELY VOID AND CANCEL ALL WARRANTIES WITH RESPECT TO THE AFFECTED EQUIPMENT IF THE EQUIPMENT IS TO BE USED IN THE UNITED STATES WE MAY VOID YOUR WARRANTY IF YOU SHIP THE EQUIPMENT OUTSIDE OF THE UNITED STATES Use restrictions You must use this equi...

Страница 8: ...ware and BPC part numbers E Hale Input into Thermo Scientific publications The accuracy of the information in this publication and your satisfaction with the scope and content of this publication are important to us Please send any corrections or suggestions you have for this user s guide or for any other Thermo Scientific technical publication to TechnicalDocumentation ThermoFisher com Related pu...

Страница 9: ...C BioProcess Container E Box Electrical control panel E Stop Emergency stop ETP Equipment Turnover Package GFCI Ground fault circuit interrupter ID Inner diameter IEC International Electrical Code OD Outer diameter S U M Single Use Mixer Thermo Scientific How to use this guide HyPerforma DS 300 Single Use Mixer User s Guide 6 ...

Страница 10: ...r S U M overview Chapter contents 1 1 Introduction to the DS 300 S U M 1 2 Hardware characteristics 1 3 BPC characteristics 1 4 Operating characteristics 1 Thermo Scientific HyPerforma DS 300 Single Use Mixer User s Guide 7 ...

Страница 11: ...300 S U M is intended for powder to liquid and liquid to liquid mixing in either open top or closed top bags with single use contact surfaces The major components of the DS 300 S U M system are shown in Figures 1 1 and 1 2 and described in more detail in the sections that follow 1 2 3 4 5 6 7 8 9 10 11 12 14 13 1 Motor assembly 2 Vertical lift 3 Horizontal support arm 4 Drive shaft stored 5 Handhe...

Страница 12: ...otprint Control of the system is managed through a tethered handheld device that manages the agitation speed and manual height adjustment The mast assembly and E Box house the electrical components and the main power switch The mixer is pre assembled and is comprised of the following sub assemblies and parts Docking station base with locking casters in the rear Adjustable handle that can be locked...

Страница 13: ... and 300 L Plastic dollies for the drums are available in two sizes one for 50 200 L drums and another for 300 L drums Figure 1 3 Reusable plastic mixing drum Single use BioProcess Container The single use BioProcess Container BPC provides gamma irradiated ready to use single use contact surfaces including Drive shaft sleeve Sealed bearing assembly closed top option only Tubing for liquid transfer...

Страница 14: ... motor vertical lift up and down buttons and emergency stop E Stop button The height is visually indicated in inches on the height indicator bar and labeled for each standard drum size Figure 1 4 Handheld control device Fixed motor head or optional adjustable motor head On the standard model the mixing motor head Figure 1 5 is fixed at a 10 angle On adjustable motor head models the angle of the ad...

Страница 15: ...em Optional drum positioner An optional drum positioner Figure 1 7 is designed to be used with the dolly that is supplied with the DS 300 S U M The drum postitioner may be utilized when the location of the drum relative to the impeller location in the drum is critical Figure 1 7 Optional drum positioner Mixing motor assembly The mixing motor assembly is a directly coupled drive assembly that suppl...

Страница 16: ...and chemical compatibility requirements The BPC is validated using gamma irradiated processes 1 3 2 Open top mixing configurations The open top mixing configuration Figure 1 9 includes an open top liner that also utilizes a separate single use sleeve that covers the drive shaft once it is inserted into the mixing assembly A reusable bearing hub is used for all open top mixing applications A quick ...

Страница 17: ...d working volume are listed in the general mixing specifications provided in Chapter 4 Specifications and part numbers Actual working volumes should not exceed the indicated rated working volumes Working volumes less than the stated minimums can result in damage to the BPC and hardware malfunction 1 4 3 Dispensing The DS 300 drums in the 50 100 and 200 L sizes are equipped with a bottom drain line...

Страница 18: ...n Chapter contents 2 1 Site preparation 2 2 Initial setup 2 3 Docking station preparation 2 4 BPC preparation and setup 2 5 BPC loading 2 6 Operating information HyPerforma DS 300 Single Use Mixer User s Guide 15 2 Thermo Scientific ...

Страница 19: ... 300 S U M will arrive with the following items Docking station mixer unit Handheld control device Motor and mount Optional drum positioner Drive shafts customer specified Torque and spanner wrenches Equipment Turnover Package ETP the standard or detailed documentation package if ordered located on the USB drive provided with the equipment DS 300 drums will arrive with the following items Outer su...

Страница 20: ...g security screws from crate latches 2 Swing the crate door down The door will create a ramp for moving items in and out Figure 2 2 Support brace Crate door and ramp Tools Drive shafts Figure 2 2 Open DS 300 S U M crate Thermo Scientific Chapter 2 Setup and operating information HyPerforma DS 300 Single Use Mixer User s Guide 17 ...

