Integrated Cell

Processing Work Station

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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

4

$20,000

$15,000

$10,000

$5,000

Cell/Issue Banking

Cancer

General Sur GI,Gyn,Others

Ophthalmalo

Organ

Dental

Skin

Urology

Osthol

Neuro

Cardio

Cord Blood and Cell Banking

Cancer

General

Ophthalmalogy and Organ

Replacement/ Preservation

Dental/Oral

Skin

Urology

Cardiology

Neurology

Orthopedics/Spine

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.

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 (H

2

O

2

) 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 H

2

O

2

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 H

2

O

2

decontamination process supplements continuous HEPA filtration. As 0.3 micron particles are removed from the fresh air exchange, H

2

O

2

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

6

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 H

2

O

2

decontamination system

Optional cell observation system with microscope and monitor

The optional incubator and optional centrifuge operate within a Class 100 environment.

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 CO

2

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

13

4

2

5

8

6

9

12

10

1

2

3

HEPA supply and exhaust filtration blower motor assembly

Hinged front access assembly. Front lifts up when total interior access is required.

Interchange pass box with manually initiated, automatic sequence H

2

O

2

, decontamination system.

4

Interior fluorescent lamps

5

Glove port

6

7

8

9

Electrical compartment

System controller

Centrifuge module accessible for the aseptic work area.

Centrifuge controller

10

11

Adjustable leveling feet

Optional cell monitor LCD

12

13

Incubator cart with locking casters; offset casters nest with frame assembly when docked.

Modular CO

2 incubator, shown on cart, docked to barrier isolator.

7

Applications

Clinical Applications of Cell Therapies

DISEASE STATES

CANCER

HEMATOPOIETIC STEM CELL

(HSC) TRANSPLANTATION

IMMUNOTHERAPY

ORTHOPEDIC

NEURODEGENERATIVE

DISORDERS/TRAUMA

CELL THERAPIES

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

CARDIOVASCULAR DISEASE

Infusion of marrow/blood-derived angio blasts;

CD34 stem cells; cardiac cells*

ORGAN REPLACEMENT

PANCREAS (DIABETES)

LIVER (FAILURE, METABOLIC

DISORDERS)

KIDNEY (FAILURE)

WOUND HEALING

Pancreatic islet cells; Embryonic stem cell-derived islet cells;

Adult stem cell-derived islet cells

Bioartificial liver; Isolated hepatocytes; Hepatocyte stem cells

Bioartificial kidney

Keratinocytes; Skin stem cells

INFECTIOUS DISEASES

Antigen-loaded dendritic cells; Lymphocyte expansion;

Macrophages

GENETIC DEFICIENCIES

HEMOPHILIA

SCID

CYSTIC FIBROSIS

Gene Therapy

Gene Therapy

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.

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 Costs

1

(Nominal), Panasonic CPWS vs. Conventional Cleanroom,

PANASONIC CELL PROCESSING WORK STATION (CPWS) CONVENTIONAL GMP CLEANROOM

H

2

O

2

Cartridge, 25g, Total System Decontamination

H

2

O

2

Cartridge, 5g, Pass Box Only Decontamination

Residual H

2

O

2

Detector

Gloves, 3 gloves, 2×

Sleeves, 3 gloves, 1×

HEPA FILTERS

Work Station

Interchange Pass Box

Room

Labor

VALIDATION EXPENSES

Cleanliness and Air Volume Report

Decontamination Performance BI Inspection

H

2

O

2

Mist Uniformity Inspection

Centrifuge Module and Report

CO

2

Incubator Module and Report

POWER CONSUMPTION

NOMINAL ANNUAL BUDGET

$9,000

$13,320

$2,664

$1,140

$3,640

$907

$294

$833

$1,330

$1,440

$3,230

$720

$1,350

$1,250

$18,057

$60,000

Disinfection, Cleaning

Routine Sanitation

Particle Sensors

Sterilized, Non-Shedding Gowns

HEPA FILTERS

Biosafety Cabinet, Supply Filter

Biosafety Cabinet, Exhaust Filter

Certifier Labor, BSC Formalin Decontamination

Cleanroom Air Supply

Cleanroom Air Exhaust

Certifier Labor, CR Formalin Decontamination

VALIDATION EXPENSES

Biosafety Cabinet and Report

Cleanroom and Report

Centrifuge and Report

CO

2

Incubator Module and Report

POWER CONSUMPTION

FUNCTION

ANNUAL BUDGET

(NOMINAL)

