Sanyo STERISONIC GXP User Manual

Sterisonic™ GxP
Series Cell Culture
Incubators

CO2 Incubators

MCO-19AIC(UVH)
MCO-19AIC(UV)
MCO-19AIC

CO

/ O2 Incubators

2

MCO-19M(UVH)
MCO-19M(UV)
MCO-19M

Features:

• The industry’s most complete cell culture
solution for highly regulated applications or
conventional incubation.

• Safe, effective and documented two-hour in situ

sterilization for fastest decontamination.

H

2O2

www.sanyobiomedical.com

My Life. My Work. My Choice.

MCO-19AIC

MCO-19M
MCO-19AIC(UV)
MCO-19AIC(UVH)

MCO-19M(UV)

MCO-19M(UVH)

Sterisonic™GxP Series Cell Culture CO2 and CO2 / O2 Incubators

The industry’s most complete cell culture solution for highly regulated applications or conventional
incubation. Now with safe, effective and documented two-hour in situ H
decontamination turn-around and maximum availability.

Sterisonic™ GxP Selection

Feature

Vapor Sterilization Standard Optional Optional Standard Optional Optional

H

2O2

™

SafeCell

UV Decontamination Standard Standard Optional Standard Standard Optional

Single Beam, Dual Detector IR CO

Oxygen Concentration Control, Zirconia Control N/A N/A N/A Standard Standard Standard

Sensor Standard Standard Standard Standard Standard Standard

2

MCO-

19AIC(UVH)

CO2 Incubators CO2/O2 Incubators

MCO-

19AIC(UV)

MCO­19AIC

sterilization for fastest

2O2

MCO-

19M(UVH)

MCO-

19M(UV)

MCO-

19M

Product Applications

The combination of Sterisonic™ GxP
incubator performance functions permit
use with condence in high-value cell
protocols among hard-to-grow cell lines,
cells highly sensitive to contamination,
ultra-sensitive media and reagents, or
protocols that require a strict isolation
and sterilization between processes.
These include but are not limited to:

Stem cell research•

Autologous tissue regeneration •
and regenerative medicine

• In vitro fertilization

1

Genomic and proteomic expression•

Esoteric plant and amphibian •
cell culture

Hypersensitive and transgenic •
cell culture

Low media volume microplate work•

1

501(k) clearance applied for. Contact SANYO for status. MCO-19AIC
and MCO-20AIC CO2 incubators have received U.S. Food and Drug
Administration 510(k) clearance for in vitro fertilization applications in
accordance with the FDA Safe Medical Devices Act of 1990 and the Medical
Device Amendments of 1992. Reference: Number K013703. Regulation
Number: 21 CFR 884-6120, Assisted Reproduction Accessories, Regulatory
Class II, Product Code 85MOG, October 30, 2001

Designed for use with a variety
of standard cell culture vessels
and protocols.

Interior components and adjustable •
shelves are congured for easy access,
in situ sterilization and exible arrange­ment for a variety of applications.

Four adjustable shelves are included, •
standard; maximum shelf capacity
is 15 shelves.

MCO-19AIC(UVH)

MC O-19M

Multi-Gas Incubator, Oxygen
and CO2 Control

Ideal for • in vitro fertilization (IVF), genetic
research, regenerative medicine and
other protocols that require CO
sub-ambient (hypoxic) or above-ambient
oxygen control.

Cabinet based on MCO-19 platform •
with inCu safe
stainless steel chamber, continuous
contamination control, patented D.H.A.
multi-point, air-jacketed temperature
control system, elevated relative humidity
with integral water-level sensor.

™

copper-enriched

and

2

2 Sterisonic™ GxP Series Cell Culture Incubators

Sterisonc™ GxP Features and Benefits

The SANYO Sterisonic™ GxP is designed for a wide array of demanding and highly regulated applications in the biomedical, pharmaceutical,
medical research and clinical laboratory. Representing years of research, development and component testing, the Sterisonic™ GxP incorporates a
collective of mutually functional systems and design attributes to offer a holistic solution to cell culture protocols, from the most sophisticated to
more familiar and conventional processes.

Sterilization and Decontamination

The unique Sterisonic•
sterilization system limits downtime
to less than three hours when total
chamber sterilization with verication
is desired.

All interior components and CO•
sampling loop are sterilized in situ;
no need for removal and autoclaving.

Active Background Contamination •

™

Control

ghts contamination while

cell culture protocols are in process.

