HYPERFORMA MIXTAINER SYSTEM USER'S GUIDE - DOC0037ES REVISION A JUNE 2020 - THERMO FISHER ...
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HyPerforma Mixtainer System User’s Guide DOC0037ES • Revision A June 2020
Contents
Advertencias e información de seguridad 1
How to use this guide 2
Chapter 1 System overview 3
1.1 Operation parameters 3
1.2 Specifications 4
1.3 System definition 5
1.4 System applications 6
1.5 System components 6
Chapter 2 System preparation and setup 7
2.1 Equipment assembly 7
2.1.1 Attaching the drum 8
2.1.2 Inserting the BPC 8
2.1.3 Filling the BPC 9
2.1.4 Mixing 9
2.1.5 Dispensing 10
2.1.6 Removing the BPC 10
Chapter 3 Maintenance11
Chapter 4 Replacement parts 12Advertencias e información de seguridad
Advertencias e información de
seguridad
ADVERTENCIA: Lea y comprenda esta guía antes de utilizar el
sistema Thermo Scientific™ HyPerforma™ Mixtainer™.
• La información de seguridad en esta guía está extraída del
conocimiento y experiencia con que contamos. No obstante, es
importante que trabaje con su personal de gestión de seguridad
para garantizar que este equipo funcione de acuerdo con sus
prácticas de seguridad. Tómese un momento para realizar
su propio análisis de seguridad en el trabajo para identificar y
controlar todos los peligros potenciales.
• No sumerja el agitador magnético en ningún líquido.
• No utilice el Mixtainer con líquidos inflamables.
• No haga funcionar el agitador magnético en presencia de
materiales inflamables o combustibles; podrían provocarse fuego
o explosiones. El agitador magnético contiene componentes que
podrían prender dichos materiales.
• Utilice únicamente tomas eléctricas con cable que cumplan con
los requisitos de potencia mostrados en el agitador magnético.
• Desconecte siempre la alimentación antes de realizar actividades
de mantenimiento o servicio técnico en el agitador magnético.
Solicite a personal cualificado que realice el servicio técnico del
agitador magnético.
• Compruebe regularmente el cable y el enchufe de alimentación
exteriores. Repare o sustituya los componentes desgastados o
dañados.
ADVERTENCIA: Peligro de vuelco. El recipiente solo debe
moverse empujándolo por su parte central.
Si se tira de él o se mueve muy rápido, puede volcarse, lo cual
puede dañar el equipo o lesionar al personal. Para reducir el riesgo
de vuelco, solo debe moverse lentamente sobre superficies planas
y regulares por parte de al menos dos miembros cualificados del
personal. Durante el desplazamiento, deben retraerse las patas de
bloqueo y las ruedas deben estar en posición de desbloqueo. No
debe moverse el recipiente mediante tirones de ningún tipo.
Thermo Scientific Guía del usuario del sistema HyPerforma Mixtainer | 1How to use this guide
How to use this guide
Scope of this publication
This guide contains specifications, safety, handling, and operating
instructions for all Thermo Scientific HyPerforma Mixtainer
components.
Document change information
Revision Date Section Change Author
Rev. A 06/2020 -- Initial release C. Jones
Related publications
Publication name Doc. number
Quick Start Guide for Hyperforma Mixtainer System DOC0036
Questions about this publication
If you have any questions or concerns about the content of this
publication, please contact technicaldocumentation@thermofisher.
com and your Thermo Fisher Scientific sales team.
Thermo Scientific HyPerforma Mixtainer System User’s Guide | 21
Chapter 1 | System overview
System overview
1.1 Operation parameters
The Mixtainer system is intended to operate within the following
environmental conditions:
• Temperature: 17°C to 27°C (63°F to 81°F)
• Humidity: 20% to 80% relative humidity (RH), non-condensing
• Maximum altitude: 2,000 m (6,500 ft)
• Atmosphere: Non-explosive
The system should be stored within the following environmental
conditions:
• Temperature: –25°C to 65°C (–13°F to 149°F)
• Humidity: 15% to 85% RH, non-condensing
Thermo Scientific HyPerforma Mixtainer System User’s Guide | 3Chapter 1 | System overview
1.2 Specifications
Specifications for Mixtainer system components are shown below.
Table 1.1. Mixtainer system specifications
Specifications
Nominal capacity 50 L 100 L 200 L
Holdup volume 0.5 – 1 L
Drum height 59 cm (23 in.) 75 cm (29.5 in.) 113 cm (44.5 in.)
Assembled height 71 cm (28 in.) 86 cm (34.5 in.) 126 cm (49.5 in.)
Length and width 62 cm (24.25 in.)
