Sanyo Validation User manual

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
Broad based
Most Sanyo specific experience
Up to date technical info
General knowledge
General knowledge
Direct updates
Unexpected service issues
Must be certified
Must be certified
Immediate solutions
Time consuming
More prep. time
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 2 O 2
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 2 /CO 2 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 [phone]
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