EQUIPMENT

DESIGN & QUALIFICATIONS

Equipment Qualification
Equipment Qualification (EQ) is the overall
process of ensuring that an instrument is
appropriate for its intended use.
Qualification Stages
Design Qualification

Installation Qualification

Operational Qualification

Performance Qualification
Qualification Purposes
Design qualification (DQ) for setting
functional and performance
specifications (operational
specifications).
Installation qualification (IQ) for
performing and documenting the
installation in the selected user
environment.

Qualification Purposes
Operational qualification (OQ) for testing
the equipment in the selected user
environment to ensure that it meets the
previously defined functional and
operational specifications.
Performance qualification (PQ) for
testing that the system consistently
performs as intended for the selected
application.

Design Qualification
Description of the process
Selection of the process technique
Description of the intended use of the equipment
Description of the intended environment
Preliminary selection of the functional and performance
specifications
(technical, environmental, safety)
Preliminary selection of the supplier
Instrument tests (if the technique is new)
Final selection of the equipment
Final selection of the supplier and equipment
Development and documentation of final functional and
operational specifications

Equipment Design
Appropriate design & specifications
Should be based on process
requirement
Adequate size
Suitably located
To facilitate operations
To facilitate proper cleaning


Equipment Design
Constructed material should be
Non- reactive
Non- additive
Non-absorptive
To prevent product contact with
equipment
lubricants and coolants
Maintenance

Installation Qualification
The process of checking/verifying the
installation to ensure that the critical
components meet the approved specifications
and that they are installed correctly in
accordance with design documentation
To establish that the critical components are
installed correctly and in accordance with
design documentation requirements (ie
purchase orders, contracts etc), that
supporting documentation is in place and of
suitable quality.

IQ Methodology
Verification of utilities and building services
Compare equipment, as received, with
purchase order (including software,
accessories, spare parts)
Check documentation for completeness
(operating manuals, maintenance
instructions, standard operating procedures
for testing, safety and validation certificates)
Check equipment for any damage

IQ Methodology
Install hardware (computer, equipment,
fittings and tubing for fluid connections, power
cables, data flow and instrument control
cables)
Materials in product contact verification
Switch on the instruments and ensure that all
modules power up and perform an electronic
self-test
Verify correct software installation, e.g., are
all files loaded. Utilities to do this should be
included in the software itself.

IQ Methodology
Identify and make a list with a description of
all hardware, include drawings where
appropriate.
Instrumentation (Critical /Non-critical)
List equipment manuals and SOPs
Instrument features (Model no.,Capacity,
Identification no.,)
Prepare an installation report

OQ Methodology
Application SOPs
Utilization list
Process description
Test instruments utilized and calibration
Critical functional parameters
Test reports functions (Challenge tests)
Traceable standards establishment
Training
PQ Methodology
"Performance Qualification (PQ) is the
process of demonstrating that an equipment
consistently performs according to a
specification appropriate for its routine use "
Important here is the word consistently. The
test frequency is much higher than for OQ.
Another difference is that PQ should always
be performed under conditions that are
similar to routine process requirements.
PQ Methodology
Placebo trails (If applicable)
Define the performance criteria and
operating conditions.
Select critical parameters with some
allowance to drift out of predefined
specifications.
Define corrective actions on what to do if
the system does not meet the criteria, in
other words if the system is out of
specification


Basic IQ,OQ & PQ
Commissioning and Qualification
Project Phases Qualification Phases
Technology Transfer Collecting data
Conceptual Design
Basic Design Preliminary VMP
Detailed Design Detailed VMP
Procurement Detailed planning,DQ
Construction IQ
Pre commissioning
Commissioning OQ