Weights
Drum 10 kgf (22 lb) 2.3 kgf (27 lb) 17.3 kgf (38 lb)
Dolly 14.5 kfg (32 lb)
Stirrer 18.2 kgf (40 lb)
BPC 1.5 kgf (3.3 lb) 1.7 kgf (3.8 lb) 2.1 kgf (4.6 lb)
Contents (rated vol
50 kgf (110 lb) 100 kgf (220 (lb) 200 kgf (440 lb)
of H2O)
Total empty 44.2 kgf(97.3 lb) 46.8 kgf (102.8 lb) 52.1 kgf (114.6 lb)
252.6 kgf
Total full 94.2 kgf (207.3 lb) 146.8 kgf (322.8 lb)
(555.6 lb)
Materials
Materials: Welded type-304 stainless steel with four casters.
Dolly Dimensions: 62 cm x 62 cm x 15 cm (24.25 in. x 24.25 in. x 6.00
in.)
Drum and lid High-density polyethylene (HDPE).
Thermo Scientific CX5-14TM film, four top add and dispense ports,
BPC
integrated stir-bar.
Teflon TM -coated Alnico V magnet retained in an HDPE dish at the
Stir-bar
bottom of each BPC.
Power
Maxi stirrer
120 V, 160 W, 50/60 Hz, 1.4 A
(SV30029.01)
Maxi stirrer
220-240 V, 160 W, 50/60 Hz, 0.7 A, European cord
(SV30029.02)
Certification CE (220-240 V models)
Thermo Scientific HyPerforma Mixtainer System User’s Guide | 4Chapter 1 | System overview
1.3 System definition
The Mixtainer is a convenient-to-use closed system for mixing, storing,
and dispensing sterile liquids. The mixing feature is effective and non-
foaming. It ensures homogenous contents and uniformity over long
dispense periods. A dolly with casters allows the Mixtainer to roll over
smooth surfaces between fill and dispense stations.
The Thermo Scientific single-use flexible BioProcess Container (BPC)
lines the drum of the Mixtainer. This gamma-sterilized BPC eliminates
the need for on-site cleaning and sterilizing. Replace the BPC prior
to each fill to ensure a clean, sterile, and validated container. When
needed, use water and ordinary detergents to clean other Mixtainer
surfaces.
A Teflon-coated stir-bar, integrated into every Mixtainer BPC, is
driven by a magnetic stirrer located on the dolly under the drum.
All Mixtainer BPCs also include four ports, which can be used for
filling, dispensing, sampling, and liquid additions. Because the BPC
is discarded after each use, there is no risk of cross-contamination.
All fluid-contact surfaces are completely fresh, clean, and sterile with
every use.
Thermo Scientific HyPerforma Mixtainer System User’s Guide | 5Chapter 1 | System overview
1.4 System applications
The Mixtainer system has numerous applications. It can be used in
current good manufacturing practices and laboratory facilities to mix,
store, and dispense:
• Media, sera, and reagents
• Buffer solutions
• Process fluids
• Bulk and new product
• Microcarrier mixtures
• Powdered media with water
1.5 System components
The Mixtainer system consists of a drum lid, linear low-density
polyethylene drum (available in 50 L, 100 L or 200 L units), magnetic
stirrer, and dolly. See Figure 1.1.
Lid 200 L drum
100 L drum
50 L drum
Magnetic stirrer
Dolly
Stirrer controls
Figure 1.1. Mixtainer system components.
Thermo Scientific HyPerforma Mixtainer System User’s Guide | 62
Chapter 2 | System preparation and setup
System preparation
and setup
2.1 Equipment assembly
The Mixtainer system assembles without tools. An overview of the
assembled system is shown in Figure 2.1.
Lid
Stir-bar dish
Flexible BPC
(sold separately)
Stirrer controls
Latches
Drum
Access hole
Magnetic stirrer
Stainless steel
support
Dolly
Figure 2.1. Assembled Mixtainer system.
Thermo Scientific HyPerforma Mixtainer System User’s Guide | 7Chapter 2 | System preparation and setup
2.1.1 Attaching the drum
Follow the steps below to attach the drum onto the magnetic stirrer.
1. Place the magnetic stirrer on the dolly.
2. Center the magnetic stirrer between the brackets.
3. Route the power cord underneath the dolly.
4. Place the drum on the dolly, ensure it is placed inside the ring. Align
the access hole in the drum with the stirrer controls. See Figure 2.2.
5. Look down from the top of the drum to confirm that the top plate of
the stirrer aligns with the hole in the bottom of the drum.
6. Reposition the magnetic stirrer, if necessary.
Ring
Brackets for
magnetic stirrer
Figure 2.2. Ring and bracket support on dolly.
2.1.2 Inserting the BPC
Follow the steps below to insert the BPC into the drum.
1. Add a few liters of liquid to the BPC. (Follow the “Filling the
BPC” instructions in the next section.) The weight of the
liquid helps pull the rigid polyethylene stir-bar dish through
the hole in the drum.
2. Guide the BPC by lifting upward, where needed, to center
the stir-bar dish. Let the stir-bar dish drop through the hole in
the drum onto the magnetic stirrer.
3. Confirm that the stir-bar dish is resting firmly on the magnetic
stirrer by sighting through the access hole in the side of the
drum.
4. Extend the port tubes outside the drum so they are not
caught between the drum and liner.
