Validation Services

Seamless Integration of Validation &

Product Support

Turn key solutions

We offer the most precise and in-depth validation
resources specific to Panasonic laboratory
products. Whatever your validation needs are,
Panasonic provides comprehensive expertise in
laboratory equipment to meet your exact
compliance needs.

Complete validation & qualification

solutions for laboratory equipment
(turn key solutions)
Panasonic 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 Panasonic, we offer
the most precise and in-depth validation
resources specific to Panasonic laboratory
products. Whatever your validation needs
are, Panasonic provides comprehensive
expertise in laboratory equipment to meet
your exact compliance needs. Panasonic
validation systems employ advanced
technology coupled with the latest trends to
insure compliance with accurate and time
efficient completion.

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IOQ (formerly IQ/OQ/PQ)

Factory acceptance testing
Independent temperature mapping service
Qualification of critical utilities
National/international traceable calibration
Customised validation protocols
Onsite protocol execution
Commissioning of equipment
Panasonic warranty service coverage

Validation

Detailed Validation Support Package

As a leader in commercial, refrigeration, energy and

environmental products, Panasonic 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
Panasonic products through the development model
of Vertical Component Integration. Because many of
our key component parts are designed and built by
Panasonic, we offer only
the most precise and indepth validation resources
specific to Panasonic
laboratory products.

Panasonic also offer detailed protocols including all

required specifications, servicing manuals and
support documents. This package will assist your
validation team in the qualification process, greatly
reducing the time required to complete the entire
validation. Panasonic validation instruments 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
Panasonic equipment and a total solution in fulfilling
other regulatory requirement.

Validation Solutions

Validation solutions thermal validation

Turn Key Solutions available for:

l Ultra low freezers
l Cryogenic freezers
l Medical Freezers
l Pharmaceutical refrigerators
l Incubators
l Ovens
l Autoclaves
l Environmental test chambers
Panasonic can assist throughout the entire process
from helping you to select the best suited product(s)
through the extended warranty 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.

Installation and Operational

Qualification IOQ
Panasonic offer onsite validation of Panasonic
supplied equipment via Installation and Operational
Qualification Protocol IOQ.
Installation Qualification (IQ) Verifies and documents
the equipment installation is compliant with the
manufacturers requirements and specifications.
Operational Qualification (OQ) Verifies and
documents the full functional operation of the
installed equipment (as specified by Panasonic or
other OEM supplied equipment). Temperature
performance will be mapped over a continuous 24hr
period; also a short open door test included toward
the end of this period. Data produced will be
compared with manufacturers published equipment
specification. Product specific parameters such as
CO2/O2, %RH etc. are included within the relevant
equipment IOQ protocol.
Additional options: Additional temperature sensor
positions, extended logging period 48/72hrs,
simulated customer loaded mapping, powerfail/
recovery performance tests.
Door open recovery performance test.

User
Requirement

Manufacturer
specs DQ

PQ Ensures
User requirements
are met

OQ Verifies
Manufacturer
specs

PQ

Commissioning

(select equipment)

OQ

IQ Verifies
Proper Setup

IQ

Process Qualification (PQ) is usually conducted and

performed by customer/end-user as the equipment
will be in a environment where specific user conditions
and actual product is loaded, stored and accessed e.g.
the customers actual production or product processing
area. The PQ will probably make reference to customer
specific Standard Operating Procedures documents
(SOPs). Example: product identification and specific
storage requirements; loading patterns etc. therefore
making the PQ a unique and customer specific
document. Panasonic however will provide assistance
to customers where required in either the preparation
or assisted execution of the Process Qualification.
Panasonic is also able to offer a Temperature
Mapping Service for customers wishing to verify
actual equipment performance as installed, this
service is also available for all NON Panasonic
equipment
Factory Accceptance
We offer in depth factory acceptance testing covering
alarms as well as temperature/ CO2 stability and
recovery. This service can also be customised to your
SOPs.

Panasonic validation solutions

Equipment experience

In-House
Broad based

Third party
Broad based

Manufacturer
Most Panasonic specific
experience

Up to date technical info

Unexpected service issues
Time consuming
Knowledge of industry standards

General knowledge
Must be certified
More prep. time
Insufficient resources

General knowledge
Must be certified
More prep. time
Broad based

Direct updates
Immediate solutions
Most experience
Best applicable knowledge

Equipment setup

Thermal Validation
Panasonic 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, biotechnology and
medical device (EN285, EN554) manufacturing.
Panasonic simplifies the entire validation process by
reducing setup time and minimizing sensor
handling, automating sensor calibration,
systematically organizing study data and generating
required regulatory reports.
Panasonic 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
thermalvalidation and has broad regulatory
compliance.
We offer a complete package of thermal
management including simulations and
measurement:
l Measurement of temperature profiles, CO2,
O2, %RH, lighting and pressure
l Data analysis
l System design

Equipment Operation & Installment

In this area, we also offer support that is exactly
tailored to your requirements:
l General handling of the unit
l Functions of the unit and its components
l Safety instructions for operation of the unit
l Aspects of starting, operation, applications and
maintenance.

Calibration

Factory Acceptance
Testing

Onsite protocol execution

Commisioning

Immediate warranty
solutions

Custom Validation
Protocols

In order to trace and keep intact accuracy and

performances of your laboratory equipment a regular
schedule of calibration and preventive maintenance is
needed. Our objective is to provide confidence that the
tested equipment meets the performance 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:
l Ensure unit meets all user requirements
l Setting up the equipment
l Installation of all necessary accessories
l Calibration
l Test operation of equipment.
Panasonic validation services by model
Temp.
Validation by Model
MDF-150C Freezers
MDF-86C Freezers
MDF-30C Freezers

MPR Pharmaceutical
Refrigerators

MCO O2/CO2 Incubators

MLS Top Loading Autoclaves
MLR Environmental Test
Chamber
CBS Isothermal Freezers
CBS Standard LN2 Freezers

Panasonic Biomedical Sales Europe B.V.

Head office
Nijverheidsweg 120
4879 AZ Etten Leur
The Netherlands

O2

%RH

4
4

4
4
4
4

MBR Blood Bank

Refrigerators

MIR Incubator Series

CO2

4
4
4
4
4
4

Tel:
Fax:
Email:
Web:

Lighting Pressure
(Lux/Par)

+31 (0)76 543 38 33

+31 (0)76 541 37 32
biomedical.service.nl@eu.panasonic.com
www.biomedical.panasonic.eu