Integrated Cell
Processing Work Station
MHE-PF4025CW2-PA
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Panasonic Integrated
Cell Processing Work Station (CPWS)
Minimizes Cleanroom Expense
Self-Contained
Space-Saving
Easy to Install
GMP Compliant for Aseptic Processes
User Friendly
Energy Efficient, Green Design
The Essential Work Station for Cell Therapeutics
In designing the industry’s first viable alternative to a conventional Class 10,000 cleanroom for
both Class 100 air quality and barrier isolation, Panasonic has introduced the Cell Processing
Work Station (CPWS). It brings the potential of cell therapeutics to more facilities, while decreasing
acquisition costs, operation costs and protracted time lines.
Global Cell Therapy and Tissue Engineering Market ( 2010 & 2015 )
$25,000
Cord Blood and Cell Banking
$20,000
Cell/Issue Banking
Cancer
Cancer
General Sur GI,Gyn,Others
$15,000
Ophthalmalo
Cardiology
Neurology
General
Ophthalmalogy and Organ
Replacement/ Preservation
Organ
$10,000
Dental
Dental/Oral
Millions of Dollars -------->
Skin
Urology
Osthol
$5,000
Orthopedics/Spine
Neuro
Cardio
2010
2015
Immediate beneficiaries of the CPWS include research
focused institutions and scale-up development to treat a broad
range of diseases. The focused research can be related to
human cells, cellular therapies in clinical trials, and hospitals
deploying FDA approved cellular therapeutics. As the science
progresses, results are propagated throughout the medical
and scientific community. This exponentially expands the need
for bench-level research and production. In such situations,
Panasonic's approach with free-standing and self contained
work station is quite novel considering the conventional layered
cleanroom approach of containment and protection.
The CPWS brings the capability for on-site cellular therapeutics
to more number of facilities rather quickly, at a lower capital
and reduced operational cost. All this is within the GMP (Good
Manufacturing Practices) performance envelope required of the
cell technology itself.
4
Skin
Urology
Self-Contained System, Small Footprint
The Panasonic concept of a self-contained work station is
enabled by the company’s demonstrated proficiency for in situ
decontamination.This is necessary to separate the processes
from one patient to the next, or one protocol to another. By using
a highly effective hydrogen peroxide (H2O2) decontamination
process, the CPWS can be completely decontaminated without
heat and prepared for the next protocol within two hours.
This is extremely time efficient as compared to a cleanroom
decontamination function that can take up to days or weeks.
By increasing throughput within the compliant parameters
of GMP criteria, the CPWS is deployed for research, cellular
manipulation, cell growth, cell product extraction, and emerging
processes that fall within similar guidelines. Current and future
applications of the CPWS include organ and tissue regeneration
such as skin, cartilage, alveolar bone, cornea, cardiac muscle,
nerve, liver, and pancreas regeneration. Immunotherapy
applications may extend to dendritic cells, T-cells, and more.
Making it Work
Improving efficiency in human interaction is the primary goal
of the CPWS. All work must be performed without human
error, in an aseptic environment with detailed documentation
to assure quality and compliance. Gown-up time, expense, and
inconvenience is minimized or eliminated altogether. Integrated
systems within the CPWS permit cellular extraction, preparation,
culturing, and administration with aseptic assurance as well as
economic practicality. Because conventional autoclaving is not
possible, the Panasonic H2O2 decontamination process diminishes
both time and labor associated with this critical step between
patients. This positions the CPWS squarely in the equation for cost/
benefit justification associated with investment decision-making.
Allowances for integrated centrifuge, microscopy, data acquisition,
and incubation functions are important considerations in the CPWS
design. A unique docking station permits interface and exchange
with an unlimited number of cell culture incubators dedicated to
individual patients or cell lines.
On the Work Surface
Since humans remain the single most common source of
contamination, the CPWS provides both physical and
work flow benefits to minimize contamination and cross
contamination in the work area. Within the four-port glove
box, the CPWS delivers more than a conventional Class II,
Type A2 biological safety cabinet, typically installed within a
cleanroom to achieve the same objective. Here, the manually
initiated, automatically deployed H2O2 decontamination process
supplements continuous HEPA filtration. As 0.3 micron particles
are removed from the fresh air exchange, H2O2 decontamination
neutralizes contaminants brought forth by instrumentation or
equipment. A number of decontamination sequences are available
to protect the aseptic environment.
The glove box design offers barrier isolation protection for the
operator and the work inside. User comfort and ergonomics are
inherent to the CPWS design, including a sloped front for ease of
access and glare reduction.
