Integrated Cell Processing Work Station — CPWS - Sanyo

CPWS Features: 

www.sanyobiomedical.com 

My Life. My Work. My Choice. 

Integrated Cell 

Processing Work 

Station — CPWS 

PPLF-4205 

• Cost effective, space-saving solution 

for GMP and GTP compliant regenerative 

medicine and cell therapy. 

• Minimizes the expense of a cleanroom laboratory

PPLF-4205 

SANYO CPWS Integrated Cell Processing Work Station 

Minimizes Cleanroom Expense 

Self-Contained 

Space-Saving 

Quick to Acquire and Install 

GMP and FDA Compliant for Aseptic Process 

User Friendly 

Energy Efficient, Green Design 

The Essential Work Station for Cell Therapeutics 

Continued worldwide development of new methods and processes in cell therapy and 

regenerative medicine requires renewed emphasis on tools and technologies required to 

establish and maintain aseptic conditions demanded of the clinical environment. SANYO 

has met that challenge. 

2 CWPS Integrated Cell Processing Work Station www.sanyobiomedical.com 

In designing the industry’s first viable alternative to a conventional Class 10,000 cleanroom 

for both Class 100 air quality and barrier isolation, SANYO has introduced the Cell Processing 

Work Station (CPWS) to bring the potential of cell therapeutics to more facilities while 

mitigating acquisition and operation costs and protracted time lines. 

Ophthalmalogy and 

Organ Replacement/ 

Preservation 

Dental/Oral 

Skin 

Urology 

Global Cell Therapy and 

Tissue Engineering Market 

2010 & 2015 

General 

Cancer 

Cord Blood and Cell Banking 

Orthopedics/Spine 

Cardiology 

Neurology 

Millions of Dollars 

$25,000 

$20,000 

$15,000 

$10,000 

$5,000 

$0 

2010 2015 

Cell/Tissue 

Banking 

Cancer 

General Surgery, 

GI, Gyn, Others 

Ophthalmalogy 

Organ 

Dental 

Skin 

Urology 

Ortho 

Neuro 

Cardio

The Market 

Immediate beneficiaries of the SANYO 

CPWS include both private and public 

institutions serving the life science, 

clinical, biotechnology and pharmaceutical 

markets. These include mainstream 

and scale-up pharmaceutical companies 

focused on drug and medical device 

development related to human cells, 

medical researchers applying cellular 

therapies in clinical trials, and hospitals 

now deploying FDA approved cellular 

therapeutics to treat a broad range 

of diseases. 

As the science progresses and results 

are propagated throughout the medical 

and scientific community, the need for 

bench-level research and production is 

expanding exponentially. As a result, the 

availability of the SANYO free-standing, 

self-contained work station apart from 

the conventional layered cleanroom 

approach to containment and protection, 

is bringing the capability for on-site 

cellular therapeutics to more facilities 

more quickly and at a lower capital and 

operational cost, all within the GMP 

performance envelope required of the 

cell technology itself. 

Self-Contained System, 

Small Footprint 

The SANYO concept of a self-contained 

work station is enabled by the company’s 

demonstrated proficiency for in situ 

decontamination required to separate 

processes from one patient to the next, 

or one protocol to another. By using a 

highly effective H2O2 decontamination 

process, the CPWS can be completely 

sterilized without heat and prepared for 

the next protocol within two hours as 

compared to a cleanroom decontamination 

function can take days or weeks. 

By increasing throughput within the 

parameters of GMP compliance and FDA 

guidelines, the CPWS is deployed for 

both 

research, cellular manipulation and 

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 a primary design attribute of the 

CPWS. All work must be performed without 

human error, in an aseptic environment, 

and with detailed documentation 

to assure quality and compliance. Gownup 

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 SANYO H2O2 decontamination 

process diminishes both time 

and labor associated with this critical 

step between patients, positioning 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 

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 process 

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 sterilization sequences are 

available to protect the aseptic environ- 

ment. 

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 easier access 

and glare reduction. 

What You Don’t Need 

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 and lead times 

from decision to operation are shortened. 

Once in place, operational costs are 

highly contained and predictable, with 

sterilization available more frequently and 

at a fraction of conventional cost. 

The SANYO Difference 

SANYO Biomedical, a division of SANYO 

North American Corporation, is headquartered 

in suburban Chicago. For over 

forty years, SANYO 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, SANYO addresses global 

needs such as energy, food, housing, 

healthcare and information technology. 