Страница 21: ... inside wall of the crate 5 Remove the small cardboard box containing the tools Unwrap the tools and set them aside 6 Remove the strap that secures the mixer to the top of the crate Figure 2 3 Figure 2 3 Removing the strap securing the mixer to the top of the crate 7 Remove the strap that secures the mixer to the eyes screwed into the bottom of the crate Figure 2 4 Figure 2 4 Removing the bottom s...

Страница 22: ...ift by the bottom of the cart frame Figure 2 5 Left Removing the wing nuts from the front support brace Figure 2 6 Right Removing the front support brace Figure 2 7 Rolling the DS 300 out of the crate 10 Remove all foam and plastic wrap packaging materials from the unit The handheld control unit is wrapped separately and attached to the side of the handle Use caution when cutting the packaging mat...

Страница 23: ...it to ensure that no damage occurred during shipping Contact your sales representative immediately if damage has occurred 13 Place all packaging and shipping materials back into the crate for possible future use 14 Place the bearing hub torque wrench and spanner wrench into the appropriate storage holes on the docking station unit Place the drive shaft s in the appropriate storage holder s on the ...

Страница 24: ...S 300 S U M hardware unit should be over smooth surfaces with the unit detached from the drum and dolly and disconnected from all power and feed sources Figure 2 10 Lowering the steering handle 2 Verify that the facility s electrical supplies are sufficient to support the power requirements of the DS 300 The unit should be plugged into a minimum 8 amp outlet 3 Engage the caster brakes on the rear ...

Страница 25: ...acility 7 Refer to hardware electrical label to ensure that proper electrical voltage is connected to the DS 300 Then turn on the main power switch 8 Engage the E Stop button on the top of the handheld control device by turning the red button in the direction of the arrows Figure 2 13 When engaged the button will be slightly elevated Figure 2 13 Engaging the E Stop button Figure 2 12 Pushing in th...

Страница 26: ...the front of the bag is designated as the panel containing the bearing port This should face the bearing port receiver and motor as the bag is loaded In addition confirm that the correct volume BPC is being used in a drum with a corresponding volume 2 4 1 BPC handling instructions Do not use scissors or any sharp objects when opening outer polybags When placing the BPC in containers do not drag it...

Страница 27: ...of the liquid falls below the top level of the impeller doing so will cause splashing and foaming of the remaining product With the exception of the 300 L BPC all BPCs are equipped with a drain line that allows for liquid removal by means of a peristaltic pump The drain is located at the bottom of the BPC allowing for minimal hold up volumes Connect the bottom drain line using the provided 1 27 cm...

Страница 28: ...tom drain lines 6 For 50 100 and 200 L BPCs ensure that the circular plastic support collar on the drain line is positioned close to the bottom of the bag This stop will support the BPC over the drain hole Note 300 L BPCs do not use support collars 7 If it is not already open remove the outside drain line cap and washer from the bottom of 100 and 200 L drums 8 Insert the drain line through the hol...

Страница 29: ...e of the drum and fold the edge of the liner over the top lip of the drum Figure 2 17 Figure 2 17 Folding the liner over the lip of the drum 12 Roll the drum and dolly under the motor head of the docking station Figure 2 18 Figure 2 18 Rolling the drum and dolly under the motor head Note To properly place the drum under the docking station the motor head may need to be lifted To operate the lift m...

Страница 30: ...e feet away from the docking station 3 For 50 L BPCs be sure the plastic spacer is in the bottom of the 100 L drum under the conical insert Figure 2 20 The spacer allows a 100 L drum to be used with 50 L BPCs Figure 2 20 50 L spacer being placed in the bottom of the drum 4 Carefully unpack the BPC from its two protective polybags The easy to use safety blade polybag opener available from Thermo Fi...

Страница 31: ...h the bottom front face of the drum if applicable 10 Carefully lower the bottom of the BPC into the drum with any tubing sets on the top of the BPC draped over the side until the bearing assembly at the top of the BPC is about level with the drive shaft motor Figure 2 21 Figure 2 21 Inserting the BPC into the drum 11 Roll the drum directly under the motor assembly of the docking station Note To pr...

Страница 32: ...lar are positioned correctly in the drum if applicable 14 Remove the protective packaging from the lines at the top of the BPC 15 If your unit is equipped with the optional drum positioner use it to secure the drum and dolly in place with the supplied strap Figure 2 23 Figure 2 23 Securing the drum and dolly to the positioner with the strap Thermo Scientific Chapter 2 Setup and operating informati...