The CPWS Advantage
The relatively small footprint permits installation into existing
or new Class 100,000 lab space with conventional utilities and
minimal site preparation. Multi-layered airlocks in multiple
treated rooms are avoided. Capital intensive expenses are
lowered, while the lead times from decision to operation are
shortened. Once in place, operational costs are highly contained
and predictable, with decontamination available more frequently
and at a fraction of conventional cost.
The Panasonic Difference
For over forty years, Panasonic has established a reputation as
a premier manufacturer of precision biomedical and laboratory
equipment. Known throughout the world as a leading brand in
consumer electronics and appliances, Panasonic addresses
global needs such as energy, food, housing, healthcare, and
information technology.
As a part of the Panasonic product line worldwide, the CPWS
exemplifies our unique vertical component integration approach
to product development. This combines ideas and innovations
from our global industrial and consumer products network into
an integrated product featuring advanced technology, controls,
construction, and performance attributes.
The CPWS and subcomponent systems have been extensively
tested to meet the toughest quality standards for performance,
ergonomics, and cost of ownership. The CPWS is designed
to minimize its carbon footprint through energy savings and
environmental stewardship.
5
Technical Attributes
The Panasonic CPWS is a component-based design that permits a long-term or quick turnover of self-contained protocols
with efficiency and safety. As an integrated system, all functions associated with good laboratory technique, environmental
control, and ergonomic comfort are selected for compatibility and complementary functional performance.
The Panasonic CPWS work station is designed to deliver efficient, cost effective, GMP compliant cell therapy, and manufacturing
capability without the expense and inconvenience of a class 10,000 cleanroom. The CPWS offers significant advantages over
conventional hard wall cleanroom construction.
The CPWS is less expensive than a cleanroom.
It is quicker to acquire and place into operation.
The small footprint increases options for location and
orientation.
The user-friendly glove box design eliminates gowning,
improves operator comfort, and convenience.
Operating costs are lower than cleanroom costs
Central barrier isolator
Pass box interchange
Integrated H2O2 decontamination system
Optional cell observation system with microscope
and monitor
The optional incubator and optional centrifuge operate
within a Class 100 environment.
6
Work is easily suspended and resumed without the need to
de-gown and re-gown, improving user comfort.
Fast decontamination increase throughput and deliver
quicker return on investment.
Record-keeping and process documentation are easier
to manage.
Optional centrifuge integrated into the work surface
Optional CO2 incubator with docking collar
Components and operating systems are configured around
a central work station with a HEPA filtration and air
management system. This is designed to deliver Class 100
air to the work surface within the glove box.
3
1
7
11
4
13
2
5
8
6
9
12
10
1
Hinged front access
assembly. Front lifts
up when total interior
access is required.
2
3
Interchange pass
box with manually
initiated, automatic
sequence H2O2,
decontamination
system.
HEPA supply and exhaust
filtration blower motor
assembly
4
Interior fluorescent
lamps
10
Adjustable
leveling feet
5
Glove port
11
Optional cell
monitor LCD
6
Electrical
compartment
12
7
System controller
8
Centrifuge module
accessible for the aseptic
work area.
9
Centrifuge
controller
13
Incubator cart with locking
casters; offset casters nest
with frame assembly when
docked.
Modular CO2
incubator, shown
on cart, docked to
barrier isolator.
7
Applications
Clinical Applications of Cell Therapies
DISEASE STATES
CELL THERAPIES
CANCER
HEMATOPOIETIC STEM CELL
(HSC) TRANSPLANTATION
IMMUNOTHERAPY
ORTHOPEDIC
NEURODEGENERATIVE
DISORDERS/TRAUMA
CARDIOVASCULAR DISEASE
Autologous and allogeneic HSC; Ex vivo expansion of HSC;
‘Suicide’ T-cells – gene transfer; Stem cell transportation
Dendritic cells; NK/T cells; Macrophage-activated killer cells;
T-cell expansion; NK cells; Co-stimulatory molecules
(gene transfer)
Expanded chondrocytes; Mesenchymal stem cells
Adult stem cell-derived cells; Embryonic stem cell-derived neural
cells
Infusion of marrow/blood-derived angio blasts;
CD34 stem cells; cardiac cells*
ORGAN REPLACEMENT
PANCREAS (DIABETES)
Pancreatic islet cells; Embryonic stem cell-derived islet cells;
Adult stem cell-derived islet cells
LIVER (FAILURE, METABOLIC
DISORDERS)
Bioartificial liver; Isolated hepatocytes; Hepatocyte stem cells
KIDNEY (FAILURE)
WOUND HEALING
INFECTIOUS DISEASES
Bioartificial kidney
Keratinocytes; Skin stem cells
Antigen-loaded dendritic cells; Lymphocyte expansion;
Macrophages
GENETIC DEFICIENCIES
HEMOPHILIA
Gene Therapy
SCID
Gene Therapy
CYSTIC FIBROSIS
Gene Therapy
AUTOIMMUNE DISEASES
IMMUNOTHERAPY
Dendritic cells; T-cells, Mesenchymal stem cells*;
Lymphocyte expansion; Natural Killer cells
HSC, hematopoietic stem cells; NK, Natural Killer; SCID, severe combined immunodeficiency
* Currently in clinical studies.
