Thermo Fisher Scientific HyPerforma Quick Start Guide

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.

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.

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

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.

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

38.1 mm (1.5 in.) Tri-clamp

Lockout nut

VFD breaker

Main power breaker

Temp. display breaker

E-Stop power breaker

Continuous power breaker

Pressure sensor breaker

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.

Figure 3. Load cell schematic.

Lockout post

Delrin slip ring

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.

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