Страница 33: ...not already lit press the green E Stop button on the E Box When the E Stop button on the E Box is lit the system is ready for use 2 6 2 Height adjustment Use the following steps to adjust the height of the mixer 1 Operate the lift assembly by pressing the up or down button located on the handheld control device Figure 2 24 CAUTION When raising and lowering the mixing head caution should be used to...

Страница 34: ...il the motor is free to rotate relative to the horizontal plane 2 There are pin holes every 5 from 0 30 Rotate the motor head and release the knob when the motor angle is correct Ensure that it locks into the desired position Figure 2 25 CAUTION Never adjust the motor angle while the motor is running Release knob for adjustable motor head Figure 2 25 Motor angle adjustment 2 6 4 Reusable bearing h...

Страница 35: ...rtion Use the following steps to insert the drive shaft through the motor head 1 Remove the latch pin from the safety cover on the motor and lift the clear plastic safety cover Figure 2 28 Figure 2 28 Removing the motor head latch pin and safety cover Thermo Scientific Chapter 2 Setup and operating information HyPerforma DS 300 Single Use Mixer User s Guide 32 ...

Страница 36: ... bearing hub using the quick connect fitting Figure 2 30 Use two hands to load the drive shaft through the top of the motor assembly A slight back and forth twisting motion will aid in insertion When approximately 5 1 cm 2 in of shaft remains twist slightly to engage the impeller Figure 2 31 Figure 2 30 Drive shaft sleeve installation Figure 2 31 Inserting the drive shaft Thermo Scientific Chapter...

Страница 37: ...n the drive shaft 4 Use the following steps to directly couple the drive shaft to the motor drive Place the threaded cap on the hollow pass through and hand tighten clockwise Tighten the cap by placing the spanner wrench on the hollow pass through and tighten the cap using the supplied torque wrench Figure 2 33 The torque wrench is a standard 3 8 in square drive and it is calibrated at the factory...

Страница 38: ...rol device to the On position Before turning the motor on turn the motor rpm knob all the way to the left to start the motor at the lowest speed 2 Turn the motor rpm knob to increase or decrease the rate the impeller is spinning mixing speed The total mixing speed range is 30 355 rpm and is displayed on the screen of the handheld control device Figure 2 34 Note In the event of an emergency use the...

Страница 39: ...Maintenance and troubleshooting Chapter contents 3 1 Routine maintenance 3 2 Preventive maintenance 3 3 Troubleshooting 3 Thermo Scientific HyPerforma DS 300 Single Use Mixer User s Guide 36 ...

Страница 40: ... drive shaft is constructed to wear slightly with use and should be visually inspected after each run Visual inspection of wear and components and following maintenance guidelines will ensure years of dependable service 3 2 Preventive maintenance Replace the worn drive shaft assembly when the drive hex diameter at its widest location measures equal to or less than 1 44 cm 0 56 in Measure the diame...

Страница 41: ... button on the top of the handheld control device to return it to the operating position then press the E Stop reset button on the E Box The green E Stop button on the E Box should be illuminated There are loose cord connections or a fuse is tripped or blown inside the unit Verify that all cords are plugged in tightly to the connections on the outside of the E Box Disconnect the main power cord an...

Страница 42: ...rly Reload the BPC using the instructions provided in Chapter 2 The motor has been calibrated improperly Contact Thermo Scientific support personnel There is excess tension in the film near the bearing port of the loaded BPC If possible reload the BPC by carefully following the instructions provided in Chapter 2 Provide excess film to the region of the BPC nearest the bearing port when aligning th...

Страница 43: ...re features and specifications 4 2 BPC specifications 4 3 General mixing specifications 4 4 Part numbers for components parts and accessories 4 5 Part numbers for replacement and spare parts 4 Thermo Scientific HyPerforma DS 300 Single Use Mixer User s Guide 40 ...

Страница 44: ...2 14 13 1 Motor assembly 2 Vertical lift 3 Horizontal support arm 4 Drive shaft stored 5 Handheld control device 6 E Stop reset button 7 Main disconnect switch 8 E Box 9 Height indicator and cable management housing 10 Dolly 11 Plastic drum 12 Liquid drain port 13 Mounted drive shaft sleeve and impeller 14 Conical insert Thermo Scientific HyPerforma DS 300 Single Use Mixer User s Guide 41 Chapter ...

Страница 45: ... Maximum speed 350 rpm Impeller to bag location 5 1 off center Table 4 2 DS 300 BPC specifications Impeller Single impeller with 3 blades Impeller material USP Class VI HDPE Impeller sleeve with quick connect C Flex Open top mixing liner Chamber made of CX 3 9 film Closed top mixing BPC Chamber made of CX 5 14 film 4 2 BPC specifications See Table 4 2 below for general DS 300 BPC specifications 4 ...

