Thermo Scientific HyPerforma DynaDrive 500 L Bedienungsanleitung

500 L HyPerforma DynaDrive Single-Use

Bioreactor Quick Start Guide

This Guide provides a brief overview of setting up the Thermo Scientiﬁc™HyPerforma™DynaDrive Single-Use Bioreactor (S.U.B.)

system. For more detailed information about the DynaDrive S.U.B., refer to the 50 and 500 L HyPerforma DynaDrive S.U.B. User’s

Guide (DOC0090).

Warnings and safety

Hazardous voltage inside—risk of electrical

shock. Service should be provided by certiﬁed

personnel only.

Hot surface—do not touch.

The heating jacket is designed to heat the inner

vessel wall. Contact with surfaces may cause

burns.

Pinch hazard. Use caution when opening/

closing the door, securing the BPC to the

top and bottom ports in the tank, and during

operation of the DynaDrive S.U.B.

Burst hazard—air under pressure. Do not

exceed 30 mbar (0.5 psi) BPC pressure. Do

not exceed 34 mbar (5 psi) inlet pressure.

Ensure that the vent ﬁlter is correctly positioned

and working properly.

Tipping hazard. The vessel should only

be moved by pushing using the provided

handles or at the mid-point of the vessel.

If pulled or moved too quickly, the vessel can

tip, potentially leading to damage to equipment

or injury to personnel. To reduce the risk of

tipping, the vessel should only be moved

slowly over smooth, ﬂat surfaces by at least

two qualiﬁed personnel. During movement, any

locking feet should be retracted, and casters

should be in the unlocked position. The vessel

should not be moved by pulling of any kind.

The Thermo Scientiﬁc HyPerforma

DynaDrive S.U.B. may not be installed in

a potentially explosive atmosphere as set

forth in the applicable EU ATEX Directive.

It is the responsibility of the end user to review

and understand the potential dangers listed in

the ATEX 2014/34/EU guidelines.

Static electricity may build up in BPCs.

• BioProcess Containers (BPCs) may act

as insulators for electrostatic charge. If

electrostatic charge is transferred to a BPC,

the charge may be stored in the BPC and/or

the product inside. This phenomena varies

by product and use; therefore, it is the sole

responsibility of the end user to ensure a

hazard assessment is conducted and the

risk of electrostatic shock is eliminated.

• Where applicable, a product contact

stainless steel coupler may be grounded

to the frame to dissipate electrostatic

buildup from the material within a BPC. It

is good practice to dissipate electrostatic

buildup by grounding all BPCs prior to

coming in contact with them. When working

with BPCs, the use of nonconductive

materials, such as nonconductive gloves, is

recommended.

Rotating parts—entanglement hazard.

Rotating and moving parts can cause injury.

Keep hands away from moving parts during

operation. Do not operate this equipment unless

the supplied guarding is in place and properly

functioning. It is the responsibility of the end

user to assess this equipment and ensure that

equipment and safeguards are in good working

condition, and that all operators are trained and

aware of entanglement hazards and associated

protective devices, such as hazard signs and

guarding.

Figure 1. Front view of the 500 L DynaDrive S.U.B.

Follow lockout/tagout procedures. To

prevent injury, when servicing equipment, use

your company’s lockout/tagout procedures

to isolate electrical, mechanical, pneumatic,

hydraulic, chemical, thermal, gravitational, or

any other potential energy and protect workers

from the release of hazardous energy.

Use caution with hazardous chemicals or

materials. Personnel servicing equipment

need to know the hazards of any chemicals

or materials that may be present on or in the

equipment. Use general hazard communication

techniques such as Safety Data Sheets, labels,

and pictograms to communicate any hazards.

Note that this machine does not produce or

process any toxic, corrosive, ﬂammable, and

explosive substances, nor uses any additives,

compounds of mercury, cadmium, chromium,

asbestos, CFC, or HCFC for machine

maintenance purposes.

Use a properly conﬁgured and approved

power cord for voltage supply in your

facility.

Read and understand the user’s guide

before operating the equipment. The

HyPerforma DynaDrive S.U.B. is designed to

be operated under traditional eukaryotic cell

culture conditions. A general understanding

of bioreactor systems and their operation is

important prior to using the system for the ﬁrst

time. Read and understand this user’s guide

before operating; failure to do so could result

in injury and potential loss of product. Only

trained operators should be allowed to operate

the equipment.

For complete warnings, safety, and warranty information,

refer to the 50 and 500 L HyPerforma DynaDrive S.U.B.

User’s Guide.

Unpacking the system

First, inspect the packaging for damage. Call your

Thermo Scientiﬁc sales representative if any damage is

present. Use the instructions provided in the 50 and 500 L

HyPerforma DynaDrive S.U.B. Unpacking Guide (DOC0149)

to unpack your S.U.B. unit from the shipping crate.