8
Applications
The Panasonic CPWS enables a broader
access to cellular therapeutic research related
to both, minimally manipulated and nonminimally manipulated cell products. It lowers
the cost of entry, extends the process to the
widest range of applications, and minimizes
operating expenses, when compared to a
conventional cleanroom environment.
• Minimally manipulated products are
associated with cell washing, enrichment,
selection, HSC (PB, BM, CB), cancer
therapies, and other under GTP
requirements.
• Non-minimally manipulated products are
associated with expanded, differentiated
or transformed cells (DC, MSC, ESC, TC)
in cancer centers, biotech labs, stem cell
institutes, and contract manufacturing
facilities operating under GMP
requirements.
• GMPs (Good Manufacturing Practices) are
mandated by the United States Food and
Drug Administration to ensure that drug
development and manufacturing is safe,
under controlled environment, reproducible,
and thoroughly documented.
• GMPs typically require expensive hard wall
laboratories with laboratory suites that use
biological safety cabinets in Class 10,000
cleanrooms within a Class 100,000 room.
Cost Benefit Analysis
Approximately 35% Less Expensive to Operate
The Panasonic CPWS offers significantly lower operating costs when compared to a conventional cleanroom
(open system). Comparison methodology and assumptions are available from Panasonic. Soft-cost benefits
related to user convenience, user comfort, flexibility, throughput, and other demonstrated advantages of the
CPWS can be established through consultative review. Contact Panasonic for details.
Comparative Operating Costs1 (Nominal), Panasonic CPWS vs. Conventional Cleanroom,
PANASONIC CELL PROCESSING WORK STATION (CPWS)
FUNCTION
CONVENTIONAL GMP CLEANROOM
ANNUAL BUDGET
(NOMINAL)
FUNCTION
ANNUAL BUDGET
(NOMINAL)
H2 O 2 Cartridge, 25g, Total System Decontamination
$9,000
Disinfection, Cleaning
$9,000
H2 O 2 Cartridge, 5g, Pass Box Only Decontamination
$13,320
Routine Sanitation
$12,000
Residual H2 O 2 Detector
$2,664
Particle Sensors
$3,000
Gloves, 3 gloves, 2×
$1,140
Sterilized, Non-Shedding Gowns
$18,000
Sleeves, 3 gloves, 1×
$3,640
HEPA FILTERS
HEPA FILTERS
Biosafety Cabinet, Supply Filter
$343
$907
Biosafety Cabinet, Exhaust Filter
$190
Interchange Pass Box
$294
Certifier Labor, BSC Formalin Decontamination
Room
$833
Cleanroom Air Supply
Labor
$1,330
Work Station
VALIDATION EXPENSES
$956
$2,916
Cleanroom Air Exhaust
$1,516
Certifier Labor, CR Formalin Decontamination
$1,500
$1,440
VALIDATION EXPENSES
Decontamination Performance BI Inspection
$3,230
Biosafety Cabinet and Report
$1,050
Cleanroom and Report
$10,000
Centrifuge and Report
$1,350
H2 O 2 Mist Uniformity Inspection
$720
Centrifuge Module and Report
$1,350
CO 2 Incubator Module and Report
$1,250
POWER CONSUMPTION
$18,057
NOMINAL ANNUAL BUDGET
35% Less
Cleanliness and Air Volume Report
CO 2 Incubator Module and Report
$850
POWER CONSUMPTION
$60,000
NOMINAL ANNUAL BUDGET
$28,972
$91,600
Comparative operating costs listed herein are nominal and based on actual installations in Japan. Total cost of ownership and operation will vary
according to type of installation, method of use, geographic location and other factors. Panasonic offers consultative assistance in developing a cost/
benefit analysis specific to your facility and protocol. Contact Panasonic to arrange a report unique to your prospective application
1
Who Benefits from CPWS
MARKET
FACILITY
PROTOCOL
CPWS BENEFIT
ACADEMIC
Cancer centers
Cancer treatment, translational medicine
Easy segregation of patient-specific cells
ACADEMIC
Medical research
Regenerative medicine
CLINICAL
Hospitals
PRIVATE INDUSTRY
Biotechnology,
Pharmaceutical
Easier transition from animal
models to human clinical trials
9
Feature Benefit Analysis
Aseptic Environment Required for Cell Preparation
Usually, human derived cells must be guaranteed that they are prepared and cultured in an aseptic environment
because they cannot be treated by heat or pressure.