$9,000

$12,000

$3,000

$18,000

$343

$190

$956

$2,916

$1,516

$1,500

$1,050

$10,000

$1,350

$850

$28,972

NOMINAL ANNUAL BUDGET

$91,600

1

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

Who Benefits from CPWS

MARKET

ACADEMIC

ACADEMIC

CLINICAL

PRIVATE INDUSTRY

FACILITY

Cancer centers

Medical research

Hospitals

Biotechnology,

Pharmaceutical

PROTOCOL

Cancer treatment, translational medicine

Regenerative medicine

CPWS BENEFIT

Easy segregation of patient-specific cells

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.

10

Orginal

Cells

Extraction Preparation Culture Administration

Prepared

Cells

CPWS SOLUTION

Glove Box

HEPA Filters

35%

More Cost

Efficient

TYPICAL CLEANROOM

Detachable

Incubator

Class 100

Centrifuge

Pass

Box

Change Room

Class

100,000

Class

100,000

Class

100,000

* Drawing not to scale

Class

10,000

Class 100-BSC

Class

10,0

00

Class

10,000

COMPARISON

GENERAL

PLANNING AND LEAD TIME

SPACE/FOOTPRINT ALLOWANCE

VALIDATION COSTS

OPERATION COST

PANASONIC CPWS

BARRIER ISOLATOR

Closed system, requires only

Class 100,000 air

Minimal; Cost of Class 100,000 room plus CPWS

Minimal footprint in existing space

Minimal; Requires Class 100,000 only.

Low

CLEANROOM

WITH BIOLOGICAL SAFETY CABINETS

Open system, requires significant investment and maintenance of background environment,

Class 10,000 air

High; Cost of Class 10,000 cleanroom plus Class 100 one or more Class 100 biological safety cabinets

Dedicated new/retrofit facility with significant requirement for HVAC, filtration, air showers

High; Requires both Class 100 and Class 100,000.

High; Repeated decontamination and maintenance costs. Higher consumables cost

Months or Years IMPLEMENTATION

ERGONOMICS AND USER COMFORT

FLEXIBILITY

THROUGHPUT

DECONTAMINATION

EQUIPMENT AND

INSTRUMENTATION

Weeks

No second gowning required. Central barrier isolator with ergonomically angled front permits easy access through glove ports. Reduces stress on workforce.

Elimination of hazardous fumes for decontamination permits diverse applications. Elimination of depolymerizing formaldehyde, formalin and other toxic chemicals permits transition between applications seamlessly.

Expanded. Quick changeover extends use, optimizes return on investment. Component integration streamlines workflow while enhancing aseptic processing.

Two Hours

Microscopes and other instrumentation can be dedicated to the work station.

Conventional first and second gowning, external air supply, interlock doors/air showers

Inflexible

Limited due to product changeover criteria

Up to Two Weeks

Shared instrumentation in an open system exposes processes to cross contamination.

ISO14644-1

CLASS 5

CLASS 7

CLASS 8

CLASS 9

FDA

Class 100

In Operation 3,520

Class 10,000

In Operation 35,200

Class 100,000

In Operation 3,520,000

—

EU-GMP ANNEX 1

Grade A

In Operation 3,500

Grade B

In Operation 350,000

At rest 3,500

Grade C

In Operation 3,500,000

At rest 350,000

Grade D

At rest 3,500,000

JP

Grade A

In Operation 3,520

Grade B

In Operation 352,000

At rest 3,520

Grade C

In Operation 3,520,000

At rest 352,000

Grade D

At rest 3,520,000

WHO-GMP TRS902 ANNEX 6

Grade A

In Operation 3,500

Grade B

In Operation 350,000

At rest 3,500

Grade C

In Operation 3,500,000

At rest 350,000

Grade D

At rest 3,500,000

Aseptic Environment

Conventional GMP Cleanroom Facility (Open System) with Biological Safety Cabinets