As a part of the SANYO product line 

worldwide, the Cell Processing Work 

Station exemplifies our unique Vertical 

Component Integration approach to 

product development, combining 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. 

3

SANYO CPWS Series Technical Attributes 

The SANYO CPWS work station is 

designed to deliver efficient, costeffective 

and 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 and improves 

operator comfort and convenience. 

• Operating costs are lower than 

cleanroom costs 

• Work is easily suspended and 

resumed without the need to 

de-gown and re-gown, improving 

user comfort. 

• Fast decontamination and changeover 

improve productivity, increase 

throughput and deliver quicker return 

on investment. 

• Recordkeeping and process 

documentation are easier to manage. 

Components and operating systems are 

configured around a central work station 

with a HEPA filtration and air management 

system designed to deliver Class 

100 air to the work surface within the 

glove box. 

• Central barrier isolator 

• Pass box interchange 

• Integrated H2O2 

decontamination 

system 

• Optional cell observation system with 

microscope and monitor 

• Optional centrifuge integrated into 

the work surface 

• Optional CO2 

incubator with 

docking collar 

• The optional incubator and optional 

centrifuge operate within a Class 100 

environment. 

CPWS Work Station 

The SANYO CPWS work station is a 

component-based design that permits 

long-term or quick turnover selfcontained 

protocols with efficiency and 

safety for the product as well as personnel. 

As an integrated system, all functions 

associated with good laboratory 

technique, environmental control and 

ergonomic comfort are selected for compatibility 

and complementary functional 

performance. 

1. Modular CO2 incubator, shown on 

cart, docked to barrier isolator. 

2. Incubator cart with locking casters; 

offset casters nest with 

frame assembly when docked. 

3. Lid cam latch 

4. Centrifuge controller 

5. Centrifuge module accessible 

for the aseptic work area. 

6. Glove port 


1 

2 

14 

15 

18 

3 

7. Hinged front access assembly; 

front lifts up when total interior 

access is required. 

8. Interchange pass box with manually 

initiated, automatic sequence H2O2 

decontamination system. 

9. System controller 

10. H2O2 liquid supply cartridge 

11. HEPA supply and exhaust filtration 

blower motor assembly 

12. Electrical compartment 

13. Interior fluorescent lamps 

14. Electropolished interior surfaces 

15. Angled 6° front for user comfort, 

reduced glare 

16. Locking screws to secure 

hinged front. 

17. Adjustable leveling feet 

18. Optional cell monitor LCD 

7 

5 

16 

11 

17 

6 

13 

4 

8 

9 

12 

10

SANYO CPWS Series Applications 

Clinical Applications of Cell Therapies 

Disease States Cell Therapies 

Cancer 

Hematopoietic Stem Cell 

(HSC) Transplantation 

Immunotherapy 

Orthopedic 

Autologous and allogeneic HSC; Ex vivo expansion of HSC; 

‘Suicide’ T-cells – gene transfer; Stem cell transplantation 

Dendritic cells; NK/T cells; Macrophage-activated killer cells; 

T-cell expansion; NK cells; Co-stimulatory molecules (gene transfer) 

Expanded chondrocytes; Mesenchymal stem cells 

Neurodegenerative Disorders/Trauma 

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) 

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) Bioartificial kidney 

Wound Healing 

Infectious Diseases 

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. 

Applications 

The SANYO CPWS enables a broader 

access to cell therapeutics related to 

both minimally manipulated and nonminimally 

manipulated cell products by 

lowering the cost of entry, extending 

the process to the widest range of 

applications, and minimizing 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, quality controlled for 

repeatability and thoroughly 

documented. 

• GMPs typically require expensive 

hard wall laboratories and laboratory 

suites using biological safety 

cabinets in Class 10,000 cleanrooms 

surrounded by a Class 100,000 room. 

5

SANYO CPWS Series Benefits 

Comparative Operating Costs 1 (Nominal), SANYO CPWS vs. Conventional Cleanroom, Annual 

SANYO Cell Processing Work Station (CPWS) Conventional GMP Cleanroom 

Function Annual Budget 

(nominal) 


Function Annual Budget 

(nominal) 

H2O2 Cartridge, 25g, Total System Decontamination $9,000 Disinfection, Cleaning $9,000 

H2O2 Cartridge, 5g, Pass Box Only Decontamination $13,320 Routine Sanitation $12,000 