Страница 46: ...nect 9 5 mm 3 8 in body MPC and plug Addition line 2 19 1 mm 3 4 in x 25 4 mm 1 in x 1 22 m 4 ft 38 1 mm 1 5 in Tri clamp with 19 1 mm 3 4 in hose barb with gasket Steril Enz IIH Vent filter 6 4 mm 1 4 in x 12 7 mm 1 2 in x 10 1 cm 3 98 in Hydrophobic vent with Emflon II HB Recirculation sample line 12 7 mm 1 2 in x 19 1 mm 3 4 in x 0 91 m 2 99 ft splits to 12 7 mm 1 2 in x 19 1 mm 3 4 in x 30 5 c...

Страница 47: ... impeller sizes Left to right offset Front to back position Lift height Motor angle fixed or adjustable motor head models Motor rpm Minimum working liquid volume Turn down ratio Minimum hold up Maximum liquid fill 50 L drum 0 1 in 3 16 in 10 350 10 L 5 1 100 mL 50 L 100 L drum 0 2 in 7 8 in 10 350 20 L 5 1 100 mL 100 L 200 L drum 0 2 1 8 in 12 1 16 in 10 350 40 L 5 1 100 mL 200 L 300 L drum 1 2 in...

Страница 48: ...2 in 7 8 in 5 140 16 7 L 6 1 100 mL 100 L 200 L drum 3 4 in left 1 1 4 in 11 1 16 in 5 150 20 L 10 1 100 mL 200 L 200 L drum 3 4 in left 1 1 4 in 11 1 8 in 5 140 22 5 L 8 8 1 100 mL 200 L 300 L drum NA due to flat bottom NA 15 24 in 5 164 61 L 5 1 500 mL 300 L 300 L drum NA due to flat bottom NA 15 24 in 5 124 65 L 5 1 500 mL 300 L Table 4 5 Country specific electrical plug part numbers Country Ca...

Страница 49: ...SH30959 04 Table 4 7 Dollies for drums part numbers Size Description Cat no 50 200 L Plastic dolly SH30958 01 300 L Stainless steel dolly SH30958 02 Figure 4 4 Left Plastic dolly Figure 4 5 Right Stainless steel dolly Table 4 8 Drive shaft part numbers Drum size Drive shaft length Cat no 50 L 66 3 cm 26 1 in SV50959 03 100 L 84 1 cm 33 1 in SV50959 01 200 L 108 cm 42 5 in SV50959 02 300 L 129 5 cm...

Страница 50: ...mbers Drum size Description Sleeve length Cat no 50 L Impeller sleeve and connector for 66 cm 26 in drive shaft 35 3 cm 13 9 in SH30749 11 100 L Impeller sleeve and connector for 83 8 cm 33 in 53 1 cm 20 9 in SH30749 12 200 L Impeller sleeve and connector for 108 cm 42 5 in 77 cm 30 3 in SH30749 13 300 L Impeller sleeve and connector for 129 5 cm 51 in 96 cm 37 8 in SH30749 08 Figure 4 8 Impeller ...

Страница 51: ... replacement and spare parts Table 4 12 Part numbers for replacement and spare parts Description Cat no BLI lifting column with hall effects SV50961 01 Hub clamp door SV50177C 02 1 4 in Rubber cord SV50177 124 Surface mount latch SV50177 121 3 8 in x 150 in lb Square torque wrench SV50177 11 Wrench SV50177 10 Motor safety cap SV50177 06 50 L drive shaft safety cap SV50177 90 Common motor sleeve SV...

Страница 52: ...ordering information Chapter contents 5 1 Ordering instructions 5 2 Ordering support contact information 5 3 Technical support information 5 Thermo Scientific HyPerforma DS 300 Single Use Mixer User s Guide 49 ...

Страница 53: ...ing support contact information In the Americas and Asia 1726 Hyclone Drive Logan Utah 84321 United States Tel 1 435 792 8500 Email customerservice bioprocessing thermofisher com In Europe Unit 9 Atley Way Cramlington NE 23 1WA Great Britain Tel 44 1 670 734 093 Fax 44 1 670 732 537 Email customerservice bioprocessing thermofisher com Chapter 5 General ordering information Thermo Scientific HyPerf...

Страница 54: ...nse to overall product questions and product technical information Technical Support You can also contact Tech Support by emailing techsupport bioprocessing thermofisher com Initial setup and operation Appropriate technical support is available to assist in the initial setup and operation of each DS 300 S U M system If you require assistance in setting up and operating your DS 300 S U M system ple...

Страница 55: ... Scientific and its subsidiaries unless otherwise specified C Flex is a trademark of Saint Gobain Performance Plastics Emflon is a trademark of Pall Corporation SterilEnz is a trademark of PAW BioScience DOC 0011 Version B Logan Utah 84321 United States of America 1 435 792 8500 Cramlington NE23 1WA United Kingdom 44 0 1670 734093 Millersburg Pennsylvania 17061 United States of America 1 717 692 2...

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