The patented SafeCell

system scrubs interior airow
to destroy airborne and humidity pan
contaminants.

Exclusive inCu saFe

enriched stainless steel interior
surfaces assure constant germicidal
protection.

™

GxP H2O2

2

™

UV

™

copper-

Shelf brackets are formed
with an exaggerated angle
to minimize surface contact
with flat shelves*.

Control and Monitoring

The Sterisonic•
information center includes an intuitive
pop-up menu, high resolution LCD
for inputs, outputs and performance
at-a-glance.

Multi-point data logging offers •
push-button graphical display. An
optional PC interface permits remote
transmission for GMP/GLP protocols
as required.

Precise PID logic controls and •
adjusts to all temperature, CO
points and alarm parameters.

™

GxP control and

set-

2

CO2 Control

SANYO proprietary single-beam,
dual detector infrared (IR2) CO

sensor delivers precise CO

control,

2

quick recovery following door openings,
and auto sampling with no moving parts.

Continuous zero calibration is standard.•

An optional semi-automatic, one-point •
calibration system is available. Catalog
No. MCO-SG; see Accessories.

2

Zirconia O2 Control System,
MCO-19M Series

A zirconia oxygen sensor main-

tains sub-ambient O
1% to 18%. Additionally, enriched O
levels from 22% to 80% are enabled
with proper safety precautions.

Concurrently the MCO-19M permits •
a CO

range 0% to 20% via infrared

2

sensor.

Nitrogen gas bubbler accelerates •
recovery of chamber humidity levels
following door openings.

An electronic P.I.D. control maintains •
accurate temperature and gas set­points over the entire system range.

The MCO-19M includes an automatic •
gas switchover system that changes
from the primary to a secondary gas
cylinder for either oxygen or nitrogen;
an optional second gas switchover
system is available for CO

Cabinet based on MCO-19 platform •
with inCu saFe

™

copper-enriched
stainless steel chamber, continuous
contamination control, patented D.H.A.
multi-point, air-jacketed temperature
control system, elevated relative hum­idity with integral water-level sensor.

levels from

2

.

2

2

MC O-19M

MCO-19M shown with
four separate inner
doors with gaskets.

3

Sterisonc™ GxP Features and Benefits

Temperature
and Humidity Control

The patented Direct Heat and Air•

™

conditioning system manages setpoint
temperature through multiple, variable
warming points under microprocessor
control.

The humidity pan is easy to ll, easy •
to clean; the automatic optical sensor
advises of low water level.

H2O2 Sterilization

The use of H2O2 sterilization in
biological safety cabinets and barrier iso­lators is a popular alternative to ethylene
oxide (EtO) as a safer, more efcient
decontamination method. H
been widely used in the pharmaceutical
industry. In aerospace research, H
used to sterilize satellites.

The FDA has recently granted 510(k)
clearance to use H

in individual medi-

2O2

cal device manufacturing applications.
EtO criteria outlined in ANSI/AAMI/ISO

has long

2O2

2O2

is

14937 may be used as a validation guide­line. For references online visit
www.sanyobiomedical.com/sterisonic.

Unlike conventional incubators, unique
features of the SANYO Sterisonic
GxP incubator permit use of the H
process in situ with complete safety,
zero impact on adjacent equipment or
the environment, and speed to return
the incubator to service.

The • H
tions with the patented SANYO
SafeCell

sterilization process func-

2O2

™

UV system. Following a
seven-minute H
circulation and dwell cycle, vaporization
is stopped and the SafeCell
turned ON for up to ninety minutes.

When exposed to UV light, the • H
vapor breaks down into water and
oxygen, leaving only traces of water
droplets. These droplets automati­cally condense onto a naturally cooler
section of the interior oor for easy
wipe-up.

Throughout the entire cycle the •
Sterisonic

™

GxP airow system con­tinues to gently circulate interior air
assuring 100% vapor contact with all
interior surfaces, ultimately creating
a serial dilution of H
over the UV lamp.

vaporization,

2O2

as it passes

2O2

™

2O2

™

UV lamp

2O2

Orientation of interior sample ports •
of the single beam, dual detector IR
CO

sensor creates a slight Venturi

2

ow through the sample chamber,
permitting total sterilization of the
CO

system at the same time.

2

Shape and location of interior compo-•
nents such as shelves, shelf brackets,
plenum covers and the humidity pan
permit the components to remain
in the chamber during the sterilization
process, conveniently bypassing the
need for a separate autoclave cycle.