Residual H2O2 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 

Work Station $907 Biosafety Cabinet, Supply Filter $343 

Interchange Pass Box $294 Biosafety Cabinet, Exhaust Filter $190 

Room $833 Certifier Labor, BSC Formalin Decontamination $956 

Labor $1,330 Cleanroom Air Supply $2,916 

Validation Expenses Validation Expenses 

Cleanroom Air Exhaust $1,516 

Certifier Labor, CR Formalin Decontamination $1,500 

Cleanliness and Air Volume Report $1,440 Biosafety Cabinet and Report $1,050 

Decontamination Performance BI Inspection $3,230 Cleanroom and Report $10,000 

H2O2 Mist Uniformity Inspection $720 Centrifuge and Report $1,350 

Centrifuge Module and Report $1,350 CO2 Incubator Module and Report $850 

CO2 Incubator Module and Report $1,250 

Approximately 35% Less Expensive to Operate 

The SANYO CPWS offers significantly lower operating costs when 

compared to a conventional cleanroom (open system). Comparison 

methodology and assumptions are available from SANYO. Softcost 

benefits related to user convenience and comfort, flexibility, 

throughput and other demonstrated advantages of the CPWS can be 

established through consultative review. Contact SANYO for details. 

Power Consumption $18,057 Power Consumption $28,972 

Nominal Annual Budget $60,100 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. SANYO offers consultative assistance in developing a cost/benefit analysis specific to your facility and 

protocol. Contact SANYO to arrange a report unique to your prospective application

SANYO CPWS Benefit vs. Conventional Cleanroom (Closed System vs. Open System) 

Comparison 

General 

SANYO CPWS 

Barrier Isolator 

Closed system, requires only 

Class 100,000 air 

Lead Time and Cost Minimal; Cost of Class 100,000 room plus CPWS 

Space/Footprint Allowance Minimal footprint in existing space 

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 

Validation Costs Minimal; Requires Class 100,000 only. High; Requires both Class 100 and Class 100,000. 

Operation Cost Low 

High; Repeated decontamination and maintenance 

costs. Higher consumables cost 

Implementation Weeks Months or Years 

Ergonomics and User Comfort 

Flexibility 

Throughput 

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. 

Conventional first and second gowning, external air 

supply, interlock doors/air showers 

Inflexible 

Limited due to product changeover criteria 

Security 

Decontamination and Sterilization 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. 


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 circulation; 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 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. 

7

SANYO CPWS Series Features 

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. 

Original 

Cells 

Standard of Particle Control 

ISO14644-1 FDA EU-GMP Annex 1 JP WHO-GMP TRS902 Annex 6 

Class 5 

Class 7 

Class 8 

Class 100 

In Operation 3,520 

Class 10,000 


Class 100,000 

In Operation 3,520,000 

Class 9 — 

Extraction Preparation Culture Administration 

Grade A 


Grade B 


At rest 3,500 

Grade C 


At rest 350,000 

Grade D 

At rest 3,500,000 

H2O2 Decontamination System 

• The manually initiated, automatically 

sequenced H2O2 decontamination 

system offers a fast, safe and proven 

sterilization process to enhance 

the performance of the CPWS by 

allowing more frequent turnover of 

segregated cell lines. 

• The validated H2O2 

system generates 

an H2O2 vapor that permeates all 

exposed surfaces from the central 

interchange pass box nebulizer 

containing a replaceable bottle of 

enriched hydrogen peroxide. 

• When deployed, the H2O2 

vaporization 

sequence decontaminates the pass 

box, work station interior, centrifuge 

and 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 


Grade A 


Grade B 


At rest 3,520 

Grade C 


At rest 352,000 

Grade D 

At rest 3,520,000 

Grade A 


Grade B 


At rest 3,500 

Grade C 


At rest 350,000 

Grade D 

At rest 3,500,000 

Prepared 

Cells 

a wide range of pathogens (contact 

SANYO for independent test results). 

• 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 H2O2 

decontamination. 

• Decontamination is manually initiated 

and automatically sequenced once 

started. 

• When the H2O2 

vaporization process is 

complete, the inner door is opened and 

the transfer is completed. 

• Door interlocks permit simultaneous 

opening to protect the barrier isolator.

D 

00,000) 

SANYO CPWS Series Aseptic Environment 

Conventional GMP Cleanroom Facility (Open System) 

with Biological Safety Cabinets 

4 m2 

Class A 

(100) 

18 m2 

-152ºC 

10 m2 

18 m2 

-32ºC 

PS 

3 m2 

PS 

11 m2 

PS PS 

Class B 

(10,000) 

PS 

6 m2 

PS 

11 m2 

16 m2 

Class C 

IO(100,000) 

16 m2 

PS PS PS 

PS 

PS 

10 m2 

7 m2 

Class D 

AR(100,000) 

SANYO CPWS, Barrier Isolator 

with Integrated Systems 

The SANYO 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. 

