Sanyo MCO-19M, MCO-19AIC UV, MCO-19M UVH, MCO-19AIC, MCO-19M UV Manual

Sterisonic™ GxP

Series Cell Culture

Incubators

CO2 Incubators

MCO-19AIC(UVH)

MCO-19AIC(UV)

MCO-19AIC

CO2 /O2 Incubators

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 H2O2 decontamination for the fastest turn-around.

www.sanyobiomedical.com

My Life. My Work. My Choice.

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

MCO-19M 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 H2O2 decontamination for the fastest turn-around and maximum availability.

Sterisonic™ GxP Selection		CO2 Incubators			CO2/O2 Incubators
	MCO-	MCO-	MCO-	MCO-	MCO-	MCO-
Feature	19AIC(UVH)	19AIC(UV)	19AIC	19M(UVH)	19M(UV)	19M
H2O2 Vapor Decontamination	Standard	Optional	Optional	Standard	Optional	Optional
SafeCell™ UV Decontamination	Standard	Standard	Optional	Standard	Standard	Optional
Single Beam, Dual Detector IR CO2 Sensor	Standard	Standard	Standard	Standard	Standard	Standard
Oxygen Concentration Control, Zirconia Control	N/A	N/A	N/A	Standard	Standard	Standard

Product Applications

The combination of Sterisonic™ GxP incubator performance functions permit use with confidence 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 decontamination between processes.These include but are not limited to:

•Stem cell research

•Autologous tissue regeneration and regenerative medicine

•In vitro fertilization1

•Genomic and proteomic expression

•Esoteric plant and amphibian cell culture

•Hypersensitive and transgenic cell culture

•Low media volume microplate work

MCO-19AIC(UVH)

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

•Interior components and adjustable shelves are configured for easy access, in situ decontamination and flexible arrangement for a variety of applications.

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

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

MCO-19M

Multi-Gas Incubator, Oxygen

and CO2 Control

•Ideal for in vitro fertilization (IVF), genetic research, regenerative medicine and other protocols that require CO2 and sub-ambient (hypoxic) or above-ambient oxygen control.

•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.

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.

Decontamination System

•The unique Sterisonic™ GxP H2O2 decontamination system limits downtime to less than three hours when total chamber decontamination with verification is desired.

•All interior components and CO2 sampling loop are sterilized in situ; no need for removal and autoclaving.

•Active Background Contamination Control™ fights contamination while cell culture protocols are in process.

The patented SafeCell™ UV system scrubs interior airflow

to destroy airborne and humidity pan contaminants.

Exclusive inCu saFe™ copperenriched stainless steel interior

surfaces assure constant germicidal protection.

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

Control and Monitoring

•The Sterisonic™ GxP control and 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, CO2 setpoints and alarm parameters.

CO2 Control

SANYO proprietary single-beam, dual detector infrared (IR2) CO2

sensor delivers precise CO2 control, 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.

Zirconia O2 Control System, MCO-19M Series

A zirconia oxygen sensor main- tains sub-ambient O2 levels from

1% to 18%. Additionally, enriched O2 levels from 22% to 80% are enabled with proper safety precautions.

•Concurrently the MCO-19M permits

a CO2 range 0% to 20% via infrared 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 CO2.

•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.

MCO-19M

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

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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 fill, easy to clean; the automatic optical sensor advises of low water level.

H2O2 Decontamination

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

The FDA has recently granted 510(k) clearance to use H2O2 in individual medical device manufacturing applications. EtO criteria outlined in ANSI/AAMI/ISO

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 H2O2 process in situ with complete safety, zero impact on adjacent equipment or the environment, and speed to return the incubator to service.

•The H2O2 decontamination process functions with the patented SANYO SafeCell™ UV system. Following a

seven-minute H2O2 vaporization, circulation and dwell cycle, vaporization is stopped and the SafeCell™ UV lamp turned ON for up to ninety minutes.

•When exposed to UV light, the H2O2 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 floor for easy wipe-up.

•Throughout the entire cycle the Sterisonic™ GxP airflow system continues to gently circulate interior air assuring 100% vapor contact with all interior surfaces, ultimately creating

a serial dilution of H2O2 as it passes over the UV lamp.

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

CO2 sensor creates a slight Venturi flow through the sample chamber, permitting total decontamination of the CO2 system at the same time.

•Shape and location of interior components such as shelves, shelf brackets, plenum covers and the humidity pan permit the components to remain

in the chamber during the decontamination 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 flexible installation options available.

•Low profile 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 Decontamination Performance Value

		2 Hours			14 Hours
	SANYO
				Brand X
	Sterisonic™

H2O2 decontamination vs. high heat decontamination

= Uptime (Hours) = Downtime (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

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 efficient inventory management is simplified 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 H2O2 decontamination cycle or autoclaved separately if desired.

•Shelves are perforated to permit natural vertical air convection through and around labware.

•Shelf brackets are formed with an exaggerated angle to minimize surface contact with flat shelves (patent pending). Brackets slip easily into vertical supports that attach to interior chamber walls with clearance sufficient 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, humidified 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 removable 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™ GxP cabinet is designed for stacking, allowing one unit to be positioned on top of another, doubling interior volume without additional floor space.

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

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

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 field-reversible door allows universal installation using the left-hand hinge (standard) or a right-hand hinge modification

•The outer door includes a universal finger 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™ GxP CO2 incubator maintains ~95% RH at 37°C.

•Humidification is achieved by a combined forced-air and natural evaporation method enhanced by the Direct Heat and Air Jacket™ base heater, and 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 refill.

•When filled, the pan slides into place. The optical sensor returns to position and the SafeCell™ UV lamp destroys any contaminants introduced during the process.

•For the H2O2 in situ decontamination cycle the humidity pan is repositioned against the chamber wall to eliminate the need for separate autoclaving.

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