Sanyo Validation Bedienungsanleitung

COMPLETE VALIDATION & QUALIFICATION SERVICES

(TURN KEY SOLUTIONS)

Validation &

Qualiﬁcation

Solutions for

laboratory equipment

SANYO is a vertical component

manufacturer that can provide turn-key

solutions for validation and qualiﬁcation in

accordance with all current GMPs, GLPs, GCPs,

21 CFR Part 11, PAT, ISO and speciﬁc customer

requirements and applications. Because many

of our key component parts are designed and

built by SANYO, we offer the most precise and

in-depth validation resources speciﬁc to

SANYO laboratory products. Whatever

your validation needs are, SANYO provides

comprehensive expertise in laboratory

equipment to meet your exact compliance

needs. SANYO validation systems employ

advanced technology coupled with the latest

trends to insure compliance with accurate and

time efﬁcient completion.

Validation Services

validation

innovation

performance

reliability

support

SEAMLESS INTEGRATION OF VALIDATION

& TECHINICAL SUPPORT

ULTRA LOW FREEZERS

CRYOGENIC FREEZERS

PHARMACEUTICAL REFRIGERATORS

INCUBATORS

AUTOCLAVES

■ IQ / OQ /PQ

■ Factory acceptance testing

■ Qualiﬁcation of critical utilities

■ NIST traceable calibration

■ Customized validation protocols

■ Onsite protocol execution

■ Commissioning of equipment

■ Sanyo warranty service coverage

As a leader in commercial, refrigeration,

energy and environmental products,

SANYO offers a robust source of proven

technologies and technical services

deployed throughout a range of

biomedical and medical research

products.

Pioneering developments in consumer

and industrial products are applied to

all SANYO products through the devel-

opment model of Vertical Component

Integration™. Because many of our

key component parts are designed and

built by SANYO, we offer only the most

precise and in-depth validation resources

speciﬁc to SANYO laboratory products.

Detailed Validation Support Package

Sanyo also offers detailed protocols in-

cluding all required speciﬁcations manu-

als and support documents. This package

will assist your validation team in the

qualiﬁcation process, greatly reducing

the time required to complete the entire

validation.

Sanyo validation systems are calibrated

and maintained to the highest quality

standards, while providing and retaining

detailed records for all tested equipment.

As the manufacturer we are the most

knowledgeable on our equipment. We

offer validation services for Sanyo equip-

ment and a total solution in fulﬁlling

other regulatory requirement.

validation

VALIDATION

Sanyo provides a thermal validation

solution speciﬁcally designed to conform

with new FDA data protection guidelines

(21 CFR Part 11) and meet international

and European cGMP requirements for

inspection of pharmaceutical, biotechnol-

ogy and medical device (EN285, EN554)

manufacturing. Sanyo simpliﬁes the entire

validation process by reducing setup time

and minimizing sensor handling, automat-

ing sensor calibration, systematically

organizing study data and generating

required regulatory reports.

Sanyo implements a wired process

validation system designed around the

measurement and reporting requirements

of the most intensely regulated industries.

Our system meets the standards for cGMP

regulated industries for thermal validation

and has broad regulatory compliance.

We offer a complete package of thermal

management including simulations and

measurement:

• Measurement of temperature proﬁles

• Data analysis

• System design

Turn Key Solutions available for:

• Ultra low freezers

• Cryogenic freezers

• Pharmaceutical refrigerators

• Incubators

• Autoclaves

Sanyo can assist throughout the entire

process from helping you to choose your

equipment through the extended war-

ranty and service contract options to keep

your equipment running. We help you

match the appropriate equipment to your

requirements (DQ) as well as arranging

inside delivery and setup (commissioning)

of the equipment.

In addition, Sanyo can perform the onsite

qualiﬁcation of your equipment (IQ/OQ/

PQ); IQ documents the proper installation

of the equipment, PQ documents proper

operation of the equipment as speciﬁed

by Sanyo or other manufacturers, and PQ

documents proper performance of the

equipment as you will use it.

We offer in depth factory acceptance

testing covering alarms as well as tem-

perature/CO2 stability and recovery. This

service can also be customized to your

SOPs.

VALIDATION SOLUTIONS THERMAL VALIDATION

User Requirement Manufacturer specs

DQ(choose equipment) Commissioning

OQ Verifies Manufacturer

specs

PQ Ensures User

requirements are met

IQ Verifies Proper Setup

IQ / OQ / PQ

FACTORY ACCEPTANCE

validation validation

In order to trace and keep intact accuracy

and performances of your laboratory

equipment a regular schedule of cali-

bration and preventive maintenance is

needed.