Orginal
Cells
Preparation
Extraction
Culture
CPWS SOLUTION
TYPICAL CLEANROOM
Glove Box
HEPA Filters
Change Room
More Cost
Centrifuge
GENERAL
PLANNING AND LEAD TIME
SPACE/FOOTPRINT ALLOWANCE
VALIDATION COSTS
OPERATION COST
IMPLEMENTATION
10
Class
10,0 00
Class
10,000
Class
100,000
Pass
Box
* Drawing not to scale
PANASONIC CPWS
BARRIER ISOLATOR
CLEANROOM
WITH BIOLOGICAL SAFETY CABINETS
Closed system, requires only
Class 100,000 air
Open system, requires significant investment
and maintenance of background environment,
Class 10,000 air
Minimal; Cost of Class 100,000 room plus CPWS
High; Cost of Class 10,000 cleanroom plus Class 100 one or
more Class 100 biological safety cabinets
Minimal footprint in existing space
Dedicated new/retrofit facility with significant
requirement for HVAC, filtration, air showers
Minimal; Requires Class 100,000 only.
High; Requires both Class 100 and Class 100,000.
Low
High; Repeated decontamination and maintenance costs. Higher
consumables cost
Weeks
Months or Years
No second gowning required. Central barrier isolator
with ergonomically angled front permits easy access through
glove ports. Reduces stress on workforce.
Conventional first and second gowning, external air supply,
interlock doors/air showers
FLEXIBILITY
Elimination of hazardous fumes for decontamination
permits diverse applications. Elimination of depolymerizing
formaldehyde, formalin and other toxic chemicals permits
transition between applications seamlessly.
Inflexible
THROUGHPUT
Expanded. Quick changeover extends use,
optimizes return on investment. Component integration
streamlines workflow while enhancing aseptic processing.
Limited due to product changeover criteria
DECONTAMINATION
Two Hours
Up to Two Weeks
EQUIPMENT AND
INSTRUMENTATION
Microscopes and other instrumentation
can be dedicated to the work station.
Shared instrumentation in an open system exposes processes to
cross contamination.
ERGONOMICS AND USER COMFORT
ISO14644-1
Class
10,000
Class
100,000
Efficient
Detachable
Incubator
Class 100-BSC
Class
100,000
35%
Class 100
COMPARISON
Prepared
Cells
Administration
FDA
EU-GMP ANNEX 1
JP
WHO-GMP TRS902 ANNEX 6
CLASS 5
Class 100
In Operation 3,520
Grade A
In Operation 3,500
Grade A
In Operation 3,520
Grade A
In Operation 3,500
CLASS 7
Class 10,000
In Operation 35,200
Grade B
In Operation 350,000
At rest 3,500
Grade B
In Operation 352,000
At rest 3,520
Grade B
In Operation 350,000
At rest 3,500
CLASS 8
Class 100,000
In Operation 3,520,000
Grade C
In Operation 3,500,000
At rest 350,000
Grade C
In Operation 3,520,000
At rest 352,000
Grade C
In Operation 3,500,000
At rest 350,000
CLASS 9
—
Grade D
At rest 3,500,000
Grade D
At rest 3,520,000
Grade D
At rest 3,500,000
Aseptic Environment
Conventional GMP Cleanroom Facility (Open System) with Biological Safety Cabinets
Highest aspect level = Aseptic
(safety cabinets, etc)
Aseptic level
low (D)
6 m2
16 m2
PS
18 m2
Aseptic level
mid (C)
Aseptic level
high (B)
Aseptic level raised gradually
PS
PS
-152ºC
PS
PS
(A)
Air lock
General environment (not clean)
18 m2
-32ºC
11 m2
11 m2
10 m2
4 m2
PS
PS
PS
PS
PS
PS
10 m2
16 m2
7 m2
3 m2
Class A
(100)
Class B
(10,000)
Class C
IO(100,000)
Class D
AR(100,000)
Panasonic CPWS, Barrier Isolator with Integrated Systems
The Panasonic CPWS offers significant throughput potential in a
comparatively small footprint.
Cleanroom:
The biological safety cabinets within
the cleanroom are open systems,
which require a stricter background
environment. Access in and out of the
cleanroom must comply with gown-up
protocols consistent with GMP facilities.
Class 100 air is ultimately delivered to the
work product in one or more biological
safety cabinet(s) operating independent
of the cleanroom. Decontamination is
costly and time-consuming; changeover
from one protocol to another is difficult
and expensive.
The CPWS can be installed in manageable Grade D (Class 100,000)
environment, providing biological and physical protection between the
6 m2
work and the user.
16 m2
PS
18 m2
Access through the glove ports improves user comfort.
