| CLIMATIC CHAMBERS VALIDATION
All the reason to have rely on Eratis
To answer the requirements of the auditors and quality
departments, we suggest us the validation of your equipments : climatic
chambers, refrigerated incubators, and ovens …With your partenership
we draw up a complete validation report IQ,OQ,PQ according to the ICH and
FDA recommendations :GuidlineValidation ProtocolValidation ReportConclusion
ReportIn accordance with its quality process, ERATIS brings you 2 new services
: Metrology department
guarantees the reliability of the measuring systems installed on our equipments
and used for the qualification according to a procedure validated by your
quality department.
Failure testing included in the OQ : Simulation of the failures
which could occur on the equipments (sensor failure, power
cut). These tests permit to validate the corrective actions
in case of an equipment.For more information on validation
procedure or on products, contact ERATIS :At 05.62.79.01.22
or on contact@eratis.com
Specialists will answer to your needs.ERATIS set up a validation protocol
in conformity with ICH and FDA standards validated by the quality departments
of the pharmaceutical and food industry laboratories. The achievement
and the approval of the validation protocol involve the responsability
of ERATIS (verifier) and the concerned laboratory (approving).PROCEDURE
INSTALLATION QUALIFICATION PROTOCOL
The aim of this protocol is to supply the documented proofs, the system
description file (with specifications) describing that :
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The systeme is physically installed at the forecasted place and
if necessary assembled with the existing systems.
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The measurement instruments and equipments of the system have been
checked and are in conformity with the specified requirements.
- The protocol includes the conformity documents, the installation and
realization documents, and the operating instructions.
OPERATIONAL QUALIFICATION PROTOCOL :
The operational qualification protocol presents :
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The elements to be checked
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The method
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The requirements (limit, nominal, tolerance)
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The frequencies of new qualification.
The supplier and the customer carry out the perfecting together.It is
a test of performance qualification in empty. This operation permits
to determinate and to validate the parameters and the securities process
(ordered values, limits, tolerances, regulation capacities). ERATIS
carries out all the operations specified on the operational protocol and
supplied a documented conclusion. The protocol is completed at each
stage of the tests achievement. The whole of the measurement, recording
and control equipments used for the measurement, display, and the follow
up of the process parameters are calibrated and certified by the COFRAC.
PERFORMANCE QUALIFICATION PROTOCOL
The tests are done in full weight. The announced performances by the
MPE are ± 1°C for temperature and ± 3 % for humidity; in accordance
with the NFX 15-140 standard (thermostactic and climatic chambers) of
may 1999. All the performance qualification operations are carried
out by an authorized organization by COFRAC (CETIAT). These operations
are documented and signed by each part.After the qualification, the equipment
is brought into service.
DEFINITIVE RECEPTION
The definitive reception is done after:
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the starting operations (IQ, OQ)
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the performance tests and perfecting (PQ)
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The realization of all the specifications clauses.
This receipt authenticates the equipment to the supply contract clauses.The
using authorization and eventual modifications are noted in a report.
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