PBS Biotech PBS-Mini User manual

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Single-Use Bioreactors with
Vertical-WheelTM Technology
User Manual
MINI
BIOREACTORS
TM
MAG MAG

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PBS MINI User Manual IC03504 Rev B
PBS Biotech Inc.
© 2021 PBS Biotech, Inc. All rights reserved. All text, images, graphics and other materials in
this manual are subject to the copyright and other intellectual property rights of PBS Biotech
Inc. Under the copyright laws, this manual may not be copied, in whole or in part, without
written consent of PBS Biotech, Inc. The marks appearing in this manual including, but not
limited to: (i) PBS Biotech and the PBS Biotech logo; (ii) Vertical-Wheel™Bioreactor and its
logo, emblem, slogans and model names and designs are trademarks of PBS Biotech Inc.,
and registered in the U.S. and other countries. Every eort has been made to ensure that the
information in this manual is accurate. PBS Biotech is not responsible for printing or
clerical errors.

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4Safety
5About the PBS MINI
6PBS MINI at a Glance
8Technical Highlights for PBS MINI
9Installing the PBS MINI
10 Removing a Sample from the PBS MINI
10 Maintenance and Cleaning
11 Troubleshooting the PBS MINI
Table of Contents
PBS MINI User Manual IC03504 Rev B

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PBS MINI User Manual IC03504 Rev B
If any PBS Biotech equipment is used in a manner not
specied by PBS Biotech, the protection provided by the
equipment may be impaired.
The power cord is the main electrical disconnect for the
unit. To remove power from the unit, unplug the power
cord. Do not position the unit in such a way that it is dicult
to unplug the power cord.
To avoid damage or injury, only use power supplies and
accessories provided by PBS Biotech. Only use vessels
manufactured by PBS Biotech for the specic model of
your bioreactor.
Do not use the equipment in hazardous atmospheres or
with hazardous materials for which the equipment is not
designed.
Biological substances such as viruses, cells, and sera,
have the potential to transmit infectious diseases. If
biohazardous materials are used with this device, follow
all applicable local, state/provincial, and/or national
regulations, including identication of samples with the
biohazard symbol. Wear appropriate protective eyewear,
clothing, and gloves.
If the equipment has been used in a biohazardous
environment, it must be decontaminated according to
all applicable local, state/provincial, and/or national
regulations prior to any shipment or disposal.
Safety

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The PBS MINI Bioreactor System is a single-use cell culturing device,
intended primarily for culture of mammalian cells in therapeutic protein,
vaccine, gene therapy, and cell therapy applications. This system
consists of a MINI Single-Use Vessel with the patented Vertical-
Wheel™Impeller and a non-disposable MINI Universal Base Unit that
holds the vessel. The Base Unit can accommodate either a PBS 0.1
Single-Use Vessel or a PBS 0.5 Single-Use Vessel.
The MINI Bioreactor Base Unit is comprised of a stainless steel chassis
and base, with an injection-molded plastic enclosure. The entire
Base Unit is environmentally sealed for use in up to 100% humidity
(condensing) conditions and is constructed to be cleanable with 70%
isopropyl alcohol, or equivalent. The Base Unit may be powered by an
AC power source at 100-120 VAC or 200-240 VAC using the included
power adapter.
The PBS 0.1 and PBS 0.5 Single-Use Vessels are primarily constructed
from injection-molded polycarbonate and are sterilized by gamma
radiation to be ready-for-use by the customer. All product-contact
surfaces in the Single-Use Vessels consist of components certied
to be Animal-Derived Component Free (ADCF) and compliant to USP
Class VI, ISO 10993, or equivalent.
The agitation rate in the Single-Use Vessel is controlled by the speed
adjust dial on the MINI Bioreactor Base Unit and is displayed on the
digital speed display next to the dial. To regulate temperature, pH, and
dissolved oxygen (DO) levels in the culture, the system must be placed
in a warm room or an incubator with appropriate temperature and gas
controls.
About the PBS MINI
PBS MINI User Manual IC03504 Rev B

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PBS MINI User Manual IC03504 Rev B
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PBS MINI at a Glance
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Vent Cap(s)
Contains a 0.22 micron sterilizing-grade lter membrane for gas
exchange. Can be removed from the Single-Use Vessel for liquid
handling.
PBS Single-Use Vessels (0.1 L or 0.5 L)
Contains and mixes up to 100 mL or 500 mL of cell culture at a
controlled speed with the integrated Vertical-Wheel™Impeller.
Vertical-Wheel™ Impeller
Rotates vertically inside the Single-Use Vessel to facilitate
ecient mixing, in combination with the unique shape of the
bioreactor vessel.
Universal Base Unit
Provides agitation power and illumination to either Single-Use
Vessel size.
Speed Adjust Dial
Allows variable control of the Vertical-Wheel™Impeller’s rotation,
with rated speed from 5 to 100 RPM. Turns impeller rotation on/
off, as indicated by a click sensation and sound.
Digital Speed Display
Indicates the speed set point (to the nearest RPM) selected by
the dial.
SEL & RST Buttons
Reserved for factory setup and programming. No eect on
function of PBS MINI.
LED Light Power Button
Turns the LED lights on or off.
External DC Power Cord
Supplies power to the Base Unit from an A/C power source. The
power supply on the cord should be kept outside of the incubator by
running the thin DC extension cable through the incubator door seal.
White LED Lights
Oer enhanced visualization of microcarrier suspension and cell
culture in the Single-Use Vessel. (Not pictured on the PBS 0.5
MINI; located underneath the vessel).
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PBS MINI User Manual IC03504 Rev B