The integral
H2O2 decontamination system is completed in less than
PS
two hours, permitting frequent changeover and assuring separation
integrity from one cell process to the next.
PS
-152ºC
PS
PS
18 m2
-32ºC
11 m2
11 m2
PS
10 m2
PS
PS
PS
PS
PS
10 m2
16 m2
7 m2
3 m2
Class A
(100)
Class B
(10,000)
Class C
IO(100,000)
Class D
AR(100,000)
11
Series Features
Barrier Isolator
The barrier isolator forms the central
component to the work station and
contains the primary operating systems
required to establish and maintain
aseptic conditions to meet GMP criteria.
• The barrier completely isolates
the interior work product from the
operator.
• The barrier isolator creates a closed
Class 100 environment, eliminating the
need for biological safety cabinets in a
cleanroom.
• Isolator interior air is 100% Class 100
total exhaust. No recirculated air is
used.
• The polished stainless steel glove
box interior is designed for maximum
exposure of all interior surfaces
subject to H2O2 decontamination.
• Before commissioning and initial use,
the isolator front can be opened on a
locking hinged frame for installation
of instrumentation or other devices
larger than the interchange pass box
opening.
• The HEPA filter and airflow system is
mounted on top of the isolator.
• The internal airflow system is
designed to create a positive pressure
to mitigate the possibility of inflow
contamination.
• Viability of the containment area is not
delegated to third-party cleanroom
contractors who are hired to
decontaminate.
Ergonomics and Safety
Because second gowning is not required,
user comfort and productivity is
significantly improved. The workplace
routine, including bathroom breaks, is
unencumbered by the need to leave and
re-enter a cleanroom, bleach, and/or
shower.
• The inconvenience and expense of
cumbersome containments suits with
air and vacuum hoses is eliminated.
If working with BL3 agents, the buddy
system is not required.
• The barrier eliminates the potential
for room contamination from blood
or other aerosols. Workflow is not
impacted by routine colds.
• Staff confidence in total containment
improves morale.
• Glove ports permit easier handling of
red bag materials when required.
• A 6º angled front includes three glove
ports to permit access to all interior
surfaces.
• The interior cabinet includes
independent interior fluorescent lamps
to supplement ambient light.
H2O2 Decontamination System
Isolator Interchange
• The manually initiated, automatically sequenced H2O2
decontamination system offers a fast, safe, and proven
decontamination process. It enhances the performance of
the CPWS by allowing more frequent turnover of segregated
cell lines.
• The interchange pass box allows safe access to the work area for
supplies, instruments, devices, sterile media, and labware.
• The validated H2O2 system generates an H2O2 vapor that
permeates all exposed surfaces from the central interchange
pass box nebulizer, which contains a replaceable bottle of
enriched hydrogen peroxide.
• When deployed, the H2O2 vaporization sequence decontaminates
the pass box, work station interior, centrifuge, CO2 incubator
exterior, and docking gaskets.
• Once the vaporization is complete, the H2O2 program implements
a dwell period to ensure that proper exposure times are
maintained for a wide range of pathogens.
• At the end of the pre-programmed dwell period a resolution
process eliminates fumes and toxic residuals.
12
• When materials are brought into the work station they are first
positioned inside the interchange for H2O2 decontamination.
• Decontamination is manually initiated and automatically
sequenced once started.
• When the H2O2 decontamination process is complete, the inner
door is opened and the transfer is completed.
• Door interlocks permit simultaneous opening to protect the
barrier isolator.
Series Features
Decontamination Sequence
Total Decontamination
A total H2O2 vapor decontamination creates aseptic
conditions in the interchange pass box, the glove
box and (optional) centrifuge module.
Pass Box Only
Instruments or materials introduced into the glove
box are decontaminated by a pass box cycle only,
avoiding the need to decontaminate the entire glove
box work area. Work can continue in the glove box
while the cycle is in process.
Cell Culture Incubator
Incubator and Work Area. After aseptic protocols are
completed, cultures are transferred to the (optional)
CO2 incubator where growth can continue under
aseptic conditions after the incubator is detached.
Unwanted materials are removed through the pass
box interchange.
$
Changeover
When handling different cells from the previous protocol,
the next (optional) cell culture incubator is docked to the
work station glove box. The work station, interchange
pass box (optional) centrifuge and incubator door are
decontaminated prior to opening. The changeover
process is completed in less than two hours.
Decontaminated
Contaminated
Possible cell-derived
contaminated
One CPWS can service multiple CO2 incubators to
permit easier cell segregation. One incubator is
attached to the work station at the docking collar
and subjected to a quick, safe H2O2 decontamination
process. When work is completed, the incubator is
sealed and returned to the staging area and another
incubator is attached and the process is repeated.
