Pharmaceutical Manufacturing Handbook: Production and

202 CLEAN-FACILITY DESIGN, CONSTRUCTION, AND MAINTENANCE ISSUES
3.3.1
INTRODUCTION
While there are discrete steps in the design and construction of a pharmaceutical
manufacturing plant project, those projects deemed successful incorporate certain
practices that promote fl ow of the construction process toward completion on time
and within budget. Proper front - end planning is not completed until it results in
appropriate values for design parameters, “ buy - in ” at all levels of management, and
clear direction for the design phase. Engineering the clean room in accordance with
recognized industry practice would produce construction documents that facilitate
clear procurement and construction planning as well as a focused, effi cient, construction
effort. A full return on the energy expended through the construction phase
cannot be realized without a well - executed start - up and validation process that
provides baseline data for effective ongoing operation and maintenance.
The steps in the clean - room construction project include:
Needs assessment
Front - end planning
Preliminary design
Construction document development
Procurement
Construction
Start - up and validation
One of the truisms of the construction industry is that the greatest impact on the
cost of a facility can be made at the earliest stages of the process. The construction
process can be likened to a snowball rolling down a snow - covered hill. It grows and
gains momentum, seemingly taking on a life of its own, until it can only be brought
under control with a major effort. So too with manufacturing plant projects. Careful
work during the fi rst three stages will ensure that the project begins on a well -
directed course and moves to a successful conclusion.
Sometimes the special nature of pharmaceutical manufacturing plant projects
clouds the fact that building such a plant is in fact a construction project. The facility
engineering team of a small to medium company may be tempted to turn away from
such projects due to the projects ’ perceived uniqueness and leave the key decision
making to others. In fact, it is the construction experience of that team that is most
required to keep the project costs under control. The way to accomplish this is for
the team to be involved in the process from its earliest stages.
Let us review the steps in such a project and identify what should occur at each
step and the potential for trouble.
3.3.2
3.3.2.1
PLANNING FOR PROJECT SUCCESS
Needs Assessment
It is during this early stage that a requirement for a clean manufacturing facility is
perceived. The need for the facility may be precipitated by a new product, an