PPLF-4205 

Aseptic level 

low (D) 

-152ºC 

Aseptic level 

mid (C) 

Aseptic level 

high (B) 

Aseptic level raised gradually 

Air lock 

General environment (not clean) 

Highest aspect level = Aseptic 

(safety cabinets, etc) 

Cleanroom: 

-32ºC 

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. 

• Access through the glove ports 

improves user comfort. 

The integral H 

• 2O2 decontamination 

system is completed in less than two 

hours, permitting frequent changeover 

and assuring separation integrity from 

one cell process to the next. 

(A) 

9


CO2 Incubator 

The modular CO2 incubator is an adaptation 

of the full-performance SANYO 

MCO-5AC(IS). This incubator is designed 

for precise temperature and CO2 control 

with elevated relative humidity to minimize 

cell desiccation. 

• 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 patient-specific cells. 

• Segregation permits compliance 

with published FDA criteria associated 

with regenerative medicine and 

in vivo cell therapies. 

• The incubator attaches to a docking 

collar adjacent to the barrier isolator. 

• Once attached, the barrier isolator 

undergoes a 2-hour H2O2 

decontamination process before 

the incubator door is opened. This 

process sterilizes the work area, 

incubator face, centrifuge and 

pass-thru interchange. 

• The H2O2 

effectively decontaminates 

the CO2 connection. 

• When work is complete, the 

incubator is sealed, detached and 

moved to a user-defined staging 

location on a wheeled cart. 

• The next incubator can be moved into 

position to repeat the process for 

another patient. 

• There is no limit to the number of 

SANYO MCO-5AC(IS) incubators that 

can be used with the work station. 

10 CWPS Integrated Cell Processing Work Station 

Incubator Features and Benefits 

The incubator is a modification of 

SANYO’s popular MCO-5AC. The compact 

1.4 cu.ft. (49 liter) interior chamber 

is constructed of SANYO’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 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 rounded-corner, electropolished 

interior is configured for use with 

a variety of standard cell culture 

vessels. 

• All interior components are designed 

to withstand repeated H2O2 decontamination 

cycles expected in high 

turnover environments. Components 

are removable without tools. 

Modular Incubator 

Model MCO-5AC(IS) 

docked to the CPWS 

Centrifuge 

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 H2O2 

vaporization cycle. 

• The integrated design eliminates 

the requirement for additional floor 

space in a GMP environment. 

• A variety of fixed and swinging 

rotorsis available. 

• Centrifuge controls are located 

external to the work area at the 

front of the centrifuge module. 

CPWS Centrifuge


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 work station 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. 

11


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 self-contained, 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. 

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 large, 19" 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 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. 

1 


2 

Pass Box Decontamination 

3 

Decontamination System 

Materials are brought into the work chamber from the The CPWS includes an H2O2 decontamination system 

outside through the pass box interchange. The H2O2 that generates H2O2 vapor to produce validated results. 

decontamination is manually initiated and automatically This system covers the pass box interchange, glove 

sequenced, thoroughly sterilizing the pass thru material box work area, optional centrifuge and optional CO2 

and protecting the integrity of the work surface. The incubator. The enriched H2O2 solution is contained in 

interchange contamination process can function alone, a replaceable bottle and inserted as a cartridge inside 

independent of the glove box. 

the decontamination module. 

Operator’s 

Monitor 

Observation 

Module 

AC Power 

Control/Relay 

Box 

2 

Images from PC 

Camera IF 

Various Signals IF 

Lighting VCC, GND 

Light Dimming Signal 

Cameral IF (power, image signals) 

Power SW Signal 

Capture SW Signal 

3 

PC for Capturing

SANYO CPWS Model PPLF-4025 Specifications 

Component Specifications 

Component Description 

Barrier Isolator Base Unit 

Interchange Pass Box Included 

Airflow and HEPA Filtration System Included 

H2O2 System Included 

Centrifuge Optional 

CO2 Incubator Optional 

Cell Observation System Optional 

Centrifuge and Module 

System Summary Specifications 

Component Order Number 

Base Work Station, 


Feature Specification 

PPLF-4025 

Interchange Included 

HEPA Filtration System Included 

Centrifuge Optional 

Cell Observation Module Optional 

CO2 Incubator MCO-5AC(IS) 

Exterior Dimensions (w x f-b x h) 21.25" × 22.9" × 30.3" (540 x 582 x 771 mm) 

Maximum Speed 2100 RPM 

Maximum Centrifugal Acceleration 10 to 970G centrifugal acceleration settable range 

Controls, Alarms Externally mounted, front, with foot switch for cut-off.Door lock status displayed. 