Electrical preparation (for systems with the

optional Thermo Scientiﬁc E-Box)

1. Using a ﬂat-head screwdriver, open the E-Box

and locate the breakers for the pressure sensor,

continuous power outlets non E-stoppable (2), and

continuous power outlets E-stoppable (2) (Figure

2 on the following page). These breakers should

be in the “on” position (“up” position or pressed in,

depending on the breaker type) during operation.

For electrical schematics, please refer to the ETP,

which is provided on a USB drive.

2. Close the E-Box and lock the panel using a

ﬂat-head screwdriver before continuing.

3. Connect all electrical plugs to facility power. Refer

to hardware/electrical labels and schematics to

ensure proper electrical voltage is connected to

the DynaDrive S.U.B. Note: The yellow plug and

receptacle are for 120 VAC, and the blue plug and

receptacle are for 240 VAC S.U.B.s.

Unlocking load cells

Figure 3 illustrates the location and components of load

cells on on a standard HyPerforma S.U.B. The location

and process is the same for DynaDrive S.U.B.s.

All load cells must be fully locked down in order to

move the DynaDrive S.U.B. For DynaDrive S.U.B.

hardware units purchased with factory-installed load

cells, the load cells are shipped in the locked position

(threaded up) for equipment protection.

1. To unlock the load cells (after the system is in its

ﬁnal location), remove and discard the delrin slip

ring if it is present. Remove the tri-clamp.

2. Loosen the lockout nut, using an adjustable or

1.25 in. wrench (not supplied), until the nut is tight

against the base or leg of the S.U.B. Repeat this

process for each load cell until all of the lockout

nuts are disengaged from the lockout posts. Do

not reinstall the tri-clamp.

3. At this point, the DynaDrive S.U.B. hardware is

ready to be prepared for BPC loading.

Leveling and connecting the system

All manual movements of the DynaDrive S.U.B.

hardware should be over smooth surfaces, with the

S.U.B. empty and disconnected from all power and

gas/feed sources. All load cells must be fully locked

down in order to move a S.U.B.

1. Verify that the facility electrical supplies are

sufﬁcient to support the power requirements of the

DynaDrive S.U.B. and ancillary components, such

as controllers or pumps.

VFD breaker

Continuous power

breaker

Temp.

display

breaker

Main power

breaker

E-Stop power

breaker

Pressure

sensor

breaker

Figure 2. DynaDrive S.U.B. E-Box interior.

Figure 3. Load cell schematic.

Lockout nut

Delrin slip

ring

Lockout

post

38.1 mm (1.5 in.)

Tri-clamp

2. Locate the outer support container in the area for

the cell culture run.

3. When monitoring the batch volume, the unit may be

placed on a weight scale if load cells are not part of

the system. Other methods may be used to measure

all incoming and outgoing liquids.

4. Level the platform by disabling the swivel casters on

the bottom of the outer support container. This is

accomplished by threading the leveling feet (at the

center of each caster) to the ﬂoor.

5. Verify the location of the pH/DO controllers and

ensure that the cable and tubing lengths are

sufﬁcient.

6. Verify that the main power is off and the emergency

stop (E-Stop) is pulled out. Note: The E-Stop

disconnects all power to the system. An alarm

buzzer will sound when the E-Stop is activated.

7. Verify that the main motor power switch is in the

“off” position.

8. Connect all electrical plugs to facility power. Refer to

hardware/electrical labels and schematics to ensure

proper electrical voltage is connected to the S.U.B.

The main power switch can now be turned on.

9. Connect the inlet and outlet lines from the

temperature control unit (TCU) quick-connects to

the jacket (Figure 4). The inlet is typically on the right

side if you are facing the connectors; refer to the

permanent labels on the inlet and outlet lines.

Figure 4. Attaching water jacket port using a

tri-clamp.

Note: Refer to the TCU manufacturer’s guidelines for

detailed TCU setup information.

10. Use the tri-clamp ﬁtting to attach the water jacket inlet/

outlet ports to the bottom of the outer support container

(Figure 5).

Figure 5. Removing the tri-clamp and attaching the ﬁtting.

Note: Figure 5 shows the tri-clamp ﬁtting and inlet/outlet

ports on a standard HyPerforma S.U.B. The location and

process is the same for DynaDrive S.U.B.s.

Loading the BPC

Use the following information to install and set up the BPC.

Checkpoints prior to BPC loading

9A 500 L DynaDrive BPC is being used for the

500 L outer support container.

9The outer support container is stationary, with the

casters locked in place.

9Two operators are available for BPC loading.

