are low, since the decision is not made by or for the client
stakeholders. Corporate politics play an important role here as
well; if the decision is not supported within the organization,
then chances of implementation are virtually nil.
As an alternative, companies need a funded, ongoing technical
evaluation and selection process that allows them to develop
an overarching technology strategy. This process is necessarily
multi-disciplinary and high level; without the support of upper
management, efforts to implement these technologies will likely
be unsuccessful. The objective of this process is to identify “best
available technologies” from a corporate perspective, and to
gather information as required for financial evaluation of these
alternatives. Certainly, some of the evaluated technologies will
prove to be “too new” or “not a good fit.” This information is
nonetheless valuable during the Conceptual Design phase, since
resources are not misdirected to evaluate these technologies.
Another key deliverable from the technology assessment
process is financial justification for these technologies. Often,
we see clients who do not understand capital costs for various
technologies. As a result, these technologies are often de-scoped
during the “Value Engineering” phase of the project. Having
an accurate understanding of these costs, as well as broad
organizational support for the expenditures, ensures their
inclusion in the project design basis.
METRICS FOR EVALUATION
As noted above, one key objective of the technical selection
process should be to optimize Cost of Goods Sold (COGS).
For many companies, this “optimization” is synonymous with
incessant downward pressure on COGS.
However, the relentless focus on lower lowering COGS fails
to take into account the quality/cost ratio of the resultant drug
product(s). Manufacturing resources are directed to lower
quality/lower COGS facilities, as witnessed by several decades of
manufacturing outsourcing. Recent quality issues at a number of
such facilities have been a significant contributor to the current
drug shortage crisis.
This COGS-only approach generally precludes introduction/
adoption of advanced technologies, due to the increased
capital costs for these systems in conjunction with the extended
timeframes that may be required for implementation. This in
turn ensures the eventual obsolescence of these facilities, which
is accompanied by a continually eroding compliance profile for
these facilities and the company in general.
As an alternative, companies can develop metrics that
combine COGS analysis with a “Facility Grade” evaluation. The
“Facility Grade” in this case is recommended as a surrogate
for product quality, since overall product quality is difficult
to measure prospectively. However, a “Facility Grade” can
be assigned prospectively, based on technology selection,
engineering controls, personnel, materials and equipment
Use of an objective tool of this nature allows companies to
accurately assess their risk tolerance and establish COGS/“Facility
Grade” ratios. By comparing different facilities in network,
companies can establish benchmarks for these ratios, which in
turn can provide the financial justification for implementation of
In conclusion, the need for a different model to assess, justify,
and implement new technology in the aseptic fill/finish industry
is clear. Lack of continuous improvement in facilities results in
their obsolescence and associated regulatory compliance issues.
This has been a major contributing factor in the current drug
As an alternative, firms are urged to adopt a long-term,
strategic, and funded technology assessment program. Such a
program necessarily requires support from upper management,
which needs to take the form of adequate funding and
headcount allocation, as opposed to “philosophical support” for
During the upcoming IPS/INTERPHEX Technology tours, you
will no doubt see a number of exciting new technologies that
may be a great fit for your manufacturing facilities. This would be
a great time to begin considering how to lay the groundwork for
these in your company.
Another key deliverable from the
technology assessment process
is financial justification for these