COMPARISON

GENERAL

PLANNING AND LEAD TIME

SPACE/FOOTPRINT ALLOWANCE

VALIDATION COSTS

OPERATION COST

PANASONIC CPWS

BARRIER ISOLATOR

Closed system, requires only

Class 100,000 air

Minimal; Cost of Class 100,000 room plus CPWS

Minimal footprint in existing space

Minimal; Requires Class 100,000 only.

Low

CLEANROOM

WITH BIOLOGICAL SAFETY CABINETS

Open system, requires significant investment and maintenance of background environment,

Class 10,000 air

High; Cost of Class 10,000 cleanroom plus Class 100 one or more Class 100 biological safety cabinets

Dedicated new/retrofit facility with significant requirement for HVAC, filtration, air showers

High; Requires both Class 100 and Class 100,000.

High; Repeated decontamination and maintenance costs. Higher consumables cost

Months or Years IMPLEMENTATION

ERGONOMICS AND USER COMFORT

FLEXIBILITY

THROUGHPUT

DECONTAMINATION

EQUIPMENT AND

INSTRUMENTATION

Weeks

No second gowning required. Central barrier isolator with ergonomically angled front permits easy access through glove ports. Reduces stress on workforce.

Elimination of hazardous fumes for decontamination permits diverse applications. Elimination of depolymerizing formaldehyde, formalin and other toxic chemicals permits transition between applications seamlessly.

Expanded. Quick changeover extends use, optimizes return on investment. Component integration streamlines workflow while enhancing aseptic processing.

Two Hours

Microscopes and other instrumentation can be dedicated to the work station.

Conventional first and second gowning, external air supply, interlock doors/air showers

Inflexible

Limited due to product changeover criteria

Up to Two Weeks

Shared instrumentation in an open system exposes processes to cross contamination.

4 m2

18 m2

PS

6 m2

16 m2

Aseptic level low (D)

Highest aspect level = Aseptic

(safety cabinets, etc)

Aseptic level mid (C)

Aseptic level high (B)

Aseptic level raised gradually

(A)

4 m2

18 m2

Class A

(100)

10 m2

PS

11 m2

3 m2

Class B

(10,000)

PS PS

PS

11 m2

16 m2

Class C

IO(100,000)

PS

Panasonic CPWS, Barrier Isolator with Integrated Systems

The Panasonic CPWS offers significant throughput potential in a comparatively small footprint.

The CPWS can be installed in manageable Grade D (Class 100,000) environment, providing biological and physical protection between the work and the user.

18 m2

6 m2

16 m2

Access through the glove ports improves user comfort.

The integral H

2

O

2

decontamination system is completed in less than two hours, permitting frequent changeover and assuring separation integrity from one cell process to the next.

PS

PS

PS

PS

10 m2

7 m2

Class D

AR(100,000 )

-152ºC

Air lock

General environment (not clean)

-32ºC

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.

-152ºC

18 m2

-32ºC

11 m2 11 m2

10 m2

PS PS PS

10 m2

7 m2

16 m2

Class A

(100)

3 m2

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 H

2

O

2

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.

12

H

2

O

2

Decontamination System

• The manually initiated, automatically sequenced H

2

O

2 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 validated H

2

O

2

system generates an H

2

O

2

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 H

2

O

2

vaporization sequence decontaminates the pass box, work station interior, centrifuge, CO exterior, and docking gaskets.

2

incubator

• Once the vaporization is complete, the H

2

O

2

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.

Isolator Interchange

• The interchange pass box allows safe access to the work area for supplies, instruments, devices, sterile media, and labware.