9The Thermo Scientiﬁc BPC Unpacking and Inspection

Guide (DOC0021) has been reviewed for information on

handling, transporting, and storing BPCs.

1. Open the door on the bioreactor outer support

container.

2. Use a safety cutter to slit the taped sides/ends of the

cardboard box in which the BPC is shipped (Figure 6).

The BPC will be secured to a cardboard insert inside the

box (Figure 7).

3. Carefully lift the BPC out of the box (Figure 8) and

place on a raised, ﬂat surface. Fold up the cardboard

ﬂaps to release the BPC from the cling wrap on the

cardboard insert. Remove and discard the insert

(Figure 9).

Figure 10. Cutting open the outer polybag.

Figure 11. Pulling the outer polybag away

from the BPC.

6. Ensure the DynaDrive S.U.B. door is still open. Push

the blue and black button on the hub cover located at

the top of the S.U.B. to unlock it (Figure 12). Swing the

cover open (Figure 13).

4. Use a safety cutter to carefully open the outer polybag

(Figure 10). Take care to not damage the BPC.

Figure 12. Pushing button on hub

cover.

Figure 13. Hub cover opened.

Figure 14. Raising BPC lift lever.

Figure 6. Slitting open taped

sides of the BPC box.

Figure 7. BPC secured to cardboard

insert in box.

Figure 8. Carefully lifting out the BPC. Figure 9. Folding up ﬂaps

on the insert.

5. While another operator holds the exposed end of the

BPC in place, pull the outer polybag away from the

BPC (Figure 11). Repeat this step to remove the inner

polybag once the BPC is in the clean room and ready

to be loaded.

7. Raise the BPC lift mechanism lever fully, which will

simultaneously lower the bearing hub port (Figure 14).

8. Do not allow the BPC or line sets to touch the ﬂoor as

you carefully unfold the BPC and locate the top bearing

hub and front line sets. Do not remove the polybags

from the line sets at this stage, as the BPC may

become difﬁcult to manage.

9. Ensure the line sets are facing the front, and align the

top bearing with the purple bearing hub (Figure 15).

Pull down on the black hub locking mechanism as you

insert the top bearing hub into the bearing. Ensure that

the locking mechanism fully engages; the lip at the

bottom should be completely hidden from view when

the locking mechanism retracts.

10. Pull down on the BPC lift mechanism lever (Figure

16). The lever will not move all the way down until

the black hub locking mechanism is pulled down, as

well. After the hub mechanism has been lowered and

subsequently raised, the purple bearing hub will lock

into place. Note: Ensure the hub and lift mechanism

lever are fully engaged by attempting to push the lever

back up. If the hub is not locked, the hub will fall out

and the arm will raise.

12. Locate the bottom hub at the bottom center of the

BPC. Pull the hub toward the center cutout at the

bottom front of the outer support container. Once the

hub is aligned with the correct cutout, slide it toward

the back of the DynaDrive S.U.B. until you feel it shift

into place (Figure 18).

11. Once the hub is locked into place, close and lock the

hub cover. The blue and black button must be pressed

again to lock the cover (Figure 17). The BPC should be

hanging freely.

Figure 15. Aligning bearing hub

with the bearing.

Figure 16. Pulling down on BPC

lift lever and locking mechanism.

Figure 17. Locking hub cover.

13. Use the following steps to lock the bottom hub in

place:

• Pull down the metal pin to open the gate.

• Swing the gate connected to the pin forward and

to the right (Figure 19) until the pin aligns with the

drilled hole on the right side of the bottom hub

cutout (Figure 20).

• Push the pin back up to lock the gate (Figure 21).

Figure 18. Sliding the bottom hub into

place in the front center cutout.

Bottom hub

14. Place the exhaust vent ﬁlter into the holder attached

to the pneumatic motor lift (Figure 22). Note: A ladder

may be required to reach the exhaust vent ﬁlter holder.

16. Attach the top back BPC tabs to the pins on the top

back of the outer support container. Note: A ladder is

needed to reach the top back BPC tabs.

17. Guide all line sets on the bottom of the BPC through

the bottom cutout in the outer support container

(Figure 25).

Figure 20. Closing the gate

completely.

Figure 21. Pushing the metal pin

up to lock the gate.

Figure 19. Swinging the gate to

the right.

Metal pin

Figure 22. Securing the exhaust

vent ﬁlter to the holder.

15. While holding the front linesets to keep them from

tangling, use the motor lift controller (see the user’s

guide (DOC0090) for information on using the motor

lift controller) to raise the pneumatic motor lift (Figures

23 and 24). After raising the motor lift to its highest

position, turn the lock dial on the motor lift controller.

Note: The controller cannot be locked unless the

motor lift has been fully raised.