13
Series Features
CO2 Incubator
Incubator Features and Benefits
The modular CO2 incubator is an adaptation of the fullperformance Panasonic MCO-5AC(IS). This incubator is designed
for precise temperature and CO2 control with elevated relative
humidity to minimize cell desiccation.
The incubator is a modification of Panasonic’s popular MCO-5AC.
The compact 1.4 cu.ft. (49 liter) interior chamber is constructed
of Panasonic’s exclusive inCu-saFe® copper-enriched stainless
steel, creating a natural germicidal barrier against airborne
contamination.
• By using multiple, detachable CO2 incubators, the CPWS can
manage multiple patient protocols through complete product
segregation, thereby assuring aseptic conditions and eliminating
any possibility of cross-contamination or mishandling of patientspecific cells.
• Segregation permits compliance with published criteria
associated with regenerative medicine and in vivo cell therapies.
• An integrated microprocessor controller supervises all functions
including temperature and CO2 setpoints, control, alarm and
monitoring.
• The patented Direct Heat and Air Jacket control system assures
temperature uniformity and stability essential to the most
sensitive cell lines.
• The incubator attaches to a docking collar adjacent to the barrier • The rounded-corner, electropolished interior is configured for
isolator.
use with a variety of standard cell culture vessels.
• Once attached, the barrier isolator undergoes a 2-hour H2O2
decontamination process before the incubator door is opened.
This process decontaminates the work area, incubator face,
centrifuge and pass-thru interchange.
• The H2O2 effectively decontaminates the CO2 connection.
• All interior components are designed to withstand repeated H2O2
decontamination cycles expected in high turnover environments.
Components are removable without tools.
Centrifuge
• When work is complete, the incubator is sealed, detached and
moved to a user-defined staging location on a wheeled cart.
The centrifuge is installed beneath the interior work surface and
accessible under aseptic conditions without removing cells from
the protected environment.
• The next incubator can be moved into position to repeat the
process for another patient.
• The position and orientation of the centrifuge assures thorough
decontamination during the H2O2 decontamination cycle.
• There is no limit to the number of Panasonic MCO-5AC(IS)
incubators that can be used with the work station.
• The integrated design eliminates the requirement for additional
floor space in a GMP environment.
• A variety of fixed and swinging rotors available.
• Centrifuge controls are located external to the work area at the
front of the centrifuge module.
Modular Incubator
Model MCO-5AC(IS)
docked to the CPWS
CPWS Centrifuge
14
Series Features
3
2
1
1. Work station Glove Box
The work station creates Grade A Class
100 air quality within the glove box, and
permits installation within a Grade D
Class 100,000 room, eliminating the
need for a typical cleanroom. The selfcontained, closed system protects both
the user and the work product without
the need for a second gowning. An ergonomically shaped front access is angled
6° for user comfort, glare reduction, and
reach throughout the work surface.
2. Pass Box Decontamination
3. Decontamination System
Materials are brought into the work
chamber from the outside through the
pass box interchange. The H2O2 decontamination is manually initiated and
automatically sequenced, thoroughly
decontaminating the pass thru material
and protecting the integrity of the work
surface. The interchange contamination
process can function alone, independent
of the glove box.
The CPWS includes an H2O2 decontamination system that generates H2O2 vapor to
produce validated results. This system
covers the pass box interchange, glove
box work area, optional centrifuge, and
optional CO2 incubator. The enriched H2O2
solution is contained in a replaceable
bottle and inserted as a cartridge inside
the decontamination module.
Cell Monitoring System
(Optional)
An integrated cell monitoring system
reduces additional footprint required in
a GMP environment. Cell monitor
components are located within the
barrier isolator and designed to
withstand repeated H2O2 decontamination
sequences.
• The interior components include
a LCD monitor and a
separate collection module.
• The collection module includes
a high-performance CCD camera
(charge coupled device) with objective
lens and phase difference filter.
• The monitor displays real time images
with total magnification of 110×.
Images from PC
Control/Relay Box
PC for Capturing
AC Power
Camera IF
Various Signals IF
Lighting VCC,GND
Light Dimming Sygnal
Cameral IF (power, image signals)
• Images can be captured via a noncontact photo sensor, 2.4 × 1.8 mm
for monitor display and digital
recording.
• A standard personal computer,
external to the aseptic isolator work
area, is used for data acquisition and
image management.
