Sanyo Validation User Manual download pdf (Page 2)

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.

v a l i d a t i o n

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

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