Biomedical Engineering Reference
In-Depth Information
impact on project execution. They should take into account the interrelationship
of facility design, process requirements, product quality, regulatory expectations,
and system capability. Much can be learned from ineffective practices of the
past. This is helpful if system and component impact assessments are to be used
to leverage construction or engineering documentation to gain project execution
efficiency.
Integrated strategies for construction turnover, commissioning, qualification,
and equipment release should be developed and linked to product quality risk.
Construction of critical utilities that can affect product quality, such as HVAC,
purified water, clean steam, and transfer line piping, can be commissioned and
qualified on an individual equipment or system basis. Critical process systems,
such as bioreactors, buffer tanks, media tanks, and purification equipment, can be
commissioned and qualified on an individual or process system basis. Commis-
sioning and qualification of the process systems require prior completion of the
commissioning and qualification of the utility and support equipment systems.
This will mitigate the risk of changes to the utility systems, which can affect
the performance of the process systems. Consideration should also be given to
other nonproduct impact ancillary activities such as floor sealing, wall paint-
ing, and sealing of walls and ceilings. These activities may affect the ability to
perform commissioning checks, because of limits to plant and equipment acces-
sibility. These activities may also affect utility or process system performance.
For example, solvents from floor sealing or painting, dirt from construction, and
damage from installation adjacent to critical systems and lines may adversely
affect performance and product quality or at the least require additional cleaning
and repair steps.
7.2.6 System Boundaries
The commissioning and qualification plan should define boundaries between func-
tional areas for the listed programs. Boundaries are an important element in
protocol development as well as ongoing operations. The manner in which these
boundaries are defined and managed is critical to an effective project plan. They
will help organize tasks to ensure that critical systems are properly qualified and
not missed.
It is important that facility construction is managed in a disciplined manner.
Commissioning and qualification should be planned and executed on a system
level. Any system boundary may and will most likely contain components of
other systems with their boundaries. Systems boundaries are included in a risk
management strategy for traceability of routine operations. Once the initial project
is completed, validation maintenance or the procedures necessary to assure the
system remains in the state in which it was qualified are implemented. These
procedures include preventive and reparative maintenance, change control, soft-
ware security, audits, and risk assessment reviews. It is important to keep in mind
that throughout the project, people may move in and out of positions responsi-
ble for maintenance of the program. If not properly managed, maintaining the
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