• When materials are brought into the work station they are first positioned inside the interchange for H

2

O

2

decontamination.

• Decontamination is manually initiated and automatically sequenced once started.

• When the H

2

O

2

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 H

2

O

2

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)

CO

2

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 CO

2

incubators to permit easier cell segregation. One incubator is attached to the work station at the docking collar and subjected to a quick, safe H

2

O

2

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

14

Series Features

CO

2

Incubator Incubator Features and Benefits

The modular CO

2

incubator is an adaptation of the fullperformance Panasonic MCO-5AC(IS). This incubator is designed for precise temperature and CO decontamination process before the incubator door is opened.

This process decontaminates the work area, incubator face, centrifuge and pass-thru interchange.

• The H

2

O

2

effectively decontaminates the CO

2

connection.

• When work is complete, the incubator is sealed, detached and moved to a user-defined staging location on a wheeled cart.

process for another patient.

2

control with elevated relative humidity to minimize cell desiccation.

• By using multiple, detachable CO

2

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.

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.

• An integrated microprocessor controller supervises all functions including temperature and CO monitoring.

• The incubator attaches to a docking collar adjacent to the barrier isolator.

• The rounded-corner, electropolished interior is configured for use with a variety of standard cell culture vessels.

• Once attached, the barrier isolator undergoes a 2-hour H

2

O

• The next incubator can be moved into position to repeat the

• There is no limit to the number of Panasonic MCO-5AC(IS) incubators that can be used with the work station.

2

Centrifuge

2

setpoints, control, alarm and

• The patented Direct Heat and Air Jacket control system assures temperature uniformity and stability essential to the most sensitive cell lines.

• All interior components are designed to withstand repeated H

2

O

2 decontamination cycles expected in high turnover environments.

Components are removable without tools.

The centrifuge is installed beneath the interior work surface and accessible under aseptic conditions without removing cells from the protected environment.

• The position and orientation of the centrifuge assures thorough decontamination during the H

2

O

2

decontamination cycle.

• 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

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

Materials are brought into the work chamber from the outside through the pass box interchange. The H

2

O

2

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.

3.

Decontamination System

The CPWS includes an H

2

O

2

decontamination system that generates H

2

O

2

vapor to produce validated results. This system covers the pass box interchange, glove box work area, optional centrifuge, and optional CO

2 incubator. The enriched H

2

O

2 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 H

2 sequences.

O

2

decontamination

• 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 can be captured via a non- contact 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.

AC Power

Images from PC

Control/Relay Box

Camera IF

Various Signals IF

Lighting VCC,GND

Light Dimming Sygnal

Cameral IF (power, image signals)

Power SW Signal

Capture SW Signal

Observation Module

PC for Capturing

15

16

Specifications

Component Specifications

COMPONENT

BARRIER ISOLATOR

INTERCHANGE PASS BOX

AIRFLOW AND HEPA FILTRATION SYSTEM

H

2

O

2

SYSTEM

CENTRIFUGE

CO

2

INCUBATOR

CELL OBSERVATION SYSTEM

DESCRIPTION

Base Unit

Included

Included

Included

Included

Optional

Optional

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

System Summary Specifications

COMPONENT

BASE WORK STATION,

BARRIER ISOLATOR

INTERCHANGE

HEPA FILTRATION SYSTEM

CENTRIFUGE

CELL OBSERVATION MODULE

CO

2

INCUBATOR

ORDER NUMBER

MHE-PF4025CW2-PA

Included

Included

Included

Optional

MCO-5ACIS

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

CONTROLS, ALARMS

PRESSURE MONITOR

FAN MOTOR

CONSTRUCTION

EXTERIOR FINISH

INTERIOR FINISH

FRONT GLOVE PORT PANEL, ANGLE 6°

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

Red LCD and audible alarm if pressure falls below alarm setpoint.

Audible alarm during motor shutdown

Painted steel

Polished stainless steel

Polycarbonate with painted steel frame. Hinged for opening to load equipment.