Figure 23. Pneumatic motor lift

in lowest position.

Figure 24. Pneumatic motor lift

fully raised.

Figure 25. Line sets placed in bottom cutout.

Line set

placed in

outer support

container

cutout

Note: Verify that all line clamps are closed and

located as close as possible to the body of the BPC.

18. Attach the hanging tabs on the bottom of the BPC

to the pins at the bottom back of the outer support

container (Figure 26). Note: Do not attach the bottom

front BPC tabs.

19. Carefully close the door on the front of the outer

support container. Before latching the door shut,

ensure that one operator holds the front tubing line

sets above the door so none of the tubing is caught

as the door closes (Figure 27). Ensure that the row of

probe ports is aligned just below the bottom front of

the door (Figure 28).

21. Begin slowly ﬁlling the BPC with air to allow the drive

train to separate from the inside of the BPC. This also

aids in the proper alignment of the BPC in the outer

support container.

• Attach the air supply to one of the sparging gas

inlet lines after removing the bubble wrap from the

line set.

Note: Air pressure to the gas line on the DynaDrive

S.U.B. BPC should not exceed 34 mbar (0.5 psi).

• Begin air inﬂation through one of the sparging gas

lines. Times will vary based upon ﬂow rate and inlet

pressure.

WARNING: The BPC is not rated as a

pressure vessel. DO NOT EXCEED 34

mbar (0.5 psi) within the BPC or the system

could fail, causing personal injury or damage

to equipment. DO NOT leave the BPC

unattended while inﬂating. Consult your sales

representative for recommended air ﬂow rates.

The operating pressures at the level of the

DynaDrive S.U.B. are of primary importance,

and these values must be adhered to.

22. Check the BPC to ensure that the foam probe is

hanging freely, and is not entangled in the drive train.

23. Clamp (or slide on, from the front) the black top tab

holders on both sides of the outer support container

(Figure 31). Attach the two hanging tabs at the top front

side of the BPC to the black plastic pins on the top

front of the outer support container.

Figure 26. BPC bottom hanging tab

attached to bottom pin.

Figure 30. Closing and latching the top door latch.

Figure 27. Lifting tubing line sets above

the door while closing.

Figure 28. Probe port row aligned

underneath closed door (BPC shown ﬁlled).

20. Close and secure the latches at the top and bottom

of the door (Figure 30).

For Research or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals.

subsidiaries unless otherwise speciﬁed. DOC0171 Revision A 1220

Find out more at thermoﬁsher.com/dynadrive

Note: Attaching the top tabs will help keep the BPC

properly oriented inside the tank. Figure 32 shows the

top front BPC tab attached to the tab holder.

Figure 33. Inserting the RTD. Figure 34. RTD in a probe clip.

• Place a probe clip on the probe support hanger and

place the RTD so it is resting in the hook (Figure 34).

Figure 35. Foam probe in holder.

29. Clamp the black foam probe holder to the outer

support container, behind the top left tab holder, if

facing the front of the S.U.B. Insert the foam probe into

the foam probe holder on the outer support container

(Figure 35).

Figure 31. Placing black top tab

holders on the top front of tank.

Figure 32. Black top tab holder

with BPC tab attached.

24. Gently pull at the bottom corners of the BPC until the

sides of the BPC are straight. Note: You may need

to wait for the BPC to ﬁll with more air before this is

possible.

25. While the BPC continues ﬁlling with air, remove all

bubble wrap and polybags from the line sets.

26. Remove the polybag from the drain line set, position

the line clamp as close as possible to the BPC port,

and then close the clamp. Use a cable tie around the

clamp to ensure it does not open.

27. Remove the plastic insert located in the thermowell, if

present.

28. Insert the resistance temperature detector (RTD) into

the thermowell (Figure 33) using the steps below. Note:

Due to the shorter thermowell on DynaDrive BPCs, the

15.24 cm (6 in.) RTD is the ONLY compatible size. DO

NOT use larger RTDs, which will damage the BPC.

• Place a small amount of glycerol (0.5 mL) in the

thermowell to aid in heat transfer. The glycerol also

serves as a lubricant and aids in insertion.

• The sensor should be inserted until the base of the

RTD meets the mouth of the thermowell.

• Secure by twisting the luer lock collar, if provided.

CAUTION:

• The foam probe must be placed into the foam

probe holder to prevent the foam sensor inside the

BPC from becoming entangled with the drive train.

• The 500 L foam probe holder must be removed

prior to raising or lowering the motor lift to avoid

damaging the BPC.

30. Optional: Connect a pressure sensor to the CPC

aseptic connector at the top of the BPC. Then connect

the appropriate pressure transducer cable to the third-

party controller.

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