Power SW Signal
Capture SW Signal
Observation Module
15
Specifications
Component Specifications
System Summary Specifications
COMPONENT
DESCRIPTION
COMPONENT
ORDER NUMBER
BARRIER ISOLATOR
Base Unit
INTERCHANGE PASS BOX
Included
BASE WORK STATION,
BARRIER ISOLATOR
AIRFLOW AND HEPA FILTRATION SYSTEM
Included
INTERCHANGE
Included
MHE-PF4025CW2-PA
H2O2 SYSTEM
Included
HEPA FILTRATION SYSTEM
Included
CENTRIFUGE
Included
CENTRIFUGE
Included
CO2 INCUBATOR
Optional
CELL OBSERVATION MODULE
CELL OBSERVATION SYSTEM
Optional
CO2 INCUBATOR
Optional
MCO-5ACIS
Centrifuge and Module
FEATURE
EXTERIOR DIMENSIONS (W X F-B X H)
MAXIMUM SPEED
MAXIMUM CENTRIFUGAL ACCELERATION
CONTROLS, ALARMS
PRE-SETS
TIME SETTABLE RANGE
ACCELERATION/DECELERATION SETTINGS
MOTOR SHAFT
CAPACITY
16
SPECIFICATION
21.25" × 22.9" × 30.3" / 540 x 582 x 771 mm
2100 RPM
10 to 970G centrifugal acceleration settable range
Externally mounted, front, with foot switch for cut-off.Door lock status displayed.
Up to 4 patterns in memory
10 to 50 seconds (10 second increments); 1 to 99 minutes (1 minute increments); and infinite
3 stage
Stainless steel
1000ml (50ml tubes, × 20)
Specifications
Barrier Isolator
DIMENSIONS
OVERALL EXTERIOR DIMENSIONS (W X F-B X H)
INTERIOR DIMENSIONS (W X F-B X H)
INTERIOR WORK SURFACE ELEVATION
GLOVE ELEVATION
PASS BOX INTERCHANGE (W X F-B X H)
NET WEIGHT
115" × 41" × 87.8" / 2920 × 1045 × 2230 mm net of attached optional incubator
70.7" × 28.5" × 34" / 1796 × 726 × 864 mm
31.5" above floor / 800 mm
41.3" above floor / 1050 mm
19.6" × 16.7" × 15.8" / 500 × 425 × 400 mm
2207 lbs / 1000 kg, nominal
CONTROLS, ALARMS
PRESSURE MONITOR
FAN MOTOR
Red LCD and audible alarm if pressure falls below alarm setpoint.
Audible alarm during motor shutdown
CONSTRUCTION
EXTERIOR FINISH
Painted steel
INTERIOR FINISH
Polished stainless steel
FRONT GLOVE PORT PANEL, ANGLE 6°
Polycarbonate with painted steel frame. Hinged for opening to load equipment.
AIR SYSTEM
AIR QUALITY
AIRFLOW SYSTEM AND VELOCITY
Grade A Class 100 over work surface; installation in a Grade D, Class 100,000 ambient room
Vertical downflow over work surface, 0.2~0.3 m/s ± 20% @6" below supply filter screen (150 mm)
FILTRATION SYSTEM
Independent HEPA supply and exhaust filters, efficiency 99.99% (0.3 µm PAO), scan tested and passed
FILTRATION SYSTEM, PASS BOX
Independent HEPA supply and exhaust filters, efficiency 99.99% (0.3 µm PAO), scan tested and passed
INTAKE AND EXHAUST
Electrically switched system. Room air intake thru HEPA supply filter;
return exhaust to room thru HEPA exhaust filter
RELATIVE AIR PRESSURE
WORK STATION
PASS BOX INTERCHANGE
Positive pressure after decontamination of work station and pass box;
audible notification when ready, 60Pa
Positive pressure after decontamination of pass box only; audible notification when ready, 220Pa
INTERIOR WORK AREA
LIGHTING
ELECTRICAL OUTLET
Fluorescent lamps (3), 30w each, top of panel, top of right, left
Duplex, drip-proof receptacle
PASS BOX INTERCHANGE
DOOR
MATERIAL
Front opening to outside; left side opening to interior work area
Polished stainless steel
DECONTAMINATION SYSTEM
FUNCTION
H2O2 RESOLUTION AND AERATION
DECONTAMINATION CYCLE TIME
H2O2 vaporization; simultaneous decontamination of interior barrier isolator work station,
pass box interchange, optional centrifuge and optional CO2 incubator
Catalytic, external to the work area. Residual H2O2 density at catalytic outlet is at or below 1ppm
(by TLV-TWA). Fresh, HEPA filtered air follows resolution
Load dependent; typical cycle times range from 1.0 to 2.0 hours
from manual initiation of automatic sequence.
UTILITIES
ELECTRICAL
Main system, 4500w, 220V, AC, 60Hz. Electrical outlet 120V, AC, 60Hz.