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PBS MINI User Manual IC03504 Rev B
FEATURES PBS 0.1 MAG PBS 0.5 MAG
Universal Base Unit
Size:
• Width
• Depth
• Height
• Weight
5.3 in (13.5 cm)
7.3 in (18.5 cm)
6.1 in (15.5 cm)
2.8 lb (1.3 kg)
Vertical-Wheel™agitation:
• Mechanism
• Speed range
• Speed control
• Display
Magnetic coupling
5 -100 RPM
Speed Adjust Dial controls on/o and agitation rate
Digital display of agitation (RPM)
Operational ranges:
• Temperature
• Humidity
• Altitude
• Environment
16 °C to 40 °C
5% to 100% (condensing)
Up to 2,000 m
Indoor use, pollution degree 2
Electrical:
• Power supply
• Base unit
Input: 1 A MAX, 100 - 240 V~, 50 - 60 Hz, CI. II
Output: 1.5 A, 24 Vdc (LPS)
Input: 24 Vdc 120 mA
Safety and regulatory NRTL, CE
Construction Stainless steel chassis & base, injection-molded plastic
enclosure, environmentally sealed components
Illumination of vessel Two embedded white LEDs
Single-Use Vessel
Size:
• Width
• Depth
• Height
• Height (vessel on base)
2.5 in (6.4 cm)
1.8 in (4.6 cm)
5.0 in (12.8 cm)
8.0 in (20.2 cm)
4.0 in (10.2 cm)
2.4 in (6.2 cm)
8.0 in (20.2 cm)
10.1 in (25.6 cm)
Working volume range:
• For liquid mixing
• For cell culture
20 – 100 mL
60 –100 mL
100 – 500 mL
300 –500 mL
Number of ports 1 2
Gassing Diusion through 0.22 micron lter on vent cap
Liquid transfer Port with screw-on vent cap
Product contact materials Meet requirements for USP Class VI Testing for Plastics
<88> and/or ISO 10993
Technical Highlights for PBS MINI

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1. Place a PBS MINI Bioreactor Base Unit in an incubator or in a
warm room and route the extension cable to a convenient location.
2. Make the connection between the extension cable and power
supply outside of the incubator. Plug the power supply in to an
electrical outlet.
3. Add cell culture medium or other applicable solution into a PBS
0.1 or PBS 0.5 Single-Use Vessel by removing the Vent Cap.
Perform this operation in a biosafety cabinet or other controlled
environment to maintain sterility in the Single-Use Vessel.
4. Conrm the Speed Adjust
Dial on the Base Unit is
set to 0 RPM.
5. Install the Single-Use Vessel in the Base Unit by matching the back
of the Vessel with the dovetail groove on the Base Unit and sliding
it down the groove. Note that there will be a sizeable vertical gap
between the bottom of the PBS 0.1 Single-Use Vessel and the
Base Unit even when it is installed properly.
6. Turn the Speed Adjust Dial to set the agitation rate in the Vessel to
desired speed.
7. Turn on the LED lights to visualize the Vertical-Wheel™Impeller
rotation, as needed. The LEDs should be turned o whenever
possible when working with a light-sensitive process.
Installing the PBS MINI
PBS MINI User Manual IC03504 Rev B

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PBS MINI User Manual IC03504 Rev B
• To keep the cells evenly mixed during
sampling, a Base Unit should be used
in the biosafety cabinet to control
agitation rate.
• To remove sample from the very bottom
of the vessel, the Vertical-Wheel™Impeller
must be rotated so the vanes are at
the top and bottom of the wheel, as
illustrated.
Maintenance and Cleaning
• The only required maintenance is to regularly clean the Base Unit
with a solution of 70% isopropyl alcohol, or equivalent.
• The Base Unit has no user-serviceable parts. Do not attempt to
disassemble the Base Unit.
Removing a Sample from the PBS MINI

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Issue with Powering Up
1. Verify that the Base Unit is plugged into a functional electrical
outlet. Unplug the Base Unit from the outlet and re-plug it into the
outlet.
2. If you are using a power strip or a surge protector, verify that
its switch is also turned on.
3. Verify the cable on the external power supply is securely
connected.
Issues with Agitation
Note: The display gets updates from the motor several times per
revolution. This may result in the displayed rotational speed oscillating
between a few RPM.
1. Verify that the Base Unit is powered up properly.
2. Verify that the Single-Use Vessel sits all the way down in the Base
Unit to ensure proper magnetic coupling.
3. Verify that the Speed Adjust Dial is not in the o position.
4. Visually determine any faults in the Vertical-Wheel™Impeller:
•Is there any visible damage to the impeller?
•Does the impeller rotate smoothly in its bearings?
Issues with LED Lights
1. Verify that the Base Unit is powered up properly.
2. Push down rmly on the LED Light Power Button.
Troubleshooting the PBS MINI
PBS MINI User Manual IC03504 Rev B

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PBS MINI User Manual IC03504 Rev B
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