AIR SYSTEM

AIR QUALITY

Grade A Class 100 over work surface; installation in a Grade D, Class 100,000 ambient room

AIRFLOW SYSTEM AND VELOCITY

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

INTERIOR WORK AREA

LIGHTING

ELECTRICAL OUTLET

PASS BOX INTERCHANGE

DOOR

MATERIAL

DECONTAMINATION SYSTEM

FUNCTION

H2O2 RESOLUTION AND AERATION

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

Fluorescent lamps (3), 30w each, top of panel, top of right, left

Duplex, drip-proof receptacle

Front opening to outside; left side opening to interior work area

Polished stainless steel

H

2

O

2

vaporization; simultaneous decontamination of interior barrier isolator work station, pass box interchange, optional centrifuge and optional CO

2

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.

DECONTAMINATION CYCLE TIME

UTILITIES

ELECTRICAL

Main system, 4500w, 220V, AC, 60Hz. Electrical outlet 120V, AC, 60Hz.

17

18

Specifications

CO

2

Incubator (Modular), Panasonic MCO-5ACIS

DIMENSIONS

EXTERIOR DIMENSIONS WITHOUT STAND (W X F-B X H)

INTERIOR DIMENSIONS (W X F-B X H)

NET WEIGHT, NOMINAL

VOLUME

OPERATING SYSTEM

CO

2

SENSOR

INCU-SAFE

®

COPPER ENRICHED STAINLESS STEEL INTERIOR

MICROPROCESSOR CONTROLLER/DISPLAY, DOOR MOUNTED

DIRECT HEAT, AIR (DHA) JACKET

DECONTAMINATION

H

2

O

2

DECONTAMINATION

STANDARD, COPPER ENRICHED STAINLESS STEEL INTERIOR

ENVIRONMENTAL PERFORMANCE

TEMPERATURE CONTROL RANGE

TEMPERATURE CONTROL UNIFORMITY AND DEVIATION

CO

2

CONTROL RANGE AND DEVIATION

AIRFLOW

INTERIOR HUMIDITY

CONTROL, MONITORING, ALARM

TEMPERATURE AND CO

2

CONTROL

DISPLAY

COMMUNICATIONS

CABINET DESIGN AND CONSTRUCTION

SUPERSTRUCTURE, EXTERIOR CABINET AND DOOR

INTERIOR AND SHELVES

INNER DOOR

INSULATION

OUTER DOOR

ACCESS PORT

LEVELING FEET

ENERGY, ELECTRICAL, UTILITIES

MAXIMUM POWER CONSUMPTION

MAXIMUM HEAT DISCHARGE

ELECTRICAL

CO

2

GAS CONNECTION

CO

2

GAS INPUT PRESSURE

23.5"W× 22.1" × 24.7" / 597 × 561 × 626 mm)

13.8" × 14.9" × 14.8" / 350 × 378 × 375 mm)

110 lbs / 50 kg

1.7 cu.ft. / 49 liters nominal

Thermal

Standard

Standard

Standard

When docked to work station

Germicidal protection

+7.0°C above ambient to 50°C in a 5°C to 35°C ambient

±0.25°C in 25°C ambient, setting 37°C, 5% CO

2

, no load

0% to 20%, ±0.15% in 25°C ambient, setting 37°C, 5% CO

2

, no load

Continuous with inner door closed

95%RH @ 37°C through evaporation via DHA heating system; optional reflective/deflective optical low water sensor

Setpoint resolution 0.1°, 0.1%

LED, resolution 0.1°, 0.1%

Optional 4-20mA connection; Optional PC interface MTR-480

Galvanized steel exterior, baked-on enamel finish

Copper-enriched stainless steel

Tempered glass

Rigid foam polyurethane

Side oriented for docking with work station

Single, 1.18" / 30mm with silicone stopper

Adjustable

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 CO

2

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.

• 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.

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.

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:

• validation support,

• consultation,

• factory acceptance testing,

• calibration

• temperature mapping

On-site Services:

• installation qualification,

• operational qualification,

• performance qualification,

• calibration and

• 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