Pre-Sets Up to 4 patterns in memory 

Time Settable Range 10 to 50 seconds (10 second increments); 1 to 99 minutes (1 minute increments); and infinite 

Acceleration/Deceleration Settings 3 stage 

Motor Shaft Stainless steel 

Capacity 1000ml (50ml tubes, × 20) 

13



Dimensions 

Overall Exterior Dimensions (w x f-b x h) 115" × 41" × 87.8" (2920 × 1045 × 2230 mm) net of attached optional incubator 

Interior Dimensions (w x f-b x h) 70.7" × 28.5" × 34" (1796 × 726 × 864 mm) 

Interior Work Surface Elevation 31.5" above floor (800 mm) 

Glove Elevation 41.3" above floor (1050 mm 

Pass Box Interchange (w x f-b x h) 19.6" × 16.7" × 15.8" (500 × 425 × 400 mm) 

Net Weight 2207 lbs/1000 kg, nominal 

Controls, Alarms 

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

Fan Motor 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 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 

Positive pressure after decontamination of work station and pass box; 

audible notification when ready, 60Pa 

Pass Box Interchange Positive pressure after decontamination of pass box only; audible notification when ready, 220Pa 

Interior Work Area 

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

Electrical Outlet Duplex, drip-proof receptacle 

Pass Box Interchange 

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

Material 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.


CO 2 Incubator (Modular), SANYO MCO-5AC(IS) 

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 110 lbs/50 kg 

Volume 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) Air Jacket Standard 

Sterilization and Decontamination 

H2O2 Decontamination When docked to work station 

Standard, Copper Enriched Stainless Steel Interior 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 0% to 20%, ±0.15% in 25°C ambient, setting 37°C, 5% CO2, no load 

Airflow Continuous with inner door closed 

Interior Humidity 

95%RH @ 37°C through evaporation via DHA heating system; 

optional reflective/deflective optical low water sensor 

Control, Monitoring, Alarm 

Temperature and CO2 Control Setpoint resolution 0.1°, 0.1% 

Display LED, resolution 0.1°, 0.1% 

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

Cabinet Design and Construction 

Superstructure, Exterior Cabinet and Door Galvanized steel exterior, baked-on enamel finish 

Interior and Shelves Copper-enriched stainless steel 

Inner Door 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 205W 

Maximum Heat Discharge 740kJ/h 

Electrical 115V,60Hz 

CO2 Gas Connection 4 to 6 mm barbed fitting 

CO2 Gas Input Pressure Nominal 0.03 MPaG/0.3kg/cm2/5.0lbs/sq.in; from two-stage CO2 regulator 

15

SANYO Service and Support 

Unique SANYO Services 

• On-site consultation 

Model PPLF-4205 

• Specialized documentation for each 

individual unit 

• Customized testing procedures 

based on personalized customer 

requirements 

SANYO Connect 

SANYO’s customer-driven biomedical 

service program guarantees local 

attention from qualified SANYO service 

representatives, whenever and wherever 

you need it. 

• New Unit Installation and Training 

• Preventative Maintenance 

• Warranty and Non-Warranty Repairs 

• Calibration/Validation Services 

• Refurbishment and Reconditioning 

• Customized Service and Warranty 

Programs 

• In-Stock Parts for Immediate Delivery 

SafeCell UV U.S. Patent 6255103; Direct Heat and Air Jacket U.S. Patent 5519188; 

SafeCell UV, inCu saFe , Direct Heat and Air Jacket , P.I.D./R and Active Background 

Contamination Control , are trademarks of SANYO Electric Biomedical Co., Ltd. 

© 2010 Specifications subject to change without notice. 

Pre-Delivery and On-Site Services 

Pre-delivery services include factory 

acceptance testing, calibration, and 

temperature mapping. On-site services 

include installation qualification, 

operational qualification, performance 

qualification, calibration and temperature 

mapping. 

SANYO North America Corporation 

Biomedical Solutions Division 

1300 Michael Drive, Suite A, Wood Dale, IL 60191 USA 

Toll-Free 800-858-8442 Fax 630-238-0074 

www.sanyobiomedical.com

Integrated Cell Processing Work Station — CPWS - Sanyo

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