17
Specifications
CO2 Incubator (Modular), Panasonic MCO-5ACIS
DIMENSIONS
EXTERIOR DIMENSIONS WITHOUT STAND (W X F-B X H)
23.5"W× 22.1" × 24.7" / 597 × 561 × 626 mm)
INTERIOR DIMENSIONS (W X F-B X H)
13.8" × 14.9" × 14.8" / 350 × 378 × 375 mm)
NET WEIGHT, NOMINAL
VOLUME
110 lbs / 50 kg
1.7 cu.ft. / 49 liters nominal
OPERATING SYSTEM
CO2 SENSOR
Thermal
INCU-SAFE COPPER ENRICHED STAINLESS STEEL INTERIOR
Standard
MICROPROCESSOR CONTROLLER/DISPLAY, DOOR MOUNTED
Standard
DIRECT HEAT, AIR (DHA) JACKET
Standard
®
DECONTAMINATION
H2O2 DECONTAMINATION
STANDARD, COPPER ENRICHED STAINLESS STEEL INTERIOR
When docked to work station
Germicidal protection
ENVIRONMENTAL PERFORMANCE
TEMPERATURE CONTROL RANGE
+7.0°C above ambient to 50°C in a 5°C to 35°C ambient
TEMPERATURE CONTROL UNIFORMITY AND DEVIATION
±0.25°C in 25°C ambient, setting 37°C, 5% CO2, no load
CO2 CONTROL RANGE AND DEVIATION
AIRFLOW
INTERIOR HUMIDITY
0% to 20%, ±0.15% in 25°C ambient, setting 37°C, 5% CO2, no load
Continuous with inner door closed
95%RH @ 37°C through evaporation via DHA heating system;
optional reflective/deflective optical low water sensor
CONTROL, MONITORING, ALARM
TEMPERATURE AND CO2 CONTROL
DISPLAY
COMMUNICATIONS
Setpoint resolution 0.1°, 0.1%
LED, resolution 0.1°, 0.1%
Optional 4-20mA connection; Optional PC interface MTR-480
CABINET DESIGN AND CONSTRUCTION
SUPERSTRUCTURE, EXTERIOR CABINET AND DOOR
INTERIOR AND SHELVES
INNER DOOR
Galvanized steel exterior, baked-on enamel finish
Copper-enriched stainless steel
Tempered glass
INSULATION
Rigid foam polyurethane
OUTER DOOR
Side oriented for docking with work station
ACCESS PORT
Single, 1.18" / 30mm with silicone stopper
LEVELING FEET
Adjustable
ENERGY, ELECTRICAL, UTILITIES
MAXIMUM POWER CONSUMPTION
MAXIMUM HEAT DISCHARGE
ELECTRICAL
CO2 GAS CONNECTION
CO2 GAS INPUT PRESSURE
18
205W
740kJ/h
115V,60Hz
4 to 6 mm barbed fitting
Nominal 0.03 MPaG/0.3kg/cm2/5.0lbs/sq.in; from two-stage CO2 regulator
Professional
Service and Support
We provide full product service support to maintain Panasonic standards of product safety, reliability and high performance. The combination
of our multi-national network of factory-trained
service professionals, detailed documentation of
field performance, and high-value on the customer feedback helps us to deliver best-in-class,
end-user support for our customers.
Convenience of Panasonic Product Service
• Panasonic service specialists are trained to:
- perform remote and on-site diagnostics
- repair and replace worn components
- offer preventative maintenance programs
as per your needs and budget
• Many Panasonic Healthcare products include self-diagnostics that permit authorized service technicians to
determine how and when service calls are required.
Validation Services
Panasonic offers a wide range of high-quality services for all our equipment. These services include
on-site validation, customer validation support
packages, factory acceptance testing and NIST
calibration.
Choosing Panasonic as an equipment supplier and
validation consultant can greatly reduce the time
and cost involved with getting new equipment compliant and ready for use.
• We offer training to selected facility biomedical
engineers and service staff for authorized in warranty
and post-warranty repairs.
• Because our products are sold and serviced worldwide, products acquired in one country under grant
or facility-sharing programs are easily supported if
moved to facilities in the next city or around the world.
Unique Services Panasonic Offers:
• On-site consultation
• Unit specific authorized protocol documents
• Customizable testing procedures to meet customer
specific requirements
• Free archiving of unexecuted testing protocols
• Unbiased testing of competitive equipment
Pre-delivery Services:
On-site Services:
• validation support,
• installation qualification,
• consultation,
• operational qualification,
• factory acceptance testing,
• performance qualification,
• calibration
• calibration and
• temperature mapping
• temperature mapping.
19
Panasonic Healthcare Corporation of North America
1300 Michael Drive, Suite A, Wood Dale, IL 60191
Toll Free USA (800) 858-8442, Fax (630) 238-0074
us.panasonic-healthcare.com
AW/08/2014
© Panasonic Printed in USA