Considerations Beyond Cleaning
By Russ Somma, PhD; Sam Halaby; Mike Vileikis, IPS ◗
Russ Somma, PhD.
istics of the compounds you will want to produce.
For example, if your strategic plan does not include manufacturing solvent-based products, then the expense of intrinsically
safe equipment controls, Class I Division 1 electrical fixtures and
lighting, solvent abatement systems and wastewater collection is
difficult to justify. On the other hand, you can’t handle solvent-based products without that specialized infrastructure, so if they
are on the horizon, the additional upfront investment makes better
economic sense than a tear-out and retrofit. The same is true if you
are likely to want to produce potent products. It is faster and more
cost effective to switch to potent product manufacture if process
systems are equipped to accept primary containment devices and
the facility is designed to provide secondary containment, including ventilation, airlocks and decontamination capabilities.
Another factor to consider when planning multiproduct facili-
ties is whether to leverage single-use manufacturing technologies.
The best decisions in this regard take into account equipment
adaptation to process changes, capital investment restrictions and
yearly operating cost allowances. Take, for example, single-use
technologies for containment applications. Selecting a dispos-
able soft-wall containment solution may be more pragmatic than
choosing a rigid bolt-on isolator. As process needs evolve, the
single-use isolator can be adapted with minor capital investment
compared to a rigid-wall solution. Single-use isolators increase
production cycle time because they do
not require cleaning. They also eliminate
concerns regarding potential cross-contami-
nation, because no other components are
handled within these disposable isolators.
Ultimately, the flexibility of the facility
and the robustness of the processing room
design will determine how efficiently the
unit operations can be changed over, new
equipment added or swapped out and production schedules modified to align with
changes in market demand and business
Speed and agility aren’t just important to athletes. Facilities owners need these attributes in order to win the race to market. In a multi-product environment, achieving an agile plant requires moving past the mind- set that cleaning philosophies and schedules are the
only issues owners need to address in order to sustain a plant’s
viability and long-term usefulness. In reality, a number of key
decisions made when designing a new facility or a plant expansion can significantly impact the ability to respond to technological, therapeutic focus and market shifts.
DESIGNING TODAY FOR THE FUTURE
To be competitive, owners need to understand the factors that
drive the design and construction not just today, but for five to ten
years into the future. In addition to current product requirements,
what is necessary to accommodate products in the development
pipeline? Potential contract products? Drugs that are coming off
patent? By designing facilities correctly, large pharma companies,
contract manufacturers and generic manufacturers alike can lower
future rework and facility modification costs. That’s because you
can design the correct infrastructure to accommodate the character-