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