Our objective is to provide conﬁdence that

the tested equipment meets the perfor-

mance and compliance requirements of

our customers. The acceptance phase

may also act as the ﬁnal quality gateway,

where any quality defects not previously

detected may be uncovered.

Commissioning your equipment

involves the following tasks:

• Ensure unit meets all user

requirements

• Setting up the equipment

• Installation of all necessary

accessories

• Calibration

• Test operation of equipment

In this area, we also offer support that is

exactly tailored to your requirements:

• General handling of the unit

• Functions of the unit and its

components

• Safety instructions for operation of the

unit

• Aspects of starting, operation,

applications and maintenance

SANYO VALIDATION SOLUTIONS

In-House

Third party

Manufacturer

Equipment experience

Broad based

Most Sanyo specific experience

Up to date technical info

General knowledge

Direct updates

Unexpected service issues

Must be certified

Immediate solutions

Time consuming

More prep. time

Most experience

Knowledge of Industry standards

Insufficient resources

Broad based

Best applicable knowledge

We are always working to understand our equipment better and offer the best solutions

As the manufacturer we are most aware of technical bulletins and the best practices

Service issues encountered can quickly be resolved & billed to factory (when covered)

We can work from our past experience to quickly develop and execute new protocols

Aware of current FDA trends as it applies to pharmaceutical equipment

Sanyo is experienced in what many other customers are doing with our equipment

EQUIPMENT SETUP SANYO EQUIPMENT SETUP

EQUIPMENT OPERATION

& INSTALLMENT SANYO VALIDATION SERVICES BY MODEL

Temp. CO

Validation by Model x

MDF-150ºC Freezers x

MDF-86ºC Freezers x

MDF-30ºC Freezers x

MBR Blood Bank Refrigerators x

MPR Pharmaceutical Refrigerators x

SR-L Undercounter Series x

MIR Incubator Series x x

MCO O

/CO

Incubators xxx

MLS Top Loading Autoclaves x

MAC Benchtop Autoclaves x

www.sanyobiomedical.com

Service

services

SANYO Commercial Solutions

A Division of SANYO North America

1062 Thorndale Avenue, Bensenville, IL 60106 USA

Toll Free USA 800-858-8442 • Fax 630-238-0139

www.sanyobiomedical.com

Seemless integration of technical and validation services. Any service issues discovered during the validation process can be quickly

resolved. Our detailed protocols are prepared before ﬁnal customer visit reducing on-site time and cost. We can help our customers

develop all aspects of a validation master plan.

Sanyo's highly qualiﬁed engineers can help with detailed preparation and set up for customers to avoid delivery of equipment not

meeting customers’ exact needs.

Comprehensive Equipment Service

Sanyo’s customer-driven biomedical service program that guarantees local attention from qualiﬁed Sanyo service

representatives, whenever and wherever support is needed.

• New Unit Installation and Training

• Preventative Maintenance

• Warranty and Non-Warranty Repairs

• Calibration/Validation Services

• Refurbishment and Reconditioning

• Customized Service and Warranty Programs

• Loaner Units

• In-Stock Parts for Immediate Delivery

Prices and conditions may vary by market.

Your Sanyo laboratory equipment is a major investment that you will want to protect for years to come. You store your life’s work in

your preservation equipment such as ultra low freezers and medical refrigerators, and chances are that you will own your unit past the

initial warranty period. By extending your warranty you can avoid repair costs that are unexpected and unbudgeted.

The Sanyo Connect Extended Warranty Program takes the worry out of repairs. Eliminate out of pocket expenses.

• Determine the time period you want to extend your current warranty.

• Order at the time you place your purchase order for your Sanyo laboratory equipment.

Extended warranty includes:

• All mechanical, electrical & compressor components

• All labor charges

Sanyo laboratory equipment offers long lasting performance with state of the art innovative features, and now a long lasting extended

warranty that covers against unexpected expenses for up to the ﬁrst 5 years of ownership

Cost Effective • Avoid multiple service visits and extend the longevity of your purchase.

Comprehensive Coverage • Ensure years of dependable performance and reliability with a complete repair program for all defects from workmanship.

Exceptional Service • Our service specialists are factory-trained with several years of experience and committed to Sanyo's standard of excellence.

Peace of Mind • We offer a wide selection of extended warranty options to protect your valuable investment.

Valued Relationship • Our commitment to offering complete and long lasting solutions for your unique needs.

Satisfaction Guaranteed • At Sanyo we continue to meet the diverse requirements of our customers, and support programs that assure reliability & extend the

life of your equipment.

SERVICE SOLUTIONS

EQUIPMENT SERVICE

EXTENDED WARRANTY

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