Thermo Scientific HyPerforma Mixtainer System User’s Guide | 8Chapter 2 | System preparation and setup
2.1.3 Filling the BPC
Add liquid or liquid-solid mixtures to the Mixtainer system. A typical
filling rate is about 10 L/min. The filling rate depends on tubing
diameter, tubing length, and pump capacity. Ensure that you can turn
off the flow into the Mixtainer while simultaneously monitoring the
level. Use an assistant if necessary.
1. Place the Mixtainer on a scale to moniter contents by weight.
Measure the empty weight before adding contents.
2. Ensure a sterile connection is made between the fill-tube and the
supply vessel.
3. Use with a pump or gravity to transfer liquids into the Mixtainer.
4. Monitor liquid level by looking through the top of the BPC. Stop
filling before liquid enters the dispense tube.
5. Apply the lid after filling the BPC. This step is optional; the lid
prevents objects from falling into the drum.
You can begin mixing as soon as liquid covers the stir-bar dish at the
bottom of the BPC. (See the “Mixing” section below for details.)
2.1.4 Mixing
Activate the magnetic stirrer to keep solids in suspension, to blend
liquid mixtures, and to ensure that the dispensed product is uniform.
It is possible to begin mixing as soon as the stir-bar is immersed, but
it is usually just as effective to wait until the BPC is filled. The filling
process is, itself, a mixing operation. Follow the steps below to start
mixing:
1. Confirm that the magnetic stirrer is plugged into an appropriate
electrical supply source, and the speed knob on the control box is
in the OFF position (rotated fully counterclockwise).
2. Start mixing by slowly and smoothly turning the speed control
knob clockwise.
3. Use the second knob on the control box to set the duration of
mixing in minutes.
4. Determine the agitation speed appropriate for your application. The
speed setting for best mxing depends on the volume and physical
characteristics of the liquid in the BPC.
Thermo Scientific HyPerforma Mixtainer System User’s Guide | 9Chapter 2 | System preparation and setup
Note: If you try to run the stirrer too fast, or change speed too
quickly, the stir-bar and stirrer will decouple. This is not harmful, but it
results in a knocking sound and virtually no mixing. If the sound does
not stop within several seconds, set the speed to zero, wait for the
knocking to stop, and then slowly increase the speed.
2.1.5 Dispensing
Follow the steps below to dispense liquid into the Mixtainer system.
1. Make a sterile connection between the dispense port and the
dispense line.
2. Use a peristaltic pump to dispense.
2.1.6 Removing the BPC
Follow the steps below to remove the BPC from the Mixtainer system.
1. Remove the lid from the drum (if attached).
2. If necessary, empty the BPC using a peristaltic pump.
3. Disconnect user-installed tubing from the BPC.
4. Lift the BPC out of the drum.
Thermo Scientific HyPerforma Mixtainer System User’s Guide | 103
Chapter 3 | Maintenance
Maintenance
The dolly, lid, and drum require no routine maintenace other than
occassional cleaning with water and ordinary detergents. Rinse each
component thoroughly after cleaning. Do not use organic solvents
that could damage plastic. Never use hydrochloric acid or saline
solutions on stainless steel. Rinse with water if those liquids contact
the dolly.
Thermo Scientific HyPerforma Mixtainer System User’s Guide | 114
Chapter 4 | Replacement Parts
Replacement parts
Replacement parts for the Mixtainer system are listed below.
Table 4.1. Replacement parts for the Mixtainer system.
Part name Description Part number
Drum, 50 L High-density polyethylene drum with lid for 50 L Mixtainer SV50079.26
Drum, 100 L High-density polyethylene drum with lid for 100 L Mixtainer SV50079.27
Drum, 200 L High-density polyethylene drum with lid for 200 L Mixtainer SV50079.28
Dolly Stainless steel dolly with four casters for 50 L, 100 L and 200 L SV50109.01
Mixtainer
Magnetic stirrer Maxi stirrer, 120 V SV30029.01
Maxi stirrer, 200-240 V SV30029.02
Table 4.2. Replacement BPC descriptions and part numbers.
Part name Description Part number
50 L, with four top-mounted ports and tubing
• Two ports with 1/4-in. inside diameter (ID) tubing and
male/female Luer connectors SH30661.01
• Two ports with 3/1-in. ID tubing and quick-connect couplings
100 L, with four top-mounted ports and tubing
• Two ports with 1/4-in. ID tubing and male/female Luer
BPC connectors SH30661.02
• Two ports with 3/8-in. ID tubing and quick-connect couplings
200 L, with four top-mounted ports and tubing
• Two ports with 1/4-in. ID tubing and male/female Luer
connectors SH30661.03
• Two ports with 3/8-in. ID tubing and quick-connect couplings
Thermo Scientific HyPerforma Mixtainer System User’s Guide | 12Find out more at thermofisher.com/sut For Research or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals. © 2020 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. Teflon is a registered trademark of DuPont. Maxi Midi MR 1 Digital is a trademark of IKA. DOC0037ES Rev. A 0620
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