Once the cycle is complete, the door •
locking system is released; the inner
door can be opened, interior compo­nents repositioned and the incubator
is returned to service.

Ergonomic Cabinet Design

With reversible inner and outer doors,
a single SANYO incubator offers the
industry's most exible installation
options available.

Low prole cabinet with door-mounted •
control panel permits easy access and
viewing.

The outer door latch and door heater •
cable is easily switched if a reverse
opening is required.

Sterisonic™ GxP Series H2O2 Sterilization Performance Value

2 Hours

SANYO
Sterisonic™

H2O

sterilization vs. high heat sterilization

2

= Uptime (Hours)

The documented two-hour in situ H2O2 sequence puts the fully sterilized Sterisonic™ GxP available and
ready for use quicker than any other incubator worldwide.

4 Sterisonic™ GxP Series Cell Culture Incubators www.sanyobiomedical.com

Brand X

=

Downtime (Hours)

14 Hours

Sterisonc™ GxP Features and Benefits

Cabinet knock-outs are pre-drilled •
and tapped to eliminate drilling and to
simplify re-mounting of door hardware.

The outer door closes against a •
soft, easily cleaned magnetic gasket
designed to eliminate ambient air
shear across the glass inner door,
minimizing condensation.

A door ajar alarm provides an audible •
and visual warning if the outer door
is left open.

A center-mounted key lock is located •
beneath the door for added security;
model MCO-19AIC(UVH) only.

Shelves and Inventory
Management

Convenient space efcient inventory
management is simplied through a sys­tem of adjustable, extendable shelves.

Inventory shelves and brackets are •
formed from polished copper-enriched
stainless steel, removable without
tools, and can remain inside the incu­bator during the H
or autoclaved separately if desired.

sterilization cycle

2O2

Shelves are perforated to permit natu-•
ral vertical air convection through and
around labware.

Shelf brackets are formed with an •
exaggerated angle to minimize surface
contact with at shelves (patent pend­ing). Brackets slip easily into vertical
supports that attach to interior cham­ber walls with clearance sufcient to
permit proper air circulation.

Inner Door and Gasket

The inner design is critical to successful
contamination control technique.

The inner gasket body forms an •
effective thermal transition between
the ambient air and warm, humidied
incubator atmosphere, minimizing
condensation and eliminating moisture
traps which can harbor contaminants.

The inner door gasket is a dual •
durometer extrusion (two levels of
softness) from closed-cell silicone
to inhibit contamination.

The gasket feather-edge allows •
the inner glass door to close gently
against the chamber opening for
a tight peripheral seal.

The entire inner door gasket is remov-•
able for cleaning and/or replacement
if required.

Radiant heat from the outer door, •
apportioned by the microprocessor

MCO-38AIC(UVH)

Stacking Doubles Capacity
in Same Footprint.

The Sterisonic•
designed for stacking, allowing one
unit to be positioned on top of
another, doubling interior volume
without additional oor space.

The combination of stacking and •
reversible doors offers the most
installation options possible.

An optional roller base is recom- •
mended for stacked installations
to permit mobility if required;
see Accessories.

™

GxP cabinet is

control as a function of the patented
Direct Heat and Air Jacket

™

, automati­cally warms the inner door glass
in proportion to total heat demand
and condensation control.

Field Reversible Door

The eld-reversible door allows
universal installation using the left-hand
hinge (standard) or a right-hand hinge
modication

The outer door includes a universal •
nger grip at each side.

Mounting holes for hinge hardware •
are pre-drilled and capped with easily
removable trim plugs.

The door heater cable plugs into the •
alternate connection to complete
the change.

Elevated Humidity,
Low Water Level Warning

To avoid cell culture desiccation, the
SANYO Sterisonic
maintains ~95% RH at 37°C.

Humidication is achieved by a com-•
bined forced-air and natural evapora­tion method enhanced by the Direct
Heat and Air Jacket
protected by an optical water level
indicator to warn of low water in the
removable humidity pan.

The humidity pan removes easily for •
regular cleaning and rell.

When lled, the pan slides into place. •
The optical sensor returns to position
and the SafeCell
any contaminants introduced during
the process.

For the H•
the humidity pan is repositioned
against the chamber wall to eliminate
the need for separate autoclaving.

™

GxP CO2 incubator

™

base heater, and

™

UV lamp destroys

in situ